2nd Largest Health Insurer – Anthem – Won’t Pay for FDA-Approved Duchenne Drug | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health insurer Anthem Inc said it would not cover the first U.S. Food and Drug Administration-approved Duchenne muscular dystrophy (DMD) drug, developed by Sarepta Therapeutics Inc, calling it "investigational and not medically necessary".

 

Bowing to pressure from patient advocates, the FDA approved the drug, Exondys 51, last month, even though an outside panel of experts and the agency's own reviewers questioned its efficacy (read “FDA Succumbs to Industry-Sponsored ‘Patient Power’ & Accelerates Approval of Sarepta's Duchenne Drug”; http://sco.lt/4mgzvV)

 

The accelerated approval is based on data believed to predict a clinical benefit. Sarepta has to prove that benefit in a subsequent clinical trial.

 

Anthem, the second-largest health insurer in the United States, said on its website on Friday the drug's clinical benefit, including improved motor function, had not been demonstrated. (bit.ly/2e9qGhu) 

 

"Exondys 51 failed to show it improves health outcomes, and therefore it is not a covered benefit for our members," Anthem spokeswoman Leslie Porras said in an emailed statement on Friday.