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Postpartum drug is a game changer, but can women afford it?
While the first FDA-approved treatment for postpartum depression (PPD) offers hope to those suffering from the condition, it comes with a high price tag and some serious risks.
Brexanolone (Zulresso, Sage Therapeutics) injection for intravenous (IV) use must be administered by a healthcare provider in a certified healthcare facility. “Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring,” FDA said in a statement.
Expected to be available in June, the list price for Zulresso is $7,450 per vial, or $34,000 per patient for the entire course of therapy, before discounts. “When determining the price of Zulresso, Sage considered factors such as the high unmet need of the patient population, the impact of PPD on patients and society, and the clinical value of a one-time treatment with the opportunity for a rapid, acute intervention for the treatment of PPD, a condition where no FDA-approved therapy previously existed,” according to a statement from Sage Therapeutics prepared for FormularyWatch.
“PPD is a serious condition that, when severe, can be life-threatening,” said Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in FDA’s Center for Drug Evaluation and Research, in the FDA statement. “Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” she added.
Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a healthcare provider in a certified healthcare facility. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a healthcare facility for the entire 60 hours of infusion.
However, Zulresso has been shown to be well tolerated in clinical studies to date, with the most common adverse events being headache, dizziness and somnolence, according to Sage.
Sage is committed to patient access to the medication and reducing barriers to treatment, according to the Sage spokesperson. The pharma maker will take four key steps to establishing pathways to care-largely in hospital-based centers of excellence.
“The four key steps to establishing viable sites of care reflect clinical, operational, and reimbursement-oriented requirements, including: identifying patient-friendly, clinically appropriate sub-settings of care; certifying sites around FDA’s Risk Evaluation and Mitigation Strategies (REMS) program for Zulresso; establishing appropriate pharmacy and infusion service to procure and prepare Zulresso; and securing reimbursement that helps facilitate appropriate PPD patient care objectives,” according to the Sage Therapeutics statement.
“In our discussions to date, providers are willing to work with Sage to enable a pathway to care for patients because they understand the urgency associated with treating and successfully resolving this very real unmet clinical need associated with the most common medical complication of pregnancy and childbirth (PPD),” according to the Sage Therapeutics statement.
The Drug Enforcement Agency (DEA) is expected to issue an interim final rule scheduling the drug within 90 days of the March 19 approval, after which time Zulresso will be made commercially available with the final prescribing information, according to Sage Therapeutics.
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