J&J has attempted to secure reimbursement for Spravato in England and Wales multiple times, but each effort has been unsuccessful.

Its initial filing was made in July 2019, and NICE provisionally rejected Spravato in January 2020 based on a lack of clinical evidence around the benefit it provided compared to other treatment options. This draft rejection was reviewed multiple times up to May 2022, when NICE published a final decision rejecting the nasal spray for reimbursement.

In July 2022, J&J and the Royal College of Psychiatrists officially appealed the NICE decision.(Also see "Janssen May Challenge English Funding Rejection For Depression Nasal Spray" - Pink Sheet, 27 May, 2022.).

The following September, an independent panel ruled NICE did not act fairly when it rejected the nasal spray because it did not fully explain how the evidence uncertainties were taken into account in its decision making.

However, eight other appeal points made by J&J were not upheld. In October 2022, NICE issued another final guidance document in which its original recommendation remained unchanged.(Also see "Janssen Secures Only Partial Win In Appeal Against English Funding Snub For Spravato" - Pink Sheet, 13 September, 2022.).

In November 2022, J&J released the results from ESCAPE-TRD, and was invited to share these data with NICE last October. This ultimately resulted in the latest decision by NICE not to review its original decision.

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

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