Multiple myeloma

Authority to supply bortezomib (Velcade®) and lenalidomide (Revlimid®) through the Pharmaceutical Benefits Scheme (PBS) under Section 85 and Section 100 of the National Health Act 1953 for the treatment of patients with multiple myeloma.

Section 100 arrangements—for lenalidomide

This item is only available to a patient who is attending:

• an approved private hospital
• a public participating hospital

or

• a public hospital

and is a

• day admitted patient
• non-admitted patient

or

• a patient on discharge.

This item is not available as a PBS subsidised medicine for in-patients of the hospital. The hospital provider number must be included on the application form.

Restriction details

Initial PBS subsidised treatment

View a full transcript of the restriction details

Continuation of PBS subsidised treatment

Bortezomib

Beyond four cycles:

• to assess eligibility for continuing PBS subsidised bortezomib treatment beyond four cycles, the patient must have achieved at least a partial response at the completion of cycle four
• the results of the response assessment must be included in a written application to Medicare Australia for further treatment. Where a response assessment is not submitted before cycle five, patients will be deemed to have failed to respond to treatment with bortezomib
• continuing PBS subsidised supply will not be approved if there is more than six months between the initial application and subsequent application.

Beyond eight cycles:

• to assess eligibility for continuing PBS subsidised bortezomib treatment beyond eight cycles, the patient must have achieved at least a partial response at the completion of cycle eight
• the results of the response assessment must be included in a written application to Medicare Australia for further treatment. Where a response assessment is not submitted before cycle nine, patients will be deemed to have failed to respond to treatment with bortezomib
• continuing PBS subsidised supply will not be approved if there is more than 10 months between the initial application and an application following completion of eight treatment cycles.

Complete response:

• no more than two cycles of treatment after the cycle in which the complete response was confirmed will be authorised
• confirmation requires two determinations, a minimum of six weeks apart.

Applications for PBS subsidised treatment with bortezomib that extend beyond 11 cycles will not be approved.

Lenalidomide

Continuation of PBS subsidised treatment with lenalidomide, as monotherapy or in combination with dexamethasone, of multiple myeloma, in a patient who does not have progressive disease, may be obtained by phone call 1800 700 270** (option 1) between 8.00am and 5.00pm EST, Monday to Friday.

Item detail

Dose

Bortezomib

Bortezomib is available as a single dose vial which contains 38.5 mg of powder (3.5 mg bortezomib) for injection.

The recommended dose of bortezomib is 1.3 mg/m²/dose administered as a 3–5 second bolus intravenous injection twice weekly for two weeks (days one, four, eight, and 11) followed by a 10 day rest period (days 12–21). This three week period is considered a treatment cycle. At least 72 hours should elapse between consecutive doses of bortezomib.

Lenalidomide

Lenalidomide is available as 5 mg, 10 mg, 15 mg or 25 mg capsules in a pack size of 21.  The recommended starting dose of lenalidomide is 25 mg orally once daily on days one to 21 of repeated 28 day cycles.

An authority prescription should be written for the strength required, a quantity of 21 capsules and up to two repeats.

Note: lenalidomide is a category x medicine and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least four weeks following cessation of treatment with this medicine.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for subsidised medicines.

Who is eligible for the PBS?

Reciprocal Health Care Agreement

Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply of lenalidomide will be limited to the original prescription only. Repeat prescriptions for lenalidomide are not permitted.

Lodgement

The address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information call 1800 700 270** (option 1) between 8.00am and 5.00pm EST Monday and Friday.

Application forms

• Multiple myeloma – initial PBS authority application (form 4203) [PDF, 341Kb]
  Lodge this form for a patient starting initial PBS subsidised treatment of multiple myeloma. The patient and prescriber acknowledgements must be completed.
• Multiple myeloma - continuing PBS authority application (form 4205) [PDF, 328Kb]
  Lodge this form for a patient continuing PBS subsidised bortezomib treatment of multiple myeloma.

** Call charges apply from mobile and pay phones only.

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Last updated: 19 March, 2010