NICE rejects Sanofi's Sarclisa in preliminary guidelines

NICE has published initial guidelines rejecting NHS use of a therapy combination containing Sanofi's Sarclisa (isatuximab) to treat multiple myeloma.

The company proposes that Sarclisa plus pomalidomide and dexamethasone (pom-dex) be used to treat multiple myeloma only in people who have had at least three treatments before.

At this stage of disease, treatment is usually pom-dex, or daratumumab alone (via the Cancer Drugs Fund).

According to NICE's appraisal consultation document, clinical trial evidence in this group suggests that Sarclisa plus pom-dex delays the disease progressing and increases how long people live compared with pom-dex alone.

However, as the trial is not yet finished, 'it is not certain' how much more clinical benefit Sarclisa/pom-dex has over the latter alone, the Institute said.

Taking this uncertainty into account, the most likely cost-effectiveness estimates for the Sarclisa combination are 'much higher' than what NICE normally considers a cost-effective use of NHS resources, and there it is not recommended, it concluded.

Sarclisa was cleared for use in Europe earlier this month on the back of data showing that in combination with pom-dex it significantly cut the risk of progression or death by 40% versus pom-dex alone.

At the time, John Reed, global head of Research and Development at Sanofi, said that Sarclisa in combination with pom-dex “demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies.”