National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 97 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 97 of 2009

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

I, LINDA JACKSON, 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 2 October 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1 Commencement

This instrument commences on 1 November 2009.

2 Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1 Amendments

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 liquid 130 mL, 30 (MSUD Express Cooler)

Oral

MSUD Express Cooler

and substitute:

Oral liquid 130 mL, 30 (MSUD Cooler)

Oral

MSUD Cooler

Part 1 of Schedule 1, item dealing with Carvedilol in the forms Tablet 6.25 mg, Tablet 12.5 mg and Tablet 25 mg

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

Carvedilol Sandoz

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

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

Diclofenac-GA

Part 1 of Schedule 1, item dealing with Etanercept

omit from the column headed “Form”:

Injection 50 mg in 1 mL single use injection pen, 4

and substitute:

Injection 50 mg in 1 mL single use auto-injector, 4

Part 1 of Schedule 1, item dealing with Ezetimibe with Simvastatin

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

Tablet 10 mg-10 mg	Oral	30	5	Vytorin
Tablet 10 mg-20 mg	Oral	30	5	Vytorin

Part 1 of Schedule 1, item dealing with Frusemide in the form Injection 20 mg in 2 mL

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

Frusemide-Claris

Part 1 of Schedule 1, item dealing with Gemcitabine in the forms Powder for I.V. infusion 200 mg (as hydrochloride) and Powder for I.V. infusion 1 g (as hydrochloride)

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

Gemcitabine Actavis

Part 1 of Schedule 1, item dealing with Lansoprazole

omit from the columns in the order indicated:

Capsule 30 mg	Oral	30	1	Zoton
Sachet containing granules for oral suspension, 30 mg per sachet	Oral	28	1	Zoton

Part 1 of Schedule 1, item dealing with Naltrexone

omit from the column headed “Brand”:

Naltrexone QP

and substitute:

Naltrexone generichealth

Part 1 of Schedule 1, item dealing with Risperidone in the form Tablet 0.5 mg

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

Resdone 0.5

Part 1 of Schedule 1, item dealing with Risperidone in the form Tablet 1 mg

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

Resdone 1

Part 1 of Schedule 1, item dealing with Risperidone in the form Tablet 2 mg

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

Resdone 2

Part 1 of Schedule 1, item dealing with Risperidone in the form Tablet 3 mg

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

Resdone 3

Part 1 of Schedule 1, item dealing with Risperidone in the form Tablet 4 mg

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

Resdone 4

Part 1 of Schedule 1, item dealing with Terbutaline

omit from the columns in the order indicated:

Nebuliser solution containing terbutaline sulfate 5 mg in 2 mL single dose units, 30

Inhalation

Bricanyl Respules

Part 1 of Schedule 1, after item dealing with Tobramycin in the form Injection 80 mg (as sulfate) in 2 mL (without preservative)

insert in the columns in the order indicated:

Injection 500 mg (as sulfate) in 5 mL (without preservative)

Injection

Tobra-Day

Part 1 of Schedule 1, after item dealing with Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg

insert in the columns in the order indicated:

Tablet 320 mg-12.5 mg	Oral	28	5	Co-Diovan 320/12.5
Tablet 320 mg-25 mg	Oral	28	5	Co-Diovan 320/25

Part 1 of Schedule 1, item dealing with Voriconazole in the forms Tablet 50 mg and Tablet 200 mg

omit from the column headed “Maximum number of repeats”:

. .

and substitute:

2

Part 2 of Schedule 1, item dealing with Bortezomib

omit all text from the column headed “Purposes” and substitute:

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

Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with a histological diagnosis of multiple myeloma who has progressive disease after at least 1 prior therapy, who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily or who has failed to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease ; and

where progressive disease is defined as at least 1 of the following:

(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or

(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(f) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);

where oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein and less than 200 mg per 24 hour Bence-Jones proteinuria;

where thalidomide treatment failure is defined as:

(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or

(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;

where severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;

where toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or Grade 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity;

where failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:

(1) less than a 25% reduction in serum or urine M protein; or

(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels; and

where the following conditions apply:

the patient is not receiving concomitant PBS-subsidised lenalidomide;

the authority application includes:

(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and

(2) duration of thalidomide and daily dose prescribed; and

(3) a signed patient acknowledgment;

if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;

to enable confirmation of eligibility by the Medicare Australia CEO, current diagnostic reports of at least 1 of the following are required:

(a) the level of serum M protein (monoclonal protein); or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration;

as these parameters will be used to determine response, results of the above diagnostic reports must be provided with the authority application as follows:

(i) for all patients, results for (a) or (b) or (c) must be provided;

(ii) where the patient has oligo-secretory or non-secretory multiple myeloma, (c) or (d) or if relevant (e), (f) or (g) must be provided;

where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided

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

Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and

where the following conditions apply:

if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:

(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or

(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;

if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:

if serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:

(d) at least a 50% reduction in bone marrow plasma cells; or

(e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or

(f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or

(g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L;

the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;

a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment;

where a response assessment is not submitted to the Medicare Australia CEO prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib;

the authority application is made not later than 6 months after the application for initial treatment and includes:

(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and

(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;

patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS-subsidised treatment with bortezomib;

a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved

Part 2 of Schedule 1, item dealing with Etanercept

omit from the column headed “Form” (seven instances):

Injection 50 mg in 1 mL single use injection pen, 4

and substitute:

Injection 50 mg in 1 mL single use auto-injector, 4

Part 2 of Schedule 1, item dealing with Lansoprazole

omit from the columns in the order indicated:

Capsule 30 mg	Gastro-oesophageal reflux disease Scleroderma oesophagus	Oral	30	5	Zoton
Sachet containing granules for oral suspension, 30 mg per sachet	Gastro-oesophageal reflux disease Scleroderma oesophagus	Oral	28	5	Zoton
Sachet containing granules for oral suspension, 30 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor	Oral	28	1	Zoton
Sachet containing granules for oral suspension, 30 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor	Oral	28	5	Zoton

Part 2 of Schedule 1, item dealing with Risperidone in the form Tablet 0.5 mg

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

Resdone 0.5

Part 2 of Schedule 1, item dealing with Risperidone in the form Tablet 1 mg

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

Resdone 1

Part 2 of Schedule 1, item dealing with Risperidone in the form Tablet 2 mg

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

Resdone 2

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

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

Diclofenac-GA

Part 2 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

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

Diclofenac-GA

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

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

Diclofenac-GA