Multiple myeloma - bortezomib, lenalidomide and pomalidomide

The PBS subsidises bortezomib, lenalidomide and pomalidomide for patients with multiple myeloma.

Treatment with bortezomib can be subsidised through the PBS under the National Health Act 1953, Efficient Funding of Chemotherapy - Section 100 Arrangements, for patients with multiple myeloma.

Treatment with lenalidomide and pomalidomide can be subsidised through the PBS under National Health Act 1953 - Section 100 Arrangements, for patients with multiple myeloma.

Section 100 arrangements - lenalidomide and pomalidomide only

Lenalidomide and pomalidomide are available to a patient attending:

  • an approved private hospital
  • a participating public hospital, or
  • a public hospital,

who is a

  • day-admitted patient
  • non-admitted patient, or
  • patient on discharge

These items are not available as a PBS benefit for inpatients of the hospital. The hospital name and provider number must be included on the application form.

Patient eligibility

Patients must meet the relevant criteria in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing bortezomib, lenalidomide and pomalidomide.

The table below summarises PBS subsidised treatment cycles for multiple myeloma:

Newly diagnosed multiple myeloma Drug Total number of cycles Initial treatment Continuing treatment
Newly diagnosed - eligible for HDCT* and ASCT** bortezomib 4 4 cycles -
Newly diagnosed - acute renal failure bortezomib 9 4 cycles 5 cycles
Newly diagnosed - ineligible for HDCT* bortezomib 9 4 cycles 5 cycles
Newly diagnosed - ineligible for stem cell transplant lenalidomide Not limited 3 months treatment Not limited - Multiples of 3 months treatment

*High dose chemotherapy (HDCT)

**Autologous stem cell transplant (ASCT)

If disease progresses, patients may be eligible for retreatment with bortezomib under the retreatment restriction (11 cycles).

Progressive multiple myeloma Drug Total number of cycles Initial treatment Continuing treatment Subsequent continuing treatment
Progressive disease bortezomib 11 4 cycles 4 cycles 3 cycles
Progressive disease retreatment bortezomib 11 4 cycles 4 cycles 3 cycles
Progressive disease lenalidomide Not limited 3 months treatment Multiples of 3 months treatment -
Progressive disease pomalidomide Not limited 3 months treatment Multiples of 3 months treatment -

Bortezomib

Initial treatment - newly diagnosed

Make all initial authority approval applications to prescribe bortezomib for the treatment of newly diagnosed multiple myeloma in writing and:

All initial applications must include:

Initial treatment of progressive disease and retreatment

Make all initial authority approval applications to prescribe bortezomib for the initial treatment of progressive multiple myeloma (including retreatment) in writing and:

All continuing applications must include:

Continuing treatment - newly diagnosed

Newly diagnosed patients who are ineligible for high-dose chemotherapy

Patients who have received an initial treatment course, who do not have progressive disease and have not yet achieved a best confirmed response to bortezomib, are eligible for a further 5 cycles. For authority approval call the call the PBS Complex Drugs Programs enquiry line.

Newly diagnosed patients with severe acute renal failure

Patients who have received an initial treatment course, who remain in renal failure and can demonstrate at least a partial response to bortezomib, are eligible for a further 5 cycles. For authority approval fax to PBS Complex Drugs Programs. Complex Drugs Program staff will then contact the prescriber by phone.

Continuing PBS subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application.

Make all continuing authority approval applications to prescribe bortezomib for the treatment of multiple myeloma in writing and:

All continuing applications must include:

Continuing treatment - progressive disease and retreatment

Patients who have had at least a partial response at the completion of cycle 4 and cycle 8 may be eligible for continuing treatment.

Beyond 4 cycles, a continuing PBS subsidised supply will not be approved if there is more than 6 months between the initial and subsequent application.

Beyond 8 cycles, 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 8 treatment cycles.

For patients demonstrating a complete response:

  • no more than 2 cycles of treatment after the cycle in which the complete response was confirmed will be authorised, and
  • confirmation requires 2 determinations, a minimum of 6 weeks apart

Make all continuing authority approval applications to prescribe bortezomib for the treatment of multiple myeloma in writing and:

All continuing applications must include:

Lenalidomide

Initial treatment - newly diagnosed

Patients receiving lenalidomide under this PBS listing must be registered in the i-access risk management program. For more information, go to the Celgene website or call Celgene on 1800 235 436.

Make all initial authority approval applications to prescribe lenalidomide for the treatment of newly diagnosed multiple myeloma (patients ineligible for a primary stem cell transplant) in writing and:

All initial applications must include:

Initial treatment - progressive disease

Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.

For more information, go to the Celgene website or call Celgene on 1800 235 436.

Make all initial authority approval applications to prescribe lenalidomide for the treatment of progressive multiple myeloma in writing and:

All initial applications must include:

Continuing treatment

For continuing PBS subsidised treatment with lenalidomide, for patients who do not have progressive disease, call the PBS Complex Drugs Programs enquiry line.

Pomalidomide

Initial treatment

To be eligible for PBS subsidised treatment with pomalidomide, patients must have failed treatment with bortezomib and lenalidomide.

Patients receiving pomalidomide under the PBS listing must be registered in the i-access risk management program.

For more information, go to the Celgene website or call Celgene on 1800 235 436.

Make all initial authority approval applications to prescribe pomalidomide for the treatment of multiple myeloma in writing and:

All initial applications must include:

Continuing treatment

For continuing PBS subsidised treatment with pomalidomide, for patients who do not have progressive disease, call the PBS Complex Drugs Programs enquiry line.

More information

For more information contact us on the Complex Drugs enquiry line.

Page last updated: 18 May 2017

This information was printed Thursday 25 May 2017 from humanservices.gov.au/health-professionals/enablers/multiple-myeloma-bortezomib-lenalidomide-and-pomalidomide It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.