Background: Varenicline is a smoking cessation medication. Objectives: We analyzed patients' out-of-pocket costs and utilization of and persistence with varenicline. Methods: De-identified claims data in the MarketScan® Commercial Claims and Encounters Database were analyzed retrospectively. Participants were all patients at least 18 years of age continuously enrolled in plans during 2009. Plans were categorized according to restriction (no coverage; prior authorization; smoking cessation program requirement; no restrictions) and out-of-pocket cost for a 30-day supply (low: <US$12; medium: US$12-24.99; high: ≥US$25). The main outcome measures were utilization (defined as presence of a drug claim) and persistence (according to days' supply and number of days to discontinuation). Generalized linear models and time-to-event analyses were conducted. Results: There were 142,251, 458,966 and 222,241 individuals in the low, medium and high out-of-pocket cohorts, respectively. The reference group for all comparisons was the cohort with no access restrictions and low out-of-pocket costs. Higher out-of-pocket cost was associated with a lower likelihood of varenicline initiation for both the prior authorization (odds ratio [OR]=0.10, p<0.001) and smoking cessation program requirement (OR=0.19, p<0.001) groups, versus the no restriction cohort. Within the no access restriction cohort, subjects in the high out-of-pocket group were half as likely to complete a varenicline course versus the low out-of-pocket group (OR=0.47; p<0.002). Conversely, for the smoking cessation program requirement cohort, compared to the low out-of-pocket no restriction cohort, subjects who were in the high out-of-pocket group were more likely to complete a varenicline course (OR=0.70; p=0.13) than those in the low out-of-pocket group (OR=0.38; p=0.04). Conclusions: Higher varenicline out-of-pocket costs were generally associated with lower utilization of and persistence with treatment. These findings have implications for coverage policies in health plans and employers seeking to encourage smoking cessation.
Keywords: out-of-pocket; smoking cessation; utilization; varenicline.