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

Pharmacoepidemiol Drug Saf. 2020 Sep;29(9):1030-1036. doi: 10.1002/pds.5080. Epub 2020 Aug 2.


Objectives: To estimate the impact on testosterone prescribing over 3 years following the 2015 tightening of Pharmaceutical Benefits Scheme (PBS) criteria.

Design: Analysis of testosterone prescribing data from PBS and private (non-PBS) sources between 2012 and 2018 covering 2015 change in PBS prescribing criteria.

Main outcome measures: New and total PBS testosterone prescriptions estimating usage by quarter analyzed by product type, patient age-group, indication and prescriber type. Total national testosterone prescriptions (private plus PBS) was verified from an independent data supplier (IQVIA).

Results: PBS usage peaked in 2014 declining by 30% in 2017-8 with PBS prescribing covering a fall from 97.6% by usage in 2014 to 74% in 2017-18 of all testosterone prescribing. The tighter 2015 PBS restrictions sustained the selective reduction in GP initiation of prescriptions for middle-aged men without pathological hypogonadism whereas specialist initiations and prescription for adult hypogonadism or pediatric/prepubertal indications were largely unaffected.

Conclusions: The tightening of PBS criteria from 1 April 2015 to curb off-label prescribing remained effective and selective over 3 years yet total national testosterone prescribing continued with little change, reflecting a shift to private prescriptions. The continuation of off-label testosterone prescribing for unproven indications suggests that long-term androgen dependence is created in men without pathological hypogonadism who commence testosterone. This highlights the need to avoid prescribing testosterone to men without pathological hypogonadism in the absence of sound evidence of efficacy and safety, the latter including the little unrecognized risks of long-term androgen dependency when trying to quit.

Keywords: androgen deficiency; hypogonadism; pharmacoepidemiology; prescription; testosterone.

MeSH terms

  • Adult
  • Age Factors
  • Australia
  • Child
  • Drug Prescriptions / economics
  • Drug Prescriptions / statistics & numerical data*
  • Health Policy / economics
  • Health Policy / legislation & jurisprudence
  • Humans
  • Hypogonadism / drug therapy
  • Insurance Benefits / economics
  • Insurance Benefits / legislation & jurisprudence*
  • Male
  • Middle Aged
  • Off-Label Use / economics*
  • Off-Label Use / legislation & jurisprudence
  • Off-Label Use / statistics & numerical data
  • Pharmacoepidemiology / statistics & numerical data
  • Reimbursement Mechanisms / economics
  • Reimbursement Mechanisms / legislation & jurisprudence*
  • Testosterone / economics*
  • Testosterone / therapeutic use


  • Testosterone