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  • Question on Document

    Has all of the relevant evidence been taken into account?
  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Document

    Are the recommendations sound and a suitable basis for guidance to the NHS?
  • Question on Document

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Isatuximab plus pomalidomide and dexamethasone is not recommended, within its anticipated marketing authorisation, for treating relapsed and refractory multiple myeloma in adults who have had at least 2 treatments (including lenalidomide and a proteasome inhibitor) and whose disease has progressed on the last treatment.

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 for treating multiple myeloma only in people who have had at least 3 treatments before. Current treatment at this point is usually pomalidomide plus dexamethasone, or daratumumab alone (in the Cancer Drugs Fund).

Clinical trial evidence in this group 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 yet finished, so it is not certain how much more clinical benefit isatuximab plus pomalidomide and dexamethasone has than pomalidomide plus dexamethasone.

The most likely cost-effectiveness estimates for isatuximab plus pomalidomide and dexamethasone are much higher than what NICE normally considers a cost-effective use of NHS resources. Therefore, it is not recommended.