The impact of 340B disruption on patients with autoimmune rheumatic diseases
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Patients with autoimmune inflammatory rheumatic diseases (AIRDs) rely on disease-modifying antirheumatic drugs (DMARDs) to manage disease progression. AIRD patients are often prescribed biologic DMARDs (bDMARDs), which increases the financial burden of treatment. Since 1992, qualifying covered entities, such as University Health and Lakewood Medical Center, have been eligible to purchase discounted drugs through the Federal 340B Drug Pricing Program. Originally, 340B pricing was restricted to in-house hospital pharmacies. In 1996, covered entities were permitted to contract with one outside pharmacy. This was expanded to any pharmacy starting in 2010, improving medication access. In 2023, major drug manufacturers reinstated pre-2010 requirements resulting in disruption to bDMARD access. The aim of this study is to characterize the AIRD patient population affected, determine impacts on patient outcomes, and quantify changes in healthcare utilization and spending. This is a retrospective within-subject study utilizing pharmacy and EHR data from University Health and Lakewood Medical Center. This study is IRB exempt. Included patients were >18 years old, who utilized the 340B program. These patients were seen in the rheumatology clinic in the 6 months prior to and post 340B policy reversal. Patients who established care less than 3 months prior to the disruption were excluded. EHR data was deidentified, stored in REDCap, and analyzed using IMB SPSS. Of 222 patients screened, 43 were included. Patients were mostly female (67%), white (67%), and enrolled in Medicare (47%). We uncovered a significant impact on patients’ 340B usage. On average, patients filled 75 fewer days’ supply of bDMARDs through the 340B program in the 6 months post disruption [95% CI (46, 109), p <0.001]. No increased use of rescue medications such as glucocorticoids (p = 0.25), NSAIDs (p = 1.0) and opiates (p = 0.39) or ER visits (p = 0.26) was observed. We found evidence to suggest that the sudden reinstatement of pre-2010 pharmacy requirements for 340B discounts had a negative effect on medication accessibility for patients with AIRD. Future directions include quantifying prescription costs for patients as a result of decreased 340B participation and the impact of medication disruption in primary care and other subspecialty clinics.
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Introduction -- Literature review -- Methods -- Results -- Discussion
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M.S. (Master of Science)