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Treatment for newly-diagnosed transplant ineligible myeloma patients rejected in Scotland

Patient advocacy news // 9th May 2022

A treatment aimed at newly–diagnosed, stem cell transplant-ineligible myeloma patients has today been rejected by the Scottish Medicines Consortium (SMC).

The SMC opted not to recommend the use of daratumumab (Darzalex®) in combination with bortezomib (Velcade®), melphalan and prednisone (DVMP) as it failed to offer value for money to NHS Scotland.

The rejection of DVMP means that daratumumab remains unavailable at the first line for myeloma patients who are ineligible for high-dose therapy and stem cell transplantation. This is the first time the SMC has rejected a myeloma treatment since 2017.

The pharmaceutical company Janssen which was central in submitting evidence for DVMP to the SMC has decided not to pursue approval from the National Institute for Health and Care Excellence (NICE) for this combination treatment.

It will however be pushing for another highly effective treatment, daratumumab in combination with lenalidomide (Revlimid®) and dexamethasone (DRD), to be approved by both SMC and NICE for newly diagnosed transplant ineligible myeloma patients.

Data from the MAIA clinical trial suggests that DRD could give patients over 56 months of remission.

 

Daniel Cairns, Senior Patient Advocacy & Policy Officer at Myeloma UK, said:

“While we’re deeply disappointed that DVMP has been rejected by the SMC, our attention now turns to getting DRD approved. Daratumumab has been a real step change in myeloma treatment, one that can and has made a world of difference already to many and was recently introduced at first line for stem cell transplant eligible patients. We firmly believe that all patients should have equal access to the most effective treatments as early as possible to maximise their chances of a longer remission and we’ll focus all our efforts on making sure those who need it most have access to this life-changing drug combination.”

Amanda Cunnington, Director of Patient Access, Janssen-Cilag Limited said:

“We understand that this news will come as a disappointment to patients in Scotland. Our priority going forwards is to prepare a submission to the SMC for daratumumab in combination with lenalidomide and dexamethasone for newly diagnosed multiple myeloma when stem cell transplant is unsuitable. As an incurable cancer, we recognise treatment combinations which can control the disease are needed and we remain committed to working with key stakeholders to secure ongoing access to innovative treatments for patients with multiple myeloma.”

 

DRD is going through the approval process with NICE for patients in England and Wales. Myeloma UK is expecting this combination to be submitted to the SMC in the future.