Drug Reimbursement Policy Impacts Testosterone Therapy Prescribing

Prescribing of testosterone to older men has increased with the availability of topical formulations; however, the magnitude of this increase and the impact of formulary restrictions on testosterone prescribing are poorly characterized. In a recent study spanning 15 years, researchers demonstrated a significant increase in the use of testosterone replacement therapy (TRT) over time, despite the lack of long-term efficacy and safety data in older men [PLoS One. 2014;9(7):e98003].

In the study, the researchers identified prescription records using the Ontario Drug Benefit database, which identifies prescription drugs dispensed to all Ontario residents ≥65 years of age. The researchers identified men ≥66 years of age who received at least 1 prescription for a testosterone product between January 1, 1997, and March 31, 2012. The researchers conducted a cross-section time series analysis of prevalent testosterone users in quarterly intervals during the study period. Each quarter, the researchers defined prevalent users as those who had filled a prescription for testosterone products, overall and stratified by formulation. All estimates were calculated as rates, adjusted per 1000 eligible older male adults.

In a secondary analysis, the researchers described the baseline characteristics of patients initiating testosterone therapy in the final 2 years of the study period. They focused on new users to avoid comparing men at different stages of illness, defining new users as those who had not received any other prescription for a testosterone product in the previous 365 days.

The researchers found that during the primary analysis spanning 183 months, 28,477 men ≥66 years of age were treated with testosterone therapy. During this time, the researchers identified 292,307 prescriptions for all formulations of TRT (oral, topical, and injected) prescribed to older men and reimbursed by the government plan. The rates of testosterone use increased steadily, rising 286% between 1997 and 2003 (from 3.6 to 10.2 men per 1000 eligible population), after which they reached a plateau of approximately 9.5 men per 1000 eligible population in 2004 and 2005.

Overall, testosterone prescribing declined 27.9% in the 6 months following the implementation of universal prescribing restrictions for TRT in 2006 (9.5 to 6.9 men per 1000 eligible; P<.01). The researchers noted that the overall decrease was temporary, and testosterone use exceeded pre-policy levels by the end of the study period (11 men per 1000 eligible), largely driven by prescriptions for topical testosterone (4.8 men per 1000 eligible).

Results of the secondary analysis identified 3718 men ≥66 years of age who initiated TRT between April 1, 2010, and March 31, 2012. Among this patient cohort, 20.9% (n=776) initiated injectable, 28.2% (n=1049) oral, and 50.9% (n=1893) topical TRT formulations.

Men using TRT had a multitude of comorbidities; 61.2% (n=2276) had a documented diagnosis of hypertension and 36% (n=1337) had a diagnosis of diabetes. Among the men who started TRT, only 6.3% had a documented
diagnosis of hypogonadism, the main criteria for TRT reimbursement according to the new reimbursement policy. Furthermore, although a family physician initiated TRT for most men, urologists were more likely to choose topical testosterone for new users compared with injectable and oral formulations (19.2% vs 15.1% and 6.6%, respectively).

The researchers acknowledged study limitations, including that the study’s data excluded patients <65 years of age who may also use TRT; therefore, the results may not be generalizable to the entire population of men in Ontario. Also, to predict TRT usage rates, the researchers’ model was fixed around the event of introducing prescribing restrictions. They noted that other factors they were unaware of could have contributed to the decrease of TRT use at the time of the 2006 policy change.

The researchers concluded that government-imposed restrictions did not influence long-term prescribing of testosterone to older men. By the end of the study period, approximately 1 in every 90 men ≥66 years of age were being treated with TRT, most with a topical formulation. “This is particularly concerning because these men carry significant burden of illness, and there is a paucity of data regarding long-term efficacy and safety of this drug among men with multiple comorbidities and high medication use,” the researchers said.—Eileen Koutnik-Fotopoulos