Zuranolone, a new postpartum depression pill, was found to be safe and effective in a new Phase 3 trial.
CNN  — 

Drugmakers Sage Therapeutics and Biogen are still ironing out how much their newly approved postpartum depression medication, zuranolone, will cost once it’s made commercially available in the United States this year.

Zuranolone, sold under the brand name Zurzuvae, is expected to launch in the fourth quarter of 2023, and the companies’ goal is for the medication to be accessible to anyone with postpartum depression (PPD) who is prescribed it, Sage Therapeutics spokesperson Matt Henson said in an email Tuesday.

“We plan to facilitate this through patient access programs, including copay assistance for eligible adults with PPD who are commercially insured,” Henson wrote. “We intend to discuss these initiatives and other planned support for women with PPD closer to the time of launch.”

The US Food and Drug Administration approved zuranolone Friday for the treatment of postpartum depression, making it the first pill in the United States specifically indicated for the condition, which is estimated to affect about 1 in 8 new mothers. Zuranolone is a pill taken daily for two weeks.

Questions remain about what its price tag may be and when to expect announcements about that price.

“In terms of price timing, as we get closer to launch, we will be talking about our access strategy as well as some of the other aspects of our commercialization,” Sage Therapeutics CEO Barry Greene said during a company webcast with analysts on Monday. “That will be closer to launch.”

When Sage Therapeutics and Biogen applied for FDA approval of zuranolone, they submitted an application for the drug to treat not only postpartum depression but also major depressive disorder in adults.

They announced last week that the FDA said in a letter that the drug application did not provide substantial evidence to support approving zuranolone for the treatment of major depressive disorder, and for that, more research will be needed.

Since zuranolone was approved to treat only postpartum depression, “as part of our final preparations, Sage and Biogen are currently working to determine adjustments to our thinking on price, given the PPD label. We plan to provide more clarity on our overall thinking closer to product launch,” Chris Benecchi, chief business officer for Sage Therapeutics, said during Monday’s webcast.

“What we can say now is that approximately 55% of US births are covered by commercial insurance. And our planned patient access approach for women with PPD who are commercially insured has the goal of enabling a vast majority of these women to have access to Zurzuvae with minimal out-of-pocket-costs,” Benecchi said. “The remaining births receive coverage through Medicaid, which requires little or no financial responsibility for the patient.”

Benecchi added that payer decisions for the coverage of Zurzuvae are expected to be made in the months after the US Drug Enforcement Administration’s scheduling of zuranolone as a controlled substance, which is anticipated to happen within 90 days.

Sage and Biogen are expected to price Zurzuvae as much as three times higher because of its failure to win approval for major depressive disorder, a condition that affects 15 million people in the US, compared with about 500,000 for postpartum depression, according to Salim Syed and Uy Ear, analysts for the Wall Street firm Mizuho.

The expectation is that “they push it closer to Zulresso pricing,” Syed wrote in an email Tuesday, referencing another Sage drug for PPD that’s given by IV infusion and costs about $35,000. The analysts noted that Sage had said it would keep the pricing of Zurzuvae below $10,000 if it were cleared in major depressive disorder as well, a threshold important for coverage through Medicare, Ear wrote.

The idea that companies need to price drugs higher if they serve fewer patients isn’t new, said Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center.

“This is very much the way that the industry argues that the pricing works,” she said. “In the rare disease space, for example, there’s a strong argument that the price per person has to be really high because it’s a smaller group of people using it.”

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It’s estimated that each year in the United States, more than 400,000 babies are born to mothers who are depressed. According to the National Institute of Mental Health, postpartum depression can last months or even years when left untreated.

“The approval of ZURZUVAE to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” Christopher A. Viehbacher, president and chief executive officer at Biogen, said in a news release Friday.

“We appreciate the support of patients, patient advocates and researchers who helped to reach this milestone,” Viehbacher said. “We believe that ZURZUVAE will be an important option to treat PPD and we will thoroughly review the feedback from the FDA on the use of zuranolone in MDD to determine next steps.”

CNN’s Meg Tirrell contributed to this report.