Novartis’ MS therapy Mayzent approved by NICE

Novartis’ oral drug Mayzent has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for the treatment of secondary progressive multiple sclerosis (SPMS).

Mayzent (siponimod), a sphinogosine 1-phosphate receptor modulator, is the first oral disease-modifying treatment recommended by both NICE and the Scottish Medicines Consortium (SMC) for SPMS with active disease.

Novartis’ drug was first approved by the US Food and Drug Administration (FDA) in 2019 to delay disease progression in patients with SPMS. Mayzent then received approval from the European Commission (EC) earlier this year, again for the treatment of adults with active SPMS.

SPMS is typically characterised by an irreversible decline of neurological functions and there remains a high unmet need for safe and effective treatments to help delay the disability progression in this form of MS. According to NICE, around 11,000 people with SPMS will now be eligible to receive Mayzent treatment.

Initially, NICE turned down Mayzent due to a lack of clinical evidence for its clinical benefit in SPMS and also a lack of cost-efficiency evidence.

However, following changes made by Novartis to the costing of the drug in response to consultation on the initial draft guidance, NICE felt that the pharma company had addressed earlier concerns around Mayzent’s cost-effectiveness.

The NICE committee concluded that ultimately Mayzent cost-effectiveness estimates were within the normal range that NICE considers to be an acceptable use of NHS resources.

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

“We are, therefore, pleased that the company has been able to address the issues identified by the committee in our earlier draft guidance so that people with this condition now have a further treatment option,” he added.

In clinical studies of Mayzent, the use of the drug was associated with statistically significant reductions in the risk of confirmed disability progression (CDP) in SPMS patients, with a respective risk reduction at three and six months of 31% and 37%.

Mayzent also improved outcomes in an overall MS population, demonstrating reductions of 21% and 26% in the three- and six-month risk of CDP respectively.