Teclistamab restrictions in England and Wales removed by NICE after push-back from Myeloma UK

Published: Thursday, 10 Oct 2024

People with myeloma have claimed a hard-fought victory following NICE’s decision to lift restrictions on who can access a new game-changing treatment for myeloma.  

Teclistamab is the very first in a new class of drugs, known as a bispecific antibody, approved for routine commissioning on the NHS in England and Wales.   It has even allowed some people who had never fully responded to treatment up to that point to get their first complete remission.  

Teclistamab was initially approved on the NHS in England and Wales back in July, but the approval came with strict restrictions on who could access the treatment.   

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

This decision to impose restrictions was disappointing to many patients, some of whom faced the prospect of end-of-life care without treatment.  Myeloma UK felt it was unacceptable for patients to be denied treatment that could give them more time. We worked alongside patients and clinicians to present the case for wider access to NICE.

Three months on, NICE has now lifted all previous restrictions.  

Teclistamab is now available to anyone who has received at least three rounds of treatment, whose cancer has progressed and who has previously received an immunomodulatory agent such as lenalidomide (Revlimid ®), a proteosome inhibitor like bortezomib (Velcade®) and an anti-CD38 antibody like daratumumab (Darzalex®) or isatuximab (Sarclisa®).  

Caroline Donoghue, Senior Policy Officer at Myeloma UK, said:  

“This is fantastic news and a hard-earned victory for all involved. Teclistamab is the first of a new class of drugs to be approved on the NHS in England and Wales and could be a lifeline for people who are close to running out of treatment options.
“It has shown excellent results in clinical trials and allowed some people who have never responded well to treatment to experience their very first complete remission. 
“Approvals like this highlight why we continue to fight for treatment, submit evidence on behalf of the myeloma community, attend committee meetings and push for access to pioneering drugs.
“The initial decision to impose restrictions and keep the drug out of the reach of those who needed it most was deeply unfair. Over the last few weeks we have worked tirelessly to get everyone back around the table, come up with a solution and give people with myeloma a fighting chance to spend more time with their loved ones.
“Whilst this is amazing news it is disappointing that it took so long to get to get the final recommendation. Many patients will have missed out on teclistamab during this time. It is even more disappointing when compared to the recent approvals of both teclistamab and elranatamab in Scotland where the flexibility shown by the Scottish Medicines Consortium resulted in the approval the full licenced indication from the offset.
“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’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.

Kathryn Oddie, a grandmother-of-two from Nottinghamshire, was diagnosed with myeloma at the age of 38 back in 2000.  

Despite receiving 11 rounds of treatment over two decades, she had never been in remission until she was offered teclistamab through the MajesTEC-1 trial in January 2021.   

Three years on, the 62-year-old is still doing well and credits the “miracle” drug for allowing her to live her life.  The retired practice nurse, who was diagnosed after having a nosebleed, said:

“It has been life-changing. It’s a miracle drug, to be honest. I had had 11 lines of therapy – daratumumab had worked for about 18 months to two years – but none of them had put me in remission.
“At the time, my local hospital said there was nothing else for me but luckily my consultant had worked with Dr Rakesh Popat in the trials unit at UCL a few years back so he wrote to him to see if there was anything that could help me. They rang me to say they had this new drug. I was the first to get teclistamab at UCL.
“Within six months or so it worked. Now I’m in remission and I can actually get on with my life.”

Windsor father Bob Munro was diagnosed with myeloma back in 2012. He was just 52.

By early 2021 he had exhausted all treatment avenues, suffered 10 fractures in two years and taken around 100,000 tablets. His cancer had never once gone into remission.

Thankfully in 2022, he was able to receive teclistamab through a clinical trial and is now in remission for the first time since his diagnosis.

The grandfather-of-two said:

“It’s been a minor miracle and I’m so pleased other patients will be able to benefit from this incredible drug. 
“By 2021 I had exhausted all the approved myeloma drugs and I was suffering from catastrophic bone damage – 10 fractures including eight ribs and a collapsed vertebra in the previous two years.
“I joined the MajesTEC-2 trial and I’m currently two years eight months in remission. It has been my first ever complete remission in 12 years of continuous treatment.  
“Since this complete remission, I’ve been well enough to cycle over 100 miles a week, launch a charity cycling event company and, most importantly, meet a second granddaughter I thought I would never see after my diagnosis in 2012.” 

In hindsight, Bob had had a host of symptoms, including stomach and chest infections he simply couldn’t shake, for months prior to his diagnosis.

It all came to a head during a skiing trip. He caught pneumonia and was hospitalised.

An X-ray revealed he had lesions, or holes, all over his back – a tell-tale sign of myeloma. He added:

“Looking back, I realise there were all sorts of symptoms there. But after I went skiing, I felt I was having a heart attack. It was actually a massive case of pneumonia. They sent me for an X-ray, and they realised my back was covered in lesions.
“The only reason I am still alive is the advancement in research and development of new drugs over the past 10 years. I am living proof.”

What does this decision mean for patients?  

The approval means that teclistamab 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 teclistamab.

This means patients whose myeloma has become resistant to previous myeloma treatments access to an innovative treatment which kills the myeloma cells in a new way.   Has the restriction on the use of elranatamab also been removed?

NICE approved elranatamab for use on the NHS through the Cancer Drugs Fund in July. The approval was also issued as draft guidance with the same restriction as teclistamab. Myeloma UK has made the case for these to be lifted as well, however we are still awaiting NICE’s final decision.

NICE is expected to announce its decision in November.  

What about patients in Scotland and Northern Ireland?  

In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. The SMC approved teclistamab 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.  