National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 35 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 35 of 2010

Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953

I, FELICITY McNEILL, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.

Dated 1 April 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 May 2010.

2              Amendment of PB 15 of 2010

Schedule 1 amends PB 15 of 2010.

Schedule 1            Amendments

  1. Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 250 micrograms

(a)insert in alphabetical order in the column headed “Brand”: Alprazolam Sandoz

(b)omit from the column headed “Brand”: Zamhexal 0.25mg

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine

omit from the columns in the order indicated:

Oral powder 400 g (XP Analog LCP) Oral 8 5 XP Analog LCP

and substitute:

Oral powder 400 g (PKU Anamix infant) Oral 8 5 PKU Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan

omit from the columns in the order indicated:

Oral powder 400 g (XLYS, LOW TRY Analog) Oral 8 5 XLYS, LOW TRY Analog

and substitute:

Oral powder 400 g (GA1 Anamix infant) Oral 8 5 GA1 Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without methionine

omit from the columns in the order indicated:

Oral powder 400 g (XMET Analog) Oral 8 5 XMET Analog

and substitute:

Oral powder 400 g (HCU Anamix infant) Oral 8 5 HCU Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

omit from the columns in the order indicated:

Oral powder 400 g (XMTVI Analog) Oral 8 5 XMTVI Analog

and substitute:

Oral powder 400 g (MMA/PA Anamix infant) Oral 8 5 MMA/PA Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit from the columns in the order indicated:

Oral powder 400 g (XPhen, Tyr Analog) Oral 8 5 XPhen, Tyr Analog

and substitute:

Oral powder 400 g (TYR Anamix infant) Oral 8 5 TYR Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit from the columns in the order indicated:

Oral powder 400 g (MSUD Analog) Oral 8 5 MSUD Analog

and substitute:

Oral powder 400 g (MSUD Anamix infant) Oral 8 5 MSUD Anamix infant

  1. Part 1 of Schedule 1, item dealing with Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

insert as next entry in the columns in the order indicated:

Oral powder 400 g (EleCare LCP)

Oral

8

5

EleCare LCP

  1. Part 1 of Schedule 1, item dealing with Carmellose with glycerin

insert as next entry in the columns in the order indicated:

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30 Application to the eye 3 5 Optive

  1. Part 1 of Schedule 1, item dealing with Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

(a)insert in alphabetical order in the column headed “Brand”: Ciprofloxacin Sandoz

(b)omit from the column headed “Brand”: Profloxin

  1. Part 1 of Schedule 1, item dealing with Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

(a)insert in alphabetical order in the column headed “Brand”: APO-Clopidogrel

(b)insert in alphabetical order in the column headed “Brand”: Chem mart Clopidogrel

(c)insert in alphabetical order in the column headed “Brand”: Terry White Chemists Clopidogrel

  1. Part 1 of Schedule 1, after item dealing with Dasatinib in the form Tablet 70 mg

insert in the columns in the order indicated:

Tablet 100 mg Oral 60 2 Sprycel

  1. Part 1 of Schedule 1, item dealing with Diazepam in the form Tablet 5 mg

omit from the column headed “Brand”: Diazepam-DP

  1. Part 1 of Schedule 1, item dealing with Diclofenac in the forms Tablet (enteric coated) containing diclofenac sodium 25 mg and Tablet
    (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: Diclohexal     and substitute: Diclofenac Sandoz

  1. Part 1 of Schedule 1, item dealing with Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

insert in alphabetical order in the column headed “Brand”: Farine

  1. Part 1 of Schedule 1, item dealing with Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit from the column headed “Brand”: Fluoxetine-DP

  1. Part 1 of Schedule 1, after item dealing with Interferon Beta-1a in the form Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose
    pre-filled syringe

insert in the columns in the order indicated:

Solution for injection 132 micrograms in 1.5 mL multidose cartridge Injection 4 5 Rebif 44

  1. Part 1 of Schedule 1, item dealing with Irinotecan in the forms I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL and
    I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

insert in alphabetical order in the column headed “Brand”: Tecan

  1. Part 1 of Schedule 1, after items dealing with Labetalol

insert in the columns in the order indicated:

Lacosamide Tablet 50 mg Oral 14 1 Vimpat
Tablets 100 mg, 14 Oral 1 1 Vimpat
Tablet 100 mg Oral 56 5 Vimpat
Tablets 150 mg, 14 Oral 1 1 Vimpat
Tablet 150 mg Oral 56 5 Vimpat
Tablet 200 mg Oral 56 5 Vimpat

  1. Part 1 of Schedule 1, item dealing with Lansoprazole in the form Capsule 30 mg

(a)insert in alphabetical order in the column headed “Brand”: APO-Lansoprazole

(b)insert in alphabetical order in the column headed “Brand”: Lanzopran

  1. Part 1 of Schedule 1, after item dealing with Levodopa with Carbidopa and Entacapone in the form Tablet 50 mg-12.5 mg-200 mg

insert in the columns in the order indicated:

Tablet 75 mg-18.75 mg-200 mg

Oral

200

4

Stalevo 75/18.75/200mg

  1. Part 1 of Schedule 1, after item dealing with Levodopa with Carbidopa and Entacapone in the form Tablet 100 mg-25 mg-200 mg

insert in the columns in the order indicated:

Tablet 125 mg-31.25 mg-200 mg

Oral

200

4

Stalevo 125/31.25/200mg

  1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg

insert in alphabetical order in the column headed “Brand”: Metformin-GA

  1. Part 1 of Schedule 1, item dealing with Pantoprazole in the forms Tablet (enteric coated) 40 mg (as sodium sesquihydrate) and
    Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

insert in alphabetical order in the column headed “Brand”: Pantoprazole-GA

  1. Part 1 of Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg (as mesilate)

insert in alphabetical order in the column headed “Brand”: Pharmacor Paroxo 20

  1. Part 1 of Schedule 1, item dealing with Perindopril in the forms Tablet containing perindopril erbumine 2 mg, Tablet containing perindopril erbumine 4 mg and Tablet containing perindopril erbumine 8 mg

insert in alphabetical order in the column headed “Brand”: Perindopril-GA

  1. Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg

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

(b)insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 10

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 20

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 40

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 80

  1. Part 1 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Terbix 250

  1. Part 2 of Schedule 1, item dealing with Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

insert as next entry in the columns in the order indicated:

Oral powder 400 g (EleCare LCP)

In compliance with authority procedures set out in subparagraph 11 (d):

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

 Oral 8 5 EleCare LCP

  1. Part 2 of Schedule 1, item dealing with Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

(a)insert in alphabetical order in the column headed “Brand”: APO-Clopidogrel

(b)insert in alphabetical order in the column headed “Brand”: Chem mart Clopidogrel

(c)insert in alphabetical order in the column headed “Brand”: Terry White Chemists Clopidogrel

  1. Part 2 of Schedule 1, item dealing with Dabigatran etexilate

omit from the column headed “Form (strength, type, size, etc.)”:   Tablet (twice occurring)

and substitute:   Capsule

  1. Part 2 of Schedule 1, after item dealing with Dasatinib in the form Tablet 70 mg (second instance)

insert in the columns in the order indicated:

Tablet 100 mg

Chronic myeloid leukaemia

 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

 (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and

 (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

 (i) lack of response to initial imatinib therapy, defined as either:

 —  failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

 —  failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

 —  failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

 (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or

 (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or

 (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:

 (1) accelerated phase is defined by the presence of 1 or more of the following:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

 —  percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  peripheral basophils greater than or equal to 20%; or

 —  progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

 —  karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and

 (2) blast crisis is defined as either:

 —  percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

 —  extramedullary involvement other than spleen and liver; or

 (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or

 (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

 where the authority application includes:

 (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

 (b) a signed patient acknowledgement; and

 (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and

 (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or

 (2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

 for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

Oral

60

2

Sprycel

Tablet 100 mg

Chronic myeloid leukaemia

 In compliance with authority procedures set out in subsubparagraph 11 (d) (i):

 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

 where the following conditions apply:

 a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

 a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

 response to PBS-subsidised treatment with dasatinib is assessed by:

 (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

 (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

 the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

 (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

 (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

 the authority application includes:

 (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

 (2) demonstration of continued response to treatment as evidenced by:

 (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

 (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

 (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

 a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Oral

60

5

Sprycel

  1. Part 2 of Schedule 1, item dealing with Diazepam in the form Tablet 5 mg

omit from the column headed “Brand”: Diazepam-DP

  1. Part 2 of Schedule 1, item dealing with Lansoprazole in the form Capsule 30 mg

(a)insert in alphabetical order in the column headed “Brand”: APO-Lansoprazole

(b)insert in alphabetical order in the column headed “Brand”: Lanzopran

  1. Part 2 of Schedule 1, item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

insert in alphabetical order in the column headed “Brand”: Pantoprazole-GA

  1. Part 2 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg

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

(b)insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 10

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 20

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 40

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg

insert in alphabetical order in the column headed “Brand”: Pharmacor Simvastatin 80

  1. Part 2 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Terbix 250

  1. Part 2 of Schedule 1, after item dealing with Vancomycin

insert in the columns in the order indicated:

Zoledronic acid

Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

In compliance with authority procedures set out in subparagraph 11 (d):

Symptomatic Paget disease of bone, and where PBS-subsidised treatment is limited to 1 dose each year

Injection

1

..

Aclasta

  1. Part 1 of Schedule 2, item dealing with Diazepam in the form Tablet 5 mg

omit from the column headed “Brand”: Diazepam-DP

  1. Part 1 of Schedule 2, item dealing with Diclofenac in the forms Tablet (enteric coated) containing diclofenac sodium 25 mg and
    Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: Diclohexal         and substitute:    Diclofenac Sandoz

  1. Part 2 of Schedule 2, item dealing with Diazepam in the form Tablet 5 mg

omit from the column headed “Brand”: Diazepam-DP

  1. Part 2 of Schedule 2, item dealing with Diclofenac in the forms Tablet (enteric coated) containing diclofenac sodium 25 mg and
    Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: Diclohexal         and substitute:    Diclofenac Sandoz

  1. Part 1 of Schedule 3, item dealing with Diazepam in the form Tablet 5 mg

omit from the column headed “Brand”: Diazepam-DP

  1. Part 1 of Schedule 3, item dealing with Diclofenac in the forms Tablet (enteric coated) containing diclofenac sodium 25 mg and
    Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: Diclohexal         and substitute:    Diclofenac Sandoz

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