It has been a busy year for the Policy and Patient Advocacy Team with multiple health technology appraisals and appeals for myeloma and AL amyloidosis.
We have seen some big approvals with daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone (DVD) becoming routinely available following a Cancer Drugs Fund (CDF) review and daratumumab, lenalidomide (Revlimid®) and dexamethasone (DRD) being approved for newly diagnosed stem cell transplant ineligible patients.
2024 is set to be another challenging and busy year, with several new treatments being evaluated for myeloma and the CDF review of isatuximab (Sarclisa®).
Hopefully this will lead more life-changing approvals from NICE and the SMC.
Forward look
Daratumumab in combination with bortezomib (Velcade®), cyclophosphamide and dexamethasone for AL amyloidosis
In June 2023, Myeloma UK won their appeal against NICE’s decision not to recommend daratumumab plus bortezomib, cyclophosphamide and dexamethasone (DaraCyBorD) for newly diagnosed AL amyloidosis patients in England and Wales.
DaraCyBorD was reevaluated at a third committee meeting on 8 November. The committee reviewed and discussed evidence submitted during the appraisal, based on the appeal panel’s instruction. We expect to hear the outcome from the committee meeting early next year.
Isatuximab (Sarclisa®), pomalidomide (Imnovid®) and dexamethasone.
The combination of isatuximab, pomalidomide and dexamethasone (IsaPd) is being reappraised by NICE for myeloma patients who have had three prior lines of treatment.
This combination was approved by NICE in October 2020 through the CDF for fourth-line patients based in England and Wales.
Myeloma UK is involved in this reappraisal and has submitted evidence on behalf of patients in April 2023. The evidence submission data is from a Patient Treatment Survey completed by 57 patients who had received IsaPd.
The NICE committee meeting is scheduled for 17 January.
Selinexor (Nexpovio®), bortezomib and dexamethasone
The combination of selinexor plus bortezomib and dexamethasone is being appraised by NICE for myeloma patients who have received one to three prior lines of treatment.
Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in September 2023. The NICE committee meeting is scheduled for 10 January 2024.
Selinexor and dexamethasone
The combination of selinexor and dexamethasone is being appraised by NICE 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 is involved in this appraisal and submitted evidence on behalf of patients in September 2023. The NICE committee meeting is scheduled for 10 January 2024.
Elranatamab monotherapy
Elranatamab monotherapy is being appraised by NICE 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 October 2023. The NICE committee meeting is scheduled for March 2024.
Teclistamab monotherapy
NICE are 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 will submit evidence on behalf of patients in February 2024. The NICE committee meeting is scheduled for July 2024.
Belantamab mafodotin (Blenrep®)
Belantamab mafodotin is being appraised by SMC for relapsed and refractory myeloma patients who have had four or more prior lines of treatment and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Myeloma UK is involved in this appraisal and submitted evidence on behalf of patients in October 2023. We also attended the Patient and Clinician Engagement meeting in November 2023 and the Committee Meeting in December. We expect the SMC will publish the final SMC decision in January 2024.
If you would like more information on HTA processes, upcoming treatment appraisals, or Myeloma UK’s access work, contact the Policy Team.