NICE issues draft ‘no’ for use of talquetamab in England and Wales
The National Institute for Health and Care Excellence (NICE) have published draft guidance not recommending the use of talquetamab for relapsed and refractory myeloma patients.
If approved, talquetamab (Talvey®) would give fourth-line myeloma patients access to a bispecific antibody which targets myeloma in a unique way and could help overcome resistance to current treatments. Having access to this GPRC5D-targeted bispecific antibody is particularly important as more patients are exposed to BCMA-targeted treatments at earlier lines following the approval of belantamab mafodotin. Previous exposure to BCMA-targeted treatments could limit the efficacy of the available BCMA-targeted bispecific antibodies, elranatamab and teclistamab.
As it can be given fortnightly, it also offers more flexibility and respite between doses.
NICE is assessing its use for people who have received at least three previous treatments, including an immunomodulatory drug), a proteosome inhibitor and an anti-CD38 antibody.
While NICE’s decision not to recommend its use on the NHS in England and Wales is disappointing, it is only a draft recommendation at this stage, which means it is not final.
NICE is expected to review its recommendation over the coming months. Myeloma UK will work with clinicians and patients to gather and submit further evidence to NICE highlighting why talquetamab should be rolled out on the NHS.
The NICE committee decided not to recommend talquetamab because they felt that the evidence submitted was too uncertain and they needed to see further evidence before making their final decision about the cost-effectiveness of the drug.
They have specifically asked for further analysis considers the impact of COVID on overall survival estimates for teclistamab and talquetamab and updated utility values which include any quality-of-life decrements that could occur due to the taste-related side effects associated with talquetamab.
Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK, said:
“This decision will no doubt come as a blow to many, but it is only a setback and we’ll keep doing everything we can to get talquetamab approved. The appraisal process can be lengthy, and it is not unusual for treatments to go through at least two committees before they’re made available on the NHS.
“Talquetamab offers more flexibility and leads to a better quality of life. Its unique mechanism of action means it can fight myeloma in a completely different way to other currently available treatments. This is key because, as people live longer with myeloma, they gradually become resistant to existing drugs.
“Until we have a cure, it is absolutely vital that people with myeloma are given as many options as possible to keep their disease under control.”
Talquetamab was licenced in the UK based on results from the phase 1-2 MonumenTAL-1 trial. According to the latest data, around 70% of patients on talquetamab responded to treatment with almost 60% having a very good partial response, or better. The most common adverse events were cytokine release syndrome, taste changes, and infections. New data from the trial was shared as part of the appraisal, reporting a median PFS of 11.2 months.
Sue Harley, from Birmingham, was 54 when she was diagnosed with myeloma in 2017 after years of increasingly debilitating back pain.
The grandmother-of-two received five treatments including DVT, DT Pace, and CAR-T over the next six years but none managed to keep her cancer at bay for long.
That is, until she was offered talquetamab through a compassionate use scheme in September 2023.
Two years on, Sue is still in remission – her longest to date – and credits the drug for giving her her life back.
“It has absolutely given me my life back,” said Sue, whose myeloma was initially misdiagnosed as metastatic breast cancer. “This is my longest remission – I’d come very close to two years after CAR-T but I relapsed in 2023. I feel fit and healthy, I’ve run two half-marathons since I’ve been on talquetamab. I go to the gym, I go for lunch, I’m in two book groups and I volunteer for a charity once a week. I look after my grandchildren – they’re a joy.
“My granddaughter is four and she started school today and my grandson is three months old. When I was diagnosed, I didn’t know if I would live to see grandchildren, let alone live to see them grow up.”
She added:
“I’m really disappointed with NICE’s decision. It’s such a shame and it seems very short-sighted to me. We know it works, it’s a proven treatment. As patients all we want is to have options, especially at fourth line and beyond. This treatment is really manageable. It gives people a chance to live their lives, just like everybody else, to do normal things as well as exceptional things, if they want to.”
Q&A
What is a draft recommendation?
A draft recommendation is not a final decision from NICE. Draft recommendations are published if NICE decides more evidence is needed to recommend the new treatment for use on the NHS.
This can either be because NICE needs more data or because there are concerns about the cost-effectiveness of the new treatment.
Publication of a draft recommendation gives the pharmaceutical company, clinicians and patients the chance to submit further evidence or information about the new treatment to inform the final decision.
What happens next?
Myeloma UK and all other interested parties have until 25 September to submit further evidence. A second committee meeting will then be held on 14 October.
Why did NICE say no?
NICE recognised that talquetamab is safe and effective for relapsed patients whose myeloma is resistant to some treatments. However, the committee said it needed further data to confirm how well talquetamab works compared to available treatment options and, ultimately, whether talquetamab is a cost-effective use of NHS resources.
The price of drugs is a factor in NICE decisions, but it is important to bear in mind that the committee does not look at whether a drug is expensive. Rather, it looks at whether it is cost-effective compared to the current standard of treatment; that is to say, whether any additional costs associated with the treatment are justified by the additional benefit the treatment gives patients.
What is talquetamab?
Talquetamab is a new type of immunotherapy drug called a bispecific antibody.
It works by helping your T cells (a type of immune cell) find and kill myeloma cells.
Talquetamab attaches to a protein found on the surface of myeloma cells called GPRC5D and a protein found on the surface of T cells called CD3, forming a link between myeloma cells and the T cell.
What about patients in Scotland, Wales and Northern Ireland?
In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. The SMC has not started an appraisal of talquetamab yet. We hope it will start later this year.
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.
Useful resources
- NICE draft guidance: Talquetamab for treating relapsed or refractory multiple myeloma after 3 treatments
- MHRA: Talquetamab summary of product characteristics (SPC)
- MHRA: Talquetamab patient information leaflet (PIL)
