Multiple myeloma - bortezomib
The Pharmaceutical Benefits Scheme subsidises bortezomib for patients with multiple myeloma.
For patients with multiple myeloma, treatment with bortezomib (Velcade®) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under The Efficient Funding of Chemotherapy program of the National Health Act 1953.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing bortezomib.
- newly diagnosed
- progressive disease and
Newly diagnosed patients who are eligible for high dose-chemotherapy and autologous stem cell transplant
Patients are eligible to receive initial treatment with 4 cycles of bortezomib only before stem cell transplant. No continuing treatment is available.
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 who have not had a best confirmed response to bortezomib are eligible for a further 5 cycles. Approval for this treatment is available by phone.
Newly diagnosed patients with severe acute renal failure
Patients who have received an initial treatment course, who remain in renal failure and who have had at least a partial response to bortezomib are eligible for a further 5 cycles. Approval for this treatment is available by phone after you have faxed the continuing form to 1300 154 190 Monday to Friday 8.00am to 5.00 pm Australian Eastern Standard Time, call charges apply from mobile or pay phones.
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. This must be sent in writing by mail.
Beyond 4 cycles, continuing PBS-subsidised supply will not be approved if there is more than 6 months between the initial application 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.
- 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
Applications for PBS-subsidised treatment with bortezomib that extend beyond 11 cycles will not be approved.
Schedule item details
Dose - You must specify on the prescription the dose to be administered in micrograms per infusion. Vial size does not need to be specified.
|Bortezomib prescription guide for initial applications||Quantity||Repeats|
|Newly diagnosed||Eligible for stem cell transplant||Body surface area x 1300 micrograms||15|
|Ineligible for high-dose chemotherapy||Body surface area x 1300 micrograms||31|
|Severe acute renal failure||Body surface area x 1300 micrograms||31|
|Progressive disease||Body surface area x 1300 micrograms||15|
|Retreatment||Body surface area x 1300 micrograms||15|
|Bortezomib prescription guide for continuing applications||Quantity||Repeats|
|Newly diagnosed||Ineligible for high-dose chemotherapy||Body surface area x 1300 micrograms||19|
|Severe acute renal failure||Body surface area x 1300 micrograms||19|
|Progressive disease||End of cycle 4||Body surface area x 1300 micrograms||15|
|End of cycle 8||Body surface area x 1300 micrograms||11|
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
Lodging an application
Send all written applications to Complex drugs address on the contact us page. Applications for continuing treatment for Acute Renal Failure only can be faxed to us. All other applications for continuing treatment must be in writing.
- lodge Multiple myeloma - bortezomib Initial PBS authority application and supporting information form (PB103) for a patient starting initial PBS-subsidised treatment of multiple myeloma, this includes patients for retreatment. The patient and prescriber acknowledgements must be completed
- lodge Multiple myeloma – bortezomib Continuing PBS authority application Supporting information form (PB102) for a patient continuing PBS-subsidised bortezomib treatment of multiple myeloma
For more information contact us on the Complex Drugs enquiry line.