Depression drug Spravato (esketamine) nasal spray has been at the center of Johnson & Johnson’s (J&J) strong disapproval of the decision by the UK’s National Institute for Health and Care Excellence (NICE) not to conduct a new appraisal. The company voiced “grave concern” about access to innovative mental health treatments through NHS England.
In 2020, NICE declined to recommend NHS funding for Spravato, which had been approved as an add-on therapy for patients with serious depression unresponsive to at least two oral antidepressant therapies. NICE’s decision was based on its skepticism about the clinical data supporting Spravato and concerns about the drug’s cost-effectiveness. Spravato’s list price was noted to be around £10,500 per course of therapy before any discounts.
In a recent statement, J&J indicated that it has “reluctantly concluded it has exhausted all current viable avenues to gain patients access to Spravato.” The company highlighted the availability of Spravato in 20 other countries across Europe, including Ireland and Scotland. This disparity within the UK has been criticized by mental health charity SANE, which described it as “a further blow for patients.”
J&J Presses NICE to Reassess Depression Drug Spravato After New Study Results
J&J expressed hope that NICE would “prioritize adapting its appraisal methods so that all mental health treatments may be appropriately assessed in the future.” NICE, however, maintained in an update that the evidence received since its initial appraisal did not warrant a revision of the existing recommendation. As a result, the guidance will remain unchanged unless new substantive information emerges to justify reconsideration. NICE’s original appraisal of Spravato raised several concerns, including a lack of comparative data with other treatments for treatment-resistant depression and insufficient data on the outcomes following the cessation of Spravato treatment. These issues contributed to the decision against recommending the drug for NHS funding.
Recently, J&J reported promising results from a new phase 4 study of Spravato. The study demonstrated a statistically significant improvement in depressive symptoms after four weeks of treatment, measured using the MADRS total score, compared to a placebo. Notably, improvements were observed as early as 24 hours after the first dose. This rapid onset of action is a significant advantage of Spravato over other treatments for treatment-resistant depression, which often involve sequentially trying different oral therapies that may take weeks to show any benefit if they work at all.
Despite a modest uptake in the initial post-launch period, Spravato has started to gain traction globally. Last year, sales increased by 80% to $689 million. The first quarter of this year saw a further 72% increase to $225 million, putting Spravato on track to achieve blockbuster status with projected sales exceeding $1 billion in 2024.
Debate Over Spravato’s Approval Highlights Challenges in Mental Health Treatment Access and Evaluation
The ongoing debate over Spravato’s approval highlights the challenges in balancing the need for innovative mental health treatments with concerns about clinical efficacy and cost-effectiveness. J&J’s criticism of NICE’s decision underscores the importance of ensuring that appraisal processes are capable of adequately evaluating new treatments for complex conditions like treatment-resistant depression.
As J&J continues to advocate for broader access to Spravato, the conversation around mental health treatment access and evaluation criteria remains critical. The disparity in access to Spravato within the UK raises questions about the consistency and fairness of healthcare provision across different regions. For patients with severe depression unresponsive to traditional treatments, the availability of new options like Spravato could represent a significant improvement in quality of life and clinical outcomes.
In conclusion, while NICE’s current stance on Spravato remains unchanged, the pressure from J&J and the emerging data from new studies may eventually prompt a re-evaluation. The evolving landscape of mental health treatment demands continuous adaptation of appraisal methods to ensure that patients receive timely and effective care. The ongoing discourse between pharmaceutical companies, regulatory bodies, and patient advocacy groups will be crucial in shaping the future of mental health treatment accessibility.
Resource: Pharmaphorum, June 13, 2024
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