Impact of a Mandated Change in Buprenorphine Formulation.

Objective: This study examines the impact of an insurance-mandated change in formulation of buprenorphine/naloxone (BNX) for patients with opioid use disorder treated in a primary care clinic.

Methods: A retrospective cohort study was conducted to determine the proportion of patients who were switched back to the previous BNX formulation and rates of aberrant urine drug tests for the 3 months before and 3 months after a mandated change in BNX from the sublingual film to the rapidly dissolving tablet (BNX-RDT). Aberrant urine drug tests were defined as the presence of cocaine, nonprescribed opioids/benzodiazepines, or the absence of buprenorphine.

Results: In all, 186 patients were included in the analysis. At 3 months after the change, 36.0% of patients remained on BNX-RDT at equivalent dose, 9.1% were prescribed a higher dose of BNX-RDT, 52.7% were switched back to their previous formulation after a trial of BNX-RDT, and 2.2% dropped out of care. There was no significant change in the rates of aberrant urine drug tests pre and postchange (36.6% vs 33.7%; P = 0.27) or in any individual component of urine drug testing. Age, sex, and starting dose were not associated with remaining on BNX-RDT at equivalent dose, compared with increasing dose or changing formulation.

Conclusions: Most patients were dissatisfied with the change in formulation and requested a return to the previous formulation. This change did not appear to impact drug use; however, the flexibility that permitted patients to switch back to their previous BNX formulation likely attenuated the policy's impact.