NICE rejects BMS' Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance.

The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a).

But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.

NICE also noted the range of other disease-modifying drugs already available, oral rivals Novartis’ Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) from Biogen.

There are also some powerful injected drugs on the market such as Roche’s Ocrevus (ocrelizumab), Sanofi’s Lemtrada (alemtuzumab).

In its guidance, NICE did not give details of cost-effectiveness estimates because of confidential commercial arrangements for Zeposia and comparators.

But NICE said that the drug was likely to fall outside its cost-effectiveness threshold of £30,000 per Quality Adjusted Life Year (QALY).

There was also no analysis supporting Zeposia’s use as a second-line treatment.

Along with other technical data, NICE said it wanted to see data comparative with other second line treatments such as Lemtrada and Gilenya.

In a statement, the MS Society said it was “frustrating” that NICE had decided not to recommend funding for Zeposia.

Dr Sara Rawlings, director of research and external affairs at the MS Society said: “While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative.

“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS. Ozanimod would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this.”

Zeposia is important to patients because it doesn't cause the unpleasant gastrointestinal side effects associated with Biogen's Tecfidera.

Rawlings pointed out that there is still time for NICE to change its mind if BMS submits new evidence.

The guidance applies only to England and Wales and in most cases Northern Ireland. A decision is expected from the Scottish Medicines Consortium next month.