NICE lifts restrictions on elranatamab after challenge from the myeloma community

Published: Tuesday, 12 Nov 2024

More people with myeloma in England and Wales can now access the life-changing drug elranatamab following NICE’s decision to lift restrictions on who can access it.

Elranatamab is part of a new class of drugs, known as a bispecific antibody, and has been shown to stop myeloma in its tracks for more than 17 months.  

It was initially approved through the Cancer Drugs Fund for use on the NHS back in June, but the approval came with strict restrictions on who was eligible for the treatment.  

The restrictions meant that those who had previously received isatuximab, pomalidomide and dexamethasone (IsaPD) or pomalidomide plus dexamethasone (PD), were not eligible for elranatamab.   

This was extremely disappointing to the many people who were hoping to access the new drug, some of whom faced the prospect of end-of-life care without treatment. 

Myeloma UK immediately challenged the decision and together with the UK Myeloma Society we lodged an appeal with NICE. This resulted in NICE reissuing the guidance as draft guidance. Myeloma UK then worked with patients and clinicians to resubmit evidence and fight for wider access for more people.

Three months on, the National Institute for Health and Care Excellence (NICE) has lifted all previous restrictions. 

Elranatamab is now available to anyone who has received at least three lines of treatment, whose cancer has progressed and who has previously received an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 antibody.

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 March 2024 data cut (28-month data cut) which showed an overall response rate of 61%, median overall survival of 21.9 months and median progression-free survival of 17.2 months.

Caroline Donoghue, Senior Policy Officer at blood cancer charity Myeloma UK, said:

“This is brilliant news. Elranatamab is part of a brand-new class of drugs in the UK and will have a huge impact on patients and their families. We know from speaking to patients and clinicians that the drug has already changed the lives of many people who were close to running out of treatment options.   
“Back in June when the original guidance was published, we were excited to see that elranatamab had been recommended for use on the NHS but were hugely disappointed about the restrictions applied to the recommendation, which meant that only pomalidomide-naive patients would be eligible for the drug. We believed it was deeply unfair to keep this drug out of reach from those who needed it most and we knew we had to challenge the decision.
“Over the next few months, we worked hard to overturn this decision, while also ensuring that we did not jeopardise the current recommendation or delay access to elranatamab. Together with the UK Myeloma Society we appealed the decision. This resulted in NICE reissuing the guidance as draft guidance meaning we now had the opportunity to submit further evidence and challenge this restriction.
“This was an amazing result, but we still had to make our case to ensure that patients were heard and that their needs were taken into account when NICE made their final recommendation.
“Thankfully all the hard work paid off, with the committee deciding to recommend elranatamab for all triple-class-exposed patients from fourth line and beyond.
“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.” 

Elranatamab 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 systems. When the bispecific antibody brings them into close contact with the myeloma cells, they are able to destroy these cells.  

The drug is being rolled out through the Cancer Drugs Fund – a pot of money which provides cancer patients in England with faster access to the most promising new drugs pending full approval from NICE. After a period of two years, NICE will decide whether to make it available permanently on the NHS.  

Jon Missin, from Northamptonshire, is among the hundreds of people who could receive elranatamab now that the restrictions have been lifted.

“It’s fantastic, I’m absolutely delighted with this decision,” said Jon, who was diagnosed with myeloma in 2015 at the age of 41. “I am currently on fourth line treatment on IsaPD, but soon to finish it as my disease levels have been creeping up in recent months.
“For many patients, there was little available beyond their fourth line treatment, but bispecifics are a game-changer and, now elranatamab has been approved without restrictions, it provides much hope.”
The 51-year-old added: “A huge thank you to Myeloma UK for all their work behind the scenes in getting this across the line. It has certainly opened my eyes as to the amount of work they do to the benefit of the myeloma community. They should take much credit for this.”

The rollout of elranatamab follows the approval of teclistamab, another type of bispecific antibody, earlier this month.  

What does this decision mean for patients? 

The approval means that elranatamab is available to eligible myeloma patients as a potential treatment option in England and Wales.     

Patients at third relapse (fourth line) and beyond who have previously been treated with an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody can now receive elranatamab.

What about patients in Scotland and Northern Ireland?

The Scottish Medicines Consortium (SMC) approved elranatamab for use on the NHS in Scotland in September.        

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

What is the Cancer Drugs Fund?

The Cancer Drugs Fund (CDF) is a pot of money which helps cancer patients in England get faster access to promising new drugs.

The CDF provides interim funding for new cancer drugs, allowing patients to access them before they are routinely funded.

NICE can approve a treatment for use in the NHS via the CDF when a treatment shows promising results in trials but there isn’t enough evidence to recommend it for routine commissioning.

After a period of two years, NICE reconsiders the medicine and makes a final decision whether to recommend it or not.

What has the CDF done for myeloma?

Ixazomib (Ninlaro®) in combination with lenalidomide (Revlimid®) and dexamethasone was approved by the CDF in December 2017. Following a review, it was approved for continued use on the NHS in January 2023.

In 2018, daratumumab monotherapy became the second myeloma treatment to be approved via the CDF. Following a review, it was approved for continued use on the NHS in March 2022.

Daratumumab in combination with bortezomib (Velcade®) and dexamethasone was approved for use through the CDF in 2019. Following a review, it was approved for continued use on the NHS in April 2023.

Isatuximab (Sarclisa®) in combination with pomalidomide (Imnovid®) and dexamethasone was approved for use through the CDF in October 2020. The review to decide whether it should be permanently approved is ongoing following an appeal from Myeloma UK and the UK Myeloma Society.