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Challenges of securing insurance approval for oral tofacitinib for the treatment of alopecia areata: a multi-institution retrospective review

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Alopecia areata (AA) is a psychologically distressing disorder for which few reliable treatments exist. Although oral tofacitinib has demonstrated efficacy in treating AA, it is not approved by the Food and Drug Administration (FDA) for this indication. To investigate and identify the challenges associated with securing insurance approval for oral tofacitinib for AA. We conducted a retrospective review of patient records from two academic medical centers to identify patients with AA in whom insurance approval was sought for oral tofacitinib from 2015–2019. We recorded information on prior authorization (PA) submissions, appeals, and peer-to-peer reviews. We noted whether patients were documented to experience negative impact on mood/QOL or suicidal ideation (SI) due to their disease. We identified 37 patients in whom insurance approval was sought for oral tofacitinib for the treatment of AA. PAs were initially denied for 36/37 (97%) patients. The most commonly cited reason for denial was “tofacitinib not covered for AA/off-label medication use” (n = 26/36; 72%). 26/37 (70%) patients ultimately failed to obtain coverage. Of the 11 (30%) patients who obtained coverage, 10 (91%) were privately insured, 0 (0%) had Medicare and 1 (9%) had Medicaid. 13 patients (34%) experienced documented diminished QOL/mood (including SI) due to their disease burden; 6/13 (46%) of these patients eventually secured insurance approval. Lack of FDA approval of oral tofacitinib for the treatment of AA creates challenges in caring for patients with this disease. Policymakers should consider the negative implications lack of FDA approval may have for patients with recalcitrant dermatologic conditions.

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SD and KL contributed equally to this manuscript as co-first authors. AL and RAV contributed equally to this manuscript as co-senior authors. RAV and AL led the study team and conceptualized the study. All authors contributed to the study design. SD and KL contributed to data collection, data analysis and data interpretation. VN contributed to data interpretation and presentation. SD prepared the first draft of the manuscript, which was subsequently revised and edited by all authors for critical content.

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Correspondence to Ruth Ann Vleugels.

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The authors have no conflicts of interest to declare.

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This study was deemed exempt by the Partners Institutional Review Board (IRB).

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Sheena Desai and Kelly Lo co-first authors.

Avery LaChance and Ruth Ann Vleugels co-last authors.

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Desai, S., Lo, K., Nambudiri, V.E. et al. Challenges of securing insurance approval for oral tofacitinib for the treatment of alopecia areata: a multi-institution retrospective review. Arch Dermatol Res 314, 487–489 (2022).

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