Anthem reverses course, agrees to cover Sarepta's Duchenne drug
- Major U.S. insurer Anthem, Inc. has given biotech Sarepta Therapeutics Inc. a lift, agreeing to cover the biotech's Duchenne muscular dystrophy drug Exondys 51 in certain instances, reversing a decision it had made last year.
- Anthem's policy now judges the exon-skipping drug as "medically necessary" if the patient has a confirmed diagnosis, remains ambulatory and has the genetic mutation which Exondys 51 specifically targets.
- Approval of Exondys 51 last year had stirred up controversy over the drug's true efficacy, even provoking dissent within the Food and Drug Administration's ranks.
Back in October 2016, Anthem decided against covering Exondys 51 (eteplirsen) — then newly approved — judging it to be "investigational and not medically necessary", and questioning whether the drug's observed effect on dystrophin production would confer a clinically meaningful benefit.
Payer reluctance to widely cover Exondys 51 initially looked to be major hurdle for Sarepta, but the company's commercialization efforts have gained steam this year.
Anthem's reversal does have some caveats, however. In order to be initiated on the therapy, patients must have a confirmed Duchenne muscular dystrophy diagnosis, be ambulatory, and have the correct mutation. Patients can only continue with treatment if they continue to meet all the criteria — meaning they must remain able to walk with or without a cane, walker or other assistive device.
In a statement to BioCentury, Anthem spokesperson Lori McLaughlin explained the coverage update was based on new data from Sarepta's open-label extension study that showed the drug helped stave off declines in ambulatory ability.
Exondys 51 is Sarepta's only approved drug at the moment. Sales totaled $46 million in the third quarter of this year.
- Anthem Inc. Medical policy
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