Isatuximab (Sarclisa®) combination treatment approved for NHS use in England and Wales through the Cancer Drugs Fund

Patient advocacy news // 15th October 2020

Myeloma patients at third relapse in England and Wales will now be able to access isatuximab (Sarclisa®) in combination with pomalidomide (Imnovid®) and dexamethasone on the NHS after it was approved for use through the Cancer Drugs Fund (CDF).

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 decision follows an earlier draft no decision by the National Institute for Healthcare Excellence (NICE) in June.

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

“This is excellent news for patients. It is so important for multiply relapsed patients at 4th line of treatment to know there is an effective treatment option there for them when they need it.

We have been working closely on this for many months to make sure the patient voice was heard loud and clear at every stage. We did this by submitting written evidence to NICE, attending the committee meeting and making a strong case for approval following an initial draft “no”.

This was a challenging appraisal where longstanding issues, such as the burden of proving cost effectiveness in combination treatments, came through once again. We therefore commend NICE, NHS England and Sanofi for working together to deliver a positive outcome.”

Alan Chant, Patient Expert, said:

“I am delighted that NICE have approved the isatuximab/pomalidomide/dexamethasone combination through the Cancer Drug Fund for 4th line treatment for myeloma patients, and am grateful to have had the opportunity to play a part as a patient expert.

This approval provides an unique and innovative triplet combination of drugs, each of which acts on myeloma cells in a unique way at the same time, and meets an unmet need in the treatment pathway. Monoclonal antibodies such as isatuximab are breakthrough drugs which are now available at other stages of treatment and this approval now provides for the best possible treatment for relapsed and refractory patients at this critical time in their myeloma journey.”

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.

Under the CDF, treatments are initially approved for around two years and more data on their effectiveness is collected during this period. At the end of this time, NICE look again at the treatment and make a final decision on whether to approve it for routine use on the NHS.


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 NICE 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.

Does this decision apply to all patients in the UK?

The decision affects myeloma patients living in England and Wales.

The Scottish Medicines Consortium (SMC) will shortly consider a submission for the approval of this treatment combination. Myeloma UK will contribute to this process as it has done with NICE and will do all we can to help deliver a positive decision.

In Northern Ireland, the Department of Health decides whether to fund a new treatment following publication of the final NICE decision.

What is the Cancer Drugs Fund (CDF)?

The Cancer Drugs Fund is a pot of money which enables NICE to conditionally approve promising treatments while more data is collected about the treatment’s clinical effectiveness and value. This period of data collection is usually around two years. At the end of this period NICE reconsider the treatment and make a final decision.

The fund is for patients in England, but Wales and Northern Ireland have processes in place to enable CDF decisions to be implemented. The system is different in Scotland where there is no direct equivalent of the CDF, however Scotland does have the New Medicines Fund which covers myeloma.

The CDF is an increasingly common route for funding new cancer treatments. This is now the fourth CDF approval for myeloma. Previous approvals were for ixazomib (Ninlaro®), lenalidomide (Revlimid®) and dexamethasone in December 2017; daratumumab monotherapy in January 2018; and daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone in March 2019.

Further information

If you have any questions or comments on please email or call the Myeloma Infoline on 0800 980 3332 during office hours, Monday to Friday.