Oral generic tacrolimus initiation and substitution in the Medicaid population: a new user cohort study

Objective: Although existing studies have compared clinical efficacy and pharmacokinetics of generic with brand tacrolimus, little is known about generic tacrolimus utilization patterns or factors predicting generic substitution. This study examines associations between patient-level factors and generic tacrolimus initiation or substitution among new users of oral generic or brand-name tacrolimus.

Methods: This new user retrospective cohort study identified 374 beneficiaries who initiated generic or brand tacrolimus treatment, using 100% Medicaid administrative claims data from 11 states in 2011-2012. Outcomes were generic tacrolimus initiation and substitution within 12 months of treatment initiation. Multivariable logistic regression and Cox proportional hazards models were used to identify factors associated with generic tacrolimus initiation and substitution.

Results: Two-thirds of oral tacrolimus new users initiated generic tacrolimus. Patients who were older age and black were significantly more likely to initiate generic tacrolimus (adjusted odds ratio [AOR] = 1.02, 95% confidence interval [CI] = 1.001-1.03; AOR = 2.54, 95% CI = 1.40-4.62; respectively). Patients with more concomitant prescriptions, more comorbidities, or higher initial daily dosage had significantly lower likelihoods of initiating generic tacrolimus (AOR = 0.93, 95% CI = 0.87-0.99; AOR = 0.87, 95% CI = 0.77-0.99; AOR = 0.96, 95% CI = 0.93-0.993). Among brand tacrolimus new users, 23.6% substituted with generics within 12 months, and an addition of prior hospitalization or unit of initial daily dosage increment was associated with 35% (subdistribution hazard ratio [SHR] = 1.35, 95% CI = 1.02-1.76) or 2% (SHR = 1.02, 95% CI = 1.00-1.04) increase in likelihood of generic substitution, respectively.

Conclusions: Understanding associations between patient-level factors with generic tacrolimus initiation and substitution could help practitioners and policymakers monitor treatment effect and facilitate generic tacrolimus utilization.