National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 96 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 96 of 2009

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 2 October 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1 Commencement

This instrument commences on 1 November 2009.

2 Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1 Amendments

[1]Schedule 1, item dealing with Bortezomib

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

In compliance with authority procedures set out in subsubparagraph 14 (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 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; 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:

(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value;

if serum M protein and urine Bence-Jones protein levels 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 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorization of further treatment;

where a response assessment is not submitted to the Medicare Australia CEO prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib;

the authority application is made not later than 10 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;

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;

PBS-subsidised treatment with bortezomib is limited to a maximum of 11 cycles

In compliance with authority procedures set out in subsubparagraph 14 (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 14 (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

[2]Schedule 1, item dealing with Ciprofloxacin

omit from the column headed “Circumstances”:

In respect of the ear drops 3 mg (as hydrochloride) per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older

and substitute:

In respect of the ear drops 3 mg (as hydrochloride) per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older

Treatment of chronic suppurative otitis media in a patient less than 18 years of age with perforation of the tympanic membrane

Treatment of chronic suppurative otitis media in a patient less than 18 years of age with a grommet in situ

[3]Schedule 1, item dealing with Ezetimibe with Simvastatin

omit from the column headed “Circumstances”:

In compliance with authority procedures set out in subparagraph 14 (d):

and substitute in the columns in the order indicated:

In respect of the tablet 10 mg-10 mg and tablet 10 mg-20 mg: In compliance with authority procedures set out in subparagraph 14 (d):
2431	For use in accordance with paragraph 16 in patients with homozygous familial hypercholesterolaemia
3194	For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) must be reduced to a dose of 20 mg or less per day because the patient developed a clinically important product-related adverse event during treatment with a statin, and where a clinically important product-related adverse event is defined as follows:
(i) severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
In respect of the tablet 10 mg-40 mg and tablet 10 mg-80 mg: In compliance with authority procedures set out in subparagraph 14 (d):

[4]Schedule 1, item dealing with Lansoprazole

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

In respect of the tablet 30 mg (orally disintegrating):

Initial treatment of peptic ulcer

Gastro-oesophageal reflux disease

Scleroderma oesophagus

In respect of the capsule 15 mg:

Gastro-oesophageal reflux disease

Scleroderma oesophagus

[5]Schedule 1, item dealing with Terbutaline

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

―

[6]Schedule 1, item dealing with Thyrotropin Alfa

omit all text and substitute in the columns in the order indicated:

Thyrotropin Alfa	In compliance with authority procedures set out in subparagraph 14 (d):
3193	Ablation of thyroid remnant tissue, in combination with radioactive iodine, in a post thyroidectomy patient without known metastatic disease

[7]Schedule 1, item dealing with Tobramycin

omit from the column headed “Circumstances”:

In respect of the eye drops 3 mg per mL, 5 mL and eye ointment 3 mg per g, 3.5 g:

Invasive ocular infection

Perioperative use in ophthalmic surgery

Suspected pseudomonal eye infection

and substitute:

In respect of the injection 500 mg (as sulfate) in 5 mL (without preservative):

Systemic treatment of Pseudomonas aeruginosa infection in a patient with cystic fibrosis

In respect of the eye drops 3 mg per mL, 5 mL and eye ointment 3 mg per g, 3.5 g:

Invasive ocular infection

Perioperative use in ophthalmic surgery

Suspected pseudomonal eye infection

[8]Schedule 6, after Lanreotide

insert:

Lenalidomide