1 Recommendations

1 Recommendations

1.1 Isatuximab, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund as an option for treating relapsed and refractory multiple myeloma in adults who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment, only if:

  • they have had 3 previous lines of treatment

  • the conditions in the managed access agreement for isatuximab plus pomalidomide and dexamethasone are followed.

1.2 This recommendation is not intended to affect treatment with isatuximab plus pomalidomide and dexamethasone that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

The company proposes that isatuximab plus pomalidomide and dexamethasone is used only for people who have already had 3 lines of treatment. Although effective options after 2 lines of treatment are also needed, the clinical- and cost-effectiveness data for isatuximab plus pomalidomide and dexamethasone at this point in the treatment pathway are not suitable for decision making.

After 3 lines of treatment, people usually have pomalidomide plus dexamethasone, or daratumumab alone (in the Cancer Drugs Fund). Clinical trial evidence suggests that isatuximab plus pomalidomide and dexamethasone delays the disease progressing and increases how long people live compared with pomalidomide plus dexamethasone. But, the trial is not finished so the benefit in the longer term is uncertain.

The cost-effectiveness estimates for isatuximab plus pomalidomide and dexamethasone after 3 previous lines of treatment are uncertain because of limitations in the clinical data. The estimates are higher than what NICE normally considers an acceptable use of NHS resources. So isatuximab plus pomalidomide and dexamethasone cannot be recommended for routine use in the NHS.

Collecting more data from the ongoing trial and from NHS practice would help to address some of the uncertainties. Isatuximab plus pomalidomide and dexamethasone could be cost effective after 3 previous lines of treatment when the company's commercial offer as part of a managed access agreement is used. Therefore, isatuximab plus pomalidomide and dexamethasone is recommended for use in the Cancer Drugs Fund.

  • National Institute for Health and Care Excellence (NICE)