A new drug specifically for the swift and effective treatment of postpartum depression was approved by the FDA on Tuesday, offering a beacon of hope for the serious mental illness that affects about 1 in 8 new mothers. That’s the good news. The not-so-great news is that this new drug ain’t cheap; neither is it easy to administer.
Brexanolone, sold as Zulresso, is to be delivered as a one time, continuous intravenous infusion over the course of 60 hours within a hospital setting, according to the New York Times. Its price tag can run in the tens of thousands of dollars, making it all but inaccessible to those who are poor, working class, middle class, or even wealthy, especially if they are uninsured.
The Times reports:
The infusion will be expensive, averaging $34,000 per patient before discounts, according to Sage Therapeutics, the manufacturer. That does not include the costs of staying in a medical center for two and a half days. Company officials say they expect that insurers will cover the treatment; insurers said this week that they are evaluating the drug.
A pill made with a similar molecule, which would be much more accessible and easier for patients, is showing promise in its clinical trials and would be submitted for approval in a couple of years if the results are good, according to Sage.
The infusion is to be administered just once, and patients may also take standard antidepressants. Clinical trials of the drug, all sponsored by Sage, found that it produced a steeper decrease in symptoms in women with severe and moderate postpartum depression than a similar placebo infusion.
As with other health care disparities, postpartum depression hits black women and poor black women especially hard. In fact, according to a Dec. 2018 article by Rochaun Meadows-Fernandez, “Postpartum Depression in Black Women Is a Silent Epidemic,” as black women face an increased risk of mental health issues post-birth.
“While 20 percent of women display symptoms of perinatal mood or anxiety disorder (PMAD), like anxiety, depression, and obsessive-compulsive disorder, the figure climbs to 44 percent for Black women, compared to 31 percent for white women,” she writes. “Despite this prevalence, Black women face a myriad of social, economic, and cultural obstacles when seeking mental health care.”
And that’s before the significant price tag of this new drug.
According to the National Institute of Mental Health, the current treatments for postpartum depression includes antidepressants, which can take weeks to work (if at all), as well as therapy and counseling.
Untreated postpartum depression can last for months or years, posing serious threats to the health of the mother, and studies show that persistent and severe postpartum depression increases the risk of adverse outcomes in children.
USA Today reports that the FDA approved Zulresso after two clinical trials showed its efficacy for treating the symptoms of depression over a 30-day period. Also, Zulresso will only be available from certified health care facilities through a restricted program called the “Zulresso REMS Program,” according to the FDA.
The CEO of Sage Therapeutics, Jeff Jonas told CNN that the drug will be available in June.