Abstract

Isotretinoin treatment is cumbersome, especially for female patients, who must undergo monthly office visits, pregnancy tests, and labs within a strict time window. This study aims to evaluate the financial burden of iPLEDGE on female patients. The cost of treatment for females receiving isotretinoin from 2010-2020 at Children’s National Hospital was calculated using a standardized cost of Claravis 20 mg and office visit and laboratory test costs from the Centers for Medicare & Medicaid Services. The study included 71 patients. An estimated completed treatment course costs $3,657.78; 78% of costs were from isotretinoin, 18% from office visits, and 4% from labs. The average cost to complete treatment for females with and without missed windows was $3,082.50 and $2,138.79, respectively. In contrast, the expected cost for females should be $1,948.64. Missing treatment windows also extended treatment length by two months. The higher costs in the missed window cohort can be attributed to iPLEDGE requirements, such as additional follow-up visits and repeat pregnancy tests. Additional costs such as contraception and transportation were not included in the analysis, however, these are expected to increase the financial burden. Not only are females underprescribed isotretinoin, but they also face more barriers during treatment and incur higher costs than expected. These factors may result in decreased compliance and early termination of treatment. The iPLEDGE program cannot justify the significantly increased costs as it fails to prevent isotretinoin-related pregnancies; therefore, we advocate for reform to reduce the financial burden on patients.

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