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

Abstract

Background: Despite 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.

Methods: We 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.

Results: A 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.

Conclusion: Government-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.

Figure 1. Rate of Testosterone Use per 1,000 Men Eligible for Public Drug Coverage and Aged 65 and older.

Figure 1 depicts a steady 286% increase in testosterone use between 1997 and 2003, and a subsequent plateau in 2004 and 2005. In early 2006, the introduction of universal prescribing restrictions for TRT led to a 27.9% drop in total user rates within a 6 month period, driven by the decline of oral (p<0.01) and injectable (p<0.01), but not topical testosterone use. However, after this initial drop, total TRT use started to increase again and by the end of the study period (March 2012) TRT rates had reached a historical peak of 11.0 men per 1000 eligible population. This increase was largely driven by the use of topical testosterone products, while rates of oral and injectable use each fell 32% and 35% respectively after the universal restriction policy was implemented and remained at this new low.