A new FDA warning about AbbVie's ($ABBV) hepatitis C cocktail hasn't affected patients' access to treatment, pharmacy benefits manager Express Scripts ($ESRX) said on Wednesday.
Viekira Pak is still available for patients who fall under labeling guidelines, the PBM said (as reported by Reuters). Those guidelines changed last week, however, when the FDA said certain patients with liver injury shouldn't use the AbbVie treatment.
The FDA safety update came after reports of hepatic decompensation and liver failure in 26 patients taking Viekira Pak or Technivie. The patients already had liver cirrhosis when they began therapy.
|AbbVie CEO Richard Gonzalez|
When AbbVie's cocktail hit the scene late last year, Express Scripts negotiated an exclusive formulary deal in return for big discounts on Viekira Pak. Rival PBM CVS Health ($CVS) negotiated a similar deal with Gilead Sciences ($GILD), which markets the dominant hep C treatments, Harvoni and Sovaldi.
Earlier this week, Express Scripts was said to be planning a Pharmacy & Therapeutics committee meeting to review the labeling changes. It's unclear whether that review has already taken place.
AbbVie shares plummeted on news of the FDA warning, and though the stock has recovered somewhat since then, Viekira Pak has likely suffered lasting damage, Bernstein analyst Tim Anderson said in a recent note to investors. And Citigroup analysts figure the warning will "likely materially negatively impact sales" of Viekira Pak and Technivie.
The company faces stepped-up competition in the field as well, with combo therapies from Merck & Co. ($MRK) and Bristol-Myers Squibb ($BMY), among others, on the horizon.
AbbVie defended its hep C products, saying that only a small percentage of patients with advanced disease are covered by the FDA warning. Leerink Partners analyst Seamus Fernandez, however, said his physician sources expect that the FDA update would scare off prescribers in any cirrhotic patients, not just those with the specific disease designations cited by the agency.
Express Scripts' current word on AbbVie's meds doesn't preclude increased use of rival meds among its covered patients, either. "Additionally, it may give prescribers ammo to push more aggressively for Harvoni for those patients who have Viekira Pak as the preferred agent on their formulary," Fernandez noted.
- read the Reuters news
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