Home Mayzent Novartis Drug Wins FDA Approval Despite Challenges to its $88K Price

Novartis Drug Wins FDA Approval Despite Challenges to its $88K Price

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Novartis drug Mayzent was approved for multiple sclerosis.  Novartis has established a price at $88,000 per year. It exceeds most MS drugs and will get the attention of payers.  The FDA reports that the drug’s benefits are not statistically significant in patients with non-active MS.

Physicians Weekly reports Novartis sponsored the effort with a 1,651-person trial, 26% of patients who received Mayzent saw their disability progress after three months, less than the 32% of patients who got a placebo, amounting to a relative risk reduction of 21%. Drug price non-profit analyst firm ICER has already declared that the Novartis price far exceeds levels thought to be cost-effective. Thus far ICER has concluded that Novartis should have to price Mayzent between $680 and $1,000 per month for it to be considered cost-effective.

Hudson said ICER’s figures could change in its final report, due out in June. “Wait and see how that plays out,” he said, adding Novartis was still working to help people understand Mayzent’s benefits.

BILLION-DOLLAR BUSINESS

Novartis’ older Gilenya MS drug, its top seller at $3.34 billion annually, has a list price of $95,594 annually. Roche’s new MS drug, Ocrevus, with 2018 sales of $2.4 billion, lists at $65,000. Novartis sees Mayzent, a synthetic derivative of Gilenya modified to reduce side effects like a slow heart rate and better protect nerves from destruction, as a way to help often-older patients whose disease moves past relapsing MS to a progressively worsening condition.

Hudson called Mayzent a potential blockbuster with annual sales of more than $1 billion, while revenue is estimated at about $800 million by 2022, according Refinitiv data.

Stefan Schneider, a Bank Vontobel analyst, forecasts $600 million peak annual sales. With Mayzent’s approval for the active form of SPMS, Schneider said that leaves it in competition with existing drugs and puts the onus on Novartis’s marketing force to convince doctors to switch from medicines they know better.

“Novartis will need to promote SPMS testing and change of therapy, likely not an easy endeavor,” he said.

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