National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Special Authority Program (No. PB 37 of 2005)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)

SPECIAL AUTHORITY PROGRAM

No. PB 37 of 2005

I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with imatinib mesylate, being a drug or medicinal preparation declared under subsection 85(2) of the National Health Act 1953:

Commencement

1. (a) These Arrangements commence on 1 December 2005.

(b) The Arrangements made on 26 July 2005 with effect from 1 August 2005

(No. PB 23 of 2005) are repealed with effect from the commencement of these Arrangements.

Definitions

2. In these Arrangements:

(a) unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;

(b) “Act” means the National Health Act 1953;

(c) “approved supplier” includes a public hospital that is not participating in the arrangements set out in Appendix F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards;

(d) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia ;

(e) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.

3. Except where otherwise specified in these Arrangements, the provisions of the Act, the Regulations and the declarations, determinations and other instruments made under Part VII of the Act and under the Regulations will apply to the prescribing and supply of imatinib mesylate.

Entitlement to receive imatinib mesylate under these Arrangements

4. Subject to these Arrangements, a person who:

(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and

(b) is receiving medical treatment by a medical practitioner;

is entitled to receive imatinib mesylate under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraph 17.

Prescriptions for imatinib mesylate

5. The writing of a prescription for the supply of imatinib mesylate as a special pharmaceutical product under these Arrangements is authorised only in the circumstances specified in Schedule 1 or Schedule 2.

6. These Arrangements apply to imatinib mesylate for oral administration in the following forms and marketed under the following brands:

Form (strength, type, size, etc.) Proprietary name Manufacturer

Tablet 100 mg (base) (pack of 60) Glivec Novartis Pharmaceuticals Australia Pty Ltd

Tablet 400 mg (base) (pack of 30) Glivec Novartis Pharmaceuticals Australia Pty Ltd

7. Subject to paragraph 12, the maximum quantity that may be prescribed on a prescription for imatinib mesylate is:

(a) in respect of the tablet 100 mg, 3 packs of 60 tablets (unless the prescription is for the first 3 months of treatment of a previously untreated patient with a metastatic or unresectable malignant gastrointestinal stromal tumour, in which case the maximum quantity that may be prescribed is 2 packs);

(b) in respect of the tablet 400 mg, 1 pack of 30 tablets.

8. Subject to paragraph 13, the maximum number of repeats that may be prescribed on a prescription for imatinib mesylate is:

(a) 5, in the case of a prescription for the treatment of the chronic phase of chronic myeloid leukaemia; or

(b) 2, in the case of a prescription for the treatment of the accelerated phase of chronic myeloid leukaemia or the blast phase of chronic myeloid leukaemia; or

(c) 2, in the case of a prescription for the treatment of a metastatic or unresectable malignant gastrointestinal stromal tumour.

9. (1) Subject to subparagraph (2), a medical practitioner who wishes to prescribe imatinib mesylate under these Arrangements must:

(a) prepare and sign a prescription for imatinib mesylate:

(i) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or

(ii) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubparagraph (i); or

(iii) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

(iv) by a method approved in writing by the Secretary; and

(b) submit the prescription and, where appropriate, the material specified in Schedule 1 or Schedule 2:

(i) by sending it to the following address:

Medicare Australia

Prior Written Approval of Specialised Drugs

Reply Paid 9826

GPO Box 9826

Hobart Tasmania 7001; or

(ii) in the case of continuing treatment for a metastatic or unresectable malignant gastrointestinal stromal tumour, or continuing treatment for the accelerated phase of chronic myeloid leukaemia or the blast phase of chronic myeloid leukaemia, submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subparagraph (1)(a);

(2) Where the appropriate Imatinib Mesylate (Glivec) PBS Authority Application – Supporting Information Form approved by the Medicare Australia CEO is completed by the medical practitioner, it will not be necessary for the medical practitioner to complete the triplicate copy of the prescription referred to in subparagraph 1(a).

Authorisation of prescriptions for imatinib mesylate

10. The authorisation of a prescription submitted under paragraph 9 may be made:

(a) if the prescription was submitted in accordance with subparagraph 9(1)(a) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or

(ii) in any other case:

(A) by returning it to the medical practitioner; or

(B) by sending it to the person in respect of whom it was prepared; or

(b) if the prescription was submitted in accordance with subsubparagraph 9(1)(b)(ii) — verbally, at the time the Medicare Australia CEO is given details of the prescription.

11. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 10(b):

(a) the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to the authorised prescription; and

(b) the medical practitioner must:

(i) mark that number on the prescription; and

(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

12. Regulation 13 of the Regulations applies to the prescribing of imatinib mesylate only to the extent that:

(a) in respect of the tablet 100 mg, the Medicare Australia CEO may authorise a quantity of 4 of the pack of 60 tablets for the treatment of patients in the accelerated phase or the blast phase of chronic myeloid leukaemia;

(b) in respect of the tablet 400 mg, the Medicare Australia CEO may authorise a quantity of 2 of the pack of 30 tablets for the treatment of patients in the accelerated phase or the blast phase of chronic myeloid leukaemia.

13. The Medicare Australia CEO must not authorise the supply of imatinib mesylate tablets to be repeated in respect of a prescription for a foreign person who is entitled to be treated as an eligible person within the meaning of the Health Insurance Act 1973 under section 7 of that Act.

14. Regulation 24 of the Regulations applies to the supply of imatinib mesylate as if the quantity or number of units of imatinib mesylate tablets authorised by the Medicare Australia CEO under paragraph 10 or 11 were the maximum quantity or number of units applicable in relation to a pharmaceutical benefit in accordance with a determination of the Minister under paragraph 85A(2)(a) of the Act.

15. Regulation 25 of the Regulations applies to the supply of imatinib mesylate as if it were a pharmaceutical benefit in relation to which the Minister has determined, under paragraph 85A(2)(b) of the Act, that the maximum number of occasions on which the supply of the benefit may, in one prescription, be directed to be repeated is more than 4.

Supplier of imatinib mesylate under these Arrangements

16. Imatinib mesylate may be supplied:

(a) by an approved pharmacist; or

(b) by an approved medical practitioner; or

(c) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor; or

(d) by a public hospital that is not participating in the arrangements set out in Appendix F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards.

Cost to patient of imatinib mesylate under these Arrangements

17. An approved supplier that supplies imatinib mesylate may charge the person to whom the drug is supplied an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the person.

Payment to supplier of imatinib mesylate under these Arrangements

18. An approved supplier that has supplied imatinib mesylate is entitled to be paid by the Commonwealth as if paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in PB No. 35 of 2005 applies to imatinib mesylate.

Dated this twenty third day of November 2005.

JOAN CORBETT

Assistant Secretary

Pharmaceutical Benefits Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

Initial treatment for adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour

Initial treatment subsidised under the Pharmaceutical Benefits Scheme (PBS), for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining.

Patients who have not previously been treated with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour must commence treatment at a dose not exceeding 400 mg per day for at least 3 months. Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.

Patients who have previously been treated with non-PBS-subsidised imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour are eligible to receive up to 3 months treatment at a dose of up to 600 mg per day.

Authorisation process of prescriptions for imatinib mesylate for initial treatment of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and

(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease; and

(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim; and

(iv) for patients who commenced treatment with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour prior to 1 December 2004, the date on which therapy with imatinib mesylate was commenced.

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Continuing treatment for adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour

Continuing treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug.

Initial treatment of patients in the chronic phase of chronic myeloid leukaemia

Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia.

Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy from the date the first application for initial treatment was approved.

Authorisation process of prescriptions for imatinib mesylate for intial treatment of patients in the chronic phase of chronic myeloid leukaemia

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia – Supporting Information form; and

(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative polymerase chain reaction (PCR) report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and

(4) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that:

(i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment [see Note defining major cytogenetic response]; or

(ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved [see Note defining major cytogenetic response].

NOTE:

Imatinib mesylate in the chronic phase of chronic myeloid leukaemia will only be subsidised for patients who are not receiving concomitant PBS-subsidised interferon alfa therapy.

Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily and maintained on a minimum dose of imatinib mesylate of 400 mg (base) daily. Prescribing of lower doses should be carefully considered. Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter, irrespective of the daily imatinib mesylate dose received.

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Continuing treatment of patients in the chronic phase of chronic myeloid leukaemia

Continuing treatment of patients who have received initial treatment with imatinib mesylate as a special pharmaceutical product for the chronic phase of chronic myeloid leukaemia and who have demonstrated a major cytogenetic response in the preceding 12 months.

Authorisation process of prescriptions for imatinib mesylate for continuing treatment of patients in the chronic phase of chronic myeloid leukaemia

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) demonstration of continued response to treatment as evidenced by major cytogenetic response [see Note explaining requirements]. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.

NOTE:

Definition of response.

A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.

Authority approval requirements.

For the purposes of assessing response to PBS-subsidised treatment with imatinib mesylate, cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping must be submitted. Where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr-abl specific probe or quantitative PCR must be submitted. The cytogenetic analyses must be submitted as follows:

(i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response has been demonstrated may receive authorisation for a further 12 months of treatment; and

(ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response at between 10 and 12 months (patients in whom a major cytogenetic response is demonstrable by 18 months may also receive authorisation for a further 12 months of treatment); and

(iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response has been sustained.

For each authority application where eligibility for continuing PBS-subsidised treatment is to be demonstrated, a copy of the cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping must be submitted as described in (i) to (iii) above, unless, at the time of the authority application, the standard karyotyping is not informative. Where the standard karyotyping conducted at the time of application is not informative, a copy of a cytogenetic analysis conducted on the bone marrow using either FISH with bcr-abl specific probe or quantitative PCR must be submitted with the authority application. For patients in whom cytogenetic status is determined on the basis of bcr-abl transcript level measured by quantitative PCR performed on the bone marrow, continuation of treatment will be authorised irrespective of changes to bcr-abl transcript levels. A copy of the non-informative standard karyotype analysis must be included with the authority application.

For patients in whom failure to obtain a bone marrow sample (dry tap) has occurred on 2 separate consecutive occasions at any point described in (i) to (iii) above and at no greater than 2 months between each attempt, results of a quantitative PCR analysis of peripheral blood providing bcr-abl transcript levels will be accepted as the basis for continuing therapy thereafter. The first application for continuing treatment for patients in whom there has been a failure to obtain bone marrow samples on 2 separate consecutive occasions, must include 2 pathology reports demonstrating failure to obtain an adequate bone marrow sample. In cases where pathology reports are not obtainable, a statement from the treating specialist that no bone marrow sample could be obtained from 2 separate attempts will be accepted. A pathology report from an Approved Pathology Authority providing the results of the quantitative PCR analysis of peripheral blood must also be submitted and must clearly state the level of bcr-abl transcript which reliably corresponds to less than 35% Philadelphia positive bone marrow cells.

Where a patient has previously received PBS-subsidised treatment with imatinib mesylate, no approval will be granted for PBS-subsidised re-treatment in the chronic phase of chronic myeloid leukaemia, where that patient has at any time failed to meet the criteria for continuing treatment.

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Initial treatment of patients in the accelerated phase of chronic myeloid leukaemia

Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia. Progress to the accelerated phase is defined by the presence of 1 or more of the following:

(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

(3) Peripheral basophils greater than or equal to 20%; or

(4) 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

(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).

Authorisation process of prescriptions for imatinib mesylate for initial treatment of patients in the accelerated phase of chronic myeloid leukaemia

Applications for authorisation must be in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and

(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly.

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Initial treatment of patients in the blast phase of chronic myeloid leukaemia

Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia. Progress to myeloid blast crisis is defined as either:

(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

(2) Extramedullary involvement other than spleen and liver.

Authorisation process of prescriptions for imatinib mesylate for initial treatment of patients in the blast phase of chronic myeloid leukaemia

Applications for authorisation must be in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and

(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement.

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Continuing treatment of patients in the accelerated or blast phase of chronic myeloid leukaemia

Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of:

(i) the accelerated phase of chronic myeloid leukaemia; or

(ii) the blast phase of chronic myeloid leukaemia.