BPD knocked back for people at second line
A new treatment shown to improve the lives of people at second line has been knocked back by NICE.
The drug approval body has turned down the use of belantamab mafodotin (Blenrep®) in combination with pomalidomide (Imnovid®) and dexamethasone (BPD) in England and Wales for people who have received one previous line of treatment including lenalidomide (Revlimid®).
This is despite trial data showing that 71% of people on BPD were still in remission after 12 months.
While it is a setback, NICE’s decision is only a draft recommendation at this stage, which means it is not final.
NICE is expected to review its decision over the coming months.
Although its appraisal committee agreed that BPD works, members felt they could not accurately assess whether the treatment would be cost-effective for the NHS. The committee noted that the submitted clinical trial evidence compared BPD with pomalidomide, bortezomib (Velcade®) and dexamethasone (PVD). They have requested additional information to better compare BPD with second line treatment regimens currently in use in NHS practice, and to understand the long-term benefits of BPD.
Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK, said:
“We’re hugely disappointed with NICE’s decision, but it is only a setback and we’re determined to get this new promising treatment across the line.
We’ve been working extremely hard to get BPD approved over the last few months by working with patients and clinicians to gather evidence as part of the appraisal process and we’ll continue to do everything we can to bring everyone back around the table, remove barriers to access and come up with a solution.
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, no matter where they are on their treatment journey.”
According to the latest evidence from the DREAMM-8 clinical trial, which looked at how effective BPD is compared to PVD – 71% of people on BPD were still in remission after 12 months.
This is compared to just 51% of patients on PVD.
Belantamab mafodotin is an antibody-drug conjugate, which specifically targets a protein on the surface of myeloma cells called BCMA. This helps deliver chemotherapy straight to the myeloma cells and flags them for the patients’ immune system to kill.
Q&A
What is a draft no?
A draft recommendation is not a final decision from NICE. This draft no means that the treatment has benefits but there are underlying issues that need to be resolved before NICE can approve it. NICE published a report summarising the evidence presented as part of the appraisal and outlined the rationale for the draft no. It highlighted the clinical benefit of BPD but also stated the uncertainties around cost-effectiveness.
Why did NICE say no?
NICE recognised that BPD is safe and effective for patients at second line, but felt that it needed to understand more about how effective BPD is compared to other treatments already available at second line in the NHS. NICE also reflected that it needed to further assess the cost-effectiveness of the treatment to determine if it should be available on the NHS.
What happens next?
Myeloma UK has until 17July 2025 to submit a consultation response. During this period, Myeloma UK, along with the pharmaceutical company that makes belantamab mafadotin, and clinicians will be able to submit further evidence to address NICE’s concerns. A second committee meeting will be held in September to review the additional evidence provided.
What about people living in Scotland and Northern Ireland?
In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. BPD is not currently available in Scotland but we expect an appraisal with the SMC in the next few months.
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.
