Multiple Sclerosis (MS) is an immune-mediated disease of the central nervous system.
Relapsing-remitting MS (RRMS) is the most common disease course and is characterized
by periods of worsening neurologic symptoms (“relapses”) followed by partial or complete
recovery. Incomplete recovery from relapses may contribute to worsening neurologic function (“disability progression”). Over time, RRMS may transition to secondary progressive MS (SPMS). SPMS is characterized by irreversible disability progression that occurs in the absence of, or independent of, relapses.
The independent appraisal committee voted that evidence is adequate to demonstrate siponimod offers superior effectiveness for patients with active SPMS, but not inactive SPMS, compared to best supportive care.
The policy roundtable discussion highlighted siponimod’s evidence limitations, its similarity to fingolimod, and its high price, suggesting that siponimod does not merit a unique role in therapy.
2019 Review: Secondary Progressive MS
Intervention of Interest:
- Siponimod (MAYZENT®, Novartis)
Below you will find the final documents from the assessment review process:
“There is a large unmet need for effective treatments for progression in SPMS. Like other disease modifying therapies (DMTs), including the related drug fingolimod, siponimod has demonstrated the ability to reduce relapses in patients with relapsing forms of MS, but siponimod has not been proven to affect the disability progression independent of relapses that is the devastating hallmark of SPMS. Additionally, it is unfortunate that Novartis chose a price that is so far out of line with siponimod’s benefits to patients with active SPMS, particularly with it entering a crowded field of DMTs.”