Isatuximab combination available to patients through the Early Access to Medicines Scheme

Myeloma patients can now access Isatuximab, Pomalidomide (Imnovid®) and Dexamethasone after it was given a positive opinion through the Early Access to Medicines Scheme (EAMS).

Patients across the UK with relapsed and refractory myeloma can now access this new treatment only if they have received three previous lines of therapies (that have included lenalidomide and a proteasome inhibitor) and whose myeloma is  progressing.

Isatuximab, produced by the pharmaceutical company Sanofi, 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 Isatuximab Horizons Infosheet.

What is EAMS?

This scheme gives access to certain treatments for serious medical conditions, which are not yet licensed but show promise. The aim is to make these treatments available to patients who are lacking other treatment options.

The new treatment is currently going through the National Institute for Health and Care Excellence (NICE) Health Technology Appraisal (HTA) process. We also anticipate that this will soon be appraised by the Scottish Medicines Consortium (SMC). However, patients across the UK can now have access to this treatment through EAMS.

Access to a treatment through EAMS does not guarantee that the treatment will be available long term.  Access is only available until the treatment is granted a licence by the European Medicines Agency (EMA). An application for a licence has been submitted to the EMA, but it is not currently known when the EMA might grant an approval. If the EMA authorises the treatment, it will no longer be available in the UK through the EAMS scheme. It will then be for NICE and the SMC to decide whether the treatment should be available on the NHS.

If the EAMS scheme finishes at any time, patients who have already started treatment with isatuximab through the scheme will be able to continue it for as long as needed.

In order to get access to a treatment that is provided through EAMS the patients doctor must request access through the EAMS treatment protocol. More information can be found here.

Shelagh McKinlay, Head of Patient Advocacy, Myeloma UK said:

“This is positive news for myeloma patients and gives access to a new combination treatment for relapsed and refractory patients.

Gaining access through EAMS allows patients to benefit from novel treatments earlier whilst also allowing for the HTA process to continue.

We will continue to advocate for this combination throughout the appraisal process to ensure that patients have access to this treatment option long-term.”

Further information

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

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