J&J's Spravato gets no love from NICE, jeopardizing its prospects in the UK
UK’s cost-effectiveness watchdog NICE is taking the same track laid out by ICER — J&J’s pharmaceutical version of the hallucinogenic anesthetic ketamine, Spravato, is low value for money. On Tuesday, the agency refused to endorse the therapy for inclusion as a reimbursable drug on the UK’s National Health System.
Cognizant of the myriad of approved antidepressants that often don’t work, EU regulators endorsed J&J’s low-dose, nasal-spray formulation of ketamine last month for treatment-resistant depression.
Due to its side-effect profile, the therapy is designed to be administered in the presence of a healthcare practitioner, a limitation that seemingly played a role in NICE’s math on Spravato’s overall cost.
“Introduction of esketamine into clinical practice in the NHS will be complex because the structure and delivery of services would need to be changed. Estimates of the costs of providing the clinical service for esketamine were highly uncertain, as are the costs of repeated courses of the drug,” said Meindert Boysen, director of the center for health technology evaluation at NICE, in a statement.
NICE acknowledged that while the drug may be more effective at relieving the symptoms of depression than placebo and oral antidepressants — Spravato’s current list price exceeds a common cost-effectiveness threshold considered acceptable, the agency said, noting that according to the company’s economic model, an average course costs £10,554.25.
Most antidepressants usually take a few weeks to work – and half of the patients fail to fully respond. Ketamine (sometimes referred to as a party drug Kit Kat or Vitamin K) can lift depression in many patients within hours, must be administered through infusion but can have profound dissociative side-effects, and patients typically relapse after treatment ends.
Like ICER, NICE highlighted it wasn’t clear whether Spravato provided a benefit over oral antidepressants if they are administered with adjunctive therapy, or versus electroconvulsive therapy or antipsychotics — as these different regimens have not been compared directly with the J&J therapy. There is also uncertainty improvements will linger after Spravato therapy is ceased, the agency added.
J&J is deeply disappointed by the recommendation, the company said in a statement, vowing to address NICE’s concerns and to find a way to get the nasal spray on the NHS.
NICE’s determination came as part of its draft guidance. Feedback from different stakeholders will be accepted for another month before a final determination is made.