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PB 36 of 2019 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters. It provides for additions, deletions and changes to drugs, forms, brands, schedule equivalence, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
Administered by: Health
Registered 31 May 2019
Tabling HistoryDate
Tabled HR02-Jul-2019
Tabled Senate02-Jul-2019
To be repealed 17 Sep 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 36 of 2019

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 5)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

 

Dated                                                                  24 May   2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 5).

(2)          This Instrument may also be cited as PB 36 of 2019.

2          Commencement

This Instrument commences on 1 June 2019.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1     Amendments

[1]             Schedule 1, after entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial

Injection

 

Bleomycin for Injection, USP

QY

MP

C6224 C6275

 

See Note 3

See Note 3

1

 

D(100)

[2]             Schedule 1, entry for Captopril in the form Tablet 12.5 mg

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Captopril Sandoz”: a

                   (b)        omit:

 

 

 

a

Zedace

AF

MP NP

 

 

90

5

90

 

 

[3]             Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

                            omit:

 

 

 

a

Ciproxin 250

BN

MP NP

C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780

 

14

0

14

 

 

[4]             Schedule 1, entry for Clindamycin in the form Capsule 150 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Clindamycin-Link

LI

PDP

C5487

 

24

0

24

 

 

                   (b)        omit:

 

 

 

a

Clindamycin-Link

LI

MP NP MW

C5470

 

48

1

24

 

 

[5]             Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

                   (a)        omit:

 

 

 

a

Cyprone

AF

MP

 

P5532

20
CN5532

5
CN5532

20

 

 

 


 


                   (b)        omit:

 

 

 

a

Cyprone

AF

MP

 

 

100

5

50

 

 

[6]             Schedule 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

ENTECAVIR APO

GX

MP

C4993 C5036

 

60

5

30

 

D(100)

[7]             Schedule 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

ENTECAVIR APO

GX

MP

C5037 C5044

 

60

5

30

 

D(100)

[8]             Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]

                   (a)        insert in numerical order in the column headed “Circumstances”: C7251

                   (b)        insert in numerical order in the column headed “Circumstances”: C7289

                   (c)        insert in numerical order in the column headed “Circumstances”: C8054

                   (d)        insert in numerical order in the column headed “Circumstances”: C8103

                   (e)        insert in numerical order in the column headed “Circumstances”: C8692

                    (f)        insert in numerical order in the column headed “Circumstances”: C8839

                   (g)        insert in numerical order in the column headed “Circumstances”: C8873

[9]             Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C7251

                   (b)        insert in numerical order in the column headed “Circumstances”: C7289

                   (c)        insert in numerical order in the column headed “Circumstances”: C8054

                   (d)        insert in numerical order in the column headed “Circumstances”: C8103

                   (e)        insert in numerical order in the column headed “Circumstances”: C8692

                    (f)        insert in numerical order in the column headed “Circumstances”: C8839

                   (g)        insert in numerical order in the column headed “Circumstances”: C8873

                   (h)        insert in numerical order in the column headed “Purposes”: P7251


                    (i)        insert in numerical order in the column headed “Purposes”: P7289 P8054

                    (j)        insert in numerical order in the column headed “Purposes”: P8103

                   (k)        insert in numerical order in the column headed “Purposes”: P8692

                    (l)        insert in numerical order in the column headed “Purposes”: P8839

                  (m)        insert in numerical order in the column headed “Purposes”: P8873

[10]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 3]

                   (a)        insert in numerical order in the column headed “Circumstances”: C7251

                   (b)        insert in numerical order in the column headed “Circumstances”: C7289

                   (c)        insert in numerical order in the column headed “Circumstances”: C8054

                   (d)        insert in numerical order in the column headed “Circumstances”: C8103

                   (e)        insert in numerical order in the column headed “Circumstances”: C8692

                    (f)        insert in numerical order in the column headed “Circumstances”: C8839

                   (g)        insert in numerical order in the column headed “Circumstances”: C8873

[11]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C7251

                   (b)        insert in numerical order in the column headed “Circumstances”: C7289

                   (c)        insert in numerical order in the column headed “Circumstances”: C8054

                   (d)        insert in numerical order in the column headed “Circumstances”: C8103

                   (e)        insert in numerical order in the column headed “Circumstances”: C8692

                    (f)        insert in numerical order in the column headed “Circumstances”: C8839

                   (g)        insert in numerical order in the column headed “Circumstances”: C8873

                   (h)        insert in numerical order in the column headed “Purposes”: P7251

                    (i)        insert in numerical order in the column headed “Purposes”: P7289 P8054

                    (j)        insert in numerical order in the column headed “Purposes”: P8103

                   (k)        insert in numerical order in the column headed “Purposes”: P8692

                    (l)        insert in numerical order in the column headed “Purposes”: P8839

                  (m)        insert in numerical order in the column headed “Purposes”: P8873


 


[12]           Schedule 1, entry for Ethosuximide

                           substitute:

Ethosuximide

Capsule 250 mg

Oral

 

Zarontin

IX

MP NP

 

 

200

2

100

 

 

 

 

 

 

 

 

MP NP

 

 

200

2

200

 

 

 

Oral solution 250 mg per 5 mL, 200 mL

Oral

 

Zarontin

IX

MP NP

 

 

1

5

1

 

 

[13]           Schedule 1, entry for Fenofibrate

                           substitute:

Fenofibrate

Tablet 48 mg

Oral

a

FENOFIBRATE RBX

RA

MP NP

 

 

60

5

60

 

 

 

 

 

a

Lipidil

GO

MP NP

 

 

60

5

60

 

 

 

 

 

a

FENOFIBRATE RBX

RA

MP

 

P7640

60

11

60

 

 

 

 

 

a

Lipidil

GO

MP

 

P7640

60

11

60

 

 

 

Tablet 145 mg

Oral

a

FENOFIBRATE RBX

RA

MP NP

 

 

30

5

30

 

 

 

 

 

a

Lipidil

GO

MP NP

 

 

30

5

30

 

 

 

 

 

a

FENOFIBRATE RBX

RA

MP

 

P7640

30

11

30

 

 

 

 

 

a

Lipidil

GO

MP

 

P7640

30

11

30

 

 

[14]           Schedule 1, after entry for Ferric carboxymaltose in the form Injection 500 mg (iron) in 10 mL

                           insert:

 

Injection 1000 mg (iron) in 20 mL

Injection

 

Ferinject

VL

MP NP

 

 

1

1

1

 

 

 


 

[15]           Schedule 1, entry for Filgrastim

                   (a)        omit:

 

Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)

Injection

 

TevaGrastim

TB

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

                   (b)        omit:

 

Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim)

Injection

 

TevaGrastim

TB

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

[16]           Schedule 1, entry for Fluticasone with salmeterol in the form Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Pavtide

GC

MP NP

C4930

 

1

5

1

 

 

                   (b)        omit from the column headed “Responsible Person” for the brand “SalplusF Inhaler 125/25”: YC                               substitute: SZ

[17]           Schedule 1, entry for Fluticasone with salmeterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Pavtide

GC

MP NP

C4689 C4930

 

1

5

1

 

 

                   (b)        omit from the column headed “Responsible Person”  for the brand “SalplusF Inhaler 250/25”: YC              substitute: SZ


 

[18]           Schedule 1, entry for Gabapentin in the form Tablet 600 mg

                            omit:

 

 

 

a

Nupentin Tabs

AF

MP NP

C4928

 

100

5

100

 

 

[19]           Schedule 1, entry for Gabapentin in the form Tablet 800 mg

                            omit:

 

 

 

a

Nupentin Tabs

AF

MP NP

C4928

 

100

5

100

 

 

[20]           Schedule 1, entry for Guanfacine in each of the forms: Tablet 1 mg (as hydrochloride); Tablet 2 mg (as hydrochloride); Tablet 3 mg (as hydrochloride); and Tablet 4 mg (as hydrochloride)

                   (a)        omit from the column headed “Circumstances”: C8564

                   (b)        insert in numerical order in the column headed “Circumstances”: C9031 C9034

[21]           Schedule 1, entry for Hydromorphone

                           omit:

 

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL

Oral

 

Dilaudid

MF

PDP

C4926

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

C4959

 

1

0

1

 

 

[22]           Schedule 1, entry for Insulin aspart

                           insert as first entry:

 

Injection (human analogue) (fast acting) 100 units per mL, 10 mL vial

Injection

 

Fiasp

NO

MP NP

 

 

5

2

1

 

 

[23]           Schedule 1, after entry for Insulin aspart in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

                           insert:

 

Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5

Injection

 

Fiasp FlexTouch

NO

MP NP

 

 

5

1

1

 

 

[24]           Schedule 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg

                           omit:

 

 

 

a

Zircol

AF

MP NP

 

 

28

5

28

 

 

[25]           Schedule 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg

                           omit:

 

 

 

a

Zircol

AF

MP NP

 

 

28

5

28

 

 

[26]           Schedule 1, entry for Modafinil

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Modafinil GH

GQ

MP

C6547 C8694

 

120

5

60

 

 

[27]           Schedule 1, entry for Nilotinib in the form Capsule 200 mg (as hydrochloride monohydrate)

                           omit from the column headed “Circumstances”: C7024          

[28]           Schedule 1, entry for Oxycodone in each of the forms: Capsule containing oxycodone hydrochloride 5 mg; and Capsule containing oxycodone hydrochloride 10 mg

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Oxycodone BNM

LI

PDP

C4926

 

20

0

20

 

 

 

 

 

 

 

 

MP NP

C4959

 

20

0

20

 

 

                   (b)        insert in the column headed “Schedule Equivalent” for the brand “OxyNorm”: a

[29]           Schedule 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 20 mg

                   (a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Oxycodone BNM

LI

MP NP

C4959

 

20

0

20

 

 

                   (b)        insert in the column headed “Schedule Equivalent” for the brand “OxyNorm”: a

[30]           Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Brand: Pantoprazole APOTEX; Maximum Quantity: 30; Number of Repeats: 1]

                           insert in numerical order in the column headed “Circumstances”: C8776

[31]           Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Brand: Pantoprazole APOTEX; Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C8776

                   (b)        insert in numerical order in the column headed “Purposes”: P8776

[32]           Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

Pemetrexed SUN

RA

MP

C4792 C7195

 

See Note 3

See Note 3

1

 

D(100)

[33]           Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium)

                   (a)        omit:

 

 

 

 

Pemetrexed Sandoz

SZ

MP

C4792 C7195

 

See Note 3

See Note 3

1

 

D(100)

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

Pemetrexed SUN

RA

MP

C4792 C7195

 

See Note 3

See Note 3

1

 

D(100)

[34]           Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 1 g (as disodium)

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

 

Pemetrexed SUN

RA

MP

C4792 C7195

 

See Note 3

See Note 3

1

 

D(100)

[35]           Schedule 1, entry for Temozolomide in each of the forms: Capsule 5 mg; Capsule 20 mg; Capsule 100 mg; Capsule 140 mg; and Capsule 180 mg

                   (a)        omit:

 

 

 

a

Orion Temozolomide

ON

MP

 

 

5

5

5

 

 

                   (b)        omit:

 

 

 

a

Orion Temozolomide

ON

MP

 

P4897

15

2

5

 

 

[36]           Schedule 1, entry for Temozolomide in the form Capsule 250 mg

                           omit:

 

 

 

a

Orion Temozolomide

ON

MP

 

 

5

5

5

 

 

 

[37]           Schedule 1, entry for Teriflunomide in the form Tablet 14 mg

                   (a)        insert in the column headed “Schedule Equivalent” for the brand “Aubagio”: a

                   (b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Teriflunomide Sandoz

SZ

MP

C6854 C7741

 

28

5

28

 

 

[38]           Schedule 1, entry for Tobramycin in the form Capsule containing powder for oral inhalation 28 mg (for use in podhaler)

                           omit from the column headed “Responsible Person”: NV        substitute: GO

[39]           Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

                           omit from the column headed “Responsible Person” for the brand “Tobi”: NV                 substitute: GO

[40]           Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

                           omit:

 

 

 

a

Tramedo SR 100

AF

MP NP

C5822

 

20

0

20

 

 

[41]           Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

                           omit:

 

 

 

a

Tramedo SR 150

AF

MP NP

C5822

 

20

0

20

 

 

[42]           Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

                           omit:

 

 

 

a

Tramedo SR 200

AF

MP NP

C5822

 

20

0

20

 

 

[43]           Schedule 1, entry for Ursodeoxycholic acid in the form Capsule 250 mg

                           omit from the column headed “Circumstances” (all instances): C5757                substitute: C9032

[44]           Schedule 1, entry for Ursodeoxycholic acid in the form Tablet 500 mg

                           omit from the column headed “Circumstances”: C5757           substitute: C9032

[45]           Schedule 3, after details relevant to Responsible Person code QH

                           insert:

QY

Pro Pharmaceuticals Group Pty. Ltd.

20 605 457 430


 

[46]           Schedule 3

omit:

YC

Cipla Australia Pty Ltd

46 132 155 063

[47]           Schedule 4, Part 1, entry for Blinatumomab

                   (a)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8949”: bllinatumomab                substitute: blinatumomab

                   (b)        omit from the column headed “Circumstances and Purposes” for circumstance code ”C8966”: bllinatumomab                substitute: blinatumomab

[48]           Schedule 4, Part 1, entry for Guanfacine

                   (a)        omit:

 

C8564

 

 

Attention deficit hyperactivity disorder
Must be treated by a paediatrician or psychiatrist.
The condition must be or have been diagnosed according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.

Compliance with Authority Required procedures - Streamlined Authority Code 8564

                   (b)        insert in numerical order after existing text:

 

C9031

 

 

Attention deficit hyperactivity disorder
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).

Compliance with Authority Required procedures - Streamlined Authority Code 9031

 

C9034

 

 

Attention deficit hyperactivity disorder
Initial treatment
Must be treated by a paediatrician or psychiatrist.
The condition must be or have been diagnosed according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.

Compliance with Authority Required procedures - Streamlined Authority Code 9034

[49]           Schedule 4, Part 1, entry for Nilotinib

                           omit:

 

C7024

 

 

Chronic Myeloid Leukaemia (CML)
The condition must be in the chronic phase; OR
The condition must be in the accelerated phase; AND
Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR
Patient must have failed an adequate trial of PBS-subsidised first line treatment with dasatinib for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Failure of an adequate trial of imatinib or dasatinib is defined as:(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia.
Accelerated phase is defined by the presence of 1 or more of the following:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or(3) Peripheral basophils greater than or equal to 20%; or(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR(v) Disease progression (defined as a greater than or equal to.50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.
Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.
Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or dasatinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

Compliance with Authority Required procedures

 


 

[50]           Schedule 4, Part 1, entry for Somatropin

                   (a)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8407”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                   (b)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8423”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                   (c)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8433”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                   (d)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8439”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                   (e)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8452” (all instances): 7.5mg/m2/week                substitute: 7.5mg/m2/week

                    (f)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8468” (all instances): 7.5mg/m2/week                substitute: 7.5mg/m2/week

                   (g)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8472”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                   (h)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8494”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

                    (i)        omit from the column headed “Circumstances and Purposes” for circumstance code “C8503”: 30mL/minute/1.73m2                substitute: 30mL/minute/1.73m2

[51]           Schedule 4, Part 1, entry for Ursodeoxycholic acid

                           substitute:

Ursodeoxycholic acid

C9032

 

 

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)

Compliance with Authority Required procedures - Streamlined Authority Code 9032