There continues to be a very active pipeline of health technology appraisals for myeloma treatments going through the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) with six ongoing appraisals at NICE and two at the SMC.
The SMC has also published two final decisions in September.
Hopefully, this will lead to more life-changing approvals for myeloma patients.
Recent final decisions: Recommended by NICE
Teclistamab (Tecvayli®) monotherapy
In July, NICE published draft guidance recommending teclistamab monotherapy for relapsed and refractory myeloma patients who have had three or more previous treatments (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) and who would otherwise be offered pomalidomide (Imnovid®) plus dexamethasone.
The recommendation with issued as draft guidance to allow consultation on the restriction limiting its use to pomalidomide naive patients. Myeloma UK responded to the consultation providing additional evidence to support the removal of the restriction.
The second committee meeting took place on 3 September 2024, and we expect the final decision on the restriction will be published in October 2024.
Recent final decisions: Recommended by SMC
Elranatamab (Elrexfio®) monotherapy
The SMC accepted elranatamab on an interim basis for relapsed and refractory myeloma patients who have had at least three prior treatments including an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody (triple-class refractory).
Myeloma UK was involved this appraisal and submitted evidence on behalf of patients in June 2024 and participated in the Patient and Clinician Engagement and Committee Meetings for this appraisal.
Teclistamab (Tecvayli®) monotherapy
The SMC accepted teclistamab for relapsed and refractory myeloma patients who have had at least three prior treatments including an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody (triple-class refractory).
Myeloma UK was involved this appraisal and submitted evidence on behalf of patients in June 2024 and participated in the Patient and Clinician Engagement and Committee Meetings for this appraisal.
Forward look: NICE
Elranatamab (Elrexfio®) monotherapy
In June, NICE has approved elranatamab monotherapy through the Cancer Drugs Fund for relapsed or refractory myeloma patients who have had at least three treatments, including an immunomodulatory drug, a proteasome inhibitor and an antiCD38 monoclonal antibody (triple-class exposed), who would otherwise be offered pomalidomide plus dexamethasone. In July, NICE withdrew the final guidance document replacing it with draft guidance to allow for consultation on the pomalidomide-related restriction. Myeloma UK responded to the consultation providing additional evidence to support the removal of the restriction. The second committee meeting for this treatment will be held on 9 October.
Isatuximab (Sarclisa®), pomalidomide (Imnovid®) and dexamethasone
In June, NICE decided not to recommend isatuximab with pomalidomide and dexamethasone for continued use on the NHS in England and Wales following a reappraisal.
Myeloma UK and the UK Myeloma Society are appealed the decision. The appeal hearing took place on 23 September with a myeloma patient and representatives from Myeloma UK and the UKMS putting our best arguments asking NICE to relook at the final decision. The outcome will be published towards the end of the year and if successful will lead to a third committee meeting.
The decision does not affect patients currently on IsaPD. They will continue to get their treatment as long as it is working for them.
The treatment will remain available and can be offered to patients not currently on IsaPD while an appeal is in progress.
Belantamab mafodotin (Blenrep®), bortezomib (Velcade®) and dexamethasone
NICE is appraising belantamab mafodotin, bortezomib and dexamethasone for relapsed or refractory myeloma patients who have had one or more previous treatments. Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in May 2024. The NICE committee meeting will take place on 8 January 2025.
Belantamab mafodotin (Blenrep®), pomalidomide (Imnovid®) and dexamethasone
NICE has started the appraisal of belantamab mafodotin, pomalidomide and dexamethasone for relapsed or refractory myeloma patients who have had one or more previous treatments. Myeloma UK will submit evidence on behalf of patients in August 2024. The NICE committee meeting is scheduled to take place in January 2025.
Isatuximab (Sarclisa®), bortezomib (Velcade®), lenalidomide (Revlimid®) and dexamethasone
NICE has started the appraisal for isatuximab with bortezomib, lenalidomide and dexamethasone for newly diagnosed myeloma patients who are not eligible for stem cell transplantation. The deadline for evidence submission is 31 October and the first committee meeting will be held on 2 April 2025.
Forward look: SMC
Selinexor (Nexpovio®), bortezomib (Veclade®) and dexamethasone
The SMC has started appraising selinexor plus bortezomib and dexamethasone (SVD) for myeloma patients who have received at least one prior therapy.
Myeloma UK submitted evidence on behalf of patients in July 2024 and attended the PACE and Committee Meetings for this appraisal. The SMC will publish the final SMC decision on October 2024.
Selinexor (Nexpovio®) and dexamethasone
The SMC has started appraising selinexor and dexamethasone for myeloma patients who have received at least four previous treatments and who are refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody (penta-refractory).
Myeloma UK submitted evidence on behalf of patients in July 2024 and attended the PACE and Committee Meetings for this appraisal. The SMC will publish the final SMC decision on October 2024.
If you would like more information on HTA processes, upcoming treatment appraisals, or Myeloma UK’s access work, contact the Policy Team.