National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 6) (PB 55 of 2017) (Cth)

PB 55 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 6)

National Health Act 1953

I, PENNY SHAKESPEARE, 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    21 July 2017

PENNY SHAKEPEARE

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 2017 (No. 6).

(2)        This Instrument may also be cited as PB 55 of 2017.

2          Commencement

This Instrument commences on 1 August 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, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 25 g, 30 (TYR express 15)

insert in the columns in the order indicated:

Sachets containing oral powder 34 g, 30 (TYR express 20) Oral TYR express 20 VF MP NP C5533 4 5 1

1. Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

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

a Amlodipine Amneal EF MP NP 30 5 30

1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a)omit:

a AmoxyClav RBX 875/125 RA PDP C5833 C5894 10 0 10

(b)omit:

a AmoxyClav RBX 875/125 RA MP NP C5832 C5893 10 1 10

1. Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg

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

a Aripiprazole AN EA MP NP C4246 30 5 30

1. Schedule 1, entry for Azacitidine

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

a Azacitidine Accord OC MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Bosentan

substitute:

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

a

APO-BOSENTAN

GX

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan APOTEX

TX

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

BOSENTAN -DRLA

RZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan Mylan

AF

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan RBX

RA

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan Sandoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

BOSLEER

RW

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Tracleer

AT

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

Tablet 125 mg (as monohydrate)

Oral

a

APO-BOSENTAN

GX

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan APOTEX

TX

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

BOSENTAN -DRLA

RZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan GH

GQ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan Mylan

AF

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan RBX

RA

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Bosentan Sandoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

BOSLEER

RW

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

a

Tracleer

AT

MP

See Note 3

See Note 3

See Note 3

See Note 3

60

D(100)

1. Schedule 1, entry for Carvedilol in the form Tablet 6.25 mg

omit:

Carvedilol generichealth GQ MP NP C5324 C5394 60 5 60

1. Schedule 1, entry for Chorionic Gonadotrophin

substitute:

Chorionic gonadotrophin	Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL	Injection	Pregnyl	MK	MP	C6991	1	0	1	C(100)
MP	C6979 C6987 C6989 C6990 C6995	1	5	1
Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3	Injection	Pregnyl	MK	MP	C6991	1	0	1	C(100)
MP	C6979 C6987 C6989 C6990 C6995	1	5	1
Powder for injection 5,000 units with solvent	Injection	Pregnyl	MK	MP	C6991	2	0	1	PB(100)

1. Schedule 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg

omit from the column headed “Circumstances”:          C5047 C5048 C5049substitute:             C6981 C6994

1. Schedule 1, entry for Dorzolamide

omit:

a APO-Dorzolamide TX MP AO 1 5 1

1. Schedule 1, entry for Dorzolamide with timolol

omit:

a	APO-Dorzolamide/ Timolol 20/5	TX	MP	C4343	1	5	1
AO	C5038	1	5	1

1. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

omit:

a Duloxetine RBX RA MP NP C5650 28 0 28

1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

omit:

a Duloxetine RBX RA MP NP C5650 28 5 28

1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit:

a Fluoxetine RBX RA MP NP C4755 C6277 28 5 28

1. Schedule 1, entry for Granisetron in each of the forms: Tablet 2 mg (as hydrochloride); and Concentrated injection 3 mg (as hydrochloride) in 3 mL

omit from the column headed “Responsible Person” for the brand “Kytril”:        RO       substitute:             IX

1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6540
insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6551

(b)insert in numerical order in the column headed “Purposes” for the brand “CIPLA IMATINIB ADULT”:                  P6540
insert in numerical order in the column headed “Purposes” for the brand “CIPLA IMATINIB ADULT”:                  P6551

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

a Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6896 C6907 C6942 C6948 C6949 C6973 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60

1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6540
insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6551

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

a Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6896 C6907 C6942 C6948 C6949 C6973 P6948 P6949 P6973 60 5 60

1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6540
insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6551

(b)insert in numerical order in the column headed “Purposes” for the brand “CIPLA IMATINIB ADULT”:                  P6540
insert in numerical order in the column headed “Purposes” for the brand “CIPLA IMATINIB ADULT”:                  P6551

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

a Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6896 C6907 C6942 C6948 C6949 C6973 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30

1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6540
insert in numerical order in the column headed “Circumstances” for the brand “CIPLA IMATINIB ADULT”:        C6551

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

a Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6896 C6907 C6942 C6948 C6949 C6973 P6948 P6949 P6973 30 5 30

1. Schedule 1, entry for Infliximab

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

a	Renflexis	MK	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	D(100)
MP	C4524 C4535	P4535	1	1	1	D(100)
MP	C4524 C4535	P4524	5	1	1	D(100)

1. Schedule 1, entry for Latanoprost with timolol

(a)omit from the column headed “Schedule Equivalent” for Authorised Prescriber “AO” (all instances):               a

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

a	Lantim	JU	MP	C4343	1	5	1
AO	C5038	1	5	1

1. Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for
   I.V. infusion 100 mg in 10 mL

omit from the column headed “Circumstances”:          C6083
omit:       C6116
insert in numerical order:  C6988 C6993 C6996 C6997 C6999

1. Schedule 1, entry for Nortriptyline in the form Tablet 10 mg (as hydrochloride)

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

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

a NortriTABS 10 mg GH MP NP C6235 C6300 50 2 50

1. Schedule 1, entry for Nortriptyline in the form Tablet 25 mg (as hydrochloride)

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

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

a NortriTABS 25 mg GH MP NP C6235 C6300 50 2 50

1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

omit:

Lanzek EL MP NP C5856 C5869 28 5 28

1. Schedule 1, entry for Olanzapine in each of the forms: Wafer 5 mg; and Wafer 10 mg

omit:

Lanzek Zydis EL MP NP C5856 C5869 28 5 28

1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg

(a)omit:

Omeprazole RBX RA MP NP C4074 C4075 C4089 C4152 P4074 30 1 30

(b)omit:

Omeprazole RBX RA MP NP C4074 C4075 C4089 C4152 P4075 P4089 P4152 30 5 30

1. Schedule 1, entry for Pregabalin

substitute:

Pregabalin	Capsule 25 mg	Oral	a	APO-Pregabalin	TX	MP NP	C4172	56	5	56
a	LYPRALIN	RW	MP NP	C4172	56	5	56
a	Lyrica	PF	MP NP	C4172	56	5	56
a	Lyzalon	AF	MP NP	C4172	56	5	56
a	Pregabalin APOTEX	GX	MP NP	C4172	56	5	56
a	PREGABALIN-DRLA	RZ	MP NP	C4172	56	5	56
a	Pregabalin GH	GQ	MP NP	C4172	56	5	56
a	Pregabalin Sandoz	SZ	MP NP	C4172	56	5	56
a	Pregabalin-Teva	TB	MP NP	C4172	56	5	56
Capsule 75 mg	Oral	a	APO-Pregabalin	TX	MP NP	C4172	56	5	56
a	LYPRALIN	RW	MP NP	C4172	56	5	56
a	Lyrica	PF	MP NP	C4172	56	5	56
a	Lyzalon	AF	MP NP	C4172	56	5	56
a	Pregabalin APOTEX	GX	MP NP	C4172	56	5	56
a	PREGABALIN-DRLA	RZ	MP NP	C4172	56	5	56
a	Pregabalin GH	GQ	MP NP	C4172	56	5	56
a	Pregabalin Sandoz	SZ	MP NP	C4172	56	5	56
a	Pregabalin-Teva	TB	MP NP	C4172	56	5	56
Capsule 150 mg	Oral	a	APO-Pregabalin	TX	MP NP	C4172	56	5	56
a	LYPRALIN	RW	MP NP	C4172	56	5	56
a	Lyrica	PF	MP NP	C4172	56	5	56
a	Lyzalon	AF	MP NP	C4172	56	5	56
a	Pregabalin APOTEX	GX	MP NP	C4172	56	5	56
a	PREGABALIN-DRLA	RZ	MP NP	C4172	56	5	56
a	Pregabalin GH	GQ	MP NP	C4172	56	5	56
a	Pregabalin Sandoz	SZ	MP NP	C4172	56	5	56
a	Pregabalin-Teva	TB	MP NP	C4172	56	5	56
Capsule 300 mg	Oral	a	APO-Pregabalin	TX	MP NP	C4172	56	5	56
a	LYPRALIN	RW	MP NP	C4172	56	5	56
a	Lyrica	PF	MP NP	C4172	56	5	56
a	Lyzalon	AF	MP NP	C4172	56	5	56
a	Pregabalin APOTEX	GX	MP NP	C4172	56	5	56
a	PREGABALIN-DRLA	RZ	MP NP	C4172	56	5	56
a	Pregabalin GH	GQ	MP NP	C4172	56	5	56
a	Pregabalin Sandoz	SZ	MP NP	C4172	56	5	56
a	Pregabalin-Teva	TB	MP NP	C4172	56	5	56

1. Schedule 1, after entry for Sofosbuvir

insert:

Sofosbuvir with velpatasvir Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir Oral Epclusa GI MP NP C5969 28 2 28

1. Schedule 1, entry for Tenofovir

substitute:

Tenofovir	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	GQ	MP	C6980 C6982 C6983 C6984 C6992 C6998	60	5	30	D(100)
Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Viread	GI	MP	C6980 C6982 C6983 C6984 C6992 C6998	60	5	30	D(100)
Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Mylan	AF	MP	C6980 C6982 C6983 C6984 C6992 C6998	60	5	30	D(100)

1. Schedule 1, entry for Tenofovir with Emtricitabine

substitute:

Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg	Oral	Tenofovir EMT GH	GQ	MP	C6985 C6986	60	5	30	D(100)
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Truvada	GI	MP	C6985 C6986	60	5	30	D(100)
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Mylan 300/200	AF	MP	C6985 C6986	60	5	30	D(100)

1. Schedule 1, entry for Valganciclovir

omit:

Tablet 450 mg (as hydrochloride) Oral Valcyte RO MP C4980 C4989 C5031 120 5 60 D(100)

substitute:

Tablet 450 mg (as hydrochloride)	Oral	a	Valcyte	RO	MP	C4980 C4989 C5031	120	5	60	D(100)
a	Valganciclovir AN	EA	MP	C4980 C4989 C5031	120	5	60	D(100)
a	Valganciclovir Mylan	AF	MP	C4980 C4989 C5031	120	5	60	D(100)
a	Valganciclovir Sandoz	SZ	MP	C4980 C4989 C5031	120	5	60	D(100)

1. Schedule 1, entry for Vinblastine

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

Vinblastine Teva DZ MP See Note 3 See Note 3 1 D(100)

1. Schedule 4, Part 1, entry for Chorionic Gonadotrophin

substitute:

Chorionic gonadotrophin	C6979	Combined deficiency of human growth hormone and gonadotrophins Patient must be one in whom the absence of secondary sexual characteristics indicates a lag in maturation. Patient must be male.
C6987	Infertility The condition must be due to hypogonadotrophic hypogonadism. Patient must be male.
C6989	Anovulatory infertility
C6990	Infertility The condition must be associated with isolated luteinising hormone deficiency. Patient must be male.
C6991	Assisted Reproductive Technology Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.	Compliance with Authority Required procedures - Streamlined Authority Code 6991
C6995	Hypogonadism or delayed puberty Patient must show clinical evidence of the condition; AND The treatment must not extend beyond 6 months. Patient must be male; AND Patient must be aged 16 years or older.

1. Schedule 4, Part 1, entry for Crizotinib

substitute:

Crizotinib	C6981	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must have previously been issued with an authority prescription for this drug; AND Patient must not have progressive disease.	Compliance with Authority Required procedures
C6994	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Netupitant with Palonosetron [Circumstances Code C6879]

omit from the column headed “Circumstances and Purposes”:

The condition must must be associated with

substitute:

The condition must be associated with

1. Schedule 4, Part 1, entry for Nivolumab

(a)omit:

C6083 Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 1 The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2016; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks. Compliance with Authority Required procedures - Streamlined Authority Code 6083

(b)omit:

C6116 Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 2 The condition must be negative for a BRAF V600 mutation; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2016; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks. Compliance with Authority Required procedures - Streamlined Authority Code 6116

(c)insert in numerical order after existing text:

C6988	Stage IV clear cell variant renal cell carcinoma (RCC) Initial Treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; OR Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6988
C6993	Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 6993
C6996	Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6996
C6997	Locally advanced or metastatic non-small cell lung cancer Grandfathering treatment Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must have stable or responding disease; AND Patient must have a WHO performance status of 0 or 1. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures - Streamlined Authority Code 6997
C6999	Locally advanced or metastatic non-small cell lung cancer 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 have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6999

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

insert:

Sofosbuvir with velpatasvir C5969 Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Tenofovir

substitute:

Tenofovir	C6980	Chronic hepatitis B infection Patient must have cirrhosis; AND Patient must be nucleoside analogue naive; AND Patient must have detectable HBV DNA; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6980
C6982	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6982
C6983	Chronic hepatitis B infection Patient must have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6983
C6984	Chronic hepatitis B infection Patient must not have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.	Compliance with Authority Required procedures - Streamlined Authority Code 6984
C6992	Chronic hepatitis B infection Patient must not have cirrhosis; AND Patient must be nucleoside analogue naive; AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 6992
C6998	HIV infection Initial Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6998

1. Schedule 4, Part 1, entry for Tenofovir with emtricitabine

substitute:

Tenofovir with emtricitabine	C6985	HIV infection Initial Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6985
C6986	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 6986

1. Schedule 4, Part 3, Section 3, Treatment regimen

omit the table and substitute:

Item	Kind of patient	Regimen
1	Patient: (a)   with Genotype 1; and (b)   who is treatment naïve; and (c)   who is non-cirrhotic	Either: (a)   LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (c)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or (d)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (g)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (h)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
2	Patient: (a)   with Genotype 1; and (b)   who is treatment experienced; and (c)   who is non-cirrhotic	Either: (a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (g)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (h)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (i)    SOFOSBUVIR with VELPATASVIR for 12 weeks.
3	Patient: (a)   with Genotype 2; and (b)   who is treatment naïve; and (c)   who is non-cirrhotic	Either: (a)     SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b)     SOFOSBUVIR with VELPATASVIR for 12 weeks.
4	Patient: (a)   with Genotype 2; and (b)   who is treatment experienced; and (c)   who is non-cirrhotic	Either: (a)   SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
5	Patient: (a)   with Genotype 3; and (b)   who is treatment naïve; and (c)   who is non-cirrhotic	Either: (a)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
6	Patient: (a)   with Genotype 3; and (b)   who is treatment experienced; and (c)   who is non-cirrhotic	Either: (a)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
7	Patient: (a)   with Genotype 4; and (b)   who is treatment naïve; and (c)   who is non-cirrhotic	Either: (a)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (c)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
8	Patient: (a)   with Genotype 4; and (b)   who is treatment experienced; and (c)   who is non-cirrhotic	Either: (a)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (d)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
9	Patient: (a)   with: (i)    Genotype 5; or (ii)   Genotype 6; and (b)   who is treatment naïve; and (c)   who is non-cirrhotic	Either: (a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)     SOFOSBUVIR with VELPATASVIR for 12 weeks.
10	Patient: (a)   with: (i)    Genotype 5; or (ii)   Genotype 6; and (b)   who is treatment experienced; and (c)   who is non-cirrhotic	Either: (a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)     SOFOSBUVIR with VELPATASVIR for 12 weeks.
11	Patient: (a)   with Genotype 1; and (b)   who is treatment naïve; and (c)   who is cirrhotic	Either: (a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f)    GRAZOPREVIR with ELBASVIR for 12 weeks; or (g)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
12	Patient: (a)   with Genotype 1; and (b)   who is treatment experienced; and (c)   who is cirrhotic	Either: (a)   LEDIPASVIR with SOFOSBUVIR for 24 weeks; or (b)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (e)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f)    PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or (g)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (h)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (i)    SOFOSBUVIR with VELPATASVIR for 12 weeks.
13	Patient: (a)   with Genotype 2; and (b)   who is treatment naïve; and (c)   who is cirrhotic	Either: (a)     SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b)     SOFOSBUVIR with VELPATASVIR for 12 weeks.
14	Patient: (a)   with Genotype 2; and (b)   who is treatment experienced; and (c)   who is cirrhotic	Either: (a)     SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (b)     SOFOSBUVIR with VELPATASVIR for 12 weeks.
15	Patient: (a)   with Genotype 3; and (b)   who is treatment naïve; and (c)   who is cirrhotic	Either: (a)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (e)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (f)    SOFOSBUVIR with VELPATASVIR for 12 weeks.
16	Patient: (a)   with Genotype 3; and (b)   who is treatment experienced; and (c)   who is cirrhotic	Either: (a)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (d)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (e)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (f)    SOFOSBUVIR with VELPATASVIR for 12 weeks.
17	Patient: (a)   with Genotype 4; and (b)   who is treatment naïve; and (c)   who is cirrhotic	Either: (a)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (c)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
18	Patient: (a)   with Genotype 4; and (b)   who is treatment experienced; and (c)   who is cirrhotic	Either: (a)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or (c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or (d)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
19	Patient: (a)   with: (i)    Genotype 5; or (ii)   Genotype 6; and (b)   who is treatment naïve; and (c)   who is cirrhotic	Either: (a)   SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or (b)   SOFOSBUVIR with VELPATASVIR for 12 weeks.
20	Patient: (a)   with: (i)    Genotype 5; or (ii)   Genotype 6; and (b)   who is treatment experienced; and (c)   who is cirrhotic	Either: (a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or        SOFOSBUVIR with VELPATASVIR for 12 weeks.

1. Schedule 5, entry for Imatinib

substitute:

Imatinib	GRP-21074	Capsule 100 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT Glivanib IMATINIB AN Imatinib-APOTEX IMATINIB-DRLA Imatinib GH
Tablet 100 mg (as mesilate)	Oral	Glivec IMATINIB RBX Imatinib-Teva
GRP-21076	Capsule 100 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT Glivanib IMATINIB AN Imatinib-APOTEX IMATINIB-DRLA Imatinib GH
Tablet 100 mg (as mesilate)	Oral	Glivec IMATINIB RBX
GRP-21079	Capsule 400 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT Glivanib IMATINIB AN Imatinib-APOTEX IMATINIB-DRLA Imatinib GH
Tablet 400 mg (as mesilate)	Oral	Glivec IMATINIB RBX Imatinib-Teva
GRP-21080	Capsule 400 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT Glivanib IMATINIB AN Imatinib-APOTEX IMATINIB-DRLA Imatinib GH
Tablet 400 mg (as mesilate)	Oral	Glivec IMATINIB RBX

1. Schedule 5, entry for Olanzapine in the form Tablet 2.5 mg [GRP-15492]

omit from the column headed “Brand”:       Lanzek

1. Schedule 5, entry for Olanzapine in the form Tablet 5 mg [GRP-15921]

omit from the column headed “Brand”:       Lanzek

1. Schedule 5, entry for Olanzapine in the form Tablet 7.5 mg [GRP-15884]

omit from the column headed “Brand”:       Lanzek

1. Schedule 5, entry for Olanzapine in the form Tablet 10 mg [GRP-15513]

omit from the column headed “Brand”:       Lanzek

1. Schedule 5, after entry for Sumatriptan

insert:

Tenofovir	GRP-21636	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH
Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Viread
Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Mylan
Tenofovir with emtricitabine	GRP-21638	Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg	Oral	Tenofovir EMT GH
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Truvada
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Mylan 300/200