March 2019 welcomed two new specialty drugs approved by the Food and Drug Administration (FDA), one for postpartum depression, and one for treatment-resistant depression. In clinical trials, both medications show relief for patients in mere hours — a big shift from the weeks- or months-long improvement common with other antidepressants.
First-of-its-kind postpartum depression treatment
According to the National Institute of Mental Health, as many as 1 in 9 American women experience postpartum depression (PPD) — making it the most common complication of pregnancy. Sage Therapeutic’s ZulressoTM External Site (brexanolone) IV injection could be a good option for women with severe or persistent symptoms. It's the first-ever FDA-approved drug1 for PPD, and while current treatments may take weeks (or even months) to work, the one-time 60-hour Zulresso infusion begins working in 48 hours.
But this advancement comes with a hefty price tag: $7,450 per vial or $34,000 per course of treatment. However, these prices don't include the costs associated with the close monitoring that's required External Site during the 60-hour administration of the drug. Zulresso carries a boxed warning External Site, or an alert for serious side effects, for excessive sedation and sudden loss of consciousness. To ensure patient safety, and an intervene if necessary, a healthcare provider must be available on-site during the treatment.
This breakthrough, which Sage believes will be available beginning in late June, opens the doors for more development of drugs specifically designed to treat debilitating, and potentially life-threatening, PPD.
Sage Therapeutics already has another PPD treatment in development External Site as an oral pill, which will likely be easier to access for patients. It's currently undergoing clinical trials and is anticipated to be available in a few years if approved by the FDA.
Nasal spray for difficult-to-treat depression
Featuring the first new treatment delivery method for a major depressive disorder in 30 years, Janssen and J&J’s SpravatoTM External Site (esketamine) nasal spray recently received FDA approval2 for treatment-resistant depression (TRD). About one-third of U.S. adults with a major depressive disorder have TRD, or depression that remains despite trying at least two different antidepressants within one episode.
Esketamine, the active ingredient in Spravato, is derived from the same molecule as ketamine. Ketamine, approved in the 1970s for anesthetic use, is also used to treat depression3 even though it wasn't approved specifically for that condition (and has become a popular illicit party drug, known as Special K). In high doses, both drugs can cause sedation, disassociation and hallucinations. Esketamine is also categorized as a schedule III controlled substance External Site.
For these reasons, Spravato will be limited to certified treatment centers External Site to prevent potential misuse. Patients will inhale the drug one to two times per week under close supervision. And Spravato acts fast — patients may experience relief from depression symptoms in under two hours.
Similar to Zulresso, the per-dose price for Spravato does not include administration and observation costs. Each treatment will likely range from $590 to $885. For twice-weekly treatments, this amounts to $4,720 to $6,785 for the first month.
Coverage decisions coming soon
Wellmark uses several strategies to evaluate and manage high-cost specialty drugs, and our independent medical and pharmacy experts will review both drugs and coverage options in the coming months. Zulresso and Spravato will likely be covered under the medical benefit with prior authorization to clearly identify members ready for these innovative treatments. This article will be updated once a final decision has been made.
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1 FDA press release for Zulresso External Site
2 FDA press release for Spravato External Site
3 Wellmark considers ketamine investigational when used for depression due to the lack of data on long-term safety and effectiveness.