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We’ve recommended 2 new treatments for multiple myeloma, an incurable blood cancer that affects bone marrow, in draft guidance issued for public consultation.

In total we’ve now made 14 positive recommendations for multiple myeloma treatments in the past 5 years. 

Positive recommendations for elranatamab are open for consultation until 9 August 2024 and teclistamab until 13 August 2024. Teclistamab and elranatamab are immunotherapies that work by redirecting T-cells to multiple myeloma cells and helping to destroy them. Both are given by injection under the skin.   

The recommendations are ‘optimised’ which means the treatments were approved with some modifications to the population the Medicines and Healthcare products Regulatory Agency licence covers.  

The draft guidance for elranatamab replaces the final draft guidance published on 21 June 2024 which was withdrawn to allow consultation on the optimised recommendation. 

Why ‘optimised’?

Elranatamab and teclistamab sit in a similar place in the treatment pathway to each other and have the same indication wording in their marketing authorisations (MA):  

‘a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy’.  

Because both companies (Pfizer and Johnson & Johnson Innovative Medicine, respectively) only compared their treatments with pomalidomide plus dexamethasone, our draft recommendation for both treatments is that they should be limited to the population that would be eligible for pomalidomide plus dexamethasone at this stage in the pathway.

People who have already been treated with pomalidomide plus dexamethasone earlier in their treatment pathway would not therefore be eligible under these draft recommendations.   

Not recommended 

We were not able to make a positive recommendation for isatuximab with pomalidomide and dexamethasone (IsaPD) for people with relapsed and refractory multiple myeloma who have already been treated with lenalidomide and a proteasome inhibitor.

Our independent committee found that the cost of the drug in relation to the size of the benefits is considerably higher than what is considered an acceptable use of NHS resources. 

This decision follows a review of TA 658 which recommended IsaPD for entry into the Cancer Drugs Fund - a funding arrangement that allowed its use in the NHS while more evidence about its potential clinical and cost effectiveness was collected.  

We have received 2 appeals against this final draft guidance which will be heard on 23 September. 

People will still be able to start IsaPD treatment until final guidance is published after the resolution of the appeal. When final guidance is published, whatever the recommendation, people already on this treatment will be able to continue it until they and their NHS healthcare professional consider it appropriate to stop.  

Alternative treatment options for people eligible for isatuximab with pomalidomide and dexamethasone are daratumumab monotherapy or pomalidomide and dexamethasone.  

IsaPD sits in a similar place in the treatment pathway, but different previous treatments means that different people may be eligible for isatuximab plus pomalidomide and dexamethasone than are eligible for elranatamab and teclistimab. 

Funding 

As there is a positive draft recommendation for managed access in the relevant population, interim funding is available for anyone eligible for elranatamab under this recommendation.  

Again, because there is a draft recommendation for routine commissioning in place, interim funding is available for people eligible for teclistamab.

Associated guidance and resources

Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma appraisal