ICER calls price of Novartis' Mayzent "far out of line" with benefits in active secondary progressive MS

The Institute for Clinical and Economic Review (ICER) published its final report on Novartis' Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS), noting that the price of the selective sphingosine 1-phosphate does not tally with its benefits. David Rind, ICER's chief medical officer, said "it is unfortunate that Novartis chose a price that is so far out of line with [its] benefits to patients with active SPMS, particularly with it entering a crowded field of [disease modifying therapies]."

Mayzent gained approval from the FDA in March for the treatment of relapsing forms of multiple sclerosis, including active SPMS in adults, with the product having an annual list price of $88,000. The ICER's analysis focused on the clinical and cost-effectiveness of Mayzent just for patients with SPMS, which was the population studied in the Phase III trial, with a draft version released last month.

ICER noted that economic analyses assessing long-term cost-effectiveness found that, when compared to best supportive care for the active SPMS sub-population, Mayzent is estimated to cost $433,000 per quality-adjusted life year (QALY) and nearly $1.6 million per life year gained.

According to ICER, the majority of members of an advisory committee that reviewed the report voted that the evidence demonstrated Mayzent to be clinically superior to best supportive care for patients with active SPMS. However, panel members unanimously found that the evidence was insufficient to demonstrate that the drug is superior to best supportive care for patients with non-active SPMS.

Rind noted that similar to other disease modifying therapies, including Novartis' Gilenya (fingolimod), Mayzent "has demonstrated the ability to reduce relapses in patients with relapsing forms of MS, but…has not been proven to affect the disability progression independent of relapses that is the devastating hallmark of SPMS."

Meanwhile, Novartis stated that ICER failed to take into account the feedback and recommendations that the drugmaker had provided. It also argued that ICER did not use proper comparisons to establish Mayzent's cost effectiveness. "Novartis believes that Mayzent brings value to MS patients," said a company spokesman, adding that the therapy has demonstrated a significant effect in delaying disability progression in a representative SPMS population.  

For related analysis, see ViewPoints: Mayzent - everything you need to know about Novartis' new multiple sclerosis treatment, and Physician Views snap-poll results: Neurologists cautiously optimistic about Novartis' Mayzent.

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