Evaluation of testosterone prior authorization and step therapy in the Department of Defense : costs, utilization, adherence, and persistence

Testosterone utilization rates have increased significantly in the last 10 years as demonstrated in the United Kingdom, Australia, United States, and by the US Department of Defense. Studies show that patients treated with testosterone may not be adherent or persistent, and exhibit patterns of restarting, switching, and cycling on testosterone therapy. These medication use behaviors may not be readily detected with traditional persistence measures. Managed care organizations and the Department of Defense responded to increased testosterone use by implementing prior authorization and step therapy programs in order to ensure safe, appropriate use of testosterone. Previous testosterone use studies failed to account for the widespread use of these utilization programs for testosterone products. The purpose of this study was to evaluate changes in testosterone costs, utilization, and medication use behavior before and after the March 1, 2013 implementation of prior authorization and step therapy programs by the Department of Defense. This study included adult men, 18 years of age or older, from the Department of Defense Military Health System who received testosterone (other than injectable or implant) any time from March 1, 2012 through February 28, 2014. Data were extracted from the Department of Defense Pharmacy Data Transaction Service. From March 1, 2012 to February 28, 2014, there were 78,623 patients in the Department of Defense using the included forms of testosterone. Of those patients, 26,464 (33.7%) had testosterone therapy only in the pre-index period, 18,111 (23.0%) had prescriptions only in the post-index period, while the remaining 34,048 (43.3%) patients had prescriptions both before and after implementation. Testosterone costs decreased by $27.5 million in the year following implementation of PA and ST programs. During the post-implementation year there were over 8,000 less patients started on testosterone treatments, and over 20,000 less testosterone prescriptions dispensed compared to the pre-intervention year. In the pre-PA/ST period, adherence (as measured by a medication possession ratio of 0.80 or greater) was 55.22%, and in the post-PA/ST period adherence was 53.46%. The percent of persistent patients using a 30-day gap, a 60-day gap and a gap of 1.5 times the previous days supply was calculated. In the pre-index period this rate was 64%, 75% and 58% respectively; similar to the rates in the post-index period (63%, 74% and 56% respectively). In the post-PA/ST period, 19.10% of patients switched products, 23.39% restarted therapy, and 18.60% of patients had cycles of therapy. When comparing only the 34,048 patients with prescriptions both before and after the PA/ST implementation, the mean gap period pre-index was 47 (SD 69) days but the gap at the point of implementation averaged 94 (SD 100) days (p <0.001). Post PA/ST costs were lower, adherence and persistence rates were similar (although statistically significantly different) between the two periods, but the gap in receiving treatment after the PA/ST was implemented may be cause for concern. This study adds to the existing testosterone use literature, specifically how prior authorization and step therapy programs influence testosterone use behaviors. The effectiveness and impact of testosterone benefit design will inform future Department of Defense formulary decisions and deepen understanding of testosterone use behaviors.