Interventions of interest, 2019 review: 

  • Esketamine (SPRAVATO®, Janssen)

Major depressive disorder (MDD) is a common and debilitating condition; on an annual basis, it is estimated that nearly 14 million Americans will have at least one episode of MDD. While definitions of so-called “treatment-resistant” depression vary, this generally refers to patients with persistent depression after attempted management with two or more medications.

The independent appraisal committee voted that the evidence was adequate to demonstrate clinical benefits of esketamine versus the placebo, but concerns remain about the study criteria used to define treatment-resistant depression and the lack of longer-term data on esketamine’s safety and effectiveness.

Esketamine’s list price would require a 25-52% discount to reach a fair value-based price benchmark, and the potential short-term budget impact associated with treating the eligible patient population lead ICER to issue an Access and Affordability Alert.

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Final Documents

Below you will find the final documents from the assessment review process:

“Treatment-resistant forms of major depression are common and have large negative effects on patient quality of life, so new therapies are badly needed. It is hard to understand how a price exceeding usual cost-effectiveness thresholds is appropriate for a treatment that could be very widely used, particularly when that price is an order of magnitude higher than that of intravenous generic ketamine, a closely related therapy.”