Aetna: Entresto’s Label Enabled Outcome-Based Risk Share

Including the impact on hospitalizations in the label for Novartis's heart failure drug Entresto was critical to enable execution of outcome-based agreements. Such deals present an opportunity for pharma and payers to work together, but many challenges remain.

Speaking at NextLevel Pharma’s Spring PharmAccess Leaders event, Aetna’s national medical director Ed Pezalla said that Novartis AG's success in including reductions in hospitalizations on Entresto’s FDA label was critical in enabling outcome-based risk-sharing deals to be penned for the drug. Having recognized that it faced an uphill struggle in competing against generic standard of care, Novartis talked to lots of different payers in the US and decided it had to go the extra mile and design the trials in such a way that resource utilization data could be included on the label, Pezalla said.

Payers, he added, were usually supportive when it came to creating safe harbors for outcomes deals but that pharma companies were often too worried that the FDA might still go...

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