NICE updates on controversial multiple myeloma decisions
NICE has defended a trio of decisions on new therapies for multiple myeloma, which saw two drugs approved for restricted use in England and Wales and a third turned down altogether.
The recent recommendations were for Pfizer's Elrexfio (elranatamab) and Johnson & Johnson's Tecvayli (teclistamab), both BCMAxCD3 bispecific antibodies approved for use after three prior therapies for multiple myeloma, including at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody.
NICE recommended Elrexfio and Tecvayli with what it calls 'optimised' guidance, which means that they can be used with modifications to the MHRA-approved indication.
Specifically, that means that because Pfizer and J&J only compared their treatments with pomalidomide plus dexamethasone (PomDex) in clinical trials, NICE has concluded that both should be limited to patients who would be eligible for PomDex at this stage in their treatment pathway, it explained in a new statement.
That means those already treated with PomDex earlier in their treatment pathway would not be eligible. The only treatment that is routinely used by the NHS for relapsed and refractory multiple myeloma after three or more treatments is PomDex.
Patient advocacy group Myeloma UK has previously said the decision to limit the to restrict access of Tecvayli for certain groups of patients "is hugely disappointing, not to mention unexpected", is based on flawed reasoning, and is "deeply unjust and will no doubt come as a blow to those for whom this new drug could have been a lifeline."
The comment period for Elrexfio concluded last Friday, while for Tecvayli it ends tomorrow.
Sarclisa appeal will be heard next month
The health technology assessment (HTA) agency also reiterated that it was unable to recommend Sanofi's Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (PomDex) in patients who have already been treated with immunomodulatory agent lenalidomide and a proteasome inhibitor, saying the cost of the drug was simply too high.
The decision – which was made in final draft guidance in June – has been appealed by Sanofi and Myeloma UK, and NICE's appeal panel has scheduled an open meeting on 23rd September via Zoom to hear arguments from the two organisations.
When the decision was announced, Sanofi claimed that NICE would not consider Sarclisa cost-effective even if it had been offered at no cost to the NHS. The Sarclisa regimen is available to multiple myeloma patients in Scotland and Northern Ireland.
Approximately 5,000 people are diagnosed with multiple myeloma in England each year, and the five-year survival rate is estimated to be around 52%. NICE said it made 14 positive recommendations for multiple myeloma treatments in the past five years.
