The PBAC met in November this year to review the most recent applications for new drugs or amendments to the prescribing rules for existing drugs. Four myeloma drugs were reviewed during this meeting.
CARFILZOMIB (Kyprolis®)
You may recall in August in edition 7 of the Myeloma Muster we announced that the PBAC had made a positive recommendation that carfilzomib (Kyprolis®), a proteasome inhibitor in the same family as bortezomib (Velcade®) be used in combination with dexamethasone for patients who have failed at least one prior line of therapy.
We are now pleased to announce that as of 1 January 2018, carfilzomib (Kyprolis®) will be available for reimbursement on the Pharmaceutical Benefits Scheme (PBS). Those who have already gained access via special access schemes will be able to access supply via the PBS. Those who are being administered carfilzomib (Kyprolis®) via clinical trial will see no change to their supply.
DARATUMUMAB (Darzalex®)
The PBAC reviewed an application for a new monoclonal antibody therapy, daratumumab (Darzalex®) to be included on the PBS in combination with bortezomib (Velcade®) or lenalidomide (Revlimid®).
Myeloma Australia invited you to provide consumer comments to add strength to the application. The PBAC welcomed these comments and took them into consideration when making their decision however decided not to recommend daratumumab (Darzalex®) for reimbursement at this stage.
It is quite common for drugs to go before the PBAC more than once before gaining approval. The manufacturer will consider the feedback from the PBAC and resubmit the application in due course.
Thank you to everyone who provided their consumer comments. They really do add strength to an application. We will continue to invite you to make submissions to the PBAC when the application is resubmitted for daratumumab (Darzalex®).
LENALIDOMIDE (Revlimid®)
Lenalidomide (Revlimid®) is currently available on the PBS for patients who are newly diagnosed and not eligible for a stem cell transplant or who have progressive disease and have had at least one prior line of therapy that includes thalidomide. The necessity to have thalidomide before gaining access to lenalidomide (Revlimid®) has been counter-intuitive for some patients so the manufacturer (Celgene), with the support of our Medical and Scientific Advisory Group (MSAG), lobbied the PBAC to remove this requirement.
The PBAC have agreed to modify the rules for prescribing lenalidomide (Revlimid®) to remove the necessity to have thalidomide before being eligible for lenalidomide (Revlimid®).
Also, previously lenalidomide (Revlimid®) was only available for treatment once. With the new listing it will also be possible to gain access to treatment with lenalidomide (Revlimid®) a second time if the first treatment was successful.
These positive recommendations are fantastic news for patients needing treatment with lenalidomide (Revlimid®) in the future. We will provide further updates as they become finalised and available to the public.
The next PBAC meeting is set for March 2018. On the agenda for this meeting is to review an application to make lenalidomide (Revlimid®) available to patients as maintenance post autologous stem cell transplant. Currently doctors can only prescribe thalidomide (Thalomid®) in this setting which, for some patients, cannot be tolerated long-term. Lenalidomide as maintenance post autologous stem cell transplant will be a huge step forward for improved quality of life and overall survival for people living with myeloma.
You can help strengthen the application by making a public submission via the link below:
http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form
Choose lenalidomide as the medicine you would like to make comment about. If you need help with your application or would like to ask questions, please contact our experienced Myeloma Support Nurses on our toll-free support line 1800 MYELOMA (1800 693 566) Monday – Friday 9am – 5pm AEST or email nurses@myeloma.org.au.
POMALIDOMIDE (Pomalyst®)
Pomalidomide (Pomalyst®) is currently available on the PBS for patients who have progressive disease and have previously failed treatment with lenalidomide (Revlimid®) and bortezomib (Velcade®). This is barrier to patients who would benefit from treatment with pomalidomide (Pomalyst®) but are unable to have lenalidomide (Revlimid®) or bortezomib (Velcade®).
The PBAC have ruled that pomalidomide (Pomalyst®) also be made available to patients with relapsed or refractory myeloma in special circumstances where it is not in their best interests to be prescribed lenalidomide (Revlimid®) or bortezomib (Velcade®) or they have tried either drug and side effects or intolerances mean they cannot continue with that therapy.
These changes will mean a much smoother transition between lines of therapy and again, we will provide an update when they are made available on the PBS.
If you have any questions in relation to your access to carfilzomib (Kyprolis®), daratumumab (Darzalex®), lenalidomide (Revlimid®) or pomalidomide (Pomalyst®) please contact your treating team or access an experienced Myeloma Support Nurse on our toll-free support line 1800 MYELOMA (1800 693 566) Monday – Friday 9am-5pm AEST or email nurses@myeloma.org.au
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Myeloma Support Nurse Blogger
