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  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    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 age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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Draft guidance consultation

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1 Recommendations

1.1

Isatuximab plus pomalidomide and dexamethasone is not recommended, within its marketing authorisation, 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.

1.2

This recommendation is not intended to affect treatment with isatuximab plus pomalidomide and dexamethasone that was funded with managed access before final guidance is published. If this applies, NHS England and the company have an arrangement to make sure people who started treatment during the period of managed access will continue to have isatuximab plus pomalidomide and dexamethasone until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This evaluation reviews the evidence for isatuximab plus pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma (NICE technology appraisal guidance 658). It also reviews new data collected as part of the managed access agreement.

After 3 lines of treatment, people with multiple myeloma usually have pomalidomide plus dexamethasone, or daratumumab by itself.

Clinical trial evidence shows that people on isatuximab plus pomalidomide and dexamethasone have longer before their cancer gets worse and live longer compared with people on pomalidomide plus dexamethasone. Other evidence suggests that people on isatuximab plus pomalidomide and dexamethasone also have longer before their cancer gets worse and live longer compared with people on daratumumab alone. But this evidence is uncertain because it is from a comparison of people having treatment in the NHS without the controls of a clinical trial.

The economic evidence for isatuximab plus pomalidomide and dexamethasone is also uncertain. This is because there are uncertainties around how well it works in the long-term and some of the assumptions used to estimate its cost effectiveness.

The most likely cost-effectiveness estimates are higher than what NICE considers an acceptable use of NHS resources, even when considering the condition's severity and effect on quality and length of life. So isatuximab plus pomalidomide and dexamethasone is not recommended.