The impact of drug reimbursement policy on rates of testosterone replacement therapy among older men.

Jolanta Piszczek,Muhammad Mamdani,Tony Antoniou,David N Juurlink,Tara Gomes,Barbara Mintzes

doi:10.1371/journal.pone.0098003

Abstract

BackgroundDespite a lack of data describing the long-term efficacy and safety of testosterone replacement therapy (TRT), prescribing of testosterone to older men has increased with the availability of topical formulations. The magnitude of this increase and the impact of formulary restrictions on testosterone prescribing are poorly characterized.MethodsWe conducted a time series analysis using the linked health administrative records of men aged 66 years or older in Ontario, Canada between January 1, 1997 and March 31, 2012. We used interventional autoregressive integrated moving average models to examine the impact of a restrictive drug reimbursement policy on testosterone prescribing and examined the demographic profile of men initiating testosterone in the final 2 years of the study period.ResultsA total of 28,477 men were dispensed testosterone over the study period. Overall testosterone prescribing declined 27.9% in the 6 months following the implementation of the restriction policy (9.5 to 6.9 men per 1000 eligible; p<0.01). However, the overall decrease was temporary and testosterone use exceeded pre-policy levels by the end of the study period (11.0 men per 1000 eligible), largely driven by prescriptions for topical testosterone (4.8 men per 1000 eligible). Only 6.3% of men who initiated testosterone had a documented diagnosis of hypogonadism, the main criteria for TRT reimbursement according to the new policy.ConclusionGovernment-imposed restrictions did not influence long-term prescribing of testosterone to older men. By 2012, approximately 1 in every 90 men aged 66 or older was being treated with TRT, most with topical formulations.

Highlights

Testosterone-replacement therapy (TRT) is increasingly prescribed to older men with non-specific symptoms attributed to agerelated declines in circulating testosterone levels. [1,2] A recent study of younger men with commercial health insurance showed that the rate of testosterone replacement therapy (TRT) use has increased 359% in the United States in the last decade
[3] This trend has occurred despite ongoing ambiguity surrounding the diagnosis of late-onset hypogonadism and the lack of high quality evidence demonstrating the long-term efficacy of TRT. [4,5,6,7] studies examining TRT are limited by short follow-up, [8,9] small sample sizes [9,10] and use the of surrogate outcomes such as changes in hormone levels, bone mineral density and measures of muscle strength. [11,12,13] the safety of extended TRT is poorly characterized, among older men with multiple comorbidities. [14]
We identified 292,307 prescriptions for all formulations of TRT prescribed to elderly men reimbursed by the government plan

Summary

Methods

Setting and Design We conducted a cross-sectional time series analysis examining changes in rates of use of testosterone products reimbursed by the provincial drug plan in Ontario, Canada, from January 1st, 1997 to March 31th, 2012. Identification of Patients We identified men aged 66 years or older who received at least one prescription for a testosterone product over the study period. Patient characteristics examined included general demographic information (age, location of residence, income) and cardiovascular conditions (hypertension, heart failure, acute coronary syndrome, stroke) in the previous 3 years, any past diabetes diagnosis, and the specialty of the physician who initiated the testosterone therapy. Statistical Analysis In the primary analysis, we conducted time series analysis using autoregressive integrated moving-average (ARIMA) models [23] to examine the impact of the restriction of public drug coverage of testosterone products in March 2006 on the quarterly prevalence of testosterone therapy. All analyses were conducted using the SAS software (version 9.2)

Results

Introduction