UK’s NICE Issues Draft ‘No’ Decision for Sarclisa Triple Combo

The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a draft “no” statement on the triple combination of Sarclisa (isatuximab), Pomalyst (pomalidomide) and dexamethasone as a treatment for people with relapsed or refractory multiple myeloma.

This draft decision means that, at present, NICE will not recommend to the United Kingdom’s National Health Service (NHS) that the triple combination be made available to people with myeloma in England and Wales. NICE will now undergo a period of consultation before turning the draft into a final decision. The deadline for the final decision is June 25.

“This draft ‘no’ from NICE is obviously disappointing for myeloma patients in England and Wales,” Sarah McDonald, director of research at Myeloma UK, said in a press release.

Sarclisa, by Sanofi, is a monoclonal antibody that binds to the CD38  protein receptor on the surface of myeloma cells, blocking cell growth and prompting these cells to die.

The triplet combination therapy, with Pomalyst — an oral immunomodulatory treatment by Celgene —and the corticosteroid dexamethasone, already has been approved in the United States. It also was recently approved by the European Commission, an approval that included the U.K.

Sanofi had proposed to NICE that the triple combination be approved as a fourth-line treatment. That means it would be available only to people who continued to have disease progression after receiving three prior lines of treatment.

Evidence from the ICARIA-MM Phase 3 trial (NCT02990338), which had supported the approvals, indicated that the addition of Sarclisa — to treatment with Pomalyst and dexamethasone alone —reduced the risk of disease progression or death by about 40% in people with myeloma who had received at least two previous lines of therapy.

The draft decision issued by NICE acknowledged the efficacy of the triple combination, but raised doubts as to whether the benefits that would be derived would be worth the cost of treatment.

“NICE listened to and agreed with our evidence that more new treatment options are needed in myeloma,” McDonald said.

“They also agreed that this triplet does have benefits compared to current standard treatments; but they felt that uncertainties remain about just how much benefit it delivers,” she said. “This meant that, at the price currently set by the company, NICE do not believe it would be a cost effective use of NHS resources.”

During the consultation period before a final decision is made, Sanofi, clinicians, and Myeloma UK will have the opportunity to present additional evidence to NICE. In addition, Sanofi will have the opportunity to propose a revised discount scheme that might make the treatment more cost-effective. NICE also has requested data on the use of the triple therapy as a third-line treatment.

“There is still the possibility of a positive decision being reached, although there are significant challenges to be overcome,” McDonald said. “It is vital that the company, NICE and NHS England now do everything possible to deliver a positive outcome. We will submit more evidence and do all that we can to secure a ‘yes’ for myeloma patients and their families and carers.”

A decision regarding the approval of the triplet combination therapy in Scotland will be made by the Scottish Medicines Consortium. It has not yet assessed the treatment. In Northern Ireland, the Department of Health, Social Services and Public Safety will decide on its approval. The department has historically decided on whether to fund new treatments after NICE has made a decision.