daratumumab (Darzalex)

Myeloma patients at first relapse in Scotland will now be able to access the new treatment of daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone on the NHS after it was approved for use by the Scottish Medicines Consortium (SMC).

This decision brings Scotland into line with the rest of the UK following the decision by NICE in January to approve the treatment through the Cancer Drugs Fund (CDF).

Daratumumab, which is produced by the pharmaceutical company Janssen, belongs to a group of drugs known as monoclonal antibodies, which work in an innovative way by harnessing the body’s own immune system. You can read more in our daratumumab Treatment Guide.

In announcing the approval the SMC confirmed that, because myeloma is a rare condition, they had been more flexible in making their decision. Janssen also applied a confidential discount to the cost of the medicine which made it more cost-effective.  You can read more about the SMC’s decision here.

Myeloma UK Head of Patient Advocacy, Shelagh McKinlay said: “This is really positive news and is a major step-change in the treatment available to patients in Scotland at this stage in their myeloma.

“It is important that the most effective new treatments like daratumumab are introduced earlier into the treatment pathway where more patients will benefit from the improved remission which daratumumab can deliver.”

“We made sure the patient voice was heard by the SMC by submitting evidence and taking part in the Patient and Clinician Engagement meeting (PACE) where together with expert myeloma clinicians we were able to explain what access to this treatment really means for patients, covering issues that might not be fully captured in clinical and economic data.” 

What does the approval mean for patients in Scotland?

Only patients at first relapse (also known as second line) will be eligible to receive daratumumab, bortezomib and dexamethasone.

When drug approval bodies like the SMC consider whether to approve a treatment, they must consider the point in the treatment pathway it will be used. All approvals for myeloma treatments include conditions on which patients are eligible to receive the treatment. For example, carfilzomib (Kyprolis®) is also currently only approved for NHS use for myeloma patients in Scotland at first relapse.

Janssen applied for daratumumab, bortezomib and dexamethasone to be approved only at first relapse because clinical trial results show that it is particularly effective in this patient population.

Even if you are a patient at first relapse, there may still be reasons why you may not be eligible to receive daratumumab, bortezomib and dexamethasone, similar to the restrictions placed on entry into clinical trials. Your doctors will discuss this with you if applicable.

Does this decision apply to all patients in the UK?

The decision affects myeloma patients living in Scotland and brings it into line with other parts of the UK.

In January the National Institute for Health and Care Excellence (NICE) approved daratumumab, bortezomib and dexamethasone for NHS use in England and Wales, via the Cancer Drugs Fund (CDF).

In Northern Ireland, the Department of Health, Social Services and Public Safety, recently announced that it would apply its usual decision-making process to drugs approved by NICE via the CDF. The Department decides whether to fund a new treatment following publication of the final NICE decision.

This decision does not affect the availability of daratumumab as a monotherapy (that is for use on its own) at fourth line.