Johnson & Johnson (J&J) is making significant strides in expanding the reach of SpravatoⓇ (esketamine), an FDA-approved psychedelic treatment, by seeking approval for its use as a monotherapy for adults with treatment-resistant depression (TRD). J&J’s application came just weeks before the FDA declined Lykos Therapeutics' new drug application for MDMA for treatment of PTSD, highlighting the challenges in gaining regulatory approval for psychedelic treatments.
Spravato's Financial and Clinical Success
Spravato is on track to generate over $1 billion in revenue this year, reflecting its growing acceptance and success in the market. Sales of the drug have accelerated significantly, with a 61% increase in the second quarter compared to the same period last year and a 20% increase from the first quarter, indicating increased confidence among physicians and patients. This financial success supports the notion that psychedelic treatments can become commercially viable for mental health conditions, even amidst regulatory scrutiny.
Current and Proposed Use of Spravato
Currently, to qualify for Spravato, patients must have tried two or more antidepressants that have not worked and must use Spravato alongside an antidepressant. Although insurance companies often have stricter requirements for prior authorization, like requiring three failed antidepressants. The supplemental New Drug Application (sNDA) submitted by Johnson & Johnson aims to remove the requirement for concurrent use with an antidepressant, making Spravato more accessible to patients and allowing practitioners to administer it without prescribing an additional antidepressant alongside it. This change could provide a more flexible and rapid treatment option for patients with treatment resistant depression who often already endure prolonged periods of ineffective treatments.
Although the supplemental application, if approved, would remove one obstacle for patient access there still are plenty of challenges to patient access. Patients still need to have tried and failed two antidepressants which can mean patients having to endure months or even years of antidepressants and their side effects.
Cost to the healthcare system
Qualified patients with insurance coverage won’t bear the direct cost of Spravato, their employers, providing self-funded or fully funded insurance plans, will. The approximate annual cost of Spravato is $33,000-$49,000. This is significantly higher than some other available treatments for depression, including racemic ketamine, an FDA approved anesthetic, that is increasingly being offered off-label for mental health conditions. With an approximate annual cost of $5,500-$8,000 racemic ketamine is less than 20% the cost of an annual course of Spravato. When savvy employers compare the effectiveness of ketamine vs esketamine they will likely opt to cover racemic ketamine to keep healthcare costs down and give patients more options.
Implications for the Psychedelic Treatment Landscape
The FDA's rejection of Lykos Therapeutics' application for MDMA approval highlights the challenges in gaining regulatory approval for psychedelic therapies. However, Spravato's success and potential expanded approval could pave the way for broader acceptance and use of psychedelics in treatment, offering hope for patients with challenging-to-treat mental health conditions. As the field of psychedelic research continues to evolve, Spravato's trajectory demonstrates the potential for these treatments to generate meaningful sales and provide new therapeutic options but it also shines a light on affordable legal off-label therapies available today.
