NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance.

The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of active inflammation of neurons on imaging.

Secondary progressive disease can occur after the relapsing/remitting stage of the disease, where patients experience fewer or no relapses but find their disability is increasing.

In June, NICE said it wasn’t able to support the use of Mayzent because there was limited clinical evidence for its benefits in SPMS, and it was not persuaded by the cost-effectiveness modelling submitted by Novartis.

Now, a consultation period and a new commercial agreement with Novartis to supply the drug at a discount on its £1,643.72 monthly list price means that around 38,000 people with SPMS across the UK could get access to the drug – which the MS Society charity says is “a huge step forward” for patients.

The NICE judgment for England and Wales follows a positive verdict from the Scottish Medicines Consortium (SMC) a few days ago. In Northern Ireland, the Department of Health reviews NICE guidance before deciding on use of a new drug.

Mayzent provides a treatment option to many people living with MS where once there was none, according to the MS Society, which said that people transitioning from relapsing/remitting MS to SPMS “have faced an immensely difficult challenge – being forced to go from having a range of treatments available to them, to severely limited choices.”

At the same time, for some people living with the secondary progressive form of the disease who are able to take beta interferons – currently given by injection – Mayzent provides a less intrusive choice, according to the charity.

Historically, the diagnosis of SPMS with active disease has often been delayed or avoided due to uncertainty around disease progression, as well as the lack of any effective treatment, says Novartis.

“We are working closely with the NHS to ensure eligible patients can start benefiting from siponimod as soon as possible,” said Chinmay Bhatt, managing director for Novartis Pharma UK, Ireland & Nordics.

Mayzent has the same mechanism of action as Novartis’ older drug Gilenya (fingolimod), which is approved for RRMS but not SPMS.

The drug was approved in Europe in January based on the 779-patient phase 3 EXPAND trial which showed that it significantly reduced the risk of disease progression, including physical disability and cognitive decline.

In a subgroup of Mayzent-treated patients with active disease, the data showed that the risk of three-month and six-month confirmed disability progression was significantly reduced, by 31% and 37% respectively, compared with placebo.

“By slowing down disability progression and improving cognition, siponimod has the potential to allow people to carry on working, remain independent and stay connected with family and friends,”  commented David Martin, chief executive of the MS Trust patient organisation.

“More broadly, we hope that the availability of this new treatment will lead to a greater focus on services for progressive MS which would benefit a much wider group of people,” he added.

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