As we step into the summer of 2023, it’s time to take a comprehensive look at the latest developments in myeloma and AL amyloidosis Health Technology Appraisals (HTAs).
Our mission at Myeloma UK remains steadfast, with seven active appraisals underway between the National Institute for Healthcare Excellence (NICE) and the Scottish Medicines Consortium (SMC).
In this roundup, we bring you the most recent decisions, terminated appraisals, and upcoming treatments on the horizon.

Recent decisions

Recommended: Daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone

NICE has approved the combination of daratumumab plus bortezomib and dexamethasone (DVD) for routine commissioning following a reappraisal of the original Cancer Drug Fund approval.
DVD is recommended for myeloma patients at first relapse who have either previously received lenalidomide or for whom lenalidomide is unsuitable.
Clinicians can offer DVD to all second-line patients for whom it is the most appropriate treatment option.

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
We are working with manufacturer GlaxoSmithKline to understand what this decision could mean for future HTA developments.

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.

In June 2023, the appeal was upheld on all grounds. NICE will now reassess the final decision not to recommend DaraCyBorD.

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

The combination of isatuximab, pomalidomide and dexamethasone (IsaPd) is being reappraised for myeloma patients.
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 October 2023.

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

A NICE appraisal for elranatamab monotherapy is due to start in August 2023. The appraisal will assess its use for treating relapsed or refractory myeloma patients who have had three or more previous lines of treatment.

If you would like more information on HTA processes, upcoming treatment appraisals, or Myeloma UK’s access work, contact the Policy Team.