Days ago, Johnson & Johnson’s controversial nasal depression drug Spravato was criticized as being too pricey. In response, the company has now come up with its own study to champion the drug’s cost-effectiveness.
Using a cost-per-remitter model, Johnson & Johnson said in stable remission patients with treatment-resistant depression, Spravato in conjunction with an oral antidepressant could cost $20,000 less per patient than oral therapy plus placebo, according to a new analysis the company presented at the International Society for Pharmacoeconomics and Outcomes Research annual meeting.
“[B]ecause it can help more patients have a significant reduction in their depressive symptoms […] Spravato is a meaningful clinical and economic investment,” John Sheehan, director of real-world value and evidence at Janssen Scientific Affairs, said in a statement. “People who no longer experience ongoing depressive symptoms pay less to manage their disease, reduce the cost to the overall healthcare system, and are able to get back to their lives.”
The analysis draws on data from two phase 3 trials that examined Spravato’s treatment outcomes including remission, response and relapse rates over a one-year period. After considering the indirect costs of loss of productivity, the cost savings per remitter jumped nearly threefold versus the $20,000 improvement, according to J&J.
J&J’s study can be seen as a direct rebuttal to the Institute for Clinical and Economic Review (ICER). In a recent report, the U.S. cost watchdog concludes that Spravato would cost $198,000 per quality-adjusted life year gained, above the usual $150,000 threshold the organization uses to evaluate drug cost-effectiveness.
While J&J has trumpeted the ketamine-like drug’s benefits because it can treat some patients who have failed multiple oral antidepressants, ICER argued the evidence so far isn’t enough to offer certainty about its health benefits, especially when compared with its potential harms. Of the three pivotal trials that evaluated Spravato in the short term, only one saw statistically significant improvement on the primary endpoint.
“[A] number of worrisome findings were revealed that should give potential users some pause and call for a concise framework for assessing the risk-benefit balance for using this formulation of ketamine,” Stanford University researcher and previous president of the American Psychiatric Association Alan Schatzberg warned in an accompanying commentary that ran Tuesday in The American Journal of Psychiatry alongside the study of that successful trial.
Spravato carries a boxed warning for risk of sedation and difficulty with attention or thinking, risk of abuse, and suicidal thoughts and behaviors. On the one hand, Schatzberg cautioned about the potential abuse of ketamine; on the other, he pointed to data from the maintenance study—the other successful trial J&J presented—which showed high relapse rates after Spravato discontinuation even though patients were still receiving oral antidepressants.
“This raises the question as to whether patients should be receiving [Spravato] for even longer periods—or would that be even more risky?” Schatzberg asked.