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Download White Paper Theme | category AmerisourceBergen I Xcenda Executive Summary Alopecia Areata: A Disease That Extends Beyond Physical Manifestations Approximately 700,000 people in the United States (US) are The High Costs of AA for Patients diagnosed or affected by alopecia areata (AA), with just under half of these patients estimated to have complete scalp or total Beyond the physical and mental health impact of AA, patients body baldness.1 AA is a serious, recurring autoimmune disease with AA face significant out-of-pocket costs. These costs are from that affects all ages, both sexes, and all skin types.2 Although cost-sharing associated with medically covered services for AA symptoms range from bald patches to total hair loss, this is not and comorbid conditions as well as other interventions not simply a cosmetic issue. The converging physical and mental covered by insurance. For example, many AA patients reported impact of AA often carries a lifetime burden and has a use of non-medical interventions such as wigs or camouflage (71%) 8 substantial cost for payers and patients. and/or dietary changes or supplements (64%). All of this is potentially compounded by work productivity and activity Unmet Medical Need—Recognizing impairment due to AA.9 Mitigating the high out-of-pocket costs faced by patients with AA is key to improving access to treatment. This Is an Autoimmune Condition There are currently no Food and Drug Administration (FDA)- Coverage Policies Must Ensure Access to approved treatments available for patients with AA—just several FDA-Approved Treatments for AA therapies used off-label to manage the condition. With the current lack of formal treatment guidelines, patients are prescribed a AA should not be overlooked as a cosmetic condition. There is variety of therapeutics for AA.3 This makes it difficult for providers to an unmet need for an efficacious long-term treatment option. serve patients with AA effectively. As a result, nearly 8 in 10 patients AA is unpredictable, with spontaneous regrowth of sections of with AA are unsatisfied with the current treatment options.4 hair occurring in 80% of patients within the first year followed by sudden relapse. The Mental Health Impact of AA Over the next two years, US payers and policymakers need to AA is not just the loss of one’s hair, the disease can also have a drive coverage policies for new FDA-approved therapies devastating emotional impact. Patients with AA often experience currently in development to ensure appropriate patient access a variety of mental health issues related to their hair loss, such as and affordability when innovation becomes available. Coverage anxiety and depression.5 About 70% of patients reported that AA of future FDA-approved treatments will bring patients with AA had a marked impact on their self-esteem, an impact that did not stability and improved quality of life. 6 abate over time. Mortality risk associated with intentional Currently, a group of dermatologic conditions (acne, psoriasis, self-harm and psychiatric diseases is shown to be increased in and rosacea) are specifically listed as non-cosmetic by the 7 patients with AA compared to individuals without AA. Centers for Medicare & Medicaid Services for the purposes of Transitioning the view of AA is vital; thinking of AA as simply “hair Medicare Part D coverage. As a result, FDA-approved loss” diminishes the suffering of many with the disease and lessens treatments for these conditions are covered by Medicare. With the importance of providing coverage for treatment. Much of the several shared characteristics between AA and these non- public continues to incorrectly regard AA as a cosmetic or cosmetic, Medicare-covered dermatologic conditions, there is communicable disease. Many patients with AA experience no question that future FDA-approved treatments for AA should diminished health-related quality of life, but patients with AA often be covered by payers. report feeling that their concerns are dismissed.6 01 AmerisourceBergen I Xcenda Changing the Path Forward for AA Patients Innovative FDA-approved treatments for AA should be covered and deemed “medically necessary” by payers. There are actions payers and policymakers can take to change the trajectory of this condition by improving access to effective treatment, reducing costs, and managing this major life impact: 01 Update the Medicare Part D Drug manual to include 05 Ensure that cost-sharing is affordable for patients any future FDA-approved AA treatments as covered on a monthly and annual basis Part D drugs 06 Capture the medical and therapeutic advances for 02 Establish access and reimbursement for FDA-approved AA in physician-developed treatment guidelines treatments for AA as medically necessary once they become available 07 Support people with mental illness associated with AA in achieving access to affordable therapy to help 03 Avoid utilization management tools such as step manage the psychological impact of AA therapy and prior authorization that restrict patients’ access to preferred FDA-approved treatments 08 Identify any health disparities based on race or ethnicity and ensure health equality by delivering 04 Recognize the long-term nature of AA (hair grows personalized care through coverage and access to minimally every 2 months) and the potential for relapse treatments for AA when developing coverage and access guidelines 09 Involve a diverse range of participants in AA clinical trials References 1. Benigno M, Anastassopoulos KP, Mostaghimi A, et al. A large cross-sectional survey study of the prevalence of alopecia areata in the United States. Clin Cosmet Investig Dermatol. 2020;13:259-266. 2. Korta D, Christiano A, Bergfeld W, et al. Alopecia areata is a medical disease. Commentary. J Am Acad Dermatol. 2018;78(4):832-834. 3. Meah N, Wall D, York K, et al. The Alopecia Areata Consensus of Experts (ACE) study: Results of an international expert opinion on treatments for alopecia areata. J Am Acad Dermatol. 2020 Jul;83(1):123-130. 4. Hussain ST, Mostaghimi A, Barr PJ, Brown JR, Joyce C, Huang KP. Utilization of mental health resources and complementary and alternative therapies for alopecia areata: a U.S. survey. Int J Trichology. 2017;9(4):160-164. 5. Conic R, Miller B, Piliang M, Bergfeld W, Atanaskova Mesinkovska N. Comorbidities in patients with alopecia areata. Research letter. J Am Acad Dermatol. 2017;76(4):755-757. 6. Mesinkovska N, King B, Mirmirani P, Ko J, Cassella J. Burden of illness in alopecia areata: a cross-sectional online survey study. J Investig Dermatol Symp Proc. 2020;(20) S62-S68. 7. Burns LJ, Mesinkovska N, Kranz D, Ellison A, Senna MM. Cumulative life course impairment of alopecia areata. Int J Trichology. 2020;12(5):197-204. 8. National Alopecia Areata Foundation data on file [not yet published]. NAAF Survey: 2020. 9. Burge R, Anderson P, Austin J, et al. The patient-reported burden of alopecia areata by current severity: a real-world study in US. [unpublished abstract]. 2021. 10. Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015;8:397-403. 11. Centers for Medicare & Medicaid Services (CMS). Medicare Prescription Drug Benefit Manual: Chapter 6 – Part D drugs and formulary requirements. January 15, 2016. Accessed April 28, 2021. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf © 2021 AmerisourceBergen This work was done through support of Eli Lilly; editorial control was maintained by the authors. 02 AmerisourceBergen I Xcenda Alopecia Areata: A Disease That Extends Beyond Physical Manifestations Alopecia areata (AA) is a serious recurring autoimmune disease that affects all ages, both sexes, and all skin types.1 This is not simply a cosmetic issue. AA can also have a devastating physical and emotional impact. The converging physical and mental impact of AA often carries a lifetime burden, and when left untreated or undertreated, has a substantial cost for payers and patients. A significant unmet need exists to improve treatment strategies and the Alopecia areata is a recurring options available to people with AA. There are currently no Food and Drug autoimmune disease; it is not Administration (FDA)-approved treatments available for patients with AA— just several therapies used off-label to manage the condition. This makes it simply a cosmetic issue. difficult for healthcare providers to treat patients with AA effectively. The converging physical and Nearly 8 in 10 patients with AA report being unsatisfied with the current treatment options.2 Patients are commonly prescribed off-label treatments mental impact of AA often carries with limited effectiveness and often face relapse after treatment. a lifetime burden, and when left Additionally, despite advanced understanding of the autoimmune nature of the disease and the low quality of life (QoL) for patients, many insurers do untreated or undertreated, has a not consider treatment for AA to be medically necessary.1 As a result, substantial cost for payers and patients’ annual and lifetime out-of-pocket costs can be significant. patients. Expanding policymakers’ and payers’ view of AA is vital; thinking of AA as simply “hair loss” diminishes the suffering of many patients living with this disease and minimizes the importance of providing coverage for treatment. In fact, the FDA recognizes AA as a chronic autoimmune disease with a “debilitating emotional and psychological impact on patients
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