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October 17, 2016

Politico

By Sarah Karlin-Smith and Brett Norman
10/10/16 12:00 PM EDT

Major Insurer Denies Coverage of Controversial Drug
Anthem, the country’s second-largest health insurer, won’t provide its members with access to Sarepta’s recently-approved Duchenne muscular dystrophy treatment, Exondys 51 (eteplirsen), the insurer announcedFriday. Anthem said the drug is “considered investigational and not medically necessary.” The treatment for a disease that kills young people has a price tag of $300,000 per year – high, but not atypical for a drug that treats rare disease. In its coverage denial, Anthem cited problems with the drug’s clinical trials, as well as the uncertainty that treatment will provide patients with a meaningful benefit. This is the latest act in the drama around Sarepta’s rollout.

FDA drug center director Janet Woodcock and commissioner Robert Califf overrode the agency’s own drug reviewers and an independent panel of experts when they granted accelerated approval to Exondys 51 in late September. This raised questions as to whether the agency’s top leadership pushed too aggressively for the unproven drug, bowing to the pressure of patient advocates and politicians. Here’s more on the backstory. Other large insurers like UnitedHealthcare and Cigna are covering the drug. Read the full article here.