Novartis ($NVS) has predicted that its launch of newly FDA-approved heart failure med Entresto would be its "most exciting" ever. And now, it's one step closer to bringing that excitement to Europe.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Friday that regulators on the continent approve the drug, which got the FDA's green light in July. With CHMP's nod in hand, Novartis is on track to win the European Commission's (EC) backing by the end of the year, according to Reuters.
Analysts have predicted Entresto could rack up $4.4 billion in annual sales by 2020, but that figure will depend, in part, on pricing and reimbursement decisions. As far as setting prices for the med in Europe, that'll happen after the EC hands down its final word on approval, a company spokesman told the news service by email.
They'll "be determined according to local pricing and reimbursement regulations, submissions and evaluation processes," he said.
|Novartis' David Epstein|
Across the pond, Novartis is trying something new with Entresto when it comes to reimbursement. Even before unveiling a sticker price of $12.50 per pill, pharma chief David Epstein said the company was in talks with potential purchasers about a performance-based pricing system to help secure payers' favor.
That plan has its skeptics, though, and outspoken high-price critic Steve Miller, the CMO at leading PBM Express Scripts ($ESRX), is among them.
"If patients on this new drug go out and have a salty pizza and end up in the emergency room, is that the drug's fault or the patient's fault?" he told Bloomberg in July. "If the patient isn't adherent with taking the drug, is it the drug's fault or the patient's fault? … These are the discussions we're having with Novartis--how will we actually do this so it's not burdensome for patients, payers and the pharma industry?"
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Special Report: The 25 most influential people in biopharma in 2015 - Steve Miller - Express Scripts - David Epstein - Novartis