Towards the end of 2023, a group of clinician-researchers from the National Network of Depression Centers issued an appeal to payers to provide insurance coverage for ketamine infusion therapy (KIT) (Niciu et al. 2023).

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Their letter was inspired in part by evidence from previous randomized control trials (RCTs) and the publication of a study in the prestigious journal Lancet, showing that KIT was non-inferior to electroconvulsive therapy (ECT) (Anand et al. 2023), a treatment previously considered to be the gold standard for depression. However, as the authors only briefly alluded to the extensive corpus of real-world evidence (RWE), including many more patients than studied in RCTs, we published our own letter to detail the effectiveness of KIT in real-world care. Moreover, we wanted to emphasize how critically important RWE has been for medicine (e.g. oncology) in general and mental health in particular.

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In our letter, we underscore the point made by Niciu et al. (2023) who remind readers that ketamine is an off-patent, repurposed medication presenting little financial incentive for a sponsor to conduct FDA-registered trials to support an indication for depression. However, by embracing pragmatism and leveraging RWE, it is possible that we can accelerate the reimbursement of KIT for depression without additional interventional studies. Payers can draw inspiration from the FDA, which has approved label expansions for many treatments spanning cancer drugs to implantable heart valves primarily based on RWE, without requiring dedicated clinical trials for those specific indications (Rahman et al., 2023; FDA, 2021).

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The lack of financial incentives for biopharmaceutical development should not stop this treatment from being accessible for patients who are suffering. Hopefully we will see robust insurance coverage for mental health treatments, which will help both patients and their hardworking clinicians.

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This work was led by Dr. L. Alison McInnes, Osmind’s VP Scientific Affairs with Jimmy Qian (Osmind’s co-founder) and Dr. Toby Marton (Osmind Community Advisory Board member).

You can access the full letter via this link to the Full PDF download, published in the Journal of Affective Disorers.