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September 2008
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Multiple myeloma

Authority to supply bortezomib (Velcade®) through the Pharmaceutical Benefits Scheme (PBS) under Section 85 of the National Health Act 1953.

Bortezomib is available on the PBS as an authority required benefit for patients with multiple myeloma.

Restriction details

Initial PBS subsidised treatment

Initial PBS subsidised treatment of multiple myeloma in a patient:

  • as monotherapy or in combination with a corticosteroid and/or cyclophosphamide
  • with a World Health Organisation (WHO) performance status of two or less
  •  who has progressive disease,
  • who has received at least one 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 four weeks of thalidomide at a dose of at least 100 mg daily.

Disease progression

Progressive disease is defined as at least one of the following:

  • at least a 25% increase and an absolute increase of at least 5g/L in serum monoclonal protein (serum M protein)
  • at least a 25% increase in 24 hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg/24 hours
  • at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy
  • an increase in the size or number of lytic bone lesions (not including compression fractures)
  • 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)
  • development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol/L not attributable to any other cause).

Thalidomide intolerance and toxicity:

  • Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living.
  • Toxicity from thalidomide is defined as:
    • Peripheral neuropathy (Grade 2 or higher, interfering with function)
    • Drug related seizures
    • Serious Grade 3 or Grade 4 drug related dermatological reactions, such as Stevens-Johnson Syndrome
    • Other Grade 3 or 4 toxicity.

Continuation of PBS subsidised treatment

Beyond four cycles:

  • 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 achieved will be authorised
  • confirmation requires two determinations, a minimum of six weeks apart.

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

Partial response compared with baseline is defined as:

  • at least a 50% reduction in the level of serum monoclonal (M) protein or,
  • at least a 90% reduction in 24 hour urinary light chain M-protein excretion, or to less than 200 mg/24 hours.

If serum M protein and/or urine Bence-Jones protein are unmeasurable as the patient has non-secretory/oligo-secretory multiple myeloma partial response compared with baseline is defined as:

  • at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.

If serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:

  • at least a 50% reduction in bone marrow plasma cells
  • normalisation of corrected serum calcium to less than or equal to 2.65 mmol/L
  • no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response)
  • at least a 50% reduction in the size of soft tissue plasmacytoma by clinical or applicable radiographic examination [i.e. Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) scan].

Item detail

Dose

Bortezomib (Velcade®) is presented 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 1,4,8, 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.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Lodgement

The postal address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart Tasmania 7001

(No stamp required if posted in Australia)

For assistance please call 1800 700 270** and select option 1 (8 am to 5 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only.

Application forms

Some documents on this page may require the free Adobe PDF reader.

Last updated: 30 October, 2008

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