NICE says no to Novartis’ Mayzent in secondary progressive MS

There isn’t enough evidence to back the use of Novartis Mayzent for secondary progressive multiple sclerosis on the NHS (SPMS), despite a desperate lack of treatments for this form of the disease, says NICE.

The cost-effectiveness watchdog says it can’t recommend Mayzent (siponimod) in patients with SPMS because there is only limited clinical evidence of a benefit with the drug, and it wasn’t swayed by cost-effectiveness evidence submitted by Novartis.

In particular, NICE has concluded that comparisons with drugs used to treat relapsing-remitting forms of MMS (RRMS) are not relevant for cost-effectiveness analyses.

The outcome of the appraisal has been met with consternation by medical charity the MS Trust, which said “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 … highlighted the significant gaps in support and services for people with SPMS,” continued the charity’s chief executive David Martin.

“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.”

Mayzent was approved for the treatment of SPMS by the EMA in January, having already been given a green light by the regulator for both SPMS and RRMS in the US a few months earlier.

In trials, the drug reduced the risk of disability getting worse by 21% compared to placebo. Further analysis also showed a 33% cut in the risk of worsening disability for those with active SPMS, defined as patients who had relapsed in the two years prior to starting the study.

Novartis has previously said it thinks S1P inhibitor Mayzent has the potential to become a $1 billion-plus drug as SPMS patients have such limited treatment options, but NICE’s verdict undermines that aspiration.

Mayzent will compete with Merck KGaA’s oral therapy Mavenclad (cladribine), which was approved for active SPMS in Europe since 2017 and the US earlier this year, as well as Roche’s fast-growing infusion therapy Ocrevus (ocrelizumab) in this indication.

“The diagnosis of SPMS with active disease is often delayed or avoided due to uncertainty around when [RRMS] progresses to SPMS,” said Novartis in a statement.

That means patients with this form of the disease “continue to receive treatment licensed for use in RRMS, which has not been proven effective,” it added. That use makes RRMS therapies the most appropriate comparator for Mayzent, according to the company.

NICE’s position however is that the best comparison would be against interferon beta-1a, an injectable drug which it says is “is the only disease-modifying treatment available for people with active SPMS.”

Novartis and the MS Trust are both planning to engage with NICE to try to change its position during a comment period, which has been extended to 16 July.

The Scottish Medicines Consortium (SMC) has also scheduled an appraisal of siponimod but this is currently on hold.