Daratumumab approved for limited use on the NHS in England and Wales

Patients in England and Wales will now be able to access the new myeloma treatment, daratumumab (Darzalex®) on the NHS, after the drug approval body, the National Institute for Health and Care Excellence (NICE), approved it for limited use, through the Cancer Drugs Fund (CDF).

This is the first time an innovative immunotherapy drug of this kind has been approved for use in myeloma in England and Wales. Immunotherapy drugs help to direct a patient’s own immune system to recognise and kill myeloma cells.

NICE 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

The treatment, which is manufactured by the pharmaceutical company Janssen, can be prescribed from today.

Myeloma UK Chief Executive, Rosemarie Finley said, “This is really heartening news for myeloma patients 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.

“This is an important new treatment option for patients whose myeloma has come back and who may have exhausted other treatment options, or who are not responding well to other types of myeloma treatments.

“Myeloma UK has been working hard to secure access to daratumumab on the NHS and we are really pleased to have helped bring about this positive outcome for patients. However, we are disappointed that the current approval does not extend to patients who have had more than three previous lines of treatment and will continue discussions with NICE and with Janssen with the aim of widening future access.”  

Myeloma UK has been working hard to secure access to daratumumab on the NHS and we are really pleased to have helped bring about this positive outcome for patients.

Myeloma UK Chief Executive, Rosemarie Finley

The NICE 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.

Under the terms of the CDF approval, daratumumab will not be available to patients who have had more than three previous lines of treatment. This restriction on access is disappointing and in the coming weeks we will be working to better understand the reasons for this and to widen future access.

What is daratumumab?

Daratumumab (Darzalex®) belongs to a group of drugs known as monoclonal antibodies. It works in an innovative way by harnessing the body’s own immune system. For more information you can read our Daratumumab (Darzalex®) Infosheet.

What about other areas of the UK?

This decision only applies to myeloma patients living in England and Wales. Scotland’s drug approval body the Scottish Medicines Consortium (SMC) approved daratumumab for use in Scotland in October 2017, with the same access arrangements as in England and Wales. In Northern Ireland the Department of Health, Social Services and Public Safety (DHSPSS) usually reviews NICE guidance within three months of publication. However, there is currently a lack of clarity about the process for providing access in Northern Ireland to treatments approved via the CDF. Now that this approval has been granted via the CDF, we will contact the DHSPSS to clarify their intentions in relation to funding daratumumab for patients in Northern Ireland.

What does it mean that daratumumab has been funded through the Cancer Drugs Fund?

Under the Cancer Drugs Fund (CDF), NICE are able to issue a “conditional yes” to treatments which are promising but where there is still uncertainty about their clinical effectiveness. Treatments are approved under the CDF subject to an agreement between the pharmaceutical company and NHS England (in this case called a Commercial Access Agreement). Under this agreement, there is a two year period where more data on the effectiveness of the treatment is collected. NICE then make a final decision as to whether it should be approved for routine use.

The (CDF) is a government fund (currently £340m for 2017-2018) which aims to:

• Provide patients with faster access to the most promising new cancer treatments
• Help ensure more value for money for taxpayers
• Offer pharmaceutical companies a new fast-track route to NHS funding

What part did Myeloma UK play in helping to approve daratumumab?

Myeloma UK worked with NICE, Janssen, doctors and patients to make sure the patient voice was heard throughout the appraisal process. We did this by submitting written evidence and participating in NICE meetings where, alongside patients and myeloma doctors, we described the positive impact which daratumumab would have on the lives of patients and family members.

We are very grateful to patients, carers and family members who share their experience with us so that we can ensure that drug approval bodies have the best possible evidence for their decisions. If you are interested in supporting the work of the Patient Advocacy team in securing approval for new treatments please contact them on policy@myeloma.org.uk

Where can I find more information?

The full decision on daratumumab can be read here.

To find out more about this decision contact the Patient Advocacy team on policy@myeloma.org.uk. For information and advice on myeloma treatment and care, call the Myeloma Infoline on 0800 980 3332.