Following this decision by England’s National Institute for Health and Care Excellence (NICE) — which reversed its opinion announced in June — the National Health Service (NHS) will have two months in Wales and three months in England to prepare for providing the medication.
The NHS is then expected to make Mayzent available at discounted prices when prescribed to patients.
Most people with relapsing-remitting multiple sclerosis (RRMS) eventually progress to SPMS. Whereas RRMS is characterized by relapses — where symptoms get worse, then better — in SPMS, symptoms tend to get steadily worse. Active SPMS refers specifically to a disease course in which a person continues to experience relapses and/or has evidence of new and active brain lesions.
“At the moment there are few options for someone whose MS is changing from relapsing remitting to secondary progressive, so this approval is very welcome and a big step forward,” David Martin, CEO of the MS Trust, said in the U.K. association’s press release.
The MS Trust played a central role in NICE’s reappraisal of the treatment, including in its recent submission arguing for approval views that the group gathered from nearly 400 patients. These views gave “a compelling account of the challenges of living with secondary progressive MS and [made] a strong case for this new treatment” the MS Trust stated in its release.
Mayzent, marketed by Novartis, is a once-daily tablet. The medication works by binding to the sphingosine-1-phosphate (S1P) receptor, a protein on immune cells. By targeting the S1P receptor, Mayzent is designed to prevent immune cells from leaving lymph nodes and entering the nervous system via circulating blood, causing disease-driving inflammation.
The therapy’s safety and efficacy in these patients were demonstrated in the Phase 3 clinical trial EXPAND (NCT01665144), which enrolled 1,651 people with active and non-active SPMS.