National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 7) (PB 62 of 2017) (Cth)

PB 62 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 7)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 28 August 2017

PENNY SHAKESPEARE

First Assistant Secretary

Technology Assessment and Access Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2017 (No. 7).

(2)        This Instrument may also be cited as PB 62 of 2017.

2          Commencement

This Instrument commences on 1 September 2017.

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 Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

omit:

a Alendronate D3 70 mg/70 microgram EA MP NP C6307 C6315  C6320 4 5 4

1. Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit:

a Alendronate D3 70 mg/140 microgram EA MP NP C6306 C6319 C6325 4 5 4

1. Schedule 1, entry for Alendronic acid with colecalciferol and calcium

(a)omit:

Alendronate Plus D3 and Calcium Sandoz SZ MP NP C6306 C6319 C6325 1 5 1

(b)omit:

Alendronate Plus D3 Calcium Actavis EA MP NP C6306 C6319 C6325 1 5 1

1. Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain tryglycerides

(a)omit from the column headed “Listed Drug”:     tryglycerides    substitute:             triglycerides

(b)after entry for the form “Oral powder 400 g (Alfamino Junior)” insert in the columns in the order indicated:

Oral powder 400 g (Neocate Junior) Oral Neocate Junior SB MP NP C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 C5945 C5974 8 5 1

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

(a)omit:

Chem mart Amoxycillin CH PDP 1 0 1

(b)omit:

Terry White Chemists Amoxycillin TW PDP 1 0 1

(c)omit:

Chem mart Amoxycillin CH MP NP 1 1 1

(d)omit:

Terry White Chemists Amoxycillin TW MP NP 1 1 1

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

(a)omit:

Chem mart Amoxycillin CH PDP 1 0 1

(b)omit:

Terry White Chemists Amoxycillin TW PDP 1 0 1

(c)omit:

Chem mart Amoxycillin CH MP NP 1 1 1

(d)omit:

Terry White Chemists Amoxycillin TW MP NP 1 1 1

1. Schedule 1, entry for Anastrozole

omit:

a Anastrozole RBX RA MP NP C5464 30 5 30

1. Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)

(a)insert in the column headed “Schedule Equivalent” for the brands “Ceftriaxone‑AFT” and “Ceftriaxone Alphapharm”:      a

(b)omit from the column headed “Pack Quantity” for the brand “Ceftriaxone Alphapharm”:                    1substitute:      5

1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

(a)omit:

Chem mart Cephalexin CH PDP 20 0 20

(b)omit:

Terry White Chemists Cephalexin TW PDP 20 0 20

(c)omit:

Chem mart Cephalexin CH MP NP MW 20 1 20

(d)omit:

Terry White Chemists Cephalexin TW MP NP MW 20 1 20

(e)omit:

a Chem mart Cephalexin CH MP P4243 40 CN4243 2
CN4243 20

(f)omit:

a Terry White Chemists Cephalexin TW MP P4243 40 CN4243 2
CN4243 20

1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a)omit:

Chem mart Cephalexin CH PDP 20 0 20

(b)omit:

Terry White Chemists Cephalexin TW PDP 20 0 20

(c)omit:

Chem mart Cephalexin CH MP NP MW 20 1 20

(d)omit:

Terry White Chemists Cephalexin TW MP NP MW 20 1 20

(e)omit:

a Chem mart Cephalexin CH MP P6188 40
CN6188 1
CN6188 20

(f)omit:

a Terry White Chemists Cephalexin TW MP P6188 40
CN6188 1
CN6188 20

1. Schedule 1, entry for Gabapentin in each of the forms: Tablet 600 mg; and Tablet 800 mg

omit:

a Gabaran RA MP NP C4928 100 5 100

1. Schedule 1, entry for Hydromorphone

omit:

Injection containing hydromorphone hydrochloride 50 mg in 5 mL Injection Dilaudid‑HP MF MP NP 5 0 5

1. Schedule 1, after entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL [Brand: Zavedos Solution]

insert:

Idelalisib	Tablet 100 mg	Oral	Zydelig	GI	MP	C7051 C7052 C7053 C7060	60	5	60
Tablet 150 mg	Oral	Zydelig	GI	MP	C7051 C7052 C7053 C7060	60	5	60

1. Schedule 1, entry for Lamivudine in the form Tablet 150 mg

omit:

Lamivudine RBX RA MP C4454 C4512 120 5 60 D(100)

1. Schedule 1, entry for Lamivudine in the form Tablet 300 mg

omit:

Lamivudine RBX RA MP C4454 C4512 60 5 30 D(100)

1. Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent

omit from the column headed “Circumstances”:          C4559 C4567     substitute:             C7042 C7063

1. Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre‑filled syringe; Injection 90 mg (as acetate) in single dose pre‑filled syringe; and Injection 120 mg (as acetate) in single dose pre‑filled syringe

omit from the column headed “Circumstances”:          C4570 C4574    
insert in numerical order:  C7025 C7041

1. Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; and Tablet 500 mg

omit:

a Levitaccord RA MP NP C4928 60 5 60

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 1;
   Number of Repeats: 0]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 2;
   Number of Repeats: 5]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 4;
   Number of Repeats: 5]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 6;
   Number of Repeats: 5]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 8;
   Number of Repeats: 5]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1

1. Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g [Maximum Quantity: 10;
   Number of Repeats: 5]

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

a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1

1. Schedule 1, entry for Nevirapine in the form Tablet 200 mg

omit:

Nevirapine RBX RA MP C4454 C4512 120 5 60 D(100)

1. Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)

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

a Nevirapine XR APOTEX TX MP C4454 C4526 60 5 30 D(100)

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

1. Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

omit from the column headed “Circumstances” (all instances):               C6389
omit from the column headed “Circumstances” (all instances):               C6476
insert in numerical order:  C7028 C7043

1. Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe

omit from the column headed “Circumstances”:          C5896
omit from the column headed “Circumstances”:          C5900
insert in numerical order:  C7029 C7057

1. Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg
   (as hydrochloride dihydrate) in 4 mL

omit:

a	Ondansetron-Claris	AE	MP NP	C4077 C4092	1	0	1
MP	C5749	1	0	1	C(100)

1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

(a)omit:

Chem mart Pantoprazole CH MP NP C5444 C5512 C5529 30 5 30

(b)omit:

Terry White Chemists Pantoprazole TW MP NP C5444 C5512 C5529 30 5 30

1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a)omit:

Chem mart Pantoprazole CH MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

(b)omit:

Terry White Chemists Pantoprazole TW MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

(c)omit:

Chem mart Pantoprazole CH MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

(d)omit:

Terry White Chemists Pantoprazole TW MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

1. Schedule 1, entry for Pasireotide

substitute:

Pasireotide	Injection (modified release) 20 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	NV	MP	See Note 3	See Note 3	See Note 3	1	D(100)
Injection (modified release) 40 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	NV	MP	See Note 3	See Note 3	See Note 3	1	D(100)
Injection (modified release) 60 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	NV	MP	See Note 3	See Note 3	See Note 3	1	D(100)

1. Schedule 1, after entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 5]

insert in the columns in the order indicated:

Pegvisomant	Injection set containing powder for injection 10 mg, 30 and diluent, 30	Injection	Somavert	PF	MP	See Note 3	See Note 3	See Note 3	1	D(100)
Injection set containing  powder for injection 15 mg, 30 and diluent, 30	Injection	Somavert	PF	MP	See Note 3	See Note 3	See Note 3	1	D(100)
Injection set containing powder for injection 20 mg, 1 and diluent, 1	Injection	Somavert	PF	MP	See Note 3	See Note 3	See Note 3	1	D(100)
Injection set containing powder for injection 20 mg, 30 and diluent, 30	Injection	Somavert	PF	MP	See Note 3	See Note 3	See Note 3	1	D(100)

1. 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”:          C4706  
insert in numerical order:  C7040

1. Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Ventolin Nebules GK MP NP C6815 C6825 2 5 1

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

(a)omit:

a Chem mart Telmisartan HCTZ 40/12.5 CH MP NP C4374 28 5 28

(b)omit:

a Terry White Chemists Telmisartan HCTZ 40/12.5 TW MP NP C4374 28 5 28

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

(a)omit:

a Chem mart Telmisartan HCTZ 80/12.5 CH MP NP C4374 28 5 28

(b)omit:

a Terry White Chemists Telmisartan HCTZ 80/12.5 TW MP NP C4374 28 5 28

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

(a)omit:

a Chem mart Telmisartan HCTZ 80/25 CH MP NP C4374 28 5 28

(b)omit:

a Terry White Chemists Telmisartan HCTZ 80/25 TW MP NP C4374 28 5 28

1. Schedule 1, after entry for Ursodeoxycholic Acid in the form Capsule 250 mg [Brand: Ursosan]

insert in the columns in the order indicated:

Tablet 500 mg Oral Ursofalk OA MP NP C5757 100 2 100

1. Schedule 1, entry for Ustekinumab

substitute:

Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C6378 C6419 C6459 C6469 C6504 C6588 C6698 C6699 C6700 C6758 C6783 C6784 C6794 C6795 C7035 C7048 C7049 C7059 C7061	P6419 P6459 P6588 P6698 P6758 P6783	1	1	1
MP	C6378 C6419 C6459 C6469 C6504 C6588 C6698 C6699 C6700 C6758 C6783 C6784 C6794 C6795 C7035 C7048 C7049 C7059 C7061	P6378 P6469 P6504 P6699 P6700 P6784 P6794 P6795	1	2	1
MP	C6378 C6419 C6459 C6469 C6504 C6588 C6698 C6699 C6700 C6758 C6783 C6784 C6794 C6795 C7035 C7048 C7049 C7059 C7061	P7035 P7048 P7049 P7059 C7061	2	0	1
Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)

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

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

a Valganciclovir Juno JU MP C4980 C4989 C5031 120 5 60 D(100)

1. Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity; 224; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:               C6831 C6924     substitute:             C6013 C6044

(b)omit from the column headed “Purposes”:         P6831   substitute:             P6044

1. Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity; 224; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6831 C6924     substitute:             C6013 C6044

(b)omit from the column headed “Purposes”:         P6924   substitute:             P6013

1. Schedule 4, Part 1, after entry for Idarubicin

insert:

Idelalisib	C7051	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab; AND The condition must have relapsed or be refractory to at least one prior therapy; AND The condition must be CD20 positive; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND Patient must be inappropriate for chemo-immunotherapy. A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced: 1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or 2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or 3. Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). Full blood count results must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: a) A completed authority prescription form; b) A completed CLL/SLL PBS Authority Application - Supporting information form; and c) Pathology report indicating that the patient can be considered inappropriate for chemo-immunotherapy due to one or more of the following: 1) Recent severe neutropenia; or 2) Recent severe thrombocytopenia; or 3) Presence of 17p chromosomal deletion using fluorescence in situ hybridisation (FISH).	Compliance with Written Authority Required procedures
C7052	Refractory follicular B-cell non-Hodgkin's lymphoma Initial treatment The condition must be refractory to a prior therapy with rituximab; AND The condition must be refractory to a prior therapy with an alkylating agent; AND The treatment must be the sole PBS-subsidised treatment for this condition. The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy. The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) A completed Refractory follicular B-cell non-Hodgkin's lymphoma PBS Authority Application - Supporting information form which must include date of completion of prior therapies with rituximab and an alkylating agent.	Compliance with Written Authority Required procedures
C7053	Refractory follicular B-cell non-Hodgkin's lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C7060	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Continuing treatment The treatment must be in combination with rituximab; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Lanreotide

(a)omit:

:	C4559	Where the patient is receiving treatment at/from a private hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Written or Telephone Authority Required procedures
C4567	Where the patient is receiving treatment at/from a public hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4567

(b)omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4569:
Written or Telephone

(c)omit:

C4570	Where the patient is receiving treatment at/from a public hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4570
C4574	Where the patient is receiving treatment at/from a private hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Written or Telephone Authority Required procedures

(d)omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4575:
Written or Telephone

(e)insert in numerical order after existing text:

C7025	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 7025
C7041	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures
C7042	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures - Streamlined Authority Code 7042
C7063	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Octreotide

(a)omit:

C5896 Where the patient is receiving treatment at/from a private hospital Acromegaly The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Compliance with Written or Telephone Authority Required procedures

(b)omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C5899:
Written or Telephone

(c)omit:

C5900 Where the patient is receiving treatment at/from a public hospital Acromegaly The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5900

(d)omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Codes C5901; C5906; and C5910:
Written or Telephone

(e)omit:

C6389 Where the patient is receiving treatment at/from a public hospital Acromegaly The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Compliance with Authority Required procedures - Streamlined Authority Code 6389

(f)omit:

C6476 Where the patient is receiving treatment at/from a private hospital Acromegaly The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Compliance with Authority Required procedures

(g)insert in numerical order after existing text:

C7028	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 7028
C7029	Acromegaly The condition must be controlled with octreotide immediate release injections; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures - Streamlined Authority Code 7029
C7043	Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures
C7057	Acromegaly The condition must be controlled with octreotide immediate release injections; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Rituximab

(a)omit:

C4706 Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy Compliance with Authority Required procedures - Streamlined Authority Code 4706

(b)insert in numerical order after existing text:

C7040 Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive; AND
The treatment must be in combination with chemotherapy or idelalisib. Compliance with Authority Required procedures - Streamlined Authority Code 7040

1. Schedule 4, Part 1, entry for Ustekinumab

insert in numerical order after existing text:

C7035	P7035	Severe Crohn disease Initial PBS-subsidised treatment (Grandfather) Patient must have a documented history of severe Crohn disease; AND Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 September 2017; AND Patient must be receiving treatment with ustekinumab at the time of application; AND Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease Grandfathered PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment; and (v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase. A patient may qualify for PBS-subsidised treatment under this restriction once only.	Compliance with Written Authority Required procedures
C7048	P7048	Severe Crohn disease Initial treatment (new patient - initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to steroids; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; AND Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 if affected by extensive small intestine disease; OR Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 if not affected by extensive small intestine disease, short gut syndrome or is an ostomy patient; AND Patient must have evidence of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; OR Patient must (a) have evidence of intestinal inflammation, including: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; or (b) be assessed clinically as being in a high faecal output state; or (c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) two completed authority prescription forms; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment; and (v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 2 vials of 45 mg and no repeats. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised. The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for further continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.	Compliance with Written Authority Required procedures
C7049	P7049	Severe Crohn disease Balance of supply for Initial treatment, Continuing treatment or Grandfathered treatment Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 16 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Grandfathered treatment restriction to complete 24 weeks of treatment. Patient must be aged 18 years or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services	Compliance with Authority Required procedures
C7059	P7059	Severe Crohn disease Change or Re-commencement of treatment (initial 2) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have a documented history of severe Crohn disease; AND Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) two completed authority prescription forms; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD. A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised. The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.	Compliance with Written Authority Required procedures
C7061	P7061	Severe Crohn disease Continuing treatment Patient must have a documented history of severe Crohn disease; AND Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks. If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Vemurafenib

substitute:

Vemurafenib	C6013	P6013	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6013
C6044	P6044	Unresectable Stage III or Stage IV malignant melanoma Initial treatment The condition must be positive for a BRAF V600 mutation; AND The condition must not have been treated previously with PBS subsidised therapy; OR Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must have a WHO performance status of 2 or less.	Compliance with Authority Required procedures - Streamlined Authority Code 6044

1. Schedule 4, Part 3, Section 3, Treatment regimen, Table Item 20

omit from the column headed “Regimen”:

SOFOSBUVIR with VELPATASVIR for 12 weeks.

substitute:

(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.

1. Schedule 5

insert as first entry:

Chorionic gonadotrophin	GRP-21684	Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL	Injection	Pregnyl
Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3	Injection	Pregnyl

1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]

(a)omit from the column headed “Brand”:           Ventolin Nebules

(b)sort remaining brands in alphabetical order