National Health Act 1953 Amendment Special Arrangements under subsection 100(1) Highly specialised drugs program for public hospitals (No. PB 116 of 2009) (Cth)

Amendment Special Arrangements —Highly specialised drugs program for public hospitals

(PB 116 of 2009)

made under subsection 100(1) of the

National Health Act 1953

I, CHRIS BEDFORD, Acting 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 18 November 2009

Signed

CHRIS BEDFORD
Acting Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program for public hospitals

1 Commencement

This instrument commences on 1 December 2009.

2 Amendment of PB 61 of 2009

Schedule 1 amends PB 61 of 2009.

Schedule 1 Amendments

Paragraph 17

omit subparagraphs (b) and (c) and substitute:

(b) in the case of a prescription for "cinacalcet", a quantity of number of units of the drug sufficient to provide for up to 4 weeks treatment at a dose of 30 to 180 mg per day;

(c) in the case of a prescription for "natalizumab", a quantity of number of units of the drug sufficient to provide the supply of a single infusion.

Paragraph 20

omit subparagraph (a) and substitute:

(a)in the case of a prescription for “ambrisentan”, "bosentan", "clozapine", “epoprostenol”, "etanercept", "iloprost", "sildenafil" and "sitaxentan", the supply of a quantity of number of units of the highly specialised drug sufficient for up to 1 month of treatment with the drug;

omit subparagraph (f) and substitute:

(f) in the case of a prescription for “abatacept”, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose;

(g) in the case of a prescription for "lenalidomide", the supply of a quantity of number of units of the highly specialised drug sufficient for up to 21 days treatment with the drug.

Paragraph 22

omit subparagraph (k) and substitute:

(k) in the case of a prescription for “rituximab”, 1 repeat supply;

(l) in the case of a prescription for "ambrisentan" for initial PBS-subsidised treatment of patients who were receiving non-PBS-subsidised treatment with ambrisentan for less than 6 months prior to 1 December 2009, sufficient repeat supplies of the drug to allow the patient to complete a period of combined PBS-subsidised and non-PBS-subsidised therapy of up to 6 months duration in total;

(m) in the case of a prescription for "lenalidomide”, up to 2 repeat supplies may be authorised.

Schedule 1, after item dealing with Adefovir

insert in the columns in the order indicated:

Ambrisentan	Initial treatment 1 (new patients)
Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment 2 (new patients)
Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; or
(c) WHO Functional Class IV primary pulmonary hypertension; or
(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment (previous treatment not PBS-subsidised)
Initial PBS-subsidised treatment with ambrisentan of patients who were receiving treatment with ambrisentan prior to 1 December 2009 and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension; or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; or
(c) WHO Functional Class IV primary pulmonary hypertension; or
(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) for patients who have received less than 6 months of ambrisentan treatment at the time of application — a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT) at the time treatment with ambrisentan was commenced, or, where results from all 3 of the tests are not available or it was not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) the date of commencement of ambrisentan treatment; and
(3) a signed patient acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(4) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
for patients who have received less than 6 months of non-PBS-subsidised ambrisentan treatment at the time of application — the maximum duration of treatment which will be authorised under this criterion is sufficient to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy;
if the duration of treatment authorised for the written application under this criterion is less than that to which the patient is entitled, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete the maximum allowable duration of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment (change or re-commencement for all patients)
Initial treatment with ambrisentan of patients:
(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised ambrisentan after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with ambrisentan; or
(b) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with an alternate PAH agent other than ambrisentan; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and
(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Continuing treatment (all patients)
Continuing PBS-subsidised treatment with ambrisentan of patients who have received approval for initial PBS-subsidised treatment with ambrisentan and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of ambrisentan treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Definitions
For the purpose of PBS-subsidised supply of ambrisentan for the circumstances specified above:
“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium
Primary pulmonary hypertension and pulmonary arterial hypertension secondary to connective tissue disease are defined as:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
Response to ambrisentan or prior vasodilator treatment is defined:
(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iv) for patients aged less than 18 years – as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

Schedule 1, items dealing with Bosentan, Epoprostenol and Iloprost

omit the following text under the heading “Definitions” from the column headed “Circumstances”:

“PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

and substitute:

“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

Schedule 1, item dealing with Lenalidomide

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

Initial PBS-subsidised treatment, as monotherapy or in combination with dexamethasone, 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 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 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 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

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) 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)

Schedule 1, items dealing with Sildenafil and Sitaxentan

omit the following text under the heading “Definitions” from the column headed “Circumstances”:

“PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

and substitute:

“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

Schedule 1, item dealing with Tenofovir

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

Treatment, as sole PBS-subsidised therapy, of chronic hepatitis B in a patient who is nucleoside analogue naive and satisfies all of the following criteria:

(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);

(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or

(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;

(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

Persons 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

Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:

(1)(a) 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

(b) 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;

(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

Schedule 2, after item dealing with Adefovir

insert in the columns in the order indicated:

Ambrisentan	Tablet 5 mg	Oral	Volibris
Tablet 10 mg	Oral	Volibris