Zulresso is a breakthrough in new mothers' mental health. But its cost and accessibility may make it prohibitive for most women. Here's what you need to know. 

By Tracy Collins Ortlieb

Women's health professionals lauded the announcement that the US Food and Drug Administration (FDA) had approved the first drug targeting post postpartum depression (PPD). But experts in PPD say that while the drug represents a game-changing breakthrough in women's mental health treatment, its use may lie firmly out of reach to the women who need it most.

One intravenous infusion of brexanolone, which is being marketed by the manufacturer Sage Therapeutics as Zulresso, will likely cost an average of $34,000 without insurance. Administered over a period of 60 hours, Zulresso protocol requires a patient's admission to a perinatal inpatient unit, of which only a handful currently exist in the United States.

 

Is Zulresso Better For Postpartum Depression Than Existing Anti-Depressants?

Dr. Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina who led the clinical trials for the drug, says three elements separate Zulresso from current treatment models: its rapid onset of action, an entirely new method of action, and the fact that the drug was specifically developed for postpartum depression.

"Within 60 hours, the majority of women that participated in these trials had a marked reduction and/or complete remission of symptoms—and that's unlike anything we have available," says Dr. Meltzer-Brody. "The best-case scenario with SSRI therapy—drugs that were not developed to treat postpartum specifically—is that it can be weeks to months, if in fact you respond. That's just an incredibly long time for women with severe symptoms who are really struggling. The postpartum period is so vulnerable for all families, and it's also when one of the primary challenges is appropriate bonding and attachment with the baby. For women who are severely depressed, that attachment can be disrupted. So something that works quickly during this critical window is extraordinarily important."

Affecting one in nine new mothers, PPD transcends the "baby blues," lasting beyond two weeks and often worsening, and in some cases endangering the lives of mother and baby. While anti-depressants and counseling are standard treatments, mothers may need to cycle through several medications to find one that's effective, and relief—if it comes—may not appear for four to six weeks.

Meltzer-Brody says while the cost is significant, "so is every new drug in pharma. Mental health has for so long been treated as a condition in which you should just be able to 'get over it.'"

She adds, "As a women's health physician and passionate women's health advocate, to finally have a drug for a women's mental health condition which has been underdiagnosed and undertreated for years is amazing, and is deeply meaningful for someone suffering in severe ways that this drug could save lives and make a real difference for their children."

Depression during pregnancy and soon after childbirth can be incapacitating, even leading to hospitalization for some women. PPD reduces a mother's ability to care for her baby and prohibits mother-child bonding, negatively impacting the baby's development and emotional well-being, and has even been shown to increase an infant's risk of having depression later in life.

Concerns Around Access to Zulresso

Maria Muzik, M.D., a faculty member in the University of Michigan Department of Psychiatry and Department of Obstetrics and Gynecology, says that while the groundbreaking drug is exciting, providing universal access to it should go hand-in-hand with its release.

"This is a great opportunity, and the initial results from phase three trials were very encouraging for these severely depressed moms to get better quickly," says Dr. Muzik, who is also the co-director of the university's Women and Infants Mental Health Program. "All of this is very encouraging, but the challenge will be the implementation and making it feasible and accessible for all depressed moms by having a population-level approach to this problem."

Postpartum depression remains more common in women in lower socio-economic groups, placing Zulresso beyond the reach of the most vulnerable mothers.

Karen Kleiman, founder and director of the Postpartum Stress Center and author of the newly released Good Moms Have Scary Thoughts: A Healing Guide to the Secret Fears of New Motherssays the new mothers she works with are giving the news of Zulresso's approval "mixed reviews."

"Many are excited about the progress being made on behalf of women with perinatal mood and anxiety disorders. They say it feels good to have postpartum depression validated and supported through research," Kleiman says. "The reservations being expressed are from moms who are concerned that this research and ultimate outcome only impacts a small percentage of women and worry that the majority of mothers will continue to fall through the cracks."

Will Zulresso Be Covered By Insurance?

Dr. Muzik says that the months between fresh FDA approval and its June release is the ideal opportunity for stakeholders to come together to make Zulresso widely available.

"From the outset, we need be make sure insurers are on board, and that Medicaid would cover those women with clear inclusion criteria, that there are accessible sites for the medication to be safely delivered, and where mothers could bring children and get the infusion while their baby is also present or cared for by onsite providers," Dr. Muzik says. "Right now, that means that pharmaceutical manufacturers and legislature and policyholders need to consider, 'How do we make this accessible to all women?' This is an amazing opportunity, but we'll need novel solutions so that women can get this treatment."

Sage Therapeutics is currently developing a pill made with a similar molecule. Already showing promise in its clinical trials, the pill would be far more accessible and easier for patients.

"The most exciting part about this new drug being approved is that it sets the momentum forward for more research and new interventions," notes Kleiman. "We are hopeful that this will eventually lead to interventions that are more readily accessible and more easily administered so more women can look forward to rapid relief from symptoms that impair such a critical transition in their lives."

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