The major depressive disorder (MDD) market has many unmet needs; a large number of MDD patients do not respond to the available treatments, and products used for the treatment of depression are associated with significant side-effects and risk factors, which directly affect compliance.

MDD therapies

None of the previously marketed products for depression can demonstrate rapid antidepressant effects, and most of the products take weeks to show effectiveness. The need for fast-acting therapies is more pressing in patients with the severe form of the disease and new therapies can help to meet this unmet need.

Spravato (esketamine), developed by Johnson & Johnson, is a nasal spray with a novel mechanism of action, approved by the US Food and Drug Administration in March, and is the first MDD treatment to be approved in the US market in many years.

Spravato is a new option of treatment for patients with depression who do not respond to existing therapies, known as treatment-resistant depression (TRD), making a significant impact on the treatment of many MDD patients who have been unresponsive to current anti-depressant therapy.

The Institute for Clinical and Economic Review (ICER) in their Evidence Report assessed the clinical value and effectiveness of Spravato and the results showed that it achieves a comparable, small, or substantial health benefit compared to other classes of therapies. However, the lack of enough evidence and the absence of long-term safety data do not exclude the possibility that harms may exceed benefits.

Spravato cost

Furthermore, the report assessed the cost-effectiveness of Spravato and results showed that Spravato is estimated to cost $198,000 per quality-adjusted life year (QALY) gained, exceeding the commonly cited cost-effectiveness thresholds of between $50,000–150,000 per QALY. In addition, Spravato direct treatment costs are 10 times higher than that of ketamine in the first year, even when considering increased administration costs associated with providing ketamine intravenously.

This Evidence Report will be reviewed by an appraisal committee comprising medical evidence experts, practising clinicians, and leaders in patient engagement in a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in Rosemont, Illinois, on 23 May.

Spravato provides a new FDA-approved treatment for TRD that may be reimbursed, as it shows some clinical benefits for TRD patients; however, the high price of the therapy can limit its uptake as evidence showed non-significant benefit in terms of cost-effectiveness. Moreover, the similarity of Spravato to ketamine, a relatively inexpensive anaesthetic that has been prescribed off-label by some psychiatrists, can significantly affect the market of Spravato.