The FDA approval of the postpartum depression (PPD) pill zuranolone (Zurzuvae), based on two successful phase III trials, represents a scientific triumph. This neuroactive steroid-based treatment joins a related treatment, IV infused brexanolone (Zulresso), as the only approved psychopharmacological treatments specifically for PPD.
Any safe and effective treatments for PPD, a common disorder with for mothers and infants and a public health priority, are worthy of celebration -- and these drugs perhaps more so, as they are both based on a new biological target, allopregnanolone, and its modulation of the GABAA receptor. The of these agents, with significant symptom improvement in , is unique compared to pharmacological and psychotherapeutic interventions. The development of new treatment classes is dually beneficial, both improving the well-being of individual patients and potentially revealing new insights about the fundamental pathophysiology of complex psychiatric disorders.
Encouragingly, the research and approval of these treatments illustrates a pharmaceutical company -- Sage Pharmaceuticals -- prioritizing and investing in women's health. Nonetheless, the excitement about the recent approval of this novel oral treatment for PPD is paired with the familiar concern about who, realistically, will be able to access it.
The drugmaker announced the initial wholesale cost of Zurzuvae will be for a full 14-day course of treatment. With already existing challenges for women to access perinatal mental health care from a provider with expertise in mental health treatment, as well as socioeconomic, racial, and ethnic inequities in care access, we must ask: Is zuranolone well-positioned to address the extensive maternal mental health needs mired in systemic health care dysfunction?
Drug development is only one element of the progress needed to address the gaps in maternal mental health care. Insufficient screening, expensive care, and limited access to treatment all contribute to poor maternal outcomes, which are unlikely to be addressed in the near future by novel therapeutics.
We've already seen this play out with infused brexanolone: barriers to treatment, such as cost, insurance coverage, availability, and logistical difficulties, have hampered uptake. We've observed this through a few different avenues. This treatment was priced at , and at this price, the rapid resolution of symptoms and return to full pre-morbid function offered was found to be theoretically . While such calculations should inform public policy, they do not always guide insurance coverage or determine what an individual can realistically afford. Furthermore, even if insurance coverage lowers a patient's charges, it does not necessarily bring their costs to $0.
Per our direct clinical experience and discussion with colleagues, we've found that insurance authorization for brexanolone is often difficult and time-consuming to obtain. Even when approved, patients may still face in co-pays. This financial estimate does not include the additional costs associated with hospitalization or infusion -- the 60-hour infusion requires a prolonged hospital stay with monitoring. Taken together, such challenges have slowed the adoption of infused brexanolone, with some major academic centers not offering the treatment at all. For example, our recent search using the official Zulresso lists no treatment centers in New York City, where we are based.
We were hopeful that the new oral line of neurosteroid treatment might address care logistics and access. But the high price tag of zuranolone in the context of insurance barriers and other access obstacles is discouraging and raises equity concerns.
Inability to access maternal mental health treatment is arguably a larger issue than a dearth of efficacious treatments for PPD. of maternal mental health diagnoses are missed and of diagnosed patients undergo treatment. While there are many factors involved in low treatment utilization, lack of adequate insurance and high costs are to care.
Lack of access to affordable mental health care further exacerbates existing mental health inequities and disparities. and patients are more likely to suffer from PPD, less likely to have insurance with mental health coverage, less likely to mental health care, and less likely to receive a prenatal . In this health care climate, it appears even less likely that those experiencing the highest toll of PPD will be able to utilize novel, expensive treatments.
Providers, too, contribute to the lack of access to maternal mental health care. Despite laws intended to ensure universal basic mental health coverage, many insurance programs across the U.S. still fail to meet basic requirements. Individual providers and academic psychiatry departments frequently respond to lower insurance reimbursement rates for mental health care versus physical health care and what they can earn in private mental health practice by opting out of taking insurance altogether; this leads their patients who are in need of mental health care to pay high out-of-pocket costs or simply forgo treatment.
For those with severe PPD, these barriers to care can be life-threatening. For patients with mild-to-moderate PPD, the first-line treatment is expert psychotherapy, but there is a dearth of qualified providers in most areas. This may paradoxically lead patients with mild-to-moderate PPD who possess adequate financial resources (including generous health insurance) to be prescribed zuranolone by their ob/gyn providers, even though only patients with severe PPD were included in the for .
Novel neurosteroid treatments have rightfully been the subject of many popular and scientific editorials and commentaries. Patients may ask about these neurosteroid treatments, so it is incumbent on health providers to familiarize themselves with the medications, as well as their associated contextual issues.
In our experience, some patients with PPD or a history of PPD are already asking about the availability of zuranolone. For patients with severe PPD, we will quickly find out whether only the wealthiest patients, or those with premium health insurance, are able to obtain it.
Andrew Drysdale, MD, PhD, is a research fellow in the Department of Psychiatry at Columbia University. Catherine Monk, PhD, is the inaugural Diana Vagelos Professor of Women's Mental Health in the Department of Obstetrics & Gynecology and Professor of Medical Psychology in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons. She is also a research scientist at the New York State Psychiatric Institute.