Johnson & Johnson's Spravato® (esketamine) continues its expansion as a mental health treatment, solidifying its position as a groundbreaking therapy for treatment-resistant depression (TRD). In July J&J submitted a supplemental New Drug Application to expand Spravato’s use as a monotherapy for TRD.
Spravato FDA Approval for Monotherapy
In a significant development, the U.S. Food and Drug Administration (FDA) has approved Spravato as the first and only monotherapy for adults with TRD. This landmark decision removes the requirement for concurrent use with an oral antidepressant, marking a pivotal moment in the treatment of depression.
This approval grants greater flexibility to healthcare providers and patients alike. Now, adults with TRD can receive Spravato treatment without the necessity of an additional antidepressant, potentially streamlining the treatment process and offering a more direct approach to managing their condition.
The monotherapy approval could lead to more rapid and flexible treatment options for those struggling with TRD. This is particularly crucial for patients who have endured prolonged periods of ineffective treatments and may be hesitant to add another oral medication to their regimen.
Financial Success and Market Impact
Spravato's clinical success has translated into remarkable financial performance, underscoring its growing acceptance in the healthcare market.
Johnson & Johnson's 2024 earnings report reveals that Spravato has surpassed the billion-dollar revenue mark ($1.077B), a testament to its increasing adoption. This achievement not only validates J&J's investment in Spravato but also signals a shift in the broader acceptance of such treatments in mainstream healthcare.
The drug's sales have shown impressive acceleration, with significant year-over-year and quarter-over-quarter increases. This growth trajectory suggests rising confidence among both physicians and patients in Spravato's efficacy and safety profile.
Who is paying for Spravato?
Spravato's cost is covered by insurance for qualified patients, but the annual expense of $33,000-$49,000 falls on employers with self-funded or fully funded insurance plans. Spravato is significantly more expensive than similar depression treatments like ketamine infusions, which costs $5,500-$8,000 annually. Ketamine, an FDA-approved anesthetic, is increasingly being used off-label for mental health and offers a cost-effective alternative to Spravato. Employers who are aware of the cost and effectiveness differences between ketamine and esketamine are likely to choose ketamine coverage to reduce healthcare expenses and provide patients with more treatment options. In fact, in Wisconsin, racememic ketamine infusions are now covered by Medicaid for treatment of depression.
Looking Ahead
Spravato will continue to gain traction in the market with its expanded FDA approval as a monotherapy for TRD. We can expect that Spravato’s 2024 revenue of $1.08 billion will continue to climb in the coming years. J&J will continue to expand revenue and drive profits from Spravato until self-funded employers get more transparency from pharmacy benefit managers (PBMs). With this transparency, employers can see how much they are spending on expensive brand name drugs when there are cheaper and more effective generics that aren’t covered in their formulary.
