Sanofi to appeal NICE's final draft guidance for Sarclisa

Sanofi (Euronext: SAN) today revealed that UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance (FDG) not recommending Sarclisa (isatuximab) plus pomalidomide and dexamethasone (Isa-Pd), within its marketing authorization, for treating relapsed and refractory multiple myeloma (RRMM) in adults who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment.

The French pharm major pointed out that Isa-Pd has become a standard-of-care for eligible patients in England and Wales through its availability on the Cancer Drugs Fund (CDF), with over 1,700 patients registered to have started Isa-Pd treatment in England and said it plans to appeal the NICE’s final draft guidance.

“However, we believe under NICE’s preferred assumptions, Isa-Pd is not cost-effective within the current NICE framework, even if isatuximab is offered at zero price (£0). This is due to inflexibility in the current system which does not enable a fair process for appraising combination medicines,” said Sanofi.