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PB 88 of 2014 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (No. PB 71 of 2012) to determine the pharmaceutical benefits that are on the PBS.
Administered by: Health
Registered 28 Nov 2014
Tabling HistoryDate
Tabled HR01-Dec-2014
Tabled Senate02-Dec-2014
Date of repeal 02 Dec 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

PB 88 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 12)

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits 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 25 November 2014

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2014 (No. 12).

            (2)        This Instrument may also be cited as PB 88 of 2014.

2          Commencement

This Instrument commences on 1 December 2014.

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, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 3]

(a)      omit from the column headed “Circumstances”:            C3996  C3997  C3998    substitute:             C4664  C4720  C4739  C4745  C4746

(b)      omit from the column headed “Purposes”:       P3996  P3997    substitute:             P4664  P4745  P4746

[2]           Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 5]

(a)      omit from the column headed “Circumstances”:            C3996  C3997  C3998    substitute:             C4664  C4720  C4739  C4745  C4746

(b)      omit from the column headed “Purposes”:       P3998   substitute:             P4720  C4739

[3]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

[4]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

(c)      omit from the column headed “Purposes”:       P3706  P3745

(d)      insert in numerical order:       P4700  P4710  P4751

[5]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

[6]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

(c)      omit from the column headed “Purposes”:       P3746

(d)      insert in numerical order:       P4666  P4724

[7]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

[8]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

(c)      omit from the column headed “Purposes”:       P3706  P3745

(d)      insert in numerical order:       P4700  P4710  C4751

[9]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

[10]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)      omit from the column headed “Circumstances”:            C3706  C3745  C3746

(b)      insert in numerical order:       C4666  C4700  C4710  C4724  C4751

(c)      omit from the column headed “Purposes”:       P3746

(d)      insert in numerical order:       P4666  P4724

[11]         Schedule 1, entry for Adefovir

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

 

 

 

APO-Adefovir

TX

MP
See Note 1

C3971 C3972 C3973 C3974

 

60

5

30

 

D(100)

[12]         Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium)

omit from the column headed “Responsible Person” for the brand “Austrapen” (twice occurring):                        LN                substitute:             AL

[13]         Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]

(a)      omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”:                     AS        substitute:    AF

(b)      omit from the column headed “Responsible Person” for the brand “Austrapen”:                LN        substitute:          AL

[14]         Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 1]

(a)      omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”:                     AS        substitute:    AF

(b)      omit from the column headed “Responsible Person” for the brand “Austrapen”:                LN        substitute:          AL

[15]         Schedule 1, after entry for Botulinum Toxin Type A Purified Neurotoxin Complex

insert:

Brentuximab vedotin

Powder for I.V. infusion 50 mg

Injection

Adcetris

TK

MP
See Note 1

C4675 C4719

 

See Note 3

See
Note 3

1

 

D(100)

[16]         Schedule 1, entry for Budesonide with eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

(a)      omit from the column headed “Circumstances”:            C4416  

(b)      substitute:  C4689

[17]         Schedule 1, entry for Budesonide with eformoterol in the form Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses

(a)      omit from the column headed “Circumstances”:            C4327 

(b)      insert in numerical order:     C4689

[18]         Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms

omit:

 

 

 

Tinexa

QA

MP

C2659 C2660 C2661 C2662

P2659 P2660 P2661 P2662

8

5

8

 

 

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

omit:

 

 

 

Bergoline 1

QA

MP NP

C1255

 

30

5

30

 

 

[20]         Schedule 1, entry for Cabergoline in the form Tablet 2 mg

omit:

 

 

 

Bergoline 2

QA

MP NP

C1255

 

30

5

30

 

 

[21]         Schedule 1, entry for Carmellose in each of the forms: Mouth spray containing carmellose sodium 10 mg per mL, 25 mL; and Mouth spray containing carmellose sodium 10 mg per mL, 100 mL

omit from the column headed “Responsible Person”:             VT          substitute:             IA

[22]         Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)

omit:

 

 

 

Rocephin

RO

MP NP

C1169 C1846 C1847

 

5

0

1

 

 

[23]         Schedule 1, entry for Celecoxib

substitute:

Celecoxib

Capsule 100 mg

Oral

APO-Celecoxib

TX

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Blooms the Chemist Celecoxib

IB

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celaxib

AF

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celebrex

PF

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celecoxib Actavis

GN

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celecoxib AN

EA

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celecoxib GH

GQ

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celecoxib RBX

RA

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celecoxib Sandoz

SZ

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Celexi

QA

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Chem mart Celecoxib

CH

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Kudeq

FZ

MP NP

C1547 C1848

 

60

3

60

 

 

 

 

 

Terry White Chemists  Celecoxib

TW

MP NP

C1547 C1848

 

60

3

60

 

 

 

Capsule 200 mg

Oral

APO-Celecoxib

TX

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Blooms the Chemist Celecoxib

IB

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celaxib

AF

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celebrex

PF

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celecoxib Actavis

GN

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celecoxib AN

EA

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celecoxib GH

GQ

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celecoxib RBX

RA

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celecoxib Sandoz

SZ

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Celexi

QA

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Chem mart Celecoxib

CH

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Kudeq

FZ

MP NP

C1547 C1848

 

30

3

30

 

 

 

 

 

Terry White Chemists  Celecoxib

TW

MP NP

C1547 C1848

 

30

3

30

 

 

[24]         Schedule 1, entry for Certolizumab pegol

(a)      omit from the column headed “Circumstances”:            C3714  C3768  C3769

(b)      insert in numerical order:       C4696  C4697  C4737  C4763  C4764

[25]         Schedule 1, entry for Clindamycin

substitute:

Clindamycin

Capsule 150 mg (as hydrochloride)

Oral

APO-Clindamycin

TX

MP NP MW PDP

C1145

 

24

0

24

 

 

 

 

 

Chem mart Clindamycin

CH

MP NP MW PDP

C1145

 

24

0

24

 

 

 

 

 

Cleocin

FZ

MP NP MW PDP

C1145

 

24

0

24

 

 

 

 

 

Dalacin C

PF

MP NP MW PDP

C1145

 

24

0

24

 

 

 

 

 

Terry White Chemists Clindamycin

TW

MP NP MW PDP

C1145

 

24

0

24

 

 

[26]         Schedule 1, entry for Clopidogrel with aspirin

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

 

 

 

DuoPlidogrel

GZ

MP NP

C1722 C3219 C3880

 

30

5

30

 

 

[27]         Schedule 1, entry for Dapagliflozin

omit from the column headed “Circumstances”:        C4331    substitute:             C4736

[28]         Schedule 1, entry for Deferiprone in each of the forms: Tablet 500 mg; and Oral solution 100 mg per mL, 250 mL

omit from the column headed “Responsible Person”:             OA          substitute:             TX

[29]         Schedule 1, entry for Dexamethasone in each of the forms: Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL; and Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

omit from the column headed “Responsible Person” for the brand “Dexmethsone”:                    AS          substitute:             AF

[30]         Schedule 1, entry for Diazepam in the form Tablet 2 mg

(a)      omit:

 

 

 

Valium

RO

MP NP PDP

 

50

0

50

 

 

 

 

 

 

MP NP

 

P3656

50
CN3656

0

50

 

 

(b)      omit:

 

 

 

Valium

RO

MP NP

P3655

50
CN3655

3
CN3655

50

 

[31]         Schedule 1, entry for Dipyridamole with Aspirin

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

 

 

 

APO-Dipyridamole/ Aspirin 200/25

TX

MP NP

C1728

 

60

5

60

 

 

[32]         Schedule 1, entry for Dorzolamide with timolol

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

 

 

 

Dorzolamide/ Timolol Sandoz 20/5

SZ

MP

C4343

 

1

5

1

 

 

 

 

 

 

 

AO

C4326

 

1

5

1

 

 


 

[33]         Schedule 1, after entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0;
Pack Quantity: 7; Brand: Doxylin 100]

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

 

 

 

Doxycycline AN

EA

MP NP

 

P4485

21

0

21

 

 

[34]         Schedule 1, after entry for Dutasteride with tamsulosin

insert:

Eculizumab

Solution concentrate for I.V. infusion 300 mg in 30 mL

Injection

Soliris

XI

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[35]         Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg

omit:

 

 

 

Renitec M

MK

MP NP

 

 

30

5

30

 

 

[36]         Schedule 1, after entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg

insert:

Enzalutamide

Capsule 40 mg

Oral

Xtandi

LL

MP

C4670

 

112

2

112

 

 

[37]         Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 10”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”:
      C1211    substitute:                C4755

[38]         Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Esipram”:         C1211  C2964  C2965  C2966  C2967  C2968  C2969
substitute:             C4690  C4703  C4755  C4756  C4757

[39]         Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 10”:         C1211    substitute:                C4755

[40]         Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexapro”:         C1211  C2964  C2965  C2966  C2967  C2968  C2969
substitute:             C4690  C4703  C4755  C4756  C4757

[41]         Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 10”; and “Terry White Chemists Escitalopram”: C1211
substitute:             C4755


 

[42]         Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 20”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”:
      C1211    substitute:                C4755

[43]         Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Esipram”:         C1211  C2964  C2965  C2966  C2967  C2968  C2969
substitute:             C4690  C4703  C4755  C4756  C4757

[44]         Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 20”:         C1211    substitute:                C4755

[45]         Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexapro”:         C1211  C2964  C2965  C2966  C2967  C2968  C2969
substitute:             C4690  C4703  C4755  C4756  C4757

[46]         Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 20”; and “Terry White Chemists Escitalopram”: C1211
substitute:             C4755

[47]         Schedule 1, entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL

omit from the column headed “Circumstances”:        C1211  C2964  C2965  C2967  C2968  C3092  C3093
substitute:             C4680  C4681  C4707  C4721  C4747

[48]         Schedule 1, after entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL

insert in the columns in the order indicated:

 

Oral solution 20 mg (as oxalate) per mL, 15 mL

Oral

Lexapro

LU

MP NP

C4680 C4681 C4707 C4721 C4747

 

1

5

1

 

 

[49]         Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation
in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose,
60 doses

(a)      omit from the column headed “Circumstances”:            C4372

(b)      insert in numerical order:     C4689

[50]         Schedule 1, after entry for Fluticasone with Salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

insert:

Fluticasone with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 100/25

GK

MP NP

C4689 C4711

 

1

5

1

 

 

 

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 200/25

GK

MP NP

C4731

 

1

5

1

 

 

[51]         Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

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

 

 

 

Galantamine AN SR

EA

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

[52]         Schedule 1, entry for Gliclazide in the form Tablet 60 mg (modified release)

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

 

 

 

ARDIX GLICLAZIDE 60mg MR

RX

MP NP

 

 

60

5

60

 

 

[53]         Schedule 1, after entry for Glyceryl Trinitrate in the form Transdermal patch 120 mg

insert:

Glycine with carbohydrate

Sachets of oral powder 4 g containing 500 mg glycine, 30 (Glycine500)

Oral

Glycine500

VF

MP NP

C4704

 

4

5

1

 

 

[54]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3]

(a)      omit from the column headed “Circumstances”:            C3718  C3782  C3783

(b)      insert in numerical order:       C4676  C4702  C4744 C4754  C4766

(c)      omit from the column headed “Purposes”:       P3718  P3782

(d)      insert in numerical order:       P4702  P4754  P4766

[55]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5]

(a)      omit from the column headed “Circumstances”:            C3718  C3782  C3783

(b)      insert in numerical order:       C4676  C4702  C4744 C4754  C4766

(c)      omit from the column headed “Purposes”:       P3783

(d)      insert in numerical order:       P4676  P4744

[56]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3]

(a)      omit from the column headed “Circumstances”:            C3718  C3782  C3783

(b)      insert in numerical order:       C4676  C4702  C4744 C4754  C4766

(c)      omit from the column headed “Purposes”:       P3718  P3782

(d)      insert in numerical order:       P4702  P4754  P4766

[57]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5]

(a)      omit from the column headed “Circumstances”:            C3718  C3782  C3783

(b)      insert in numerical order:       C4676  C4702  C4744 C4754  C4766

(c)      omit from the column headed “Purposes”:       P3783

(d)      insert in numerical order:       P4676  P4744

[58]         Schedule 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

insert as first item in the columns in the order indicated:

 

Oral liquid 200 mL, 32 (KetoCal 4:1 LQ)

Oral

KetoCal 4:1 LQ

SB

MP NP

C4709

 

5

5

1

 

 

[59]         Schedule 1, entry for Hypromellose in the form Oral gel 20 mg per g, 100 g

omit from the column headed “Responsible Person”:             VT          substitute:             IA

[60]         Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)

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

 

 

 

Tenaxil SR

QA

MP NP

 

 

90

1

90

 

 

[61]         Schedule 1, after entry for Ivabradine in the form Tablet 7.5 mg (as hydrochloride)

insert:

Ivacaftor

Tablet 150 mg

Oral

Kalydeco

VR

MP
See Note 1

See Note 3

 

See Note 3

See
Note 3

1

 

D(100)

[62]         Schedule 1, entry for Leflunomide in the form Tablet 10 mg

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

 

 

 

Leflunomide AN

EA

MP

C2644

 

30

5

30

 

 

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

 

 

 

Leflunomide Sandoz

SZ

MP

C2644 C2682

 

30

5

30

 

 

[63]         Schedule 1, entry for Leflunomide in the form Tablet 20 mg

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

 

 

 

Leflunomide AN

EA

MP

C2644

 

30

5

30

 

 

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

 

 

 

Leflunomide Sandoz

SZ

MP

C2644 C2682

 

30

5

30

 

 

[64]         Schedule 1, entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate)

omit from the column headed “Responsible Person”:             AS          substitute:             AL

[65]         Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)

omit from the column headed “Responsible Person” for the brand “Methylpred”:          AS          substitute:             AL

[66]         Schedule 1, entry for Metoclopramide in each of the forms: Tablet containing metoclopramide hydrochloride 10 mg; and Injection containing metoclopramide hydrochloride 10 mg in 2 mL

omit from the column headed “Responsible Person” for the brand “Maxolon”:  VT          substitute:             IA

[67]         Schedule 1, after entry for Miconazole in the form Tincture 20 mg per mL, 30 mL

insert:

Midazolam

Injection 5 mg (as hydrochloride) in
1 mL

Injection

Pfizer Australia Pty Ltd

PF

See Note 4

See Note 4

See Note 4

See Note 4

See Note 4

10

 

D(MP NP)

[68]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)

(a)      omit:

 

 

 

APOTEX-
MORPHINE MR

TX

MP NP

C1062

 

28

0

28

 

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

 

 

 

MORPHINE MR APOTEX

TX

MP NP

C1062

 

28

0

28

 

[69]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg (controlled release)

(a)      omit:

 

 

 

APOTEX-
MORPHINE MR

TX

MP NP

C1062

 

28

0

28

 

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

 

 

 

MORPHINE MR APOTEX

TX

MP NP

C1062

 

28

0

28

 

[70]         Schedule 1, entry for Nitrazepam in the form Tablet 5 mg

omit from the column headed “Responsible Person” for the brand “Mogadon” (all instances):     VT          substitute:             IA

[71]         Schedule 1, entry for Olsalazine in each of the forms: Capsule containing olsalazine sodium 250 mg; and Tablet containing olsalazine sodium 500 mg

omit from the column headed “Responsible Person”:             UC          substitute:             IX


 

[72]         Schedule 1, entry for Omalizumab

omit:

 

Powder for injection 150 mg with diluent

Injection

Xolair

NV

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[73]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)

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

 

 

 

Oxycodone  Sandoz

SZ

MP NP

C4583

 

28

0

28

 

 

(b)      omit from the column headed “Circumstances” for the brand “OxyContin”:             C1062    substitute:             C4583

[74]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 15 mg (controlled release)

omit from the column headed “Circumstances”:           C1062    substitute:             C4583

[75]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)

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

 

 

 

Oxycodone  Sandoz

SZ

MP NP

C4583

 

28

0

28

 

 

(b)      omit from the column headed “Circumstances” for the brand “OxyContin”:             C1062    substitute:             C4583

[76]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 30 mg (controlled release)

omit from the column headed “Circumstances”:           C1062    substitute:             C4583

[77]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)

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

 

 

 

Oxycodone  Sandoz

SZ

MP NP

C4583

 

28

0

28

 

 

(b)      omit from the column headed “Circumstances” for the brand “OxyContin”:             C1062    substitute:             C4583

[78]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)

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

 

 

 

Oxycodone  Sandoz

SZ

MP NP

C4583

 

28

0

28

 

 

(b)      omit from the column headed “Circumstances” for the brand “OxyContin”:             C1062    substitute:             C4583

[79]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]

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

 

 

 

Parapane

AF

PDP

 

 

100

0

100

 

 

[80]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]

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

 

 

 

Parapane

AF

MP NP

 

 

100

1

100

 

 

[81]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]

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

 

 

 

Parapane

AF

PDP

 

P2046

300

0

100

 

 

[82]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

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

 

 

 

Parapane

AF

MP NP

 

P2046

300

4

100

 

 

[83]         Schedule 1, entry for Paracetamol

omit:

 

Tablet 665 mg (modified release)

Oral

Panadol Osteo

GC

MP NP

C2094 C3649 C3650

P3650

192

0

96

 

 

 

 

 

 

 

MP NP

C2094 C3649 C3650

P3649

192

3

96

 

 

 

 

 

 

 

MP NP

C2094 C3649 C3650

P2094

192

5

96

 

 

substitute:

 

Tablet 665 mg (modified release)

Oral

Osteomol 665 Paracetamol

CR

MP NP

C2094 C3649 C3650

P3650

192

0

96

 

 

 

 

 

Panadol Osteo

GC

MP NP

C2094 C3649 C3650

P3650

192

0

96

 

 

 

 

 

Osteomol 665 Paracetamol

CR

MP NP

C2094 C3649 C3650

P3649

192

3

96

 

 

 

 

 

Panadol Osteo

GC

MP NP

C2094 C3649 C3650

P3649

192

3

96

 

 

 

 

 

Osteomol 665 Paracetamol

CR

MP NP

C2094 C3649 C3650

P2094

192

5

96

 

 

 

 

 

Panadol Osteo

GC

MP NP

C2094 C3649 C3650

P2094

192

5

96

 

 


 

[84]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

 

 

 

Perindopril CH

EA

MP NP

 

 

30

5

30

 

 

[85]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

 

 

 

Perindopril CH

EA

MP NP

 

 

30

5

30

 

 

[86]         Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

 

 

 

Perindopril and Indapamide CH 4/1.25

EA

MP NP

C4375

 

30

5

30

 

 

[87]         Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” for the brand “LPV” (twice occurring):        VT          substitute:             IA

[88]         Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” for the brand “LPV”:        VT          substitute:             IA

[89]         Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Actos”:      LY          substitute:             TK

[90]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]

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

 

 

 

Simpral

AF

MP NP

C3216

 

30

0

30

 

 


 

[91]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]

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

 

 

 

Simpral

AF

MP NP

C3216

 

100

5

100

 

 

[92]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg

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

 

 

 

Simpral

AF

MP NP

C3216

 

100

5

100

 

 

[93]         Schedule 1, entry for Prednisolone in each of the forms: Tablet 5 mg; and Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Solone”:    VT          substitute:             IA

[94]         Schedule 1, entry for Prednisone in each of the forms: Tablet 5 mg; and Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Sone”:       VT          substitute:             IA

[95]         Schedule 1, entry for Pyridostigmine in each of the forms: Tablet containing pyridostigmine bromide 10 mg; Tablet containing pyridostigmine bromide 60 mg; and Tablet containing pyridostigmine bromide 180 mg (modified release)

omit from the column headed “Responsible Person”:             VT          substitute:             IA

[96]         Schedule 1, entry for Raloxifene

substitute:

Raloxifene

Tablet containing raloxifene hydrochloride 60 mg

Oral

APO-Raloxifene

TX

MP NP

C4071

 

28

5

28

 

 

 

 

 

Chem mart Raloxifene

CH

MP NP

C4071

 

28

5

28

 

 

 

 

 

Evifyne

EL

MP NP

C4071

 

28

5

28

 

 

 

 

 

Evista

LY

MP NP

C4071

 

28

5

28

 

 

 

 

 

Raloxifene AN

EA

MP NP

C4071

 

28

5

28

 

 

 

 

 

Terry White Chemists  Raloxifene

TW

MP NP

C4071

 

28

5

28

 

 

[97]         Schedule 1, entry for Ramipril in the form Tablet 1.25 mg

omit:

 

 

 

Prilace 1.25

QA

MP NP

 

 

30

5

30

 

 

[98]         Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

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

 

 

 

Ramipril RBX Tabs

RA

MP NP

 

 

30

5

30

 

 

[99]         Schedule 1, entry for Ramipril in the form Tablet 5 mg

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

 

 

 

Ramipril RBX Tabs

RA

MP NP

 

 

30

5

30

 

 

[100]       Schedule 1, entry for Ramipril in the form Tablet 10 mg

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

 

 

 

Ramipril RBX Tabs

RA

MP NP

 

 

30

5

30

 

 

[101]       Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

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

 

 

 

Ranitidine AN

EA

MP NP MW

 

 

60

5

60

 

 

[102]       Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion
500 mg in 50 mL

omit from the column headed “Circumstances”:        C1744  C1745  C2068  C2386  C3908  C3909  C3912  C3915  C3931  C3932
substitute:             C4671  C4674  C4677  C4678  C4679  C4686  C4687  C4701  C4706  C4726  C4727  C4728  C4752  C4765

[103]       Schedule 1, after entry for Silver sulfadiazine

insert:

Simeprevir

Capsule 150 mg (as sodium)

Oral

Olysio

JC

MP
See Note 1

C4669 C4684 C4758 C4759

 

42

0

7

 

D(100)

[104]       Schedule 1, entry for Simvastatin in the form Tablet 5 mg

(a)      omit:

 

 

 

Zocor

MK

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Zocor

MK

MP

C1540 C3047

P3047

30

11

30

 

[105]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

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

 

 

 

Telmisartan HCT GH 40/12.5

GQ

MP NP

C4374

 

28

5

28

 

 


 

[106]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

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

 

 

 

Telmisartan HCT GH 80/12.5

GQ

MP NP

C4374

 

28

5

28

 

 

[107]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg

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

 

 

 

Telmisartan HCT GH 80/25

GQ

MP NP

C4374

 

28

5

28

 

 

[108]       Schedule 1, entry for Triglycerides, long chain with glucose polymer

insert as first item in the columns in the order indicated:

 

Oral liquid 200 mL, 27 (Sno-Pro)

Oral

Sno-Pro

SB

MP NP

C4438

 

2

5

1

 

 

[109]       Schedule 1, after entry for Tyrosine with carbohydrate

insert:

Umeclidinium

Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses

Inhalation by mouth

Incruse Ellipta

GK

MP NP

C4516

 

1

5

1

 

 

Umeclidinium with vilanterol

Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Anoro Ellipta 62.5/25

GK

MP NP

C4655

 

1

5

1

 

 

[110]       Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg

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

 

 

 

APO-Valsartan HCTZ 160/12.5

TX

MP NP

C4374

 

28

5

28

 

 

[111]       Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg

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

 

 

 

APO-Valsartan HCTZ 320/12.5

TX

MP NP

C4361

 

28

5

28

 

 

[112]       Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg

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

 

 

 

APO-Valsartan HCTZ 320/25

TX

MP NP

C4361

 

28

5

28

 

 

[113]       Schedule 1, entry for Voriconazole

substitute:

Voriconazole

Tablet 50 mg

Oral

Vfend

PF

MP NP

C4665 C4682 C4683 C4685 C4748

P4685

56

0

56

 

 

 

 

 

 

 

 

C4665 C4682 C4683 C4685 C4748

P4665 P4682 P4683 P4748

56

2

56

 

 

 

Tablet 200 mg

Oral

Vfend

PF

MP NP

C4665 C4682 C4683 C4685 C4748

P4685

56

0

56

 

 

 

 

 

 

 

 

C4665 C4682 C4683 C4685 C4748

P4665 P4682 P4683 P4748

56

2

56

 

 

 

Powder for oral suspension 40 mg per mL, 70 mL

Oral

Vfend

PF

MP NP

C4685 C4699 C4722 C4723 C4749

 

1

0

1

 

 

[114]       Schedule 3, after details relevant to Responsible Person code LB

insert:

LL

Astellas Pharma Australia Pty Ltd

 81 147 915 482

[115]       Schedule 3, after details relevant to Responsible Person code VP

insert:

VR

Vertex Pharmaceuticals (Australia) Pty Ltd

 34 160 157 157

[116]       Schedule 3

omit:

VT

Valeant Pharmaceuticals Australasia Pty Limited

 64 001 083 352

[117]       Schedule 3, after details relevant to Responsible Person code XH

insert:

XI

Alexion Pharmaceuticals Australasia Pty Ltd

 59 132 343 036

[118]       Schedule 4, Part 1, entry for Abatacept

substitute:

Abatacept

C4664

P4664

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application

The authority application must be made in writing and must include:
(1) completed authority prescription forms; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement

Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats

Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats

Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment 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 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 within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

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

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
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; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied

Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response

Compliance with Written Authority Required procedures


 

C4720

P4720

 

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


 

C4739

P4739

 

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

Compliance with Written Authority Required procedures


 

C4745

P4745

 

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

The authority application must be made in writing and must include:
(a) completed authority prescription forms; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

Applications for a patient who has received PBS-subsidised treatment with this drugt and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below

Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats

Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

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 a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Compliance with Written Authority Required procedures


 

C4746

P4746

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


[119]       Schedule 4, Part 1, entry for Abiraterone

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

 

 

 

 

Patient must have failed treatment with docetaxel due to resistance or intolerance; AND

 

substitute:

 

 

 

 

Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND

 

(b)      insert in the column headed “Circumstances and Purposes” following existing text:

 

 

 

 

; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal

 


 

[120]       Schedule 4, Part 1, entry for Adalimumab

(a)      omit:

 

C3706

P3706

 

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3745

P3745

 

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with adalimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised adalimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3746

P3746

 

Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of continuing treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order following existing text:

 

C4666

P4666

 

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

Compliance with Written Authority Required procedures


 

C4700

P4700

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


 

C4710

P4710

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement

Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

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

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
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; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied

Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response

Compliance with Written Authority Required procedures


 

C4724

P4724

 

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


 

C4751

P4751

 

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

If a patient 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 for this condition

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 who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Compliance with Written Authority Required procedures



 

[121]       Schedule 4, Part 1, after entry for Bortezomib

insert:

Brentuximab vedotin

C4675

 

 

CD30 positive systemic anaplastic large cell lymphoma

Continuing treatment

Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug

The treatment must not exceed a lifetime total of 16 cycles

Compliance with Authority Required procedures


 

C4719

 

 

CD30 positive systemic anaplastic large cell lymphoma

Initial treatment

The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease

Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant

A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction

Compliance with Written Authority Required procedures


[122]       Schedule 4, Part 1, entry for Budesonide with eformoterol

(a)      omit:

 

C4327

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy

 

(b)      omit:

 

C4416

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy;
The treatment must be for symptomatic treatment

 


 

(c)      insert in numerical order following existing text:

 

C4689

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment

 

[123]       Schedule 4, Part 1, entry for Certolizumab pegol

(a)      omit:

 

C3714

 

 

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with certolizumab pegol for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3768

 

 

Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with certolizumab pegol; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with certolizumab pegol; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with certolizumab pegol;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of certolizumab pegol therapy is an 18 or 20 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment

Compliance with Written Authority Required procedures


 

 

 

 

 

Continuation of a course of continuing treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3769

 

 

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with certolizumab pegol for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with certolizumab pegol are not eligible to commence treatment with certolizumab pegol until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with certolizumab pegol and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised certolizumb pegol treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised certolizumab pegol treatment is an 18 or 20 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order following existing text:

 

C4696

 

 

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

If a patient 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 for this condition

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 who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Compliance with Written Authority Required procedures


 

C4697

 

 

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

Compliance with Written Authority Required procedures


 

C4737

 

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


 

C4763

 

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have not failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement

Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment 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 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 within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

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

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
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; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied

Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response

Compliance with Written Authority Required procedures


 

C4764

 

 

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


[124]       Schedule 4, Part 1, entry for Dapagliflozin

substitute:

Dapagliflozin

C4736

 

 

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug

Compliance with Authority Required procedures - Streamlined Authority Code 4736


[125]       Schedule 4, Part 1, after entry for Entecavir

insert:

Enzalutamide

C4670

 

 

Castration resistant metastatic carcinoma of the prostate

The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must not have received prior treatment with abiraterone; OR
Patient must have developed intolerance to abiraterone of a severity necessitating permanent treatment withdrawal

Compliance with Authority Required procedures


[126]       Schedule 4, Part 1, entry for Escitalopram

substitute:

Escitalopram

C4680

 

 

Major depressive disorders

 

 

C4681

 

 

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist

 

 

C4690

 

 

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist

 

 

C4703

 

 

Moderate to severe generalised anxiety disorder (GAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared

 

 

C4707

 

 

Moderate to severe generalised anxiety disorder (GAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist

 

 

C4721

 

 

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared

 

 

C4747

 

 

Moderate to severe generalised anxiety disorder (GAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared

 

 

C4755

 

 

Major depressive disorders

 

 

C4756

 

 

Moderate to severe generalised anxiety disorder (GAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist

 

 

C4757

 

 

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared

 

[127]       Schedule 4, Part 1, entry for Fluticasone with salmeterol

(a)      omit:

 

C4372

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy;
The treatment must be for symptomatic treatment

 

(b)      insert in numerical order following existing text:

 

C4689

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment

 

[128]       Schedule 4, Part 1, after entry for Fluticasone with salmeterol

insert:

Fluticasone with vilanterol

C4689

 

 

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment

 

 

C4711

 

 

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids

Patient must be aged 12 years or over

 

 

C4731

 

 

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids

Patient must be aged 12 years or over

 

[129]       Schedule 4, Part 1, after entry for Glycerol

insert:

Glycine with carbohydrate

C4704

 

 

Isovaleric acidaemia

 

[130]       Schedule 4, Part 1, entry for Golimumab

(a)      omit:

 

C3718

P3718

 

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with golimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures


 

 

 

 

 

Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3782

P3782

 

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with golimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with golimumab are not eligible to commence treatment with golimumab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with golimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised golimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised golimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

 

C3783

P3783

 

Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with golimumab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with golimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment

Compliance with Written Authority Required procedures

 

 

 

 

Continuation of a course of continuing treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order following existing text:

 

C4676

P4676

 

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures


 

C4702

P4702

 

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

If a patient 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 for this condition

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 who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD

An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Compliance with Written Authority Required procedures


 

C4744

P4744

 

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response

The authority application must be made in writing and must include:
(1) a completed authority prescription form and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form

All applications for continuing treatment with golimumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with golimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial 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 golimumab

If a patient fails to demonstrate a response to treatment with golimumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

Compliance with Written Authority Required procedures


 

C4754

P4754

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement

Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment 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 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 within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

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

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
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; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied

Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response

Compliance with Written Authority Required procedures


 

C4766

P4766

 

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

Compliance with Written or Telephone Authority Required procedures



 

[131]       Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

insert in numerical order following existing text:

 

C4709

 

 

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency

KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist

 

[132]       Schedule 4, Part 1, entry for Oxycodone

(a)      omit:

 

C1062

 

 

Chronic severe disabling pain not responding to non-narcotic analgesics

 

(b)      insert in numerical order following existing text:

 

C4583

 

 

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

 

[133]       Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a

substitute:

Ribavirin and Peginterferon Alfa‑2a

C4184

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4184

 

C4185

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required procedures

 

C4187

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required procedures Streamlined Authority Code 4187

 

C4188

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures

 

C4193

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures


 

 

C4197

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4197

 

C4206

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre.

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4206

 

C4207

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required procedures


 

[134]       Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2b

substitute:

Ribavirin and Peginterferon Alfa‑2b

C4184

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4184

 

C4185

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required procedures

 

C4187

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4187

 

C4188

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures

 

C4189

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4189

 

C4192

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre.

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4192

 

C4193

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures

 

C4197

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required proceduresStreamlined Authority Code 4197

 

C4198

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4198

 

C4199

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4199

 

C4200

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures

 

C4203

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

Compliance with Written or Telephone Authority Required procedures

 

C4206

 

 

Where the patient is receiving treatment at/from a public hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206

 

C4207

 

 

Where the patient is receiving treatment at/from a private hospital

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant

Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre.

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required procedures


 

 

C4208