A one-time infusion that provides fast relief for postpartum depression has sparked excitement about the medicine’s potential and concerns over its $34,000 price tag.
Brexanolone (branded as Zulresso) provides a synthetic source of allopregnanolone — a neurosteroid that decreases after childbirth. Approved last month by the Food and Drug Administration, it is the first drug specifically meant to treat postpartum depression.
The drug is also unique because allopregnanolone, which binds to receptors in the brain that help regulate mood and well-being, hasn’t previously been a focus.
“I am absolutely excited about this new treatment target,” says Maria Muzik, M.D., an associate professor of psychiatry and obstetrics and gynecology at Michigan Medicine. “For these severely depressed moms to feel better quickly, there’s no question that this is wonderful.”
Three clinical trials involving more than 200 Zulresso recipients noticed improvement within hours after receiving the infusion. Better yet, the medication was still effective 30 days later.
By comparison, other antidepressants currently prescribed to treat depression — such as Prozac and Zoloft — take several weeks to start working. Which is why faster relief could help avoid or reduce effects of the common mood disorder that can put both a mother and newborn at risk.
Among those risks: inability to bond with an infant, feelings of sadness or anxiety, and, in severe cases, thoughts of suicide or harming the child.
“Postpartum suicide is the second-leading cause of maternal postpartum mortality,” Muzik says. “I think this drug is going to be very helpful for high-risk, severely depressed moms.”
Zulresso costs and concerns
Despite the enthusiasm for Zulresso, the drug’s estimated $34,000 cost marks a big barrier to many new mothers who might benefit from the infusion.
Research has found that low-income women are more likely to have postpartum depression, a gap due in part to more prevalent psychosocial stressors such as housing instability, hunger, lacking social support and not having health insurance.
“How are they going to be able to pay for this if it isn’t covered?” says Muzik, who is also co-director of Zero to Thrive, an interdisciplinary group that researches issues facing families with young children living in adversity, and the Women and Infants Mental Health Program at Michigan Medicine.
“We need to think about how this can be implemented in an equitable way so the drug reaches all those who need it.”
Jeff Jonas, the CEO of Sage Therapeutics — which developed Zulresso — has said he expects wide reimbursement based on talks with insurance companies.
Still, the drug must be administered over a 60-hour period, so a mother must secure child care during her absence — a potential challenge for those without a partner or reliable assistance. A two-night clinic stay also adds extra costs to the equation.
Muzik suggests that health care facilities implement special mother-baby units so both parties can be together during the treatment. (Doctors don’t yet know Zulresso’s effect on breastmilk; recipients cannot breastfeed after taking it.)
She adds that Zulresso, if covered, could ultimately help insurers reduce other related health care costs for women with postpartum depression, an expense that one estimate puts at $5.7 billion annually in the United States.
Who should take Zulresso
The most medical complication of childbirth, postpartum depression affects 400,000 women —or 1 in 7 moms — in the U.S. each year.
It can begin one to two weeks after giving birth and may last for months. There is no single cause, and various screening methods may be applied.
Although some women may seek professional help for suspected postpartum depression, others might not know or act until a practitioner raises the subject.
“The nurse or the medical assistant or the obstetrician working with a mom often notice first something is off, and standard screening metrics also help to detect depression,” says Muzik, who notes that Michigan Medicine providers administer the Edinburgh Postnatal Depression Scale, a set of 10 questions, at least twice to each mother across pregnancy and postpartum.
“Hopefully, we will achieve that all obstetrical clinics across the U.S. will implement a standard screening for anxiety or depression and then, if a woman is identified, refer her for treatment.”
Treatment options for low-risk cases include psychosocial support such as individual and group therapy for the mother, her partner and/or their family. Moderate or advanced cases may prompt a prescription for antidepressants.
Zulresso clinical trials found that women with severe postpartum depression saw the most benefit from taking the drug, which is expected to become commercially available in June.
But medicines should be viewed as one component of effective treatment and not a cure-all, says Muzik, who advocates that providers promote ancillary options such as exercise, yoga, omega-3 and vitamin D supplementation, and mindfulness apps.
Still, she maintains that Zulresso’s arrival marks another step in bringing more attention to postpartum depression.
“This new medicine and new delivery need might spark discussions of what other complementary services — special mother-baby units, for example — that we need to have for these moms,” Muzik says. “I think we have a great opportunity.