The Institute for Clinical and Economic Review found in a draft report that Johnson & Johnson's ketamine-based drug Spravato, approved in the U.S. earlier in March for patients with depression, did not meet the pricing watchdog's threshold for cost-effectiveness.
Spravato is the brand name for esketamine, which was found in clinical studies to be effective against symptoms of treatment-resistant depression, a condition in about one-third of all patients with major depressive disorder presenting with a high rate of suicide.
Using a benchmark called a quality-adjusted life year, or QALY, the U.S. cost-effectiveness evaluator known as ICER evaluates a drug's cost based on both how long a patient lives and the quality of life therein.
Based on a wholesale acquisition cost of $295 per medication device, ICER reported that Spravato cost about $198,000 per QALY, missing the organization's cost-effectiveness threshold of $150,000.
Despite the cost, ICER found that Spravato produced substantial gains in quality of life for patients, though few patients used the drug longer than five years.
"The results of this analysis should be considered in the context of a lack of evidence surrounding the treatment of [treatment-resistant depression], including the complete lack of comparative evidence of esketamine to other potential therapies (i.e., ketamine) and very limited evidence of the impact of important disease modifiers on clinical outcomes, cost of care, and patient quality of life," ICER wrote in the March 21 draft report.
Analysts predict Spravato could be a blockbuster drug for Johnson & Johnson, making up for losses on older drugs in other classes.
ICER plans to publish a full evidence report for Spravato May 9 and has scheduled a meeting of the Midwest Comparative Effectiveness Public Advisory Council May 23 to discuss the findings.