Throughout its quest to get an FDA approval for Exondys 51, one of Sarepta’s most influential backers has been the editorial page at the Wall Street Journal, which loudly and angrily insisted on an accelerated OK. And now that it helped win that fight, the newspaper’s editorial group — as distinct from its reporters — has turned its sights on insurers who are restricting coverage as well as the reporters and regulators they find responsible for the payer backlash.
The Journal is not the least bit happy with John Jenkins, the departing head of the Office of New Drugs at the FDA, for lambasting Sarepta’s campaign to win an approval as “NOT a good model” for other biotechs to follow. And the editorial readily blames critics for falsely maligning the drug, upset that the drug label says that the clinical benefit has not been established.
The regulatory “misinformation” campaign has prompted a series of insurers to either refuse coverage altogether or find other ways to deny coverage, says the WSJ. They write:
Anthem has declined to cover the treatment, calling it “investigational.” (That’s false.) Aetna will require boys to start the drug before age 14, among other stipulations, and insurers like Humana are limiting the treatment to boys who can walk. The companies’ explanation is that there’s no proof of clinical benefit or improved health outcomes…Excellus, a BlueCross BlueShield affiliate in New York, is also only covering patients who can walk, according to its policy online.
The Journal’s retribution extends to the journalists covering the backlash inside the FDA as well as among insurers.
Insurers are usually hypersensitive to avoid public shaming campaigns, but here they don’t seem too concerned. That’s probably because the reporters who cover FDA have taken the side of the reviewers and insurers.
The WSJ’s take-no-prisoners approach promises to keep Exondys 51 in the center of attention in 2017, though with a new focus on payers. Sarepta’s share price has melted away in the months since the FDA OK, eliminating the big spike that greeted a surprising approval. Analysts say that the insurers’ new rules to limit coverage will hit the brakes on any early sales. And the controversy will continue to simmer for Sarepta as it tries to market a drug that the agency officially views as experimental.
This is uncharted territory for biotech.
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