Novartis Entresto One Step Closer To European Commission Approval

Novartis ($NVS) has recently suggested that its kick off of recently US FDA accepted heart failure medicine Entresto will be one of the most successful ever. And now, it is much closer to extending the same excitement to Europe.

EMA Panel for Medicinal Products for Human Use (CHMP) suggested recently that regulators on the region accept the drug, which recently received a nod for marketing from the US FDA. With CHMP’s approval in hand, Novartis is focused to get the European Commission’s (EC) support by the end of this year.

According to a representative from Novartis, experts have estimated Entresto could build up $4.4 billion in annual sales by 2020, but that amount will rely, in part, on costs and refund decisions. Deciding the pricing for the medicine in Europe will take place after the EC hands down its final word on acceptance.

Novartis is attempting something new with Entresto when it comes to compensation. Prior to introduction of a price tag of $12.50 per tablet, pharma chief David Epstein stated the organization was in discussions with potential buyers about a performance-dependent costs system to help secure payers’ favor.

That plan has its skeptics, though, and outspoken higher-cost critic Steve Miller, the CMO at major PBM Express Scripts is one of them.

“If patients on this new medicine go out and have a salty pizza and finish up in the emergency room, is that the medicine’s mistake or the patient’s?” he told Bloomberg in few months back. “If the patient is not adherent with taking the medicine, is it the medicine’s mistake or the patient’s? … These are the conversations we are having with Novartis- how will we basically do this so it is not burdensome for patients, payers and the pharma sector?”