EU nod sets up Gilead's Harvoni for record-breaking sales

Open up the floodgates: Gilead's ($GILD) hep C wonder-cocktail, Harvoni, has won approval in Europe.

Graham Foster

With cure rates as high as 99.1%, analysts expect the drug--which combines Sovaldi with NS5A inhibitor ledipasvir--to outstrip solo Sovaldi as the fastest-growing drug of all time. And the EMA's green light, which grants Gilead marketing authorization in the EU's 28 countries, is certainly a necessary step if Harvoni--which won FDA approval this October--wants to live up to those forecasts.

"Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades," Graham Foster, a hepatology professor at London's Queen Mary University, said in a statement. "With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe."

But Europe, like the U.S., has already given some indication that it may have trouble affording the drug, which checks in at $94,500 per 12-week treatment course in the U.S. Though Gilead offered up predecessor Sovaldi at a deep discount of £35,000--and the U.K.'s notoriously strict watchdogs deemed it cost-effective--National Health Service documents seen by Pharmafile later suggested the government couldn't bear the aggregate cost of treating 20,000 U.K. patients.

Pricing worries echo those the company has been hearing from U.S. payers ever since Sovaldi first won approval late last year. Steve Miller, CMO at Express Scripts ($ESRX), has been particularly vocal, promising after the Harvoni price announcement that pricing based on what the market will bear is "not sustainable." His company and others have taken matters into their own hands: Last month, Miller said the PBM could quickly change its preferred drug formulary to favor an anticipated challenger from AbbVie ($ABBV) when it hits the market, provided it's less expensive.

Express Scripts CMO Steve Miller

And recent script numbers suggest Gilead may want to take threats like that seriously. As of Friday, total Harvoni prescriptions for the week had soared 33% from the week prior to reach 2,633. But scripts for Sovaldi and Harvoni combined need to reach about 95,000 for the quarter if the company wants to hit consensus estimates, ISI Group analyst Mark Schoenebaum wrote in a recent note to investors, and so far they're less than a third of the way there.

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Special Reports: The new drug approvals of 2013 - Sovaldi - Gilead | The most influential people in biopharma today - Steve Miller - Express Scripts