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A newly approved drug to treat postpartum depression will cost $15,900 per 14-day course (before insurance) when it hits the market later this year, raising concerns among doctors and researchers that some patients are struggling could pay for the medication.
The drug Zurzuvae was approved by the U.S. Food and Drug Administration in August and is the first drug to treat postpartum depression taken as a pill. Drugmaker Sage Therapeutics said Tuesday that the drug is expected to be available in December and that it and partner Biogen are talking to insurers about insurance plans.
The companies’ goal is to “provide broad and equitable access to women with PPD who are prescribed this medication,” Sage CEO Barry Greene said in a press release. The hope is that patients will be able to receive the drug, “if possible, with little or no co-payment, regardless of financial means,” and companies will provide financial assistance to cover the cost or the drug to specific patients provide free of charge.
Postpartum depression affects up to one in eight mothers, according to research from the U.S. Centers for Disease Control and Prevention. It typically occurs after birth, but can also occur in the later stages of pregnancy and cause sadness, loss of energy, and thoughts of self-harm.
Mental health specialists welcomed Zurzuvae’s approval this summer, not only because it represents a new option for treating postpartum depression, but especially because it “appears to work quickly,” Dr. Catherine Monk, chief of the Division of Women’s Mental Health in the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons.
According to Sage and Biogen, the drug was shown to relieve depressive symptoms in just three days in a clinical trial. The approval was based on two studies that showed significant improvements on a 17-point depression scale after two weeks compared to placebo.
Zurzuvae mimics the function of natural brain steroids, which act on the GABA signaling pathway to help regulate brain function. Because it can have a depressant effect on the central nervous system, the drug’s package insert contains a prominent warning that patients should not drive or engage in other “potentially dangerous activities” for at least 12 hours after taking the drug.
“Accelerated recovery is obviously a huge benefit in helping people with PPD find themselves again,” Monk wrote in an email. That can be crucial for bonding in the first days of a baby’s life, she said.
The current options for oral treatment of postpartum depression are selective serotonin reuptake inhibitors, or SSRIs, antidepressants “that take weeks to work and must be taken daily for at least six to 12 months,” said Dr. Katrina Furey, a private practice psychiatrist specializing in women’s mental health and reproductive psychiatry and clinical instructor at Yale University.
The price of Zurzuvae appears to be particularly high compared to those drugs, Furey said. SSRIs, which include the generic versions of medications 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 or whether they will require women to fail treatment with cheaper SSRIs before paying for this new treatment,” Furey said. “I hope that this is not the case and that price is not a barrier to accessing this treatment.”
However, she noted that the $15,900 price tag is less than half that of a previous postpartum depression drug from Sage called Zulresso. The drug, which costs about $35,000, is administered via intravenous infusion over a 60-hour period in a hospital.
Some financial analysts who followed Sage had predicted that Zurzuvae’s price could approach Zulresso’s after the FDA declined to grant Zurzuvae broader approval for the treatment of major depressive disorder. The broader approval was expected to have pushed companies to set the price below $10,000, a key threshold for a specialty drug tier in Medicare coverage; With a smaller patient pool, analysts at financial firm Mizuho predict the price would be higher. One of those analysts, Uy Ear, confirmed Tuesday that this tier does not apply to Medicaid.
A Sage spokesperson said in an email Tuesday that the company recognizes “that Black and brown women are disproportionately impacted and that we prioritize equal access and advocate for policies that better support underrepresented communities.” and found that “those who live in rural areas and those who have Medicaid may be more likely to receive inadequate postpartum care than those who live in urban areas and have private health insurance.”
“Therefore,” he continued, “Sage and Biogen aim to provide broad and equitable access to all women with PPD who are prescribed Zurzuvae.”
The $15,900 price tag “raises significant accessibility concerns, particularly when we don’t yet know how insurance will cover this,” Dr. Lindsay Allen, an assistant professor of emergency medicine and a health economist and health services researcher at the university’s Northwestern Feinberg School of Medicine.
“It is imperative to ensure access to such treatments as they can be life-saving for new mothers at a vulnerable time,” Allen said. “Suicide is one of the leading causes of death in the first year after birth.”
She and Columbia’s Monk raised concerns about disparities in access to medications, even with insurance coverage, “which exacerbates inequities in who has access to what type of care,” Monk said.
She noted that the drug was being tested on people with severe – and rarer – forms of depression, and said she was concerned that the “heavy media attention and advertising” surrounding Zurzuvae could lead to it being overprescribed and patients do not receive other necessary medication care, such as therapy.”
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“The gold standard of mental health care is a combination of psychotherapy and medication when medication is needed,” Monk said. And “therapy is often enough.”
It’s important to keep an eye on the “hidden costs” when postnatal depression and anxiety are untreated or inadequately treated, said Furey, who also co-hosts the podcast “Analyze Scripts” about the portrayal of mental health in the media.
“We know that PPD and other postpartum mental health problems can have a negative impact on the mother-child bond and family dynamics as a whole, and increase the risk of physical health problems [and] present difficulties in returning to work,” she said.
The cost of these impacts is “not easy to put into financial terms,” she said.