Joy as NICE lifts restrictions on myeloma drug Elrexfio
Patients in England and Wales with multiple myeloma are celebrating a decision by NICE to relax strict restrictions on eligibility to receive Pfizer's Elrexfio.
In June, the cost-effectiveness agency cleared the use of the BCMAxCD3 bispecific antibody with 'optimised guidance' that allowed it to be used for a narrower range of patients than was covered by the approved label for the drug.
Specifically, the restrictions meant that patients who had received prior treatment with a combination of isatuximab, pomalidomide, and dexamethasone (IsaPD) or pomalidomide plus dexamethasone (PD) were not eligible for Elrexfio (elranatamab).
The decision was taken because Pfizer only compared their treatments with the PD regimen in clinical trials, leading NICE to limit the availability of the drug to patients who would be eligible for PD at this stage in their treatment pathway.
That was a "huge blow" to patients, according to advocacy organisation Myeloma UK, which said it left many people who had pinned their hopes on the new drug facing the prospect of end-of-life care without treatment.
Myeloma UK joined with patients and clinicians to challenge the decision, and today NICE confirmed that Elrexfio will now be available in line with the approved label – i.e., for any patient who has received three or more prior therapies, including at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody.
The drug will be paid for by the Cancer Drugs Fund (CDF), reserved for drugs that need additional evidence before they can transition to routine NHS commissioning. NICE estimates that around 700 people in England will now be eligible for the treatment while longer-term data on its use is collected to establish whether it is clinically and cost-effective.
"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," said Myeloma UK's senior policy officer, Caroline Donoghue.
"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," she added.
The decision also brings England and Wales into line with Scotland, which backed unrestricted use of Elrexfio by the NHS 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.
Pfizer UK's oncology medical director, Dr Ruhe Chowdhury, also welcomed the news, saying: "This is important, considering the relapsing and remitting nature of the disease and the fact that patients continue to need additional options, especially as their cancer advances and stops responding to earlier lines of therapy."
NICE had imposed similar restrictions on Johnson & Johnson's rival BCMAxCD3 bispecific antibody Tecvayli (teclistamab), which were also lifted earlier this month.
Image by Myriams-Fotos from Pixabay
