There has been a lot of activity in the treatment access space over the last few months. NICE has published four final decisions and announced three new appraisals for myeloma.
The Scottish Medicines Consortium (SMC) has also started four new appraisals.
The decisions from NICE have brought both exciting and disappointing news. We will continue to work with key stakeholders to help myeloma patients access these effective treatments.
Hopefully, this will lead to more life-changing approvals for myeloma patients.
Recent final decisions: recommended by NICE
Selinexor (Nexpovio®), bortezomib (Velcade®) and dexamethasone
NICE have approved the use of selinexor plus bortezomib and dexamethasone (SVD) for patients at second line, whose myeloma has become resistant to both daratumumab (Darzalex®) and lenalidomide (Revlimid®), and patients at third line, whose myeloma has become resistant to lenalidomide.
Myeloma UK were involved in the appraisal, submitting a consultation response and took part in the second committee meeting following NICE’s earlier draft decision. We were delighted that the indication was expanded to include both second- and third-line patients after consultation.
Selinexor (Nexpovio®) and dexamethasone
NICE have approved 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 were involved in this appraisal and submitted evidence on behalf of patients in September 2023. The decision gives patients with refractory myeloma much needed access to a new treatment with a different mechanism of action.
Elranatamab (Elrexfio®) monotherapy
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).
Whilst this is fantastic news, Myeloma UK were disappointed access is restricted a restriction to patients who would otherwise be offered pomalidomide (Imnovid®) plus dexamethasone. We are concerned that restriction will mean patients who have already received pomalidomide will not be eligible for this new bispecific antibody. We are discussing with NICE and the pharmaceutical company to ensure all eligible patients at fourth line and beyond can access elranatamab.
Recent decisions: not recommended by NICE
Isatuximab (Sarclisa®), pomalidomide (Imnovid®) and dexamethasone
NICE decided not to recommend the 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 appealing the decision. Read more >
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 also remain available and can be offered to patients not currently on IsaPD while an appeal is in progress.
Forward look: NICE
Teclistamab (Tecvayli®) monotherapy
NICE is appraising teclistamab monotherapy for relapsed or refractory myeloma patients who have had three or more previous treatments.
Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in March 2024. The NICE committee meeting was held on 4 June 2024. We hope to receive news of NICE’s decision next month.
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 12 December 2024.
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 is currently in the scoping phase of the appraisal for isatuximab with bortezomib, lenalidomide and dexamethasone for newly diagnosed myeloma patients who are not eligible for stem cell transplantation. The means appraisal should start later this year.
Forward look: SMC
Elranatamab (Elrexfio®) monotherapy
The SMC is appraising elranatamab monotherapy for relapsed or refractory myeloma patients who have had at least three treatments including an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody (triple-class refractory).
Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in June 2024. The Patient and Clinician Engagement meeting is scheduled for July 2024 and the Committee Meeting for August 2024. We expect the SMC will publish the final SMC decision in September 2024.
Teclistamab (Tecvayli®) monotherapy
The SMC is appraising teclistamab monotherapy for relapsed or refractory myeloma patients who have had at least three treatments including an immunomodulatory drug, a proteosome inhibitor and an antiCD38 monoclonal antibody (triple-class refractory).
Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in June 2024. The Patient and Clinician Engagement meeting is scheduled for July 2024 and the Committee Meeting for August 2024. We expect the SMC will publish the final SMC decision in September 2024.
Selinexor (Nexpovio®), bortezomib (Velcade®) 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 will submit evidence on behalf of patients in July 2024. The Committee Meeting is scheduled for September 2024. We expect the SMC will publish the final SMC decision in 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 will submit evidence on behalf of patients in July 2024. The Committee Meeting is scheduled for September 2024. We expect the SMC will publish the final SMC decision in October 2024.
If you would like more information on HTA processes, upcoming treatment appraisals, or Myeloma UK’s access work, contact the Policy Team.