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February: Zuranolone for postpartum depression

Written by Sophia Allen

POint of View:
THE WALL STREET JOURNAL: THE TRAGEDY OF BEING A NEW MOM IN AMERICA

This article follows several women who experienced severe postpartum depression (PPD): Jaclyn, Brenda, and Denise. Of the three, Jaclyn was the only one who found the help she needed and the only survivor of PPD. However, her journey to receiving help was still too difficult; the article centers Jaclyn’ story alongside a discussion of policies that fail to designate any one provider as responsible for a woman’s mental health after pregnancy. Jaclyn is pushed around from her obstetrician to the emergency room to an in-patient facility and to countless other specialists. Finally, she learns about and travels nine hours to UNC’s Center for Women’s Mood Disorders, “one of the three inpatient facilities in the U.S. for maternal mental health.” Here, she receives Zulresso (brexanolone), a 60-hour intravenous PPD treatment that would have cost $180K without insurance. Although she pays far less, she still accrues medical debt.

Brenda and Denise were not as “lucky.” Brenda stopped breastfeeding about 3 months after birth. Her husband noticed her mood was deteriorating, and she was self-harming. Doctors skimmed over questions related to Brenda’s mental health, leaving no room for Brenda to open up. After trying therapy, Brenda ultimately committed suicide via gunshot. The executive director of the Maternal Mental Health Leadership Alliance is quoted saying that women who have recently given birth often choose more lethal means of death as “they are so desperate,” underscoring the dire importance of helping the person out of their immediate mental health crisis. Denise developed PPD about a year after the birth of her first child, and her symptoms worsened while pregnant with her second child. She was hospitalized while pregnant and, when released, had her second child. After, her symptoms worsened, and, when she expressed a desire to kill herself and her children, her children were taken from her. Not long after, Denise died of a pulmonary embolism. Her sister, who now cares for her children, is quoted as saying, “The help wasn’t there for my sister.” These stories highlight the need for rapid, accessible, and affordable PPD treatments. This POV was published a week before Zuranolone was approved by the FDA, thus sparking major publicity around PPD.

Resource:
MATERNAL MENTAL HEALTH LEADERSHIP ALLIANCE: THE FIRST ORAL TREATMENT FOR POSTPARTUM DEPRESSION IS FINALLY HERE

MMLA answers frequently asked questions about Zuranolone, including how the drug works, side effects, what makes it unique, cost and insurance info, and other considerations. Zuranolone was FDA-approved in August 2023 after two randomized controlled trials found that a 14-day course of Zuranolone vs. placebo led to significant PPD symptom improvements, effects that were rapid and lasted four weeks after the final dose. Zuranolone is a synthetic version of allopregnanolone, a hormone related to progesterone that regulates GABA-a receptors in the brain (which affect mood and cognition). Since this hormone rises during pregnancy and drops sharply in the postpartum period, Zuranolone targets PPD specifically. Reported side effects include dizziness and drowsiness. The cost of Zuranolone is almost $16K. It is still unclear which insurance companies will cover the medication and, although the manufacturers have indicated that the drug will be available with a reduced copay or at no cost for certain eligible patients, the details are still in flux and it likely that Medicaid coverage will vary by state. Another notable limitation of PPD treatment with Zuranolone is that currently there is no research on the safety of taking the Rx while pregnant or breastfeeding, meaning that it is not advised.

News Story:
THE 19th: THERE’S A NEW PILL FOR POSTPARTUM DEPRESSION, BUT WHO CAN ACCESS IT?

This article critiques the high cost of Zuranolone and discusses both barriers and facilitators to mitigating the drug’s expense for low-income people in the postpartum period. Maternal mental health advocates and researchers interviewed expressed concern over insurance coverage stipulations that vary by insurance company and state Medicare policy. For example, some states have announced that they will require prior authorizations for the medication and/or “fail-first” treatment plans (meaning the patient has to try a different medication, this medication has to be rendered ineffective, and then they can try Zuranolone), or require a psychiatrist to prescribe the medication even though OBGYNs are approved to treat PPD and many psychiatrists do not accept Medicaid. Currently, only 1% of insurance companies have released any guidance on coverage of Zuranolone, leaving the affordability of this drug very uncertain. Since Medicaid covers 40% of U.S. births and approximately two-thirds of Black and Indigenous births, insurance coverage is key to realizing the benefits of Zuranolone and preventing maternal morbidity and mortality.

Scientific Publication:
SCREENING AND THE NEW TREATMENT FOR POSTPARTUM DEPRESSION

In this research column, Dr. Summer Hawkins reviews PPD risk factors, current PPD screening guidelines (by ACOG and other associations), and gaps in mental health care policy that perpetuate disparities in PPD screening, diagnosis, treatment access, and medication uptake (i.e., an analysis of why people “slip through the cracks”). She discusses how Zuranolone (Zurzuvae) fills an important and timely gap as the first oral medication to treat PPD specifically. Before Zuranolone, the only treatment explicitly targeting PPD was Zulresso (brexanolone), a costly intravenous treatment administered over 60 hours; this treatment was released during COVID-19 (in 2020) and required patients to show up in person to receive care, making it inaccessible to those who face barriers such as lack of transportation, childcare, inflexible work schedules, and/or any sort of health issue or disability that might prohibit in-person access. Comparatively, Zuranolone is less expensive (with the caveat that insurance coverage and Medicaid reimbursement plans are still underway), fast-acting (effects start within days), less invasive (daily pill vs. intravenous administration), and more private (taken from home). Her commentary concludes with a call to action that releasing this medication is not enough: it needs to be easily accessible to everyone who needs it, and there is no time to waste.