ICER found that tiprotimod (Mayzent) reduced the risk of multiple sclerosis progression as well as decreased inflammatory disease activities however it’s analysis reveals the drug is priced too high for the market.

The Institute for Clinical and Economic Review (ICER), an independent nonprofit argues that siponimod (Mayzent) is effective but its price points are too high. ICER found that the drug reduced risk of progression as measured by the Expanded Disability Status Scale however they were not able to observe significant other benefits making the degree to which it delays progressions not clear according to NeurologyToday.

What is Siponimod?

A once-daily tablet, it was approved by the U.S. Food and Drug Administration (FDA) in March to treat the clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).

A next-generation, selective sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease, in adults.

Regulatory Timeline

Novartis originally submitted an investigatory new drug application (IND) in September 2006. The initial protocol for IND 076122 was a trial in 63 healthy volunteers comparing single and multiple-dose ranges from 2.5 mg to 500 mg. Novartis had many fits and stops with siponimod. It was until October 2017 that they began NDA discussions with actual filling in October 2018. The FDA turned around the final approval at a rapid speed (it was fast-tracked); just over five months later on March 27, 2018, the drug was approved.

ICER on Other MS Drugs

Generally, ICER leans on the side of too expensive for the rest of the MS drugs. It was reported that ICER noted Alemtuzumab (Sanofi) and ocrelizumab (Genentech/Roche) were deemed most effective at reducing progression, next followed by natalizumab (Biogen) and daclizumab (take off the market by AbbVie and Biogen). See link.

ICER reports that overall exceptionally high costs make MS treatments “not show well in ICER cost-effectiveness analyses.” Purportedly, alemtuzumab (Sanofi) was deemed to be the most cost-effective based on ICER standards—excepting safety issues: the boxed warning includes sometimes -fatal autoimmune conditions, malignancies, and other issues. It is only appropriate for a subset of patients.

Health System Kaiser Physician Perspective

Dr. Annette M. Langer-Gould reported “I don’t see us using it at all in Kaiser because no one can seem to think of a reason they would use it over fingolimod (Novartis). And that drug in and of itself has become much less population, both here and in Europe, over the last five years.

Is Novartis Losing Touch with the Markets? Patients are Consumers

Is Novartis losing touch with market reality? TrialSite News did a special on their strategy based on announced acquisitions of gene therapy, radiotherapy and other drug platforms focused on rare diseases, for example. Neurology Today reports that the factors that might be expected to influence the price—including 1) efficacy 2) route of administration and 3) class of medication essentially do not apply to MS therapies. Biologics were typically priced higher because A) they worked better B) they were harder to manufacturer than pills.

MS Groups Complain About Price

Patient groups can be powerful in America. If they are well organized, funded and managed they can influence many millions of people. Patient groups fall into this category. Although MS groups were pleased with the siponimod approval in March 2019 they surely were distributed by the high price points. May MS patient was surely happy and understood the incremental value-add for someone with MS in the secondary progressive stages.

One patient in a Multiple Sclerosis News Today article noted: “Mayzent carries a very high price tag, but that her managed care plans pays for therapies that plans don’t cover.”

Source: NeurologyToday

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