New postpartum depression drug gets almost $16,000 price tag, raising questions about access

By Meg Tirrell, CNN

(CNN) — A newly approved medication to treat postpartum depression will cost $15,900 per 14-day course, before insurance, when it reaches the market later this year, raising concerns among doctors and researchers that some patients may have trouble paying for the drug.

The medicine, Zurzuvae, was approved by the US Food and Drug Administration in August and is the first medicine cleared for postpartum depression that’s taken as a pill. Drugmaker Sage Therapeutics said Tuesday that the drug is expected to become available in December and that it and partner Biogen are talking with insurers about coverage plans.

The companies’ goal is “to enable broad and equitable access for women with PPD who are prescribed this drug,” Sage Chief Executive Officer Barry Greene said in a news release. The hope is for patients to be able to get the medicine, “where possible, with little to no co-pay regardless of financial means,” and the companies will provide financial assistance to help cover costs or provide the drug free for certain patients.

Postpartum depression affects as many as 1 in 8 people who have babies, according to research from the US Centers for Disease Control and Prevention. It typically happens after childbirth but can also set in during the later stages of pregnancy, and it can cause sadness, a loss of energy and thoughts of self-harm.

Mental health specialists welcomed the approval of Zurzuvae this summer, not just because it presents a new way to treat postpartum depression but also specifically because it “appears to be fast-acting,” said Dr. Catherine Monk, chief of the Division of Women’s Mental Health in the Department of Obstetrics and Gynecology at the Columbia University Vagelos College of Physicians and Surgeons.

The drug was shown in one clinical trial to improve depressive symptoms in as little as three days, according to Sage and Biogen. It was approved based on two trials showing significant improvements after two weeks on a 17-item scale of depression, compared with placebo.

Zurzuvae mimics the function of natural brain steroids that work on the GABA signaling pathway, helping to regulate brain function. Because it can have a depressant effect on the central nervous system, the drug’s label contains a prominent warning that patients shouldn’t drive or do other “potentially hazardous activities” for at least 12 hours after they take the medicine.

“Expedited recovery obviously is a huge plus in helping individuals with PPD feel back to themselves,” Monk wrote in an email. That can be key for bonding in the earliest days of a baby’s life, she said.

The current options to treat postpartum depression orally are selective serotonin reuptake inhibitors or SSRIs, antidepressants that “take weeks to kick in and must continue being taken on a daily basis for at least six to 12 months,” said Dr. Katrina Furey, a psychiatrist in private practice specializing in women’s mental health and reproductive psychiatry, and a clinical instructor at Yale University.

The price of Zurzuvae seems especially high in comparison with those medicines, Furey said. SSRIs, which include the generic versions of drugs like Prozac and Zoloft, typically cost less than $20 a month, according to data from GoodRx.

“It remains to be seen how much insurance companies will cover it or if they will require women to ‘fail’ treatment with less-expensive SSRIs before paying for this new treatment,” Furey said. “I hope that is not the case and that its price will not be a barrier to accessing this treatment.”

She noted, though, that the $15,900 price tag is less than half that of an earlier postpartum depression drug from Sage called Zulresso. Priced at about $35,000, that drug is given via IV infusion over the course of 60 hours in a hospital.

Some financial analysts following Sage had predicted that Zurzuvae’s price could approach Zulresso’s after the FDA declined to grant Zurzuvae broader approval in major depressive disorder. The expectation had been that the broader approval would have led the companies to set the price below $10,000, an important threshold for a specialty drug tier in Medicare coverage; with a smaller patient pool, the analysts, at financial firm Mizuho, forecast the price would be higher. One of those analysts, Uy Ear, confirmed Tuesday that tier doesn’t apply to Medicaid.

A Sage spokesman said in an email Tuesday that the company recognizes “that black and brown women are disproportionally impacted, and we are prioritizing equitable access as well as advocating for policies that better support underrepresented communities,” noting that “those who live in rural areas and those who have Medicaid may be more likely to receive inadequate postpartum care, compared to those who live in urban areas and have private health insurance.”

“As such,” he continued, “Sage and Biogen aim to enable broad and equitable access for all women with PPD who are prescribed Zurzuvae.”

The $15,900 price “raises substantial accessibility concerns, especially when we still don’t know how it’ll be covered by insurance,” said Dr. Lindsay Allen, an assistant professor of emergency medicine and a health economist and health services researcher at the Northwestern University Feinberg School of Medicine.

“Ensuring access to such treatments is imperative, as they may be lifesaving for new mothers during a vulnerable time,” Allen said. “Suicide is a leading cause of death in the first year postpartum.”

She and Columbia’s Monk raised concerns about disparities in access to the medicine, even with insurance coverage, “exacerbating inequities with respect to who has access to what kind of care,” Monk said.

She noted that the drug was tested in people with severe – and rarer – forms of depression and said she was concerned that the “heavy media attention and advertising” around Zurzuvae may mean it gets over-prescribed and that patients don’t receive other necessary care, like therapy.”

“The gold standard of mental health care is a combination of psychotherapy and medication when medication is needed,” Monk said. And “often, therapy is enough.”

The “hidden costs” of not treating, or undertreating, postpartum depression and anxiety are important to keep in mind, said Furey, who also co-hosts the “Analyze Scripts” podcast about the depiction of mental health in the media.

“We know that PPD and other postpartum mental health issues can have negative effects on maternal-infant bonding, on the family dynamics as a whole, increase risk of physical health issues [and] pose difficulties returning to work,” she said.

The costs of those effects, she said, are “not easily put into financial terms.”

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