Impact of co-pay assistance on patient, clinical, and economic outcomes.

OBJECTIVES: Patient assistance programs (eg, co-pay assistance) may reduce patients' out-of-pocket costs for prescription medicines, providing financial assistance to access medicines for reduced or no cost. A literature review to identify peer-reviewed articles on studies evaluating the impact of co-pay assistance on clinical, patient, and economic outcomes was conducted. STUDY DESIGN: A literature review was conducted by searching Embase and MEDLINE. METHODS: The population of interest was patients who had received co-pay assistance; the intervention was co-pay assistance; comparator was no co-pay assistance; and outcomes were treatment adherence, compliance, discontinuation, interruption, barriers to adherence, and specific therapeutic outcomes. Articles from the United States published between January 2015 and June 2021 were included. RESULTS: A total of 1249 initial articles were identified, of which 19 published articles representing 12 studies were included. Most studies were retrospective claims analyses (n = 10); there was also 1 randomized controlled trial and 1 prospective and observational study. One article assessed the association between co-pay assistance and patient-reported outcomes, 7 explored the relationship between co-pay assistance and clinical outcomes, and 6 assessed the impact of policy/program changes on co-pay assistance. Co-pay assistance was associated with improved treatment persistence/adherence across various diseases, with limited indirect evidence of this translating into clinical outcomes improvements. Lack of long-term outcomes and uncertainty around program sustainment from co-pay assistance programs are limitations. CONCLUSIONS: Limited evidence suggests a potential link between co-pay assistance and clinical outcomes; future research addressing study design challenges in measuring the effects of co-pay assistance is needed.