NICE has today (15 October 2020) issued draft guidance which recommends siponimod (Mayzent) for treating adults with secondary progressive multiple sclerosis (MS) who have evidence of active disease.
The main clinical evidence for siponimod came from the double-blind, randomised, placebo-controlled EXPAND trial. The randomised part of the trial was followed by an observational period in which everyone was switched to open-label (unblinded) siponimod and followed for up to 10 years. This
part of the trial is ongoing.
In the subgroup of people with active disease in EXPAND, both time to three-month and six-month confirmed disability progression were longer with siponimod than with placebo. The annualised relapse rate was lower with siponimod than with placebo.
An indirect comparison was carried out between siponimod and interferon beta-1b using data from EXPAND and two trials of interferon beta-1b which reported relevant efficacy outcomes. The analyses favoured siponimod over interferon beta-1b for six-month confirmed disability progression and annualised relapse rate but with wide confidence interval.
The most plausible cost-effectiveness estimates for siponimod compared with no disease-modifying treatment and with interferon beta-1b (Extavia) were determined to be within the range that NICE normally considers an acceptable use of NHS resources.
The drug has recently also been recommended for use in Scotland and a decision on approval in Northern Ireland is expected in the coming months.
