Recent decisions
Recommended: Daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone
Not recommended: Belantamab mafodotin (Blenrep®)
- have received at least four treatments and,
- are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and an anti-CD38 monoclonal antibody
Appraisal terminated: Ciltacabtagene autoleucel (Cilta-Cel) CAR-T treatment
NICE was evaluating cilta-cel for treating relapsed and refractory myeloma patients who had received at least three previous lines of treatment. However, in March 2023, Janssen withdrew the appraisal. This appraisal has now been terminated.
Janssen’s decision not to progress with the NICE appraisal for the approval of the treatment on the NHS will not affect clinical trials.
Appraisal terminated: teclistamab (Tecvayli®) monotherapy
The Department for Health and Social Care asked NICE to appraise teclistamab to treat relapsed or refractory myeloma patients.
However, NICE terminated the appraisal after the manufacturer, Janssen, decided not to submit evidence for the evaluation.
Appeal upheld: Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for AL amyloidosis
In December 2022, Myeloma UK appealed NICE’s decision not to recommend daratumumab plus bortezomib, cyclophosphamide and dexamethasone (Dara-CyBorD) for newly diagnosed AL amyloidosis patients in England and Wales.
The appraisal committee will reconvene to review and reevaluate key data and evidence submitted during the appraisal based on the appeal panel’s instructions.
Forward look
Isatuximab (Sarclisa®), pomalidomide (Imnovid®) and dexamethasone
Daratumumab, lenalidomide (Revlimid®) and dexamethasone
The combination of daratumumab plus lenalidomide and dexamethasone is being appraised by NICE and the SMC for newly diagnosed myeloma patients for whom high-dose therapy and stem cell transplantation (HDT-SCT) is unsuitable.
In England, we are awaiting the final decision from NICE. The second committee meeting occurred in June 2023 following the publication of a draft “no” in February 2023.
In Scotland, the SMC will discuss the treatment approval in August 2023. We expect the final decision will be published in September 2023.
Myeloma UK is involved in both appraisals and has provided evidence and testimony on behalf of patients throughout the appraisal process.
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 will submit evidence on behalf of patients in August 2023. The NICE committee meeting is scheduled for 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 prior lines of treatment.
Myeloma UK is involved in this appraisal and will submit evidence on behalf of patients in August 2023. The NICE committee meeting is scheduled for January 2024.
Elranatamab monotherapy
If you would like more information on HTA processes, upcoming treatment appraisals, or Myeloma UK’s access work, contact the Policy Team.