Pharmacoepidemiology of testosterone: Curbing off-label prescribing

Abstract

The short-term impact of 2015 PBS criteria showed highly effective and well-targeted curbing of off-label testosterone prescribing. The findings indicate that the main driver for the recent upsurge in testosterone prescribing was treatment of middle-aged men for "Low T" initiated by GPs.

Pharmacoepidemiology of testosterone: Impact of reimbursement policy on curbing off‐label prescribing

“…The remarkable worldwide increase in testosterone prescribing over recent decades despite no new approved indications is well known 1,2 . Testosterone product sales increased 100‐fold over three decades to reach $US2 billion annually in the early 2010s 3 .…”

“…This included a 40‐fold increase in Canada and 10‐fold increases in USA of national testosterone usage per capita 3 . After a peak in 2013‐14, there is evidence that testosterone prescribing has started to fall in Australia 1 and in the USA 4 following concerns about cardiovascular safety and lack of efficacy data. These concerns led to regulatory curbs including FDA safety warnings and mandated label changes in 2014‐5 5 and tightening of Australian Pharmaceutical Benefits Scheme (PBS) criteria for subsidized testosterone prescribing in 2015 1 .…”

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

“…Prescribing of testosterone to males for low testosterone levels has significantly increased since 2000 in Australia. 3,4 Changes to the eligibility for subsidy were enacted in April 2015. Subsidy by the Australian Pharmaceutical Benefits (PBS) scheme now requires consultation with a specialist in the care of the patients.…”

“…5 Although there has been a reduction in PBS subsidised prescriptions, there has been a simultaneous approximately twofold increase in private prescriptions. 4,5 Testosterone is available in oral, injectable and transdermal preparations. However, the prescribing of transdermal products has increased sharply from mid-2000.…”

“…However, the prescribing of transdermal products has increased sharply from mid-2000. 4 Topical preparations of testosterone are commonly used due to their ease of application; they may be prescribed as compounded products, some containing higher levels of testosterone. However, what remains less appreciated is that topical testosterone can be transferred skin-to-skin causing signs of androgen excess with virilisation.…”