When the news of the Food and Drug Administration’s (FDA) approval of Zurzuvae (zuranolone), the first oral treatment for postpartum depression (PPD) was announced, it was heralded as a landmark moment for maternal mental health and women’s health on the whole. But we didn’t yet have the full picture as to what the PPD pill would cost. Today, drugmakers Biogen-Sage Therapeutics announced the price for their history-making treatment: the PPD pill will cost $15,900 for a full 14-day treatment. Clinical trials found that Zurzuvae can improve symptoms of PPD in as little as three days.
Zurzuvae is expected to be available for prescription in December 2023.
Postpartum depression is estimated to affect 1 in 5 mothers up to 1 year after birth, or around 800,000 individuals each year in the US, according to the Maternal Mental Health Leadership Alliance. PPD, along with other postpartum mental health disorders (PMHDs), such as postpartum anxiety and postpartum psychosis, can severely impact a mother’s mental health, physical health and negatively affect bonding with their child. It’s estimated that 75% of women go untreated for postpartum mental health conditions due to lack of access to treatment and stigma surrounding the conditions.
Zurzuvae marked a turning point in PPD care and recognition of the impacts of the condition, but the $15,900 price tag will undoubtedly make it out of reach for many. Given the drug’s FDA approval, insurance should cover it in many cases, but it’s still unclear how much will be covered.
Still, the price of Zurzuvae is half the price of the only other medication approved by the FDA to treat PPD: Zulresso (brexanolone), which is a 60-hour IV infusion priced at $34,000. Zulresso has historically seen low uptake due ot the drug’s hefty price tag, which makes it difficult to get insurance to cover it. ”The Boston Globe” reported that it was a commercial failure because of its high price. Hopefully the same fate won’t befall Zurzuvae.
A spokesperson for Sage Therapeutics shared with CNN that the company aims to make the medication accessible to anyone with PPD who is prescribed it. “We plan to facilitate this through patient access programs, including copay assistance for eligible adults with PPD who are commercially insured,” spokesperson Matt Henson wrote to CNN. “We intend to discuss these initiatives and other planned support for women with PPD closer to the time of launch.”
Given that the drug is expected to launch in December, more information about access should be coming soon.
Sage and Biogen were hoping the FDA would have also approved Zurzuvae for major depressive disorder in addition to PPD, but that didn’t happen. The upset there meant that the price is as much as three times higher than it would have been if the agency had approved the drug for MDD, which has a much broader prevalence, affecting about 15 million people in the US. “This is very much the way that the industry argues that the pricing works,” said Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center, to CNN. “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.”
A pharmaceutical industry insider, Anna Irving, wrote in an article for Motherly that without FDA approval for the broader indication of MDD, the estimated annual sales of zuranolone for the PPD market is estimated at $250 million to $500 million. Had it been approved for MDD, the estimated annual sales were valued at over $1 billion. “Despite its landmark achievement in women’s health, Sage Therapeutics announced job cuts to minimize impacts to its bottom line and assuage investors. What should have been a celebratory week became one of trepidation,” writes Irving.
“Beyond affordability, this incident perpetuates underfunding of women’s health in clinical innovation, venture capital, and private equity… This loss may deter other companies from investing in women’s health,” she writes.