Topical Testosterone Therapy Adherence and Outcomes Among Men With Primary or Secondary Hypogonadism

Background: Men with primary or secondary hypogonadism (HG) prescribed testosterone therapy (TTh) who terminate treatment early might not obtain the benefit of symptom relief. Aim: To estimate adherence to topical TTh and to compare baseline characteristics and follow-up outcomes between adherent and non-adherent patients in a population of commercially insured US men with primary or secondary HG. Methods: A retrospective cohort of adult men with primary or secondary HG and initiating topical TTh from 2007 through 2014, with continuous coverage during 12-month baseline and follow-up periods, was identified from a large US health plan. Clinical conditions were assessed using International Classification of Diseases, 9th Revision, Clinical Modification codes. Adherence to initial topical TTh was defined as proportion of days covered of at least 80%. Characteristics and outcomes were compared across adherent and non-adherent patients. Outcomes: Adherence to topical TTh, occurrence of HG-related clinical outcomes, and total health care costs. Results: We identified 3,184 topical TTh initiators (mean age = 49 years), of whom 17% (n = 538) were adherent at 12 months. Factors positively associated with adherence included prescribing by specialists, a lower prevalence of certain comorbidities at baseline, residence in the Northeast, and an earlier start year of the topical TTh prescription. Adherence to topical TTh was associated with lower odds of having HG-associated clinical conditions (composite measure) over 12-month follow-up. In the subset of patients with available laboratory results, adherent patients had greater increases in testosterone levels compared with non-adherent patients. Increased pharmacy costs for adherent patients were partly offset by decreases in medical costs. Clinical Implications: Adherence to topical testosterone is low but associated with positive outcomes, demonstrating the need for future efforts to focus on improving adherence in this population. Strengths and Limitations: Strengths of this study include the large number of analyzed patients and the routine care (rather than interventional trial) setting, which maximizes generalizability within the source population. Limitations are primarily a result of reliance on medical claims data, which lack clinical context and are subject to potential coding errors. Certain factors of potential importance for adherence, such as patient and provider preferences, were not available in the dataset. The study analyzed commercially insured US patients and our ability to generalize these results to the entire US population or other countries might be limited. Conclusion: Study findings provide further evidence for suboptimal topical TTh adherence among men treated for primary or secondary HG. Adherence is associated with greater improvement in total testosterone laboratory values and might be associated with a lower likelihood of having certain HG-related conditions. Copyright (C) 2017, The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.