Federal Register of Legislation - Australian Government

Primary content

PB 87 of 2019 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to add, delete and make changes to drugs, forms, brands, responsible person codes, maximum quantities and repeats, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 31 Oct 2019
Tabling HistoryDate
Tabled Senate11-Nov-2019

PB 87 of 2019

 

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10)

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated 30 October 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


 

 

___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10).

(2)          This Instrument may also be cited as PB 87 of 2019.

2          Commencement

This Instrument commences on 1 November 2019.

3          Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Schedule 1     Amendments

[1]             Part 1, Division 2, Section 7

                   (a)        omit: Note 1       substitute: Note

                   (b)        omit: Note 2       substitute: Note

[2]             Part 1, Division 4, Section 14

                   (a)        omit: Note 1       substitute: Note

                   (b)        omit: Note 2       substitute: Note

[3]             Part 4, Division 2, Section 30

                  omit: Note 1     substitute: Note

[4]             Part 7, Section 51

                   (a)        omit: Note 1       substitute: Note

                   (b)        omit: Note 2       substitute: Note

[5]             Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

                           omit from the column headed “Responsible Person” for the brand “Tracleer”: AT          substitute: JC

[6]             Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

                           omit from the column headed “Responsible Person” for the brand “Tracleer”: AT          substitute: JC

[7]             Schedule 1, entry for Ciclosporin in the form Capsule 10 mg

                   (a)        omit from the column headed “Circumstances”: C6629 C6630

                   (b)        omit from the column headed “Circumstances”: C6659

                   (c)        omit from the column headed “Circumstances”: C6670 C6671

                   (d)        insert in numerical order in the column headed “Circumstances”: C9694 C9695 C9742 C9763 C9764

[8]             Schedule 1, entry for Ciclosporin in the form Capsule 25 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C6629 C6630

                   (b)        omit from the column headed “Circumstances” (all instances): C6659

                   (c)        omit from the column headed “Circumstances” (all instances): C6670 C6671

                   (d)        insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764


 

[9]             Schedule 1, entry for Ciclosporin in the form Capsule 50 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C6629 C6630

                   (b)        omit from the column headed “Circumstances” (all instances): C6659

                   (c)        omit from the column headed “Circumstances” (all instances): C6670 C6671

                   (d)        insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764

[10]           Schedule 1, entry for Ciclosporin in the form Capsule 100 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C6629 C6630

                   (b)        omit from the column headed “Circumstances” (all instances): C6659

                   (c)        omit from the column headed “Circumstances” (all instances): C6670 C6671

                   (d)        insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764

[11]           Schedule 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL

                   (a)        omit from the column headed “Circumstances”: C6629 C6630

                   (b)        omit from the column headed “Circumstances”: C6659

                   (c)        omit from the column headed “Circumstances”: C6670 C6671

                   (d)        insert in numerical order in the column headed “Circumstances”: C9694 C9695 C9742 C9763 C9764

[12]           Schedule 1, entry for Ciclosporin in the form Solution concentrate for I.V. infusion 50 mg in 1 mL

                   (a)        omit from the column headed “Circumstances”: C6677

                   (b)        insert in numerical order in the column headed “Circumstances”: C9831

[13]           Schedule 1, entry for Darbepoetin alfa in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[14]           Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesilate 500 mg

                   (a)        omit from the column headed “Circumstances”: C6408

                   (b)        insert in numerical order in the column headed “Circumstances”: C9696

[15]           Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesilate 2 g

                   (a)        omit from the column headed “Circumstances”: C6408

                   (b)        insert in numerical order in the column headed “Circumstances”: C9696

[16]           Schedule 1, entry for Epoetin alfa in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[17]           Schedule 1, entry for Epoetin beta in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[18]           Schedule 1, entry for Epoetin lambda in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[19]           Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

                           omit from the column headed “Responsible Person”: AT        substitute: JC

[20]           Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

                           omit from the column headed “Responsible Person”: AT        substitute: JC

[21]           Schedule 1, entry for Everolimus in the form Tablet 0.25 mg

                   (a)        omit from the column headed “Circumstances”: C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances”: C9691 C9693

[22]           Schedule 1, entry for Everolimus in the form Tablet 0.5 mg

                   (a)        omit from the column headed “Circumstances”: C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances”: C9691 C9693

[23]           Schedule 1, entry for Everolimus in the form Tablet 0.75 mg

                   (a)        omit from the column headed “Circumstances”: C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances”: C9691 C9693

[24]           Schedule 1, entry for Everolimus in the form Tablet 1 mg

                   (a)        omit from the column headed “Circumstances”: C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances”: C9691 C9693


 

[25]           Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Inflectra]

                   (a)        omit from the column headed “Circumstances”: C7709 C7720 C7723 C7738 C7763

                   (b)        omit from the column headed “Circumstances”: C7778 C7810 C7811 C7847 C7886 C7910 C7922 C7923 C7931 C7942 C7989 C7994 C8009

                   (c)        insert in numerical order in the column headed “Circumstances”: C8644

                   (d)        insert in numerical order in the column headed “Circumstances”: C8881

                   (e)        omit from the column headed “Circumstances”: C8931

                    (f)        insert in numerical order in the column headed “Circumstances”: C8941

                   (g)        insert in numerical order in the column headed “Circumstances”: C9065

                   (h)        omit from the column headed “Circumstances”: C9397

                    (i)        omit from the column headed “Circumstances”: C9499 C9552 C9557

                    (j)        insert in numerical order in the column headed “Circumstances”: C9587

                   (k)        insert in numerical order in the column headed “Circumstances”: C9668 C9669 C9675 C9676 C9677 C9719 C9721 C9731 C9732 C9733 C9751 C9752 C9754 C9756 C9759 C9775 C9776 C9778 C9779 C9781 C9782 C9783 C9785 C9787 C9788 C9799 C9800 C9803 C9806

[26]           Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remicade]

                   (a)        omit from the column headed “Circumstances”: C7709 C7710 C7720 C7723 C7738

                   (b)        omit from the column headed “Circumstances”: C7778 C7788 C7810 C7811 C7886 C7910 C7922 C7923 C7928 C7942 C7994 C8009

                   (c)        omit from the column headed “Circumstances”: C8931

                   (d)        insert in numerical order in the column headed “Circumstances”: C9669 C9675 C9676 C9677 C9719 C9721 C9751 C9752 C9754 C9756 C9759 C9776 C9778 C9779 C9781 C9782 C9783 C9788 C9799 C9800 C9803

[27]           Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Renflexis]

                   (a)        omit from the column headed “Circumstances”: C7709 C7720 C7723 C7738 C7763

                   (b)        omit from the column headed “Circumstances”: C7778 C7810 C7811 C7847 C7886 C7910 C7922 C7923 C7931 C7942 C7989 C7994 C8009

                   (c)        insert in numerical order in the column headed “Circumstances”: C8644

                   (d)        insert in numerical order in the column headed “Circumstances”: C8881

                   (e)        omit from the column headed “Circumstances”: C8931

                    (f)        insert in numerical order in the column headed “Circumstances”: C8941

                   (g)        insert in numerical order in the column headed “Circumstances”: C9065

                   (h)        omit from the column headed “Circumstances”: C9397

                    (i)        omit from the column headed “Circumstances”: C9499 C9552 C9557

                    (j)        insert in numerical order in the column headed “Circumstances”: C9587

                   (k)        insert in numerical order in the column headed “Circumstances”: C9668 C9669 C9675 C9676 C9677 C9719 C9721 C9731 C9732 C9733 C9751 C9752 C9754 C9756 C9759 C9775 C9776 C9778 C9779 C9781 C9782 C9783 C9785 C9787 C9788 C9799 C9800 C9803 C9806

[28]           Schedule 1, entry for Lanthanum in each of the forms: Tablet, chewable, 500 mg (as carbonate hydrate); Tablet, chewable, 750 mg (as carbonate hydrate); and Tablet, chewable, 1000 mg (as carbonate hydrate) 

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[29]           Schedule 1, entry for Macitentan

                           omit from the column headed “Responsible Person”: AT        substitute: JC

[30]           Schedule 1, entry for Methoxy polyethylene glycol-epoetin beta in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[31]           Schedule 1, entry for Mycophenolic acid in each of the forms: Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid; and Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

                   (a)        omit from the column headed “Circumstances”: C4108 C4146

                   (b)        insert in numerical order in the column headed “Circumstances”: C9692 C9809

[32]           Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C5601 C5626

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9689 C9690

[33]           Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9691 C9693

[34]           Schedule 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

                   (a)        omit from the column headed “Circumstances”: C5555 C5794

                   (b)        insert in numerical order in the column headed “Circumstances”: C9691 C9693


 

[35]           Schedule 1, entry for Natalizumab

                           omit from the column headed “Circumstances”: C7697 C9406             substitute: C9744 C9818

[36]           Schedule 1, entry for Sevelamer

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[37]           Schedule 1, entry for Sirolimus in each of the forms: Tablet 0.5 mg; Tablet 1 mg; Tablet 2 mg; and Oral solution 1 mg per mL, 60 mL 

                   (a)        omit from the column headed “Circumstances”: C5794

                   (b)        insert in numerical order in the column headed “Circumstances” : C9693

[38]           Schedule 1, entry for Sucroferric oxyhydroxide

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[39]           Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C5602

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9697

[40]           Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)

                   (a)        omit from the column headed “Circumstances”: C5602

                   (b)        insert in numerical order in the column headed “Circumstances”: C9697

[41]           Schedule 1, entry for Tacrolimus in the form Capsule 0.75 mg

                   (a)        omit from the column headed “Circumstances”: C5602

                   (b)        insert in numerical order in the column headed “Circumstances”: C9697

[42]           Schedule 1, entry for Tacrolimus in the form Capsule 1 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C5602

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9697

[43]           Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)

                   (a)        omit from the column headed “Circumstances”: C5602

                   (b)        insert in numerical order in the column headed “Circumstances”: C9697


 

[44]           Schedule 1, entry for Tacrolimus in the form Capsule 2 mg

                   (a)        omit from the column headed “Circumstances”: C5602

                   (b)        insert in numerical order in the column headed “Circumstances”: C9697

[45]           Schedule 1, entry for Tacrolimus in the form Capsule 5 mg

                   (a)        omit from the column headed “Circumstances” (all instances): C5602

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9697

[46]           Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)

                   (a)        omit from the column headed “Circumstances”: C5602

                   (b)        insert in numerical order in the column headed “Circumstances”: C9697

[47]           Schedule 1, entry for Teduglutide

                   (a)        omit from the column headed “Circumstances”: C9456 C9457 C9458

                   (b)        omit from the column headed “Circumstances”: C9543

                   (c)        insert in numerical order in the column headed “Circumstances”: C9687 C9740 C9793 C9829

[48]           Schedule 1, entry for Ustekinumab

                           omit from the column headed “Circumstances”: C7059 C7463          substitute: C9655 C9656 C9710

[49]           Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

                           omit:

 

 

 

Valganciclovir AN

JO

EMP

C4980 C4989 C9316

 

120

5

D

 

 

 

Valganciclovir Juno

JU

EMP

C4980 C4989 C9316

 

120

5

D

[50]           Schedule 1, entry for Vedolizumab

                   (a)        omit from the column headed “Circumstances”: C5104

                   (b)        omit from the column headed “Circumstances”: C5127 C6612

                   (c)        omit from the column headed “Circumstances”: C7158 C7426 C7668 C7672 C7683

                   (d)        insert in numerical order in the column headed “Circumstances”: C9682 C9683 C9708 C9738 C9739 C9771 C9792 C9796 C9815 C9825


 

[51]           Schedule 2

omit:

AT

Actelion Pharmaceuticals Australia Pty Ltd

 32 097 278 512

[52]           Schedule 3, entry for Azithromycin

                  omit:

 

C6361

 

Mycobacterium avium complex infection
The treatment must be for prophylaxis; AND
Patient must be human immunodeficiency virus (HIV) positive; AND
Patient must have CD4 cell counts of less than 75 per cubic millimetre.

Compliance with Authority Required procedures

[53]           Schedule 3, entry for Ciclosporin

                   (a)        omit:

 

C6629

 

Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies.

Compliance with Authority Required procedures

 

C6630

 

Severe psoriasis
Management (initiation, stabilisation and review of therapy)
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies; AND
The condition must have caused significant interference with quality of life.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6659

 

Severe active rheumatoid arthritis
Management (initiation, stabilisation and review of therapy)
The condition must have been ineffective to prior treatment with classical slow‑acting anti‑rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow‑acting anti‑rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist.

Compliance with Authority Required procedures

                   (c)        omit:

 

C6670

 

Management of transplant rejection
Management (initiation, stabilisation and review of therapy)
Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

C6671

 

Nephrotic syndrome
Management (initiation, stabilisation and review of therapy)
Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist.

Compliance with Authority Required procedures

                   (d)        omit:

 

C6677

 

Management of transplant rejection
The treatment must be used by organ or tissue transplant recipients.

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

C9694

 

Nephrotic syndrome
Management (initiation, stabilisation and review of therapy)
Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9694

 

C9695

 

Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologists.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies.

Compliance with Authority Required procedures - Streamlined Authority Code 9695

 

C9742

 

Severe active rheumatoid arthritis
Management (initiation, stabilisation and review of therapy)
The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9742

 

C9763

 

Severe psoriasis
Management (initiation, stabilisation and review of therapy)
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies; AND
The condition must have caused significant interference with quality of life.
Must be treated by a dermatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9763

 

C9764

 

Management of transplant rejection
Management (initiation, stabilisation and review of therapy)
Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9764

 

C9831

 

Management of transplant rejection
The treatment must be used by organ or tissue transplant recipients.

Compliance with Authority Required procedures - Streamlined Authority Code 9831

[54]           Schedule 3, entry for Darbepoetin alfa

                   (a)        omit:

 

C6260

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[55]           Schedule 3, entry for Desferrioxamine

                   (a)        omit:

 

C6408

 

Disorders of erythropoiesis
The condition must be associated with treatment‑related chronic iron overload.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9696

 

Disorders of erythropoiesis
The condition must be associated with treatment-related chronic iron overload.

Compliance with Authority Required procedures - Streamlined Authority Code 9696


 

[56]           Schedule 3, entry for Epoetin alfa

                   (a)        omit:

 

C6260

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[57]           Schedule 3, entry for Epoetin beta

                   (a)        omit:

 

C6260

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[58]           Schedule 3, entry for Epoetin lambda

                   (a)        omit:

 

C6260

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[59]           Schedule 3, entry for Everolimus

                   (a)        omit:

 

C5555

 

Management of cardiac allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

C5794

 

Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9691

 

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9691

 

C9693

 

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

[60]           Schedule 3, entry for Infliximab

                   (a)        omit:

 

C7709

 

Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C7710

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of the most recent clinical assessment.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7720

 

Severe Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment; and
(v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery;
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application and preferably should be performed whilst still on treatment with the most recent course of prior therapies.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7723

 

Severe Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7738

 

Severe Crohn disease
Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this drug for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7763

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be aged 18 years or older.
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7763


 

                   (b)        omit:

 

C7778

 

Complex refractory Fistulising Crohn disease
Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7788

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7810

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7811

 

Complex refractory Fistulising Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7847

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7847

 

C7886

 

Moderate to severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re‑commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).

Compliance with Authority Required procedures

 

C7910

 

Moderate to severe Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7922

 

Moderate to severe Crohn disease
Initial 1 ‑ New patient or recommencement of treatment after more than 5 years break in therapy
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7923

 

Moderate to severe Crohn disease
Initial 2 ‑ Change or Re‑commencement of treatment after a break in therapy of less than 5 years
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7928

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7931

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7931

 

C7942

 

Moderate to severe ulcerative colitis
Initial 2 ‑ Change or Re‑commencement of treatment after a break in therapy of less than 5 years
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; OR
Patient must have previously received PBS‑subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS‑subsidised treatment with this drug for this condition in the current treatment cycle; OR
Patient must not have failed PBS‑subsidised treatment with this drug for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) the number of total failures to courses of biological medicine therapy in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
If the response assessment to the previous course of biological medicine therapy is not met, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C7989

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7989

 

C7994

 

Moderate to severe ulcerative colitis
Initial 1 ‑ New patient or recommencement of treatment after more than 5 years break in therapy
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR
Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8‑weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C8009

 

Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re‑commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment).
Patient must be 6 years of age or older.

Compliance with Authority Required procedures

                   (c)        omit:

 

C8931

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Authority Required procedures

                   (d)        omit:

 

C9397

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9397

                   (e)        omit:

 

C9499

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

Compliance with Authority Required procedures - Streamlined Authority Code 9499

 

C9552

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Patient must be aged 18 years or older.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9552

 

C9557

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9557

                    (f)        insert in numerical order after existing text:

 

C9668

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9668

 

C9669

 

Moderate to severe Crohn disease
Balance of supply for paediatric patient
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.

Compliance with Authority Required procedures

 

C9675

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; OR
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C9676

 

Severe Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9677

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C9719

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9721

 

Moderate to severe Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9731

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 9731

 

C9732

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9732

 

C9733

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 9733

 

C9751

 

Moderate to severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9752

 

Moderate to severe Crohn disease
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9754

 

Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.

Compliance with Authority Required procedures

 

C9756

 

Severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9759

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of the most recent clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9775

 

Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9775

 

C9776

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR
Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.
Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9778

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9779

 

Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.

Compliance with Authority Required procedures

 

C9781

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9782

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9783

 

Complex refractory Fistulising Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

 

C9785

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 9785

 

C9787

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 9787

 

C9788

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures

 

C9799

 

Moderate to severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Authority Required procedures

 

C9800

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR
Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.
Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9803

 

Complex refractory Fistulising Crohn disease
Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9806

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 9806

[61]           Schedule 3, entry for Lanthanum

                   (a)        omit:

 

C5454

 

Hyperphosphataemia
Treatment Phase: Initiation and stabilisation
The condition must not be adequately controlled by calcium,AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy, AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
reatment criteria:
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762

[62]           Schedule 3, entry for Methoxy polyethylene glycol-epoetin beta

                   (a)        omit:

 

C6260

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688


 

[63]           Schedule 3, entry for Mycophenolic acid

                   (a)        omit:

 

C4108

 

Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required Procedures

 

C4146

 

WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy,
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records

Compliance with Authority Required Procedures

                   (b)        omit:

 

C5555

 

Management of cardiac allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (c)        omit:

 

C5601

 

Management of cardiac allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

C5626

 

Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (d)        omit:

 

C5794

 

Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

C9689

 

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9689

 

C9690

 

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9690

 

C9691

 

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9691

 

C9692

 

Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9692

 

C9693

 

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

 

C9809

 

WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy.
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9809

[64]           Schedule 3, entry for Natalizumab

                           substitute:

Natalizumab

C9744

 

Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Authority Required procedures - Streamlined Authority Code 9744

 

C9818

 

Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Authority Required procedures - Streamlined Authority Code 9818

[65]           Schedule 3, entry for Sevelamer

                   (a)        omit:

 

C5454

 

Hyperphosphataemia
Treatment Phase: Initiation and stabilisation
The condition must not be adequately controlled by calcium,AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy, AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
reatment criteria:
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762


 

[66]           Schedule 3, entry for Sirolimus

                   (a)        omit:

 

C5794

 

Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9693

 

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

[67]           Schedule 3, entry for Sucroferric oxyhydroxide

                   (a)        omit:

 

C5454

 

Hyperphosphataemia
Treatment Phase: Initiation and stabilisation
The condition must not be adequately controlled by calcium,AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy, AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
reatment criteria:
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762


 

[68]           Schedule 3, entry for Tacrolimus

                   (a)        omit:

 

C5602

 

Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9697

 

Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

Compliance with Authority Required procedures - Streamlined Authority Code 9697

[69]           Schedule 3, entry for Teduglutide

                   (a)        omit:

 

C9456

P9456

Type III Short bowel syndrome with intestinal failure
Initial treatment - Grandfathered patients
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2019; AND
Patient must have short bowel syndrome with intestinal failure following major surgery; AND
Patient must have had a history of dependence on parenteral support for at least 12 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have received a stable parenteral support regimen for at least 3 days per week in the 4 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
Patient must have achieved a treatment response if the patient has been on non-PBS subsidised therapy with this drug for more than 12 months.
Baseline is the mean number of days of parenteral support per week over the 4 weeks immediately prior to initiating treatment with non-PBS subsidised teduglutide for grandfathered patients.
A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
A patient has met the criteria for treatment response when there is a reduction in the mean number of days of parenteral support of at least 1 day per week since initiating non-PBS subsidised treatment, or where a patient has completely ceased treatment with parenteral support for a period of at least 4 consecutive weeks prior to application for PBS-subsidised treatment.
The number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs between commencement of non-PBS subsidised teduglutide and application for PBS-subsidised treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Grandfather PBS Authority Application - Supporting Information Form; and
(3) details of non-PBS subsidised teduglutide treatment start date; and
(4) details of the number of days on parenteral support per week for 4 consecutive weeks prior to initiating non-PBS subsidised therapy; and
(5) documented duration in months of dependence on parenteral support prior to initiating non-PBS subsidised treatment; and
(6) details of response to teduglutide treatment if patient has received 12 or more months of non-PBS subsidised treatment.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For patients who have been on this drug for less than 12 months, the maximum number of repeats that will be approved will be for an amount equivalent to an initial 12 month supply of PBS and non-PBS subsidised treatment.
For patients who have been on this drug for more than 12 months, a maximum of 5 repeats will be approved.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the First continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C9457

P9457

Type III Short bowel syndrome with intestinal failure
Subsequent continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised first-continuing treatment with this drug for this condition; OR
Patient must have received PBS-subsidised recommencement of treatment with this drug for this condition following a trial cessation period; AND
Patient must have achieved a treatment response in the preceding treatment period; OR
Patient must not have previously experienced a failure to respond to treatment with this drug for this condition.
Treatment response
For applications for subsequent continuing treatment, treatment response is when there was a reduction in the mean number of days of parenteral support of at least 1 day per week since the last assessment for PBS-subsidised treatment,
OR where a patient has completely ceased treatment with parenteral support for a period of at least 4 consecutive weeks.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for subsequent continuing treatment, failure of treatment is defined as an increase in the mean number of days per week of parenteral support requirements of at least 1 day per week over the preceding 4 week period compared to the last assessment for PBS-subsidised treatment of parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Treatment stability
Patients who neither demonstrate a treatment response nor a treatment failure since the last assessment for PBS-subsidised treatment are considered to have a stable parenteral support regimen, defined as the same mean number of days of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the 4 weeks preceding treatment period, where the number of days is greater than zero and the mean number of days of parenteral support is less than baseline. Patients with a stable parenteral support regimen over 6 months must undertake a trial cessation period. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6-month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the preceding treatment period or confirmation the patient has had 4 consecutive weeks without parenteral support; and
(4) details of completion of a trial cessation period (if applicable); and
(5) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

 

C9458

P9458

Type III Short bowel syndrome with intestinal failure
First continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with this drug for this condition as a grandfathered patient; AND
Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline.
Baseline is the mean number of days of parenteral support per week over the four weeks immediately prior to initiating treatment with teduglutide under the PBS initial treatment restriction or four weeks immediately prior to initiating treatment with non-PBS subsidised teduglutide for grandfathered patients.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for first continuing treatment, failure of treatment is defined as no change compared to baseline in the mean number of days per week in parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Current mean number of days of parenteral support should be documented in the patient's medical records.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the baseline mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

                   (b)        omit from the column headed “Purposes Code” for circumstances code “C9515”: P9515

                   (c)        omit:

 

C9543

P9543

Type III Short bowel syndrome with intestinal failure
Recommencement of treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
Patient must have undertaken a trial cessation period due to experiencing a stable parenteral support regimen in the first continuing or subsequent continuing treatment phase, and not due to a treatment failure; AND
Patient must have experienced deterioration during a trial cessation period.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6-month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
Deterioration during the trial cessation period includes an increase in parenteral support frequency of more than or equal to one day per week from the pre-cessation level, or other clinical parameters suggestive of deterioration including changes in renal function or urinary sodium levels or changes in body weight.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the reason for recommencement after trial cessation; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period

Compliance with Written Authority Required procedures

                   (d)        omit from the column headed “Purposes Code” for circumstances code “C9569”: P9569

                   (e)        insert in numerical order after existing text:

 

C9687

 

Type III Short bowel syndrome with intestinal failure
Initial treatment - Grandfathered patients
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2019; AND
Patient must have short bowel syndrome with intestinal failure following major surgery; AND
Patient must have had a history of dependence on parenteral support for at least 12 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have received a stable parenteral support regimen for at least 3 days per week in the 4 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
Patient must have achieved a treatment response if the patient has been on non-PBS subsidised therapy with this drug for more than 12 months.
Baseline is the mean number of days of parenteral support per week over the 4 weeks immediately prior to initiating treatment with non-PBS subsidised teduglutide for grandfathered patients.
A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
A patient has met the criteria for treatment response when there is a reduction in the mean number of days of parenteral support of at least 1 day per week since initiating non-PBS subsidised treatment, or where a patient has completely ceased treatment with parenteral support for a period of at least 4 consecutive weeks prior to application for PBS-subsidised treatment.
The number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs between commencement of non-PBS subsidised teduglutide and application for PBS-subsidised treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Grandfather PBS Authority Application - Supporting Information Form; and
(3) details of non-PBS subsidised teduglutide treatment start date; and
(4) details of the mean number of days on parenteral support per week for 4 consecutive weeks prior to initiating non-PBS subsidised therapy; and
(5) documented duration in months of dependence on parenteral support prior to initiating non-PBS subsidised treatment; and
(6) details of response to teduglutide treatment if patient has received 12 or more months of non-PBS subsidised treatment.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For patients who have been on this drug for less than 12 months, the maximum number of repeats that will be approved will be for an amount equivalent to an initial 12 month supply of PBS and non-PBS subsidised treatment.
For patients who have been on this drug for more than 12 months, a maximum of 5 repeats will be approved.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the First continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C9740

 

Type III Short bowel syndrome with intestinal failure
Subsequent continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised first-continuing treatment with this drug for this condition and achieved a treatment response in the preceding treatment period; OR
Patient must have received PBS-subsidised recommencement of treatment following a trial cessation period and not have previously experienced a failure to respond to treatment with this drug for this condition.
Treatment response
For applications for subsequent continuing treatment, treatment response is when there was a reduction in the mean number of days of parenteral support of at least 1 day per week since the last assessment for PBS-subsidised treatment,
OR where a patient has completely ceased treatment with parenteral support for a period of at least 4 consecutive weeks.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for subsequent continuing treatment, failure of treatment is defined as an increase in the mean number of days per week of parenteral support requirements of at least 1 day per week over the preceding 4 week period compared to the last assessment for PBS-subsidised treatment of parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Treatment stability
Patients who neither demonstrate a treatment response nor a treatment failure since the last assessment for PBS-subsidised treatment are considered to have a stable parenteral support regimen, defined as the same mean number of days of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the 4 weeks preceding treatment period, where the number of days is greater than zero and the mean number of days of parenteral support is less than baseline. Patients with a stable parenteral support regimen over 6 months must undertake a trial cessation period. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6-month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the preceding treatment period or confirmation the patient has had 4 consecutive weeks without parenteral support (if applicable); and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

 

C9793

 

Type III Short bowel syndrome with intestinal failure
First continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with this drug for this condition as a grandfathered patient; AND
Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline.
Baseline is the mean number of days of parenteral support per week over the four weeks immediately prior to initiating treatment with teduglutide under the PBS initial treatment restriction or four weeks immediately prior to initiating treatment with non-PBS subsidised teduglutide for grandfathered patients.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for first continuing treatment, failure of treatment is defined as no change compared to baseline in the mean number of days per week in parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Current mean number of days of parenteral support should be documented in the patient's medical records.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs from baseline; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

 

C9829

 

Type III Short bowel syndrome with intestinal failure
Recommencement of treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
Patient must have undertaken a trial cessation period due to experiencing a stable parenteral support regimen in the first continuing or subsequent continuing treatment phase, and not due to a treatment failure; AND
Patient must have experienced deterioration during a trial cessation period.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6-month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re-commenced after a trial cessation period are exempt from further trial cessation.
Deterioration during the trial cessation period includes an increase in parenteral support frequency of more than or equal to one day per week from the pre-cessation level, or other clinical parameters suggestive of deterioration including changes in renal function or urinary sodium levels or changes in body weight.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the reason for recommencement after trial cessation; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period
(5) details of completion of the trial cessation period including the start and end date.

Compliance with Authority Required procedures

[70]           Schedule 3, entry for Ustekinumab

                           substitute:

Ustekinumab

C9655

 

Severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9656

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9710

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[71]           Schedule 3, entry for Vedolizumab

                   (a)        omit:

 

C5104

 

Severe Crohn disease
Balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug to complete 24 weeks of treatment under the Initial PBS‑subsidised treatment restriction for patients who had previously received non‑PBS subsidised treatment (Grandfathered patient),
AND
The treatment must provide no more than the balance of up to 3 doses (new patients) or 2 repeats (Continuing or Grandfathered patients), AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Patient must be aged 18 years or older.

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Compliance with Authority Required procedures

                   (b)        omit:

 

C5127

 

Severe Crohn disease
Continuing treatment
Patient must have a documented history of severe Crohn disease, AND
Patient must have previously been issued with an authority prescription for this drug for this condition, AND
Patient must have demonstrated or sustained an adequate response to treatment with this drug, AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment, AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests and diagnostic imaging studies, must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.

Compliance with Written Authority Required procedures

 

C6612

 

Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.

Compliance with Authority Required procedures


 

                   (c)        omit:

 

C7158

 

Severe Crohn disease
Change or Re‑commencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS‑subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS‑subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7426

 

Severe Crohn disease
Initial treatment (new patient ‑ initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment; and
(v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following: (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

Compliance with Written Authority Required procedures

 

C7668

 

Moderate to severe ulcerative colitis
Balance of
supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C7672

 

Moderate to severe ulcerative colitis
Initial treatment (
new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Compliance with Written Authority Required procedures

 

C7683

 

Moderate to severe ulcerative colitis
Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Patient must have previously received PBS‑subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with vedolizumab for this condition in the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) Mayo clinical assessment (to demonstrate response to prior treatment).
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.

Compliance with Written Authority Required procedures

                   (d)        insert in numerical order after existing text:

 

C9682

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9683

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

 

C9708

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9738

 

Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Compliance with Authority Required procedures

 

C9739

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9771

 

Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Compliance with Authority Required procedures

 

C9792

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9796

 

Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9815

 

Severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9825

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures