When pharmaceutical company Sage Therapeutics announced earlier this month that the FDA approved the first drug to treat postpartum depression, the initial excitement was followed closely by questions about cost and accessibility.
Expected to be available by June, the drug Zulresso (the brand name for brexanolone) will be administered intravenously in an inpatient setting over 60 hours and under a physician’s supervision. That steep time commitment is one concern, as is the $34,000 average price tag for the drug alone, not including the costs of the hospital stay.
Mental health conditions are the most common pregnancy complications. So for the estimated one in nine people who give birth and experience postpartum depression, Zulresso could provide a welcome and faster-acting alternative to standard anti-depressants that can take weeks or months to kick in.
Dr. Marra Ackerman, a reproductive psychiatrist in New York, told Rewire.News she welcomed news about the drug as an option for women with moderate to severe postpartum depression (PPD) that hasn’t responded well to existing medications or treatment.
“In the past, PPD has been treated similarly to other types of depression, most often with [drugs such as selective serotonin reuptake inhibitors (SRRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)]. We are now realizing that the mechanism of PPD may be quite different from classic depression and much more related to hormonal changes. Brexanolone targets these hormonal changes.”
Michelle Drew, a Delaware nurse-midwife who frequently sees patients with postpartum depression, views the drug’s development with both optimism and realism. Though antidepressants are among the most frequently prescribed drugs in the country, she noted the novelty of a drug to specifically treat postpartum depression—and the role gender played in this delay.
“Previous patriarchal limitations on including childbearing women in drug research protocols has severely retarded the development for drugs for that population period. … Drug development is costly; it likely took a true visionary to even consider it important to develop a drug that targets women with a time-limited as well as sex-limited market.” Essentially, women’s health care has often been placed on the back burner, and developing a drug specifically for postpartum depression has not been considered cost-effective by investors.
But while Zulresso represents progress, Drew also has questions about the clinical trial’s methodology. She expressed these concerns in a Twitter thread, but shared additional thoughts with Rewire.News via email.
“The study population … was around 240 women divided between three groups. … How does one make a decision of the usefulness of a drug that could target a population of as many as 600,000 women based on 240 women?”
Zulresso may not reach that many people. A large share of those who could benefit from an effective treatment for postpartum depression may not benefit from Zulresso, simply because they can’t afford it. The $34,000 estimated cost of the drug doesn’t cover hospital admission or financial implications like lost income or child-care costs during treatment. Each vial of the drug costs $7,450, and study participants used an average of 4.5 vials, though that may vary from patient to patient.
Nearly 50 percent of all U.S. births are covered by Medicaid, and rates of perinatal mood and anxiety disorders are significantly higher among Medicaid recipients. Ackerman noted that “the cost of brexanolone will be one of the biggest [obstacles] to delivering this treatment to our patients. Applications in clinical practice will really depend on insurance coverage.”
And whether and how insurance will cover the treatment is not yet clear. Alexis Smith, a Sage spokesperson, said in an email that “over the past year, we have met multiple times with the majority of commercial and Medicaid payers. Based on our work to date, we expect broad payer coverage by the time of product availability in June.”
Houston’s Kay Matthews founded the Shades of Blue Project, which assists women of color experiencing postpartum depression or anxiety. She sat on several Sage advisory boards and helped refer people for clinical trials while working for the company as a patient advocate.
When asked via email about efforts to obtain coverage for Zulresso, Matthews said, “[The drug] is not designed to be exclusive. It is intended to help all women, because unlike humans, diseases have no biases.”
“Women have been suffering for too long in silence. It is a start in breaking down the issues that [can] arise with a woman during the postpartum period. I believe the release of the drug will make maternal mental health real,” she continued.
Still, average Medicaid payments for all maternal and newborn care involving vaginal and cesarean childbirths were $9,131 and $13,590, respectively, according to a 2013 report. Is it realistic to expect Medicaid to pay more than the entire cost of a birth for a drug to treat postpartum depression?
Drew is skeptical but hopes that “Sage will make the humanitarian decision to select a price point that reflects a commitment to reproductive justice and health equity.”
There are other concerns. Drugs come with side effects, and the newer the medication, the less information consumers have about how it does and doesn’t work.
Furthermore, Zulresso—and the drugs that will follow it—should be just one component of addressing postpartum depression. Currently, there is not universal screening to detect the condition. Policymakers can try to rectify structural issues—such as income inequality, infant death, and the double burden faced by working mothers—that inflate the disease’s rate. Robust paid parental leave, emphasis on women’s health care, and shifting attitudes toward mental health care are all part of the equation.
But there’s ample reason to hail the drug, if it can help some women and do it more quickly than other medicines and policy changes.
“PPD is so common and so debilitating,” Beverly Warner, a PPD survivor and advocate from Denver, said. “A medication that directly targets the related hormones and works so quickly is a huge step in battling this disease.” And, she pointed out, her “biggest improvement came after working with a postpartum psychiatrist and using both medication and a therapy program. Medication gave me the boost I needed to tackle therapy.”