A National Analysis of Temporal Changes in Prescribing of Testosterone Replacement Therapy Considering Methods of Delivery and Government Regulation

Abstract

Testosterone replacement therapy (TRT) is commonly used for various causes of androgen deficiency and subsidized by the Pharmaceutical Benefits Scheme (PBS) in Australia when appropriate. In response to a sharp increase in the prescribing of subsidized TRT, the Australian government instituted new, stricter prescription criteria in April 2015. We aim to demonstrate longitudinal changes in the prescription patterns of subsidized TRT over time. Materials and Methods: Materials and Methods: The publicly available PBS database was accessed for TRT prescription data between 1992-2018. Population estimate data was collected from the Australian Bureau of Statistics for population-adjustment. Data analysis was performed according to class and specific formulation of TRT. Total and population-adjusted trends were considered, as was indexation to 2015 when restrictions were implemented. Results: Results: Longitudinal trends in subsidized TRT prescription demonstrated a progressive overall increase since 2000, according to total prescriptions and population-adjusted estimates, with greater use of topical formulations (gel, patch, cream/spray) and injections. Since 2015, a 37% decline in total population-adjusted prescriptions was observed (1,399-883 per 100,000 persons). Since 2015, relatively increased use of injections (50%) and 1% gel (30%) comprise the majority of contemporary TRT. Annual financial burden due to TRT was $AU16,768 per 100,000 persons prior to 2000 (mean cost 1992-2000), increasing to $AU112,539 in 2018 (due to use of injections). The rate of change in costs slowed after the restrictions were introduced in 2015. Conclusions: Conclusions: The restrictions in subsidized TRT eligibility enforced by the PBS have reduced overall TRT prescriptions and slowed the cumulative financial burden.

Falsely elevated serum testosterone measurements resulting from testosterone topical gel contamination of the venipuncture site: Case Series and retrospective review

“…Testosterone therapy has increased worldwide in the last decade [ [1] , [2] , [3] , [4] ]. In the United States, testosterone formulations approved by the Food and Drug Administration (FDA) for testosterone replacement therapy (TRT) include intramuscular injections, transdermal patches, topical gels, implantable subcutaneous pellets, and buccal tablets [ [5] , [6] , [7] ].…”

“…In the United States, testosterone formulations approved by the Food and Drug Administration (FDA) for testosterone replacement therapy (TRT) include intramuscular injections, transdermal patches, topical gels, implantable subcutaneous pellets, and buccal tablets [ [5] , [6] , [7] ]. Oral administration of testosterone is limited by low bioavailability due to poor gastrointestinal absorption and extensive first pass metabolism [ [1] , [2] , [3] , [4] ]. Intramuscular testosterone cypionate or enanthate have extended duration of action and are relatively inexpensive compared to other testosterone formulations [ [5] , [6] , [7] ].…”

“…The use of TRT for treating symptoms of male hypogonadism has been rising in the United States and United Kingdom over the last decade [ [1] , [2] , [3] , [4] ]. Hypogonadism is estimated to affect one-third of men older than 45 years of age and between 30 and 50 % of men with obesity and/or type 2 diabetes mellitus [ [1] , [2] , [3] , [4] ].…”

“…The use of TRT for treating symptoms of male hypogonadism has been rising in the United States and United Kingdom over the last decade [ [1] , [2] , [3] , [4] ]. Hypogonadism is estimated to affect one-third of men older than 45 years of age and between 30 and 50 % of men with obesity and/or type 2 diabetes mellitus [ [1] , [2] , [3] , [4] ]. The diagnosis of hypogonadism is made in men with clinical symptoms and signs of testosterone deficiency (e.g., fatigue, low libido, loss of body hair, loss of muscle mass, erectile dysfunction) plus persistently low serum total testosterone and/or free testosterone concentrations [ 11 , 12 ].…”