*This article was last updated July 2020.
March 2019 welcomed two new specialty drugs approved by the Food and Drug Administration (FDA), Zulresso™ for postpartum depression, and Spravato™ 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 that was common with other antidepressants.
Zulresso®: 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 Zulresso 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 health care provider must be available on-site during the treatment. This close monitoring is a part of a program known as risk evaluation and migration strategy (REMS) that is designed to ensure proper dispensing of the drug with adequate patient safety during its administration.
With the availability of Zulresso, this 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. This drug became available for clinical trials on June 19, 2019. The next set of trail data is expected to be available in 2021-22.
Will this treatment be covered by insurance?Zulerrso® is covered under the medical benefit with prior authorization following review by Wellmark Blue Cross and Blue Shield's Pharmacy and Therapeutics committee, a team of independent medical and pharmacy experts, who evaluated the safety and efficacy of the drug in treating major depressive disorder resistant to other treatments.
Spravato®: 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 Spravato External Site (esketamine) nasal spray received FDA approval2 treatment-resistant depression (TRD) and became available March 2019. 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, though also used to treat depression3, was originally approved only for anesthetic use in the 1970s. The drug has since become a popular illicit party drug, known as Special K. In high doses, both drugs can cause sedation, disassociation and hallucinations4. 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.
Your questions about Spravato®, answered
Depression is one of the most common mental health conditions in the United States. It affects 15.7 million adults ages 18 and older. According to the Anxiety and Depression Association of America External Site, 6.7 percent of American adults experienced at least one major depressive episode in the past year.
Does Spravato® help with anxiety?Spravato is not approved for the treatment of anxiety. At this time, Spravato is only approved for the treatment of treatment-resistant depression in adults and is to be used in combination with an oral antidepressant. In a recent study, 13 percent of patients receiving Spravato reported anxiety as a side effect of the medication, as compared to 6 percent receiving placebo.
How often should Spravato® be taken?Spravato® is taken twice a week for the first four weeks under the supervision and administration of your employee's health care provider until a new treatment plan is suggested.
Is Spravato® available?While this treatment is available, it's important to know that it is not available to be purchased at a pharmacy. The appropriate use of this treatment is administered by a certified treatment center (find one here External Site) — which could be different than an employee's doctor's office. If the Spravato treatment is recommended, then their health care provider will discuss risk of abuse, misuse and sedation.
Will this treatment be covered by insurance?Spravato® is covered under the medical benefit with prior authorization following review by Wellmark's Pharmacy and Therapeutics committee.
Questions? Contact your authorized Wellmark account representative, or email us at firstname.lastname@example.org Send Email.
- 1FDA 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.
- 4 Spravato® carries a boxed warning for sedation, dissociation's, abuse/misuse, and suicidal thoughts and behaviors.