Rebates Could Play Big Role in How Payers Approach New Postpartum Depression Drug
The FDA on Aug. 4 approved Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD), making it the first oral pill available to treat a condition that affects an estimated 500,000 people annually. While that ostensibly would be good news for the drug’s manufacturers — Biogen Inc. and Sage Therapeutics, Inc. — Sage’s shares plummeted amid the FDA’s decision not to approve Zurzuvae for major depressive disorder, which affects a much larger patient population.
That setback, plus the FDA’s addition of a boxed warning that cautions patients not to drive or operate heavy machinery for at least 12 hours after taking Zurzuvae, led analysts to express significant concerns about the sales potential of the drug. Meanwhile, from a coverage standpoint, experts tell AIS Health, a division of MMIT, that rebates will play a significant role in whether payers choose to put the new drug on their formularies.
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