Isatuximab (Sarclisa®) combination treatment approved for use in Scotland at appeal

Patient advocacy news // 12th April 2021

Myeloma patients at third relapse in Scotland will now be able to access isatuximab (Sarclisa®) in combination with pomalidomide (Imnovid®) and dexamethasone through NHS Scotland after it was approved for use by The Scottish Medicines Consortium (SMC), despite the treatment having been initially rejected for use.

This combination is recommended as an option for treating relapsed and refractory multiple myeloma in adults who have had 3 previous lines of treatment, including lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment.

This announcement follows an earlier decision by the National Institute for Healthcare Excellence (NICE) in October 2020 which permitted myeloma patients at third relapse in England and Wales to have access to the same combination treatment on the NHS after it was approved for use through the Cancer Drugs Fund (CDF).

Commenting on the decision, Laura Kerby, Myeloma UK Chief Executive, said:

“This is fantastic news for patients. It is vital that relapsed patients at 4th line of treatment have access to an effective treatment option when they need it.

We have been working closely on this for many months to make sure this treatment was available equally to all patients throughout the UK.

This was a challenging appraisal where longstanding issues, such as the burden of proving cost effectiveness in combination treatments, came through once again. We worked hard to overturn the initial rejection from the SMC and make a strong case for the patient voice to be heard and we would like to commend the SMC, NHS Scotland and Sanofi for working together to deliver a positive outcome.”

Isatuximab is marketed by the pharmaceutical company Sanofi and 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 about isatuximab in our Horizons Infosheet.


What does the approval mean for patients?

Only patients at third relapse (also known as fourth line) will be eligible to receive isatuximab, pomalidomide and dexamethasone.

Eligible patients must also have received lenalidomide and a proteasome inhibitor (bortezomib (Velcade®), carfilzomib (Kyprolis®) or ixazomib (Ninlaro®) and their disease must have progressed on their last treatment.

When 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.

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