Novartis Responds to NICE Decision on Siponimod

June 25, 2020

Novartis UK has issued a statement specifying its disappointment at the initial decision by NICE to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.

Novartis UK has issued a statement specifying its disappointment at the initial decision by the National Institute for Health and Care Excellence (NICE) to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.

The Appraisal Consultation Document (ACD) published by NICE states that the committee does not recommend siponimod, within its marketing authorization, for the treatment of secondary progressive multiple sclerosis with active disease as a result of limited clinical evidence. Additionally, the committee notes that the “cost-effectiveness estimates are uncertain and none of the analyses reflect [its] preferred assumptions.” 

In response to the recommendation, Novartis UK said, in a statement issued June 25, 2020, “We at Novartis UK are disappointed by the initial decision from the NICE not to recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) with active disease, for routine use on the NHS [National Health Service]. Currently, treatment options for people diagnosed with SPMS with active disease are extremely limited and we believe siponimod addresses an unmet need in this patient population … If the initial decision from NICE remains unchanged patients will be denied access to the first licensed oral therapy for SPMS with active disease, leaving them without an effective, convenient treatment to manage their condition and help them maintain independence for longer. We are committed to continuing to work closely with NICE to address outstanding questions and data requirements in order to secure access as quickly as possible to siponimod for those patients in England and Wales that could benefit.”

The initial recommendation by NICE is now open for consultation and the final decision will follow a further appraisal, taking all comments into consideration. The deadline for the consultation period is July 16, 2020.

Sources: Novartis UKNICE