NICE knocks back Novartis’ oral MS drug Mayzent in draft guidance

The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Novartis’ multiple sclerosis therapy Mayzent in initial draft guidance published this week.

NICE has decided to reject Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) with active disease, meaning the therapy will not be available for routine use on the NHS.

SPMS has limited treatment options and diagnosis is often delayed or avoided due to the uncertainty around when relapsing remitting multiple sclerosis (RRMS) progresses to SPMS. Many people with SPMS with active disease often continue to receive treatment licensed for use in RRMS, which has not been proven effective for the treatment of SPMS.

In the draft guidance, the NICE committee acknowledge the clinical effectiveness of Mayzent, but ultimately concluded that RRMS treatments were not relevant comparators for cost-effectiveness analysis.

Novartis defended the use of RRMS treatments as a relevant comparator, given that this is standard NHS practice among SPMS patients. On the other hand, demonstrating cost-effectiveness versus no treatment is challenging, so using this approach could risk risk patients being left unable to access new medicines like Mayzent, said the Swiss pharma company.

Treatment with Mayzent has been found to reduce the risk of disability progression, including physical disability and cognitive defects, by 33% compared with placebo.

While there is one other type of treatment for secondary progressive MS in the UK, this must be injected, which requires more healthcare professional support to administer and has more stringent monitoring requirement.

“Siponimod is the first new treatment for secondary progressive MS in over a decade, and the only oral option. There’s just one alternative and it isn’t suitable for everyone. For those people to be denied a way to manage their condition will be potentially devastating,” said Jonathan Blades, head of campaigns and external relations at the MS Society.

“MS is relentless, painful and disabling, and this decision could have a profoundly negative impact on thousands of lives. But NICE, together with the drug manufacturers and NHSE, have an opportunity to turn that around. We’re urging them to look again at the evidence and the reality of life with a gradually worsening disability, and do what’s right,” he added.

Novartis has said that it is committed to continuing to work closely with NICE to address outstanding questions and data requirements to secure access to Mayzent for patients in England and Wales.