Understanding profiles of patients with treatment-resistant depression by stringency of health plan prior authorization criteria for approval of esketamine nasal spray

Author:

Harding Lisa1,Zhdanava Maryia2,Shah Aditi2,Pesa Jacqueline3,Totev Todor I.4,Tardif-Samson Anabelle2,Pilon Dominic2,Joshi Kruti3

Affiliation:

1. Mood Institute, Milford, CT, USA

2. Analysis Group, Inc, Montréal, QC, Canada

3. Janssen Scientific Affairs, LLC, a Johnson & Johnson Company, Titusville, NJ, USA

4. Analysis Group, Inc, Boston, MA, USA

Publisher

Informa UK Limited

Reference32 articles.

1. U.S. Food and Drug Administration. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic; 2021 [cited June 7]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.

2. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Major depressive disorder: developing drugs for treatment guidance for industry; Jun 2018 [cited 2024 Jan 10]. Available from: https://www.fda.gov/media/113988/download.

3. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

4. The identification, assessment and management of difficult-to-treat depression: An international consensus statement

5. Safety and effectiveness of intranasal esketamine for treatment-resistant depression: a real-world retrospective study

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