ICER says Spravato has benefits but exceeds cost-effectiveness thresholds; UPDATE

The US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of Spravato (esketamine), a nasal spray approved by the Food and Drug Administration in March as a therapy for treatment-resistant depression (TRD).

Developed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen Pharmaceuticals unit, 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 Dr David Rind, the 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,” he added.