NICE Does Not Favor Adding Mayzent to NHS England for Active SPMS

The National Institute for Health and Care Excellence (NICE) is recommending against Mayzent (siponimod) as a treatment for active secondary progressive multiple sclerosis (SPMS) in the U.K., because its cost-effectiveness relative to an existing treatment for these patients is not known.

NICE’s draft guidance for Mayzent is open for public comment up until July 16.

Mayzent, marketed by Novartis, was approved by the European Commission to treat active SPMS in January, with clinical trials demonstrating the therapy can slow disability progression and relapse rates compared with a placebo.

However, NICE in its opinion noted trial data do not directly compare Mayzent with interferon beta-1b (sold in Europe as Betaferon and Extavia).

Interferon beta-1b is the only treatment now available for active SPMS in the U.K., NICE, a branch of the country’s National Health Service (NHS), acknowledged in its opinion, adding that “few people take it” due to side effects like flu-like symptoms.

“Most people [with active SPMS] do not have any disease-modifying treatment,” it stated.

Without a head-to-head comparison of the two medications, however, NICE is unable to recommend Mayzent as a cost-effective therapy to be included in the NHS, the public health system for England and Wales.

“We know there are currently few, if any treatments available for people with this form of MS, and that siponimod is a promising drug that has the potential to address this unmet clinical need,” Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said in a press release.

“We are, therefore, committed to working with the company to help them address the issues identified by the committee that are highlighted in this draft guidance,” Boysen added.

NICE requested additional analyses to be included in Novartis’s economic model, including comparing Mayzent with best supportive care, and the assumption that treatment efficacy diminishes over time.

Mayzent carries a list price of  £1,643.72 (about $2,039) for a pack of 28 tablets, the agency noted. Novartis has agreed to a confidential commercial arrangement that would lower that price.

“We are hugely disappointed by this initial decision,” David Martin, chief executive of the U.K.’s MS Trust, said in a separate press release.

“Time and time again, we hear from people with secondary progressive MS struggling at home, feeling like they have been forgotten. Just earlier this month, a new report has highlighted the significant gaps in support and services for people with SPMS,” Martion said.

Not everybody will be eligible for siponimod, but we hope that the availability of a new treatment will lead to a renewed focus on the needs of all people with SPMS,” he added.

The MS Trust is analyzing the draft, and encourages people to contribute their thoughts on the NICE recommendation through July 16, up until the close of working hours (5 p.m.) using this link.

NICE will meet after the public comment period ends to review opinions given and  further evidence submitted by Novartis. The date for this meeting is not yet confirmed.

A similar scheduled appraisal of Mayzent public health system inclusion by the Scottish Medicines Consortium is currently on hold. Northern Ireland’s Department of Health typically follows NICE guidance after a review, which is underway.

In England, SPMS is estimated to affect around 9,000 people, NICE reported.