March 27, 2019 / 12:29 AM / in 22 days

Novartis MS drug wins FDA's blessing amid scrutiny of $88,000 annual price

ZURICH (Reuters) - Novartis AG has won U.S. Food and Drug Administration approval for multiple sclerosis drug Mayzent as the Swiss company targets patients whose disease advances from intermittent attacks to a gradually worsening condition.

FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

Novartis has priced the treatment at $88,000 annually, head of pharmaceuticals Paul Hudson told Reuters, a level exceeding some other MS drugs and one that may draw scrutiny from payers.

Mayzent was approved for adults with relapsing forms of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease (SPMS), the FDA said. It said the drug’s benefits were not statistically significant in patients with non-active MS.

In a 1,651-person trial, 26 percent of patients who got Mayzent saw their disability progress after three months, less than the 32 percent of patients who got a placebo, amounting to a relative risk reduction of 21 percent.

The drug’s cost will likely attract attention, as the independent Boston-based group Institute for Clinical and Economic Review (ICER) has already suggested in a draft report that Mayzent, at the Novartis price, likely far exceeds levels generally thought to be cost-effective.

“We will find a way to bring it to market, so patients get the best clinical choice,” Hudson said. “I think we’ve been very responsible with the pricing of it.”

So far, however, ICER has concluded Novartis would have to price Mayzent between $680 and $1,000 per month for it 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.

Reporting by John Miller and John Revill in Zurich and John Benny in Bengaluru; Editing by Sandra Maler/Keith Weir

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