Patients in Scotland will be able to access the new myeloma treatment, carfilzomib (Kyprolis®) on the NHS, after the Scottish Medicines Consortium (SMC) approved it for use.
The SMC, Scotland’s drug approval body, agreed that carfilzomib in combination with dexamethasone should be made available to myeloma patients who have received at least one prior treatment.
Myeloma UK Policy and Public Affairs Officer, Shelagh McKinlay, said, “This is great news for myeloma patients in Scotland. Today’s approval gives myeloma patients whose cancer has come back an important new treatment option. Having a range of effective options is especially vital in myeloma because it is such an individual cancer and becomes resistant to treatment.
“We played a key role in helping the SMC to reach its positive decision by ensuring that the patient and carer voice was heard in the process.”
Health Boards in Scotland now have three months to make a decision on whether to make carfilzomib available in this setting for patients in their local area. Myeloma UK does not anticipate any problems with local access.
Carfilzomib belongs to a group of treatments known as proteasome inhibitors and works in a way very similar to bortezomib (Velcade®). For more information, you can read our Carfilzomib Infosheet.
The approval of carfilzomib was informed by the results of a large Phase III clinical trial (known as the ENDEAVOR trial) which showed that carfilzomib extended the length of time following treatment before the myeloma returns and further treatment is required compared to bortezomib and dexamethasone. It also showed that carfilzomib was well tolerated in terms of side-effects. In particular patients were less likely to develop peripheral neuropathy (damage to the nerves that make up the peripheral nervous system causing pain, tingling and altered sensation).
This decision affects patients in Scotland. The SMC previously issued a ‘no’ to the combination of carfilzomib, lenalidomide (Revlimid®) and dexamethasone. The SMC issued negative guidance for this triplet combination because of its uncertainty about whether it represented a cost-effective use of NHS resources.
For England and Wales, NICE issued a restricted approval of carfilzomib and dexamethasone in June. This restricted NICE approval applies to myeloma patients at first relapse, who have had one previous treatment that did not include bortezomib. Further information on this decision and the reasons for the NICE restriction can be found here. At the same time NICE also turned down the triple combination of carfilzomib, lenalidomide and dexamethasone.
Myeloma UK will continue to work with NICE and the company to increase access to carfilzomib.
In Northern Ireland, the Department of Health, Social Services and Public Safety usually make a decision on whether to fund a new treatment following publication of the final NICE decision.
You can find out more about the Health Technology Assessment (HTA) process in our dedicated Infosheet.
Myeloma UK worked with the SMC, the pharmaceutical company, Amgen, and doctors and patients to make sure the patient voice was heard throughout the appraisal process. We did this by submitting written evidence which set out what the approval of carfilzomib would mean for patients and by participating in a Patient and Clinician Engagement (PACE) meeting where, alongside experienced clinicians, we were able to explain in more depth the positive impact which carfilzomib could have on the quality of life of patients and family members.
We are very grateful for the support of patients, carers and family members who tell us about their experience of myeloma treatments so that we can ensure that drug approval bodies have the best possible evidence for their decisions.
If you would like to help us in our treatment approval and policy work, or if you have any questions or comments about this decision or other aspects of treatment approval please contact the Policy Team on email@example.com.
If you would like to discuss your treatment and care call the Myeloma Infoline on 0800 980 3332 or email AskTheNurse@myeloma.org.uk.