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

PLoS One. 2014 Jul 16;9(7):e98003. doi: 10.1371/journal.pone.0098003. eCollection 2014.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Hormone Replacement Therapy / economics
  • Hormone Replacement Therapy / statistics & numerical data*
  • Humans
  • Insurance, Health, Reimbursement / economics*
  • Insurance, Health, Reimbursement / statistics & numerical data
  • Male
  • Models, Statistical
  • Off-Label Use / statistics & numerical data*
  • Ontario
  • Testosterone / therapeutic use*


  • Testosterone

Grant support

This study was supported by a grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC)Drug Innovation Fund and the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario MOHLTC. Tony Antoniou is funded by a post-doctoral fellowship from the Ontario HIV Treatment Network. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The opinions, results, and conclusions are those of the authors, and no endorsement by Ontario’s Ministry of Health and Long-term Care or by the Institute for Clinical Evaluative Sciences is intended or should be inferred.