The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of esketamine (Spravato™, Janssen), a nasal spray approved by the FDA in March as a therapy for treatment-resistant depression (TRD). Esketamine is one of the two mirror-image molecules (enantiomers) that make up ketamine, an anesthetic that is commonly used off-label to treat TRD.

"Major depression is a severe and common condition, and new therapies are needed for the many people who are resistant to existing treatments," said David Rind, MD, ICER's Chief Medical Officer. "Esketamine shows some benefits for such patients and provides an FDA-approved treatment for TRD that may be covered by payers; however, it is concerning to have an overpriced therapy where there is such need for treatment. Additionally, the similarity of ketamine to esketamine raises issues for all stakeholders about how to consider off-label prescription and coverage of a treatment that has not been as well studied but is being increasingly used for TRD."

This Evidence Report will be reviewed at an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in Rosemont, IL on May 23, 2019. This two-topic meeting will also cover ICER's review of siponimod for secondary-progressive multiple sclerosis. The Midwest CEPAC is one of ICER's three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here. ICER previously reviewed treatments for major depressive disorder in 2011.

Key Findings

In the absence of long-term safety data, the evidence provides moderate certainty that esketamine, when taken with a background antidepressant, achieves a comparable, small, or substantial net health benefit, but the evidence is inadequate to completely exclude the possibility that harms may exceed benefits. Given the lack of head-to-head trials and differences in study design, the evidence was insufficient to judge the net health benefit of esketamine versus ketamine, electroconvulsive therapy, transcranial magnetic stimulation, oral antidepressants, or augmentation with antipsychotics.

Using the wholesale acquisition cost (WAC) for esketamine, economic analyses assessing long-term cost-effectiveness found that treatment with esketamine is estimated to cost $198,000 per quality-adjusted life year (QALY) gained, exceeding the commonly cited cost-effectiveness thresholds of between $50,000-$150,000 per QALY. Using an alternative measure of cost-effectiveness, esketamine is estimated to cost approximately $2.6 million per life year gained.

In addition to the cost-effectiveness analysis, the evidence report also contains a cost-analysis of the direct treatment costs of a full year of treatment for either esketamine or ketamine. This analysis estimates that the direct treatment costs for esketamine are ten times higher than that of ketamine in the first year, even when considering increased administration costs associated with providing ketamine intravenously.

Register here to attend the Midwest CEPAC meeting in person or to watch by live webcast.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER's reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER's reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER's reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER's website.

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