Two new myeloma treatments for Scotland

Published: Monday, 9 Sep 2024

People with myeloma in Scotland will be able to access two breakthrough bispecific antibodies that have been approved on the NHS at fourth line and beyond.

Both elranatamab (Elrexfio®) and teclistamab (Tecvayli®) have been approved by the Scottish Medicines Consortium (SMC) and will be available for people who have received three treatments or more.

The pioneering treatments are the first new class of myeloma drugs to be approved in Scotland in nearly seven years.

Elranatamab and teclistamab are aimed at people at fourth line and beyond, who have previously received an immunomodulatory agent such as lenalidomide (Revlimid®), a proteosome inhibitor such as bortezomib (Velcade®) and an anti-CD38 antibody like daratumumab (Darzalex®). 

Myeloma UK advocated for the approval of these treatments by submitting evidence and participating in the Patient and Clinician Engagement and Committee meetings. We highlighted clear benefits the treatments deliver for people living with myeloma, including the improvements in complete response rates versus standard care and the huge quality of life benefits of a steroid free treatment option.

Scott Purdon, Head of Patient Advocacy at Myeloma UK, said:

“We’re absolutely delighted. Elranatamab and teclistamab are the first new class of drugs to be approved in Scotland in seven years and each could be a lifeline for people who are close to running out of treatment options. They have both shown excellent results in clinical trials and allowed some people who have never responded well to treatment to experience their very first complete remission.  
“We’re grateful that the Scottish Medicines Consortium (SMC) used the flexibility available to them when approving these new treatments. We will always make sure that the voice of patients is heard throughout the approval process. By being involved in every treatment appraisal for myeloma, we are able to bring forward a clear understanding of patient experiences and of the impact of these new drugs on the life expectancy and quality of life for people living with myeloma. Until we have a cure, it is absolutely vital that all myeloma patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey.”

Teclistamab and elranatamab’s pioneering mechanism of action helps the immune system to recognise and kill cancer cells by binding to both myeloma cells and to T cells. T cells are a type of white blood cell in our immune system. When the bispecific antibody brings them into close contact with the myeloma cells, they are able to destroy these cells. 

The key clinical evidence for teclistamab came from the phase 1/2, single-arm, open label, MajesTEC-1 trial. The pharmaceutical company presented data from the trial which supported its use in triple-class-exposed myeloma patients who were refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody. They presented data from the August 2023 data cut (median follow up of 30.4 months) which showed an overall response rate of 63%, median overall survival of 22.2 months and median progression-free survival of 11.4 months.

The key clinical evidence for elranatamab came from the phase 2, single-arm, open label, MagnetisMM-3 trial. The pharmaceutical company presented data from cohort A who were BCMA naive, triple-class-exposed myeloma patients. They presented data from a September 2023 data cut (median follow up of 17.6 months) which showed an overall response rate of 61%, median overall survival of 21.9 months and median progression-free survival of 17.2 months.

While teclistamab was approved permanently on the NHS, elranatamab was granted interim approval. This means that elranatamab is currently approved for use because the Scottish Medicines Consortium (SMC) recognises the benefits and cost-effectiveness of the treatment for patients, but that the drug will be reassessed later, when ongoing clinical trials provide more information about aspects like long-term effectiveness.

Myeloma UK will monitor the situation and make the case for permanent access to elranatamab.

What does this decision mean for patients?

This approval means that eligible myeloma patients at third relapse and beyond (fourth line plus) can now receive elranatamab or teclistamab. It gives patients whose myeloma has become resistant to previous myeloma treatments access to innovative treatments which kill myeloma cells in a new way.

What is an interim acceptance?

An interim acceptance is when the SMC accepts a treatment for use subject to ongoing evaluation and reassessment once further evidence is available.

It is a decision the SMC can make when a treatment has a conditional licence form the Medicines and Healthcare products Regulatory Agency (MHRA) and the committee feels additional evidence could address the key uncertainties related to the cost-effectiveness of the treatment.

The timeline for reassessment is based on the MHRA licence review with reassessment triggered by a change in the licence status.

Does this decision affect patients based in England, Wales and Northern Ireland?

In England, the National Institute for Health and Care Excellence makes decisions about which treatments to fund through the NHS. NICE approved elranatamab and teclistamab for use on the NHS earlier this year. However, the initial recommendations restricted their use to patients who have not had pomalidomide. The restriction for teclistamab has been removed and the restriction for elranatamab is currently under review. We expect to hear NICE’s final decision regarding elranatamab soon.

In Wales, decisions about which treatments to fund through the NHS are made by the All Wales Medicines Strategy Group (AWMSG) and NICE. As NICE has approved elranatamab and teclistamab for use on the NHS, the treatments can be used in Wales.

In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It usually follows guidance issued by NICE or the SMC.