Payers line up to back Mitsubishi Tanabe's pricey new ALS therapy Radicava

How do you get 100% of the payers you approach to cover a pricey new med? Launch the first novel treatment in decades to target a devastating disease, Mitsubishi Tanabe Pharma America’s commercial head says.

The Japanese pharma’s U.S. arm—which is rolling out its first product ever, thanks to May's approval of amyotrophic lateral sclerosis (ALS) treatment Radicava—hasn’t yet seen a commercial payer turn its back on the med. And more than 30 have come out with coverage decisions, Tom Larson, MTPA’s chief commercial officer, said in a recent interview. 

And that’s despite a list price of $1,086 per infusion and a dosing schedule that kicks off with 14 straight days of infusions.

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“I think they’re recognizing how devastating a disease this is and how important the approval of Radicava is and how significant our data are,” he said. In the clinic, Radicava—the first ALS med to win approval in 20 years and only the second ever—showed it could slow patients' decline by 33%.

It's not a cure; it doesn't rewind the disease itself. But the drug was impressive enough—and the unmet need strong enough—to prompt the FDA to actually solicit an approval application from Mitsubishi Tanabe. Radicava was already on the market in Korea and Japan. “After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” the FDA's Eric Bastings, deputy director of the Division of Neurology Products, said in a statement when the product was approved. 

Of course, there are still plenty of payers left to make up their minds about Radicava, which after the initial cycle is infused 10 times every 28 days. But “we’re very encouraged and expect that payers will decide to cover this product,” Larson said.

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In the meantime, MTPA is deploying what Larson calls a “comprehensive field organization that represents the various constituents and various needs” to educate ALS specialists. “Our focus is really to do quality education through the treating physician,” he said, adding that “we really respect the relationship and the trust between physician and patient and feel that’s probably the most appropriate way to educate.”

And the company is partnering with the ALS Association and other patient advocacy groups to help get the word out among doctors, too. In part because of the lack of new treatment options over the last several years, “everyone knows about Lou Gehrig and they know about ALS, but they really don’t know a lot beyond that,” Larson said. “The fact that we’re able to communicate how tragic a disease this is ... is very important. Educating people on the facts about ALS is important. “