Patients in Scotland will now be able to access the new myeloma treatment, daratumumab (Darzalex®) on the NHS, after the Scottish Medicines Consortium (SMC) approved it for use.
This is the first time an innovative immunotherapy drug of this kind has been approved for use in myeloma in the UK. Immunotherapy drugs use a patient’s own immune system to attack myeloma cells with a view to killing them or stopping them from growing.
The SMC, Scotland’s drug approval body, agreed that daratumumab should be made available for use as a monotherapy (on its own, not in combination with other drugs) in patients who:
- Have had three previous lines of treatment, including two specific types of myeloma drug and
- Whose myeloma progressed on their last treatment.
Myeloma UK Chief Executive, Rosemarie Finley said, “This is great news for myeloma patients in Scotland and their families. Daratumumab is an exciting and innovative new treatment which has been shown to have a very beneficial effect on length of remission in patients who respond.
““Despite the welcome approval of new drugs in recent years, there is still an urgent need for new myeloma treatments; especially for relapsed patients who have exhausted other standard treatment options.
“Today’s approval gives myeloma patients whose cancer has come back an important new treatment option. Patients need and deserve access to the best possible myeloma treatments and for that to happen the NHS needs to keep championing and supporting innovation. We are therefore delighted by the SMC’s decision.”
“We were glad to play our part in enabling the SMC to reach its positive decision by ensuring that the patient and carer voice was heard in the process. We will keep working with the company and with drug approval bodies to gain access to this drug in other parts of the UK.”
The SMC approval of daratumumab as a monotherapy is specifically as a fourth line treatment option for patients with relapsed and/or refractory myeloma, whose prior treatment has included a proteasome inhibitor drug (such as bortezomib (Velcade®)), and an immunomodulatory drug (such as lenalidomide (Revlimid®)) and who have demonstrated disease progression on their last treatment.
Health Boards in Scotland now have three months to make a decision on whether to make daratumumab available in this setting for patients in their local area. Myeloma UK does not anticipate any problems with local access.
This decision only applies to myeloma patients living in Scotland. Daratumumab is not currently available in any other part of the UK. The National Institute for Health and Care Excellence (NICE), the drug approval body for England and Wales, issued draft guidance recommending against the use of daratumumab as a monotherapy in March this year. Myeloma UK responded to this draft “no” and a final decision from NICE is awaited. In Northern Ireland the Department of Health, Social Services and Public Safety (DHSPSS) usually reviews NICE guidance within three months of publication.
Myeloma UK worked with the SMC, the pharmaceutical company, Janssen, 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 daratumumab 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 daratumumab 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.