Zurzuvae, the first oral therapy for postpartum depression, will launch in December.
Zurzuvae (zuranolone), the first oral therapy for postpartum depression, will launch in December with a wholesale acquisition cost of $15,900 for a 14-day course of treatment. Developed by Sage Therapeutics and Biogen, Zurzuvae is a rapid-acting neuroactive steroid that targets the GABA-A receptor.
Postpartum depression is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment was only available as an IV injection given by a healthcare provider.
The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. It is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function. Zurzuvae targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.
Zurzuvae is a once-daily tablet and is a controlled substance, designated as Schedule IV by the Drug Enforcement Administration. It was approved by the FDA in August 2023.
“We have found that most payers are aligned with its potential to be a first-line therapy for women with this disorder,” Chris Benecchi, chief business officer, said during an investor call. “We anticipate formulary reviews to begin and continue over the course of 2024.”
He said the companies have completed more than 100 “engagements” with health plan and PBM customers. “Considering the totality of evidence from our ongoing interactions, we believe our stakeholders are increasingly recognizing that Zurzuvae has the potential to fulfill an important patient need as the first and only oral, once daily 14-day treatment that can provide rapid improvement of depressive symptoms for women with PPD.”
Early treatment, he said, helps to address the significant healthcare utilization costs associated with post-partum depression. He cited a 2017 model that found the multi-year average of societal costs of untreated perinatal mood and anxiety disorders for mother and child was about $32,000. Women with PPD have more hospital admissions and overall higher healthcare resource utilization and health expenditures than women who do not have PPD.
Additionally, perinatal mood and anxiety disorders are also associated with delayed or impaired long-term developmental, psychological, cognitive, and physical outcomes in children. In one study, societal costs for these outcomes were estimated at nearly $2.0 billion for all impacted children through their first five years of life.
“We believe the wholesale acquisition cost accurately reflects the innovation, clinical value and impact of Zurzuvae can have for women with PPD,” he said.
He indicated in the call that that the company has heard from payers is that Zurzuvae represents a significant advancement to the treatment of PPD and has potential to be first line therapy. He said the price is within the range for other branded medications used to treat other brain health disorders and is within the value range for the impact it can deliver. The companies are working with payers to provide access without prior authorization or step edits.
The companies also plan to launch a patient support and access program.