National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 101 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 101 of 2009

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 8 October 2009

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 November 2009.

2              Amendment of PB 54 of 2009

Schedule 1 amends PB 54 of 2009.

Schedule 1                   Amendments

1. Paragraph 11AA

omit subparagraph (c) and substitute:

(c)in the case of the highly specialised drug "rituximab"; or

(d)in the case of the highly specialised drug “lenalidomide”, unless the prescription is for continuing PBS-subsidised treatment in a patient who has previously been issued with an authority prescription for lenalidomide.  In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i).

1. Schedule 1, item dealing with Dornase Alfa

insert after existing text in the column  headed “Circumstances”:

Treatment of cystic fibrosis in a patient less than 5 years of age who has:

(1) A severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring frequent hospital admissions more frequently than 3 times per year; or

(2) Significant bronchiectasis on chest high resolution computed tomography scan; or

(3) Severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or

(4) Severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.

In order for the patient to be eligible for participation in the highly specialised drugs program, the following conditions must be met:

(1) The patient must be assessed at a cystic fibrosis clinic/centre which is under the supervision of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis, and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. Further reassessments are to be undertaken and documented yearly.

Continuation of treatment of cystic fibrosis in a patient 5 years of age or older, who initiated treatment with dornase alfa at an age of less than 5 years and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

Treatment of cystic fibrosis in a patient less than 5 years of age who initiated treatment with dornase alfa prior to 1 November 2009 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

1. Schedule 1, item dealing with Etanercept

omit from the column headed “Circumstances”:

Juvenile chronic arthritis — initial treatment

(previous treatment not PBS-subsidised)

Initial PBS-subsidised supply for continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002, whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and

where the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment

1. Schedule 1, item dealing with Etanercept

omit from the column headed “Circumstances”:

In respect of the injections 50 mg in 1 mL single use pre-filled syringes, 4:

and substitute:

In respect of the injections 50 mg in 1 mL single use pre-filled syringes, 4 and the

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

1. Schedule 1, after item dealing with Lanthanum

insert in the columns in the order indicated:

Lenalidomide

Initial PBS-subsidised treatment, as monotherapy or in combination with dexamethasone, of multiple myeloma in a patient who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), 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; and

where thalidomide treatment failure is defined as:

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

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

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)  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

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

(e)  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

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

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 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity; and

where the following conditions apply:

the patient is not receiving concomitant PBS-subsidised bortezomib;

the authority application is made in writing and includes:

(1)  a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of 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; and details of the basis of the diagnosis of progressive disease; 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 the following are required:

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

(b)  if Bence-Jones proteinuria is present, the results of 24-hour urinary light chain M protein excretion;

if neither serum M protein nor urine Bence-Jones protein is present in measurable quantities, additional diagnostic reports are required, including:

(c)  bone marrow aspirate and trephine; and

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

(e)  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

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

(g)  if present, the serum free light chain levels;

results of the above diagnostic reports must be provided with the authority application as follows:

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

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

(iii)  in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, (g) must be provided;  

where results for 1 or more of the specified diagnostic reports cannot be provided, the authority application states the reason or reasons these cannot be provided

Continuing PBS-subsidised treatment, as monotherapy or in combination with dexamethasone, of multiple myeloma in a patient who has previously been issued with an authority prescription for lenalidomide and who does not have 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)  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

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

(e)  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

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

1. Schedule 2, after item dealing with Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

insert in the columns in the order indicated:

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in        10 mL pre-filled syringe Injection Apomine PFS

1. Schedule 2, item dealing with Atazanavir

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

Capsule 100 mg (as sulfate) Oral Reyataz

1. Schedule 2, item dealing with Etanercept

omit from the columns in the order indicated:

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

and substitute:

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

1. Schedule 2, after items dealing with Lanthanum

insert in the columns in the order indicated:

Lenalidomide	Capsule 5 mg	Oral	Revlimid
Capsule 10 mg	Oral	Revlimid
Capsule 15 mg	Oral	Revlimid
Capsule 25 mg	Oral	Revlimid

1. Schedule 2, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Injection/oral	Pegasys RBV

1. Schedule 3, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms