Ask The Nurse // 30th June 2020
Most patients and family members like to keep up to date with the latest myeloma research. This means they can learn about the new, up and coming myeloma treatments. They often ask us about how new drugs work, when they will be approved in the UK and who will have access to the new drug. This is particularly true when researchers publish results from clinical trials or drug manufacturers apply to health approval bodies to gain a licence for a new treatment.
Last month, Myeloma UK took part in a meeting to discuss whether a new treatment called isatuximab (Sarclisa®) should be approved for use on the NHS in England, Wales and Northern Ireland.
In this month’s blog, we wanted to tell you more about isatuximab (Sarclisa®), discuss how it works and when it could be available to myeloma patients in the UK.
What is isatuximab?
Isatuximab is a type of drug called a monoclonal antibody. It is licenced for use in combination with pomalidomide (Imnovid®) and dexamethasone for the treatment of myeloma patients who have relapsed multiple times or do not respond (refractory) to currently available myeloma drugs.
It is currently under review in this combination for use on the NHS to treat relapsed and/or refractory myeloma patients who have received three prior myeloma treatments including lenalidomide (Revlimid®) and a proteasome inhibitor (e.g. bortezomib (Velcade®).
How does it work?
Monoclonal antibodies work by mimicking the antibodies that your immune system makes to defend itself from harmful organisms (such as bacteria) that enter the body. They are designed to recognise and attach to specific proteins on the surface of cancer cells.
Isatuximab targets a protein found on the surface of myeloma cells known as CD38. Once attached to the surface of a myeloma cell it helps the immune system find and kill the myeloma cell and, in some cases, it kills the myeloma cell directly.
Why is isatuximab only used to treat relapsed and/or refractory patients?
The group of patients who can access a new treatment is defined by both the clinical evidence and the type of approval the drug manufacturer applies for.
Currently, the safety and effectiveness of the isatuximab combination has only been fully evaluated for the treatment of relapsed and/or refractory myeloma patients.
This is because the main clinical trial only included relapsed and/or refractory patients.
So, the current evidence can only support its use for the treatment of this group.
Is isatuximab available in the UK?
Isatuximab is not routinely available for myeloma patients in the UK as it is not approved for use through the NHS.
Although not approved for use on the NHS, some patients may be able to access the treatment via a clinical trial or privately as, it is licensed for use throughout Europe, including in the UK.
When will isatuximab be available on the NHS?
It is difficult to predict exactly when a treatment will be available to patients on the NHS. Firstly, new treatments need to get a licence from the European Medicines Agency (EMA) and be approved by one of the UK’s drug approval bodies who decide whether new treatments are clinically and cost effective.
Following the meeting on May 13, The National Institute of Health and Care Excellence (NICE) issued a draft decision advising against making isatuximab available for use on the NHS in England and Wales.
While NICE agree that isatuximab does deliver some benefits over current treatments, there are uncertainties about how much benefit it would provide and whether it is a cost-effective use of NHS resources.
The draft “no” from NICE is now being consulted on and there is still the possibility of a positive decision being reached. This has happened before with other myeloma treatments including daratumumab and ixazomib. Myeloma UK will be part of the consultation and will work with myeloma specialists to make the case for it being approved.
We expect this treatment to also be appraised by the Scottish Medicines Consortium (SMC) for its approval through NHS Scotland. Unfortunately, due to the COVID-19 pandemic, the SMC has put its appraisal programme on hold, so we can’t give a timescale for Scotland. Northern Ireland usually decide whether to fund a new treatment following the final NICE decision.
For more information about isatuximab you can download the “Isatuximab Horizons Infosheet”.
If you have any questions about upcoming or approved myeloma treatments you contact us on the Infoline (0800 980 3332 (UK) or 1800 937 773 (Ireland)) or the Ask The Nurse email service.
The Myeloma Information Specialist Team