NICE lifts lenalidomide-related restrictions on BVD
NICE has published final guidance for BVD, lifting the lenalidomide-related restrictions and expanding access to all patients at second line.
Around 1,600 people will now benefit from the highly effective treatment each year.
BVD was initially approved on the NHS in England and Wales for people at second line in June 2025, but the approval came with strict restrictions, which meant that people who had not received the drug lenalidomide (Revlimid®) in their first line of treatment were not eligible for BVD.
Myeloma UK, along with patients and clinicians, immediately challenged the decision and fought hard for wider access.
Ten months on, the National Institute for Health and Care Excellence (NICE) has lifted the lenalidomide-related restrictions.
NICE’s decision to issue draft guidance, pending further information to consider removing the restriction, also created significant problems for people living in Wales and Northern Ireland. The Health Boards were reluctant to make BVD available to patients until NICE issued its final guidance. Myeloma UK worked hard with the clinical community and health boards to find an interim solution whereby patients could access treatment via individual funding requests.
The decision to recommend BVD is based on the data from the Phase 3 DREAMM-7 clinical trial, which compared BVD to daratumumab (Darzalex®) in combination with bortezomib (Velcade®) and dexamethasone (DVD). In the trial, BVD increased median progression-free survival by 23 months compared to DVD. The most common side effects for BVD included eye-related (ocular) adverse reactions that were typically managed through ophthalmic examinations and dose reductions.
Dr Scott Purdon, Head of Patient Advocacy at blood cancer charity Myeloma UK, said:
“This is excellent news and a hard-earned victory for our myeloma community. We welcome NICE’s decision and their commitment to broaden access for patients.
“BVD has been shown in clinical trials to give patients remissions of more than three years on average. That’s three years people with myeloma will get to live their lives; more time to celebrate birthdays or graduations, to watch their children or grandchildren grow up.
“Approvals like this highlight why we continue to fight for treatment, submit evidence on behalf of the myeloma community, provide expert testimony in committee meetings and push for access to pioneering drugs.
“The initial decision to impose restrictions and keep the drug out of the reach of those who needed it most was deeply unfair. Since June, when the initial approval was announced, we have worked tirelessly to get everyone back around the table, come up with a solution and give people with myeloma a fighting chance to spend more time with their loved ones.
“While we are delighted that more people will now be able to access BVD, we are also mindful that there are many who have not had that chance while the restrictions were in place. We are also deeply concerned that the company behind BVD decided not to seek access for all eligible patients, denying people at third line access to this proven and effective medicine. We will continue to challenge the company’s decision and keep holding the broader industry to account.
“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.”
BVD combines belantamab mafodotin (Blenrep®), bortezomib (Velcade®) and dexamethasone. It has been shown in trials to give patients remissions of more than 36 months on average.
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.
Why was access to BVD initially limited to people who had previously had lenalidomide?
NICE makes decisions on who can access treatments based on the information provided to them. The cost of any treatment needs to be justified by its benefit to patients.
During the initial approval process, the manufacturer behind BVD did not submit enough data to support the approval of the treatment for a wider group of patients. This meant NICE could only approve the treatment for people at second line who had already received lenalidomide (Revlimid®).
After further evidence was submitted, NICE was able to reconsider and lift the restrictions so more myeloma patients in England and Wales can now access BVD on the NHS.
What is BVD?
BVD is a combination of belantamab mafodotin (Blenrep®), bortezomib (Velcade®) and dexamethasone. 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. Belantamab mafodotin can also be used on the NHS in combination with pomalidomide and dexamethasone.
Who can access BVD?
Myeloma patients at second line (first relapse) are now eligible for BVD.
What about patients living in Scotland and Northern Ireland?
In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. The SMC approved the use of BVD for myeloma patients who had one prior treatment including lenalidomide in October 2025. We are currently working with the manufacturer behind BVD to remove the lenalidomide-related restriction and ensure equal access to BVD across the UK.
In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It typically accepts the guidance issued by NICE, approving the use of the treatment shortly after publication of a positive final decision.
