Sarclisa Triple Combo Conditionally Approved for NHS Use in England, Wales

After first rejecting a Sarclisa (isatuximab) triple combination therapy due to cost-effectiveness concerns, the U.K.’s National Institute for Health and Care Excellence (NICE) has given conditional approval to the treatment for relapsed or refractory multiple myeloma.

The triple therapy includes Sarclisa in combination with Imnovid (pomalidomide, also sold as Pomalyst) and dexamethasone, a corticosteroid. It is particularly recommended for myeloma patients who have received three prior lines of treatment, including Revlimid (lenalidomide) and a proteasome inhibitor, and whose disease has progressed on their last line of therapy.

The combo will be available via the Cancer Drugs Fund to people living in England and Wales.

“It is so important for multiply relapsed patients at fourth line of treatment to know there is an effective treatment option there for them when they need it,” Laura Kerby, CEO of Myeloma UK, said in a press release.

Sarclisa, by Sanofi, is an antibody that binds to CD38, a protein receptor found abundantly on the surface of myeloma cells, and triggers a cascade of events that cause the death of those cells.

The medication has been approved in the U.S. and the European Union, also in combination with Imnovid and dexamethasone, for people with relapsed or refractory (resistant) myeloma. But in an initial review, the U.K.’s NICE rejected Sarclisa, claiming it was unclear whether the benefits from this medication would be worth the cost of treatment.

The new conditional approval will now make the triple combination available through the Cancer Drugs Fund for approximately two years, while further evidence is collected to address clinical uncertainty. The Cancer Drugs Fund is a National Health Service source of funding that provides access to promising cancer treatments.

After this period, NICE will re-evaluate the treatment and make its final decision on whether to approve the triple combo for routine use on the NHS.

“We have been working closely on this for many months to make sure the patient voice was heard loud and clear at every stage,” Kerby said. “We did this by submitting written evidence to NICE, attending the committee meeting and making a strong case for approval following an initial draft ‘no.'”

The current decision only applies to England and Wales. The Scottish Medicines Consortium (SMC) plans to consider a potential approval of the combination shortly, while in Northern Ireland, the Department of Health typically awaits NICE’s final decision before making its own.

Myeloma UK intends to advocate for SMC approval, as it had done with NICE.

“This was a challenging appraisal where longstanding issues, such as the burden of proving cost effectiveness in combination treatments, came through once again,” Kerby added.