Hospital Circulars

Hospital Circular 33/2002

Date Issued: 18 October 2002

Publication: 33/2002

Distribution: Public Hospitals

Subject: Pharmaceuticals - Imatinib Mesylate (Glivec)

Purpose: To advise of arrangements for the prescribing,supply and claiming of Imatinib Mesylate (Glivec), effective 21 October 2002

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We have had recent advice from the Commonwealth of arrangements for the prescribing and supply of Imatinib Mesylate (Glivec), effective 21 October 2002.

Advice from the Commonwealth:

From 21 October 2002, Glivec will be available under section 100 arrangements as an ‘Authority Required’ pharmaceutical benefit, for second line treatment of patients who are in the chronic phase of chronic myeloid leukaemia (CML) expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase.

Glivec for the treatment of new patients who are in either the accelerated or blast phases of CML will commence under section 100 arrangements effective 21 October 2002. All prescriptions for Glivec on and from that date will be assessed under the new section 100 arrangements. Patients with prescriptions written for the blast or accelerated phases prior to 21 October 2002 may continue to access the subsidy through the general schedule until 31 January 2003.

Prescribers will be required to make written application to the Health Insurance Commission (HIC) for approval to prescribe Glivec as a pharmaceutical benefit. Prescribers will also be required to make written application to HIC from 1 February 2003 for those prescriptions approved prior to 21 October 2002 that have not been supplied.

WHO CAN ACCESS GLIVEC?

• Initial treatment (for up to 18 months) of adult patients in the chronic phase of chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase, where:
  1. treatment with Glivec was commenced prior to 1 September 2002; or
  2. prior treatment with interferon-alfa has failed.
  Evidence of failure of prior treatment with interferon-alfa is specified in the section 100 restriction (attached) of the Schedule of Pharmaceutical Benefits.
  
• Continuing treatment of adult patients who have received initial treatment with Glivec as a pharmaceutical benefit for the chronic phase of chronic myeloid leukemia and have demonstrated a major cytogenetic response in the preceding 12 months.
  Major cytogenetic response is defined in the section 100 restriction (attached) of the Schedule of Pharmaceutical Benefits.
• Treatment of adult patients in the accelerated phase of chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase. Progress to the accelerated phase is defined in the section 100 restriction (attached) of the Schedule of Pharmaceutical Benefits.
• Treatment of adult patients in the blast phase of chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase. Progress to myeloid blast phase is defined in the section 100 restriction (attached) of the Schedule of Pharmaceutical Benefits.
• Continuing treatment of adult patients with chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with Glivec of:
  1. the blast phase of chronic myeloid leukemia; or
  2. the accelerated phase of chronic myeloid leukemia.

Contact HIC on 1800 242 679 for advice on prescribing Glivec

WHO CAN PRESCRIBE GLIVEC?

• There is no restriction on prescriber, however it is expected that specialist haematologists will account for most of the prescriptions written for Glivec.
  
• Non-specialist hospital staff and GPs can prescribe maintenance therapy, under usual specialist/GP arrangements.
  
• All prescribers will require a PBS prescriber number available from the Health Insurance Commission.

Contact HIC on 132 150 for information on obtaining a PBS prescriber number.

HOW DO PRESCRIBERS APPLY FOR GLIVEC AUTHORITY APPROVAL?

• Prescribers need to make written application to HIC for authority approval by completing the appropriate forms.
  
• Prescribers will be required to provide to HIC a completed authority prescription form and a completed Glivec Authority Application form, a completed Patient Agreement form, and copies of the relevant pathology reports as specified in the section 100 restrictions.
  
• HIC will assess each application individually.
  
• Once approved, the authorised prescription will be returned to the prescriber or sent direct to the patient, as indicated by the prescriber on the authority prescription form.
  
• Please allow one week for return of authorised prescriptions from HIC.
  
• Authority applications to prescribe Glivec as a pharmaceutical benefit must be posted to –
  Health Insurance Commission
  Prior Written Approval of Specialised Drugs
  Reply Paid 76335
  MELBOURNE VIC 3000
  
• Note: Authority applications to prescribe Glivec can not be faxed to HIC

Contact HIC on 1800 242 679 for information on submitting authority application forms.

HOW TO OBTAIN GLIVEC APPLICATION FORMS AND AUTHORITY PRESCRIPTION PADS

• The HIC Glivec Authority Application form and the Patient Agreement form can be downloaded from the HIC website www.hic.gov.au/providers/forms then use the quick links facility to locate the Glivec information by keying glivec into the quick links box and pressing enter. This information will be available from 21 October or can be provided by fax on request.
  
• PBS Authority prescription pads will be provided by HIC on request.

Contact HIC on 1800 242 679 to request Glivec Authority Application forms and Patient Declaration forms to be provided to prescriber by fax.

Contact HIC on 132 150 to request PBS Authority prescription pads.

HOW OFTEN WILL HIC APPLICATION FORMS NEED TO BE COMPLETED AND SUBMITTED?

• For initial treatment of adult patients in the chronic phase of chronic myeloid leukemia, prescribers will need to submit a completed authority prescription form, a completed Glivec Authority Application form, a completed Patient Agreement form, and a copy of the relevant pathology report as specified in the section 100 restriction:
  • at the commencement of initial treatment, for an original prescription for one month’s therapy plus up to five repeats.
• After six months a completed authority prescription form will need to be submitted for a further one month’s therapy plus up to five repeats.
  
• Where the patient demonstrates a major cytogenetic response within 12 months of commencing initial treatment, a completed authority prescription form and relevant pathology report (or date of report if already supplied) will need to be submitted for a further 12 months treatment;
  • a completed authority prescription form and relevant pathology report (or date of report if already supplied) will need to be submitted thereafter at no more than 12 months intervals to demonstrate that the major cytogenetic response has been maintained.
• Where the patient has failed to demonstrate a major cytogenetic response within 12 months of commencing initial treatment, a completed authority prescription form will need to be submitted for a further one month’s therapy plus up to 5 repeats.
  • at the end of that further 6 months Glivec will cease as a pharmaceutical benefit for the chronic phase of CML, unless the patient demonstrates a major cytogenetic response.
• For the treatment of patients in the accelerated or blast phases of chronic myeloid leukemia, prescribers will need to submit a completed authority prescription form, a completed Glivec Authority Application form, and a copy of the pathology report specified in the section 100 restriction.
  
• For continuing treatment of adult patients in the accelerated or blast phases of chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript bcr-abl tyrosine kinase, prescribers will need to apply for repeat authorisation every three months.

DISPENSING ARRANGEMENTS

• Only Glivec Authority prescriptions approved by HIC will be subsidised as a pharmaceutical benefit.
  
• Approved prescriptions will have a 7 digit authority form number (located in the top right hand corner of the form).
  
• Dispensing pharmacies (both hospital and community) need to ensure that Glivec Authority prescriptions being presented have an authority number.

HOW WILL PHARMACIES OBTAIN SUPPLIES OF GLIVEC?

• Hospital pharmacies will place orders for supplies of Glivec direct to the manufacturer, Novartis Pharmaceuticals Australia Pty Ltd.

Contact Novartis on 1800 064 713 for details of supply arrangements.

PAYMENT ARRANGEMENTS FOR PUBLIC HOSPITALS

• Payment is via the HIC PBS payment system.
  
• Hospitals participating in pharmaceutical reform are advised that payment will be via the hospital’s existing HIC PBS payment system. After dispensing, claim direct from HIC electronically.
  
• Non-participating hospitals should batch dispensed prescriptions together and post to HIC together with the hospital claim for payment form as a manual claim. PBS dispensing or claiming software is not required.
  
• HIC will then reconcile authorisations with supply using hospital approval numbers.
  
• Alternatively, patients can be provided with the authorised prescription form to take to a community pharmacy to be dispensed.

ARRANGEMENTS FOR PUBLIC HOSPITAL REPEAT PRESCRIPTIONS

• Repeat prescriptions can be filled by public hospital or community pharmacies.
  
• Repeat authority prescriptions can be written on forms available from HIC.
  
• The HIC PBS payment system requires repeat authorisation forms to be used.
  

Contact HIC on 132 290 to arrange for authority prescription forms

PATIENT COPAYMENT

• PBS general and concessional patient copayments will apply to Glivec.

Further information concerning arrangements to prescribe and supply Imatinib Mesylate (Glivec) should be made directly to the Health Insurance Commission on 1800 242 679. Forms are available on the medicare website.

Mr Peter Donnelly
Director, Funding and Financial Policy
Metropolitan Health and Aged Care Services