Did NICE play fair? J&J wins appeal—in part—to glean rationale behind cost watchdog's Spravato snub

The work of the U.K.’s drug pricing watchdog naturally ruffles the pharma industry’s feathers from time to time, though formal attempts to parry its appraisals rarely pan out for drugmakers.

In an unusual turn, however, an appeals panel has ruled that the National Institute for Health and Care Excellence (NICE) may have erred in its recent rejection of Janssen’s Spravato for treatment-resistant depression. Janssen in June contested NICE's rebuff of its ketamine-like nasal spray, which earned a U.S. nod in conjunction with oral antidepressants back in 2019.

Spravato won an EU green light in December 2019 as an add-on therapy alongside an oral drug to treat adults whose depression hasn’t responded to at least two different medications. Even though patients can dose themselves, a healthcare professional needs to monitor their reactions to minimize safety risks.

Alongside Johnson & Johnson’s Janssen unit, meanwhile, the U.K.’s Royal College of Psychiatrists has also appealed NICE’s latest decision.

Now, NICE’s appraisal committee must reunite to clarify the thought process behind its choice not to recommend Spravato in May. While it’s amenable to meeting up again, the cost watchdog is making no promises about reversing its original verdict.

Earlier this summer, NICE explained in its Spravato snub that “limitations in the clinical evidence and economic model mean it is not possible to determine a reliable cost-effectiveness estimate.” The watchdog turned down the drug on the assumption Spravato—also known as esketamine nasal spray—“is unlikely to be an acceptable use of [National Health Service] resources.”

Overall, one of nine specific appeal points was upheld by the independent panel, NICE said in a release Wednesday. Much of the issue comes down to “clinical uncertainties inherent in clinical trials to treat mental illness,” NICE explained.

While NICE says the appeal panel was “satisfied” with the institute’s recognition of those uncertainties, its final appraisal didn’t clearly lay out how uncertainties informed Spravato’s rejection. In turn, NICE “failed to act fairly,” according to its own summary of the appeal panel’s final determination.

Meanwhile, Janssen says its appeal isn’t just about Spravato; rather, the company says its concerns apply to NICE’s mental health appraisals “generally.” Janssen in its appeal questioned whether the cost watchdog’s approach offers a “fair and appropriate” take on the “context of the particular features of mental illness and its management in the NHS in England.”

The precedent set by NICE’s Spravato snub could spell trouble for future appraisals of other novel mental health meds, Janssen further argued.

Overall, the company contends NICE acted unfairly and overstepped its authority, with its Spravato rejection “unreasonable” in light of the evidence submitted.

The Royal College of Psychiatrists, for its part, argues NICE’s verdict “prevents any drug for treatment-resistant depression, however efficacious, ever meeting the bar that has been set.”

The precedent NICE has set allegedly “discriminates against patients suffering from mental disorders because long-term outcomes and trajectories are particularly heterogenous,” the Royal College added.

Now, NICE’s appraisal committee will reconvene in October to explain its rationale and discuss which clinical uncertainties linked to mental illness are, “in its opinion, potentially solvable,” the watchdog said.

“The appeal panel believes this might help inform future clinical trial design for treatment resistant depression,” NICE explained.

Still, the appraisal committee “is not bound to change its recommendation,” the organization pointed out.