In an unusual turn of events, an appeals panel ruled that the U.K.’s cost effectiveness watchdog agency acted unfairly and exceeded its authority by failing to thoroughly explain why it declined to recommend a Johnson & Johnson medicine called Spravato for combating treatment-resistant depression.
Specifically, the panel determined that the National Institute for Health and Care Excellence did not thoroughly convey its views on how uncertainties in the evidence that are “inherent to clinical trials in mental health were taken into account in its decision making.” The agency was directed to now “take all reasonable steps” to explain its position.
The decision was made in response to an appeal filed by the J&J unit Janssen and the Royal College of Psychiatrists after NICE twice indicted it would not recommend the nasal spray for use by the U.K.’s National Health Service. At the time, NICE expressed concerns about effectiveness in treating depression due to the ways the clinical trials were conducted, as well as the cost. (Read all the documents here).
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