NICE draft guidance rejects the use of Sarclisa combination therapy for multiple myeloma.- Sanofi

NICE has published draft guidelines rejecting use of a combination drug therapy containing Sarclisa (isatuximab), from Sanofi, plus pomalidomide and dexamethasone (pom-dex), to treat multiple myeloma within the NHS. The proposal is to treat multiple myeloma only in people who have had at least three treatments before.

According to NICE’s appraisal, evidence suggests that Sarclisa plus pom-dex delays the disease progressing and increases how long people live compared with pom-dex alone. But since the trial is not completed, NICE warns that it is not certain how much more clinical benefit Sarclisa/pom-dex has over the pom-dex alone. This uncertainty means that cost-effectiveness estimates for the Sarclisa treatment are not a cost-effective treatment for NHS use.

Comment: In March 2020, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sarclisa, recommending it in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.