Medication Adherence and Treatment Patterns for Hypogonadal
Patients Treated with Topical Testosterone Therapy: A Retrospective Medical Claims Analysis
Michael Jay Schoenfeld, MA, Emily Shortridge, PhD, Zhanglin Cui, PhD, and David Muram, MD
Eli Lilly and Company, Indianapolis, IN, USA DOI: 10.1111/jsm.12114
A B S T R A C T
Introduction. There is limited information on adherence to topical testosterone replacement therapy (TRT) among hypogonadal men.
Aim. To determine adherence rates among men treated with topical testosterone gels and to examine factors that may inﬂuence adherence, including age, presence of a speciﬁc diagnosis, and index dose.
Methods. Included were 15,435 hypogonadal men, from the Thomson Reuters MarketScan® Database, who had an initial topical testosterone prescription in 2009 and who were followed for 12 months.
Main Outcome Measures. Adherence to testosterone was measured by medication possession ratio (MPR), with high adherence deﬁned as >0.8. Persistence was deﬁned as the duration of therapy from the index date to the earliest of the following events: end date of the last prescription, date of the ﬁrst gap of >30 days between prescriptions, or end of the study period (12 months).
Results. Adherence to topical TRT was low. By 6 months, only 34.7% of patients had continued on medication; at 12 months, only 15.4%. Adherence rates were numerically similar among men who received AndroGel® or Testim® topical gels and did not differ among men of different age groups. Approximately 80% of patients initiated at the recommended dose of 50 mg/day. Over time, an increased proportion of men used a higher dose. This change was the result of dose escalation, rather than of greater adherence among men initiating therapy at a high dose. Dose escalation was seen as early as 1 month into therapy. Approximately 50% of men who discontinued treatment resumed therapy; most men used the same medication and dose.
Conclusions. Discontinuation rates are high among hypogonadal men treated with testosterone gels, irrespective of their age, diagnosis, and index dose. Further study, evaluating other measurable factors associated with low adherence among patients receiving topical TRT, may lead to interventions designed to improve adherence with therapy.
About 50% of patients who were followed over time resumed TRT. It is possible that some patients experienced alleviation of symptoms and were not sure they needed to remain on therapy. Once therapy was discontinued and symptoms recurred in some patients, the beneﬁts of replacement therapy may have become clearer; thus, prompting these men to restart therapy at the same effective dose.
An important limitation of the study is that claims data do not include important patient level data, such as symptoms, reasons for discontinuation (e.g., application method), side effects (e.g., skin reaction), testosterone levels, responses to therapy, and so forth. While perception of efﬁcacy has signiﬁcant effect on patient adherence, this study was unable to assess severity of symptoms or of symptomatic relief, once patients initiated therapy.
The study was unable to identify characteristics that were associated with the time patients would be on therapy before treatment was interrupted or who would resume therapy after a brief interruption. Most patients who resumed therapy did so by using the same topical TRT agent and the same dose they used prior to the interruption. It is possible that these patients perceived efﬁcacy, were proﬁcient in the application method, and possibly had a prescription that they were able to use or reﬁll without the need for an ofﬁce visit. Only a small percentage of patients using topical therapy resumed therapy by using a different method or a change in the dosing regimen.
Patients on testosterone should have their blood levels and symptoms evaluated after a few weeks on therapy. Depending on these follow up results, dose adjustment or change of delivery method should be explored as well as other issues that may potentially affect efficacy and adherence (life style, other medications, body mass index, etc). Expectations should also be clearly described at the start of therapy (for more on what to expect, read this ) so that patients have realistic views. Stamina and sexual function are multifactorial and testosterone blood levels are only part of the puzzle.