Connect
MJA
MJA

Pharmacoepidemiology of testosterone prescribing in Australia, 1992–2010

David J Handelsman
Med J Aust 2012; 196 (10): 642-645. || doi: 10.5694/mja11.11277

Summary

Objective: To describe patterns of testosterone prescribing in Australia over the past two decades by state or territory and by product type.

Design and setting: Observational analysis of testosterone prescribing data obtained from two independent data sources — the Pharmaceutical Benefits Scheme (PBS) and IMS, a source of commercial pharmaceutical sales data.

Main outcome measures: Temporal trends in testosterone prescribing — measured as units prescribed (converted into monthly defined doses) and expenditure — according to state or territory and product type (injectable, implantable, transdermal and oral).

Results: Over two decades, total annual expenditure on testosterone products increased ninefold to $12.7 million according to PBS data and fivefold to $16.3 million according to IMS data. When adjusted for inflation and population growth, expenditure increased 4.5-fold according to PBS data and 2.5-fold according to IMS data. The patterns of testosterone prescribing according to PBS and IMS data were highly congruent. When converted into monthly defined dose units, testosterone prescribing increased over the two decades with approximately twofold differences in total testosterone prescribed per capita between the states and territories with the highest and lowest rates of prescribing. When analysed by product type, the stable market patterns over the first 15 years were disrupted by sharp changes to create market dominance owing to introduction of two new testosterone products — a depot injectable testosterone and a transdermal testosterone gel.

Conclusions: The progressive increase in PBS-subsidised testosterone prescribing without changes in proven medical indications or improvements in diagnosis of pathologically based androgen deficiency are likely to be due to promotion-driven non-compliance with PBS prescribing criteria, indicating that more effective implementation of the criteria is needed.

  • David J Handelsman

  • ANZAC Research Institute, University of Sydney, Sydney, NSW.

Correspondence: djh@anzac.edu.au

Acknowledgements: 

I am grateful to Chris Proctor and Nicole Sweetman (IMS) for providing access to IMS data and to Lam Ly for assisting with the data analysis.

Competing interests:

I have received investigator-initiated research funding for work not directly related to this study from all companies that have marketed testosterone products in Australia.

  • 1. Butenandt A, Hanisch G. [Uber die Umwandlung des Dehydroandrosterons in Androstenol-(17)-one-(3) (Testosterone); Umweg zur darstellung des testosterons aus Cholsterin (vorlauf mitteilung)] [German]. Zeischrift Physiologische Chemie 1935; 237: 89-97.
  • 2. David K, Dingmanse E, Freud J, et al. [Uber krystallinisches mannliches Hormon aus Hoden (Testosteron), wirksamer als aus Harn oder aus Cholestrin bereites Androsteron] [German]. Zeischrift Physiologische Chemie 1935; 233: 281-282.
  • 3. Ruzicka L, Wettstein A. [Uber die krystallische Herstellung des Testikelhormons, Testosteron (androsten-3-on-17-ol)] [German]. Helv Chim Acta 1935; 18: 1264-1275.
  • 4. Hamilton JB. Treatment of sexual underdevelopment with synthetic male hormone substance. Endocrinology 1937; 21: 649-654.
  • 5. Handelsman DJ. Androgen physiology, pharmacology and abuse. In: DeGroot LJ, Jameson JL, editors. Endocrinology. 6th ed. Philadelphia: Elsevier Saunders, 2010: 2469-2498.
  • 6. Handelsman DJ. Trends and regional differences in testosterone prescribing in Australia, 1991–2001. Med J Aust 2004; 181: 419-422.
  • 7. Fennell C, Sartorius G, Ly LP, et al. Randomized cross-over clinical trial of injectable vs. implantable depot testosterone for maintenance of testosterone replacement therapy in androgen deficient men. Clin Endocrinol (Oxf) 2010; 73: 102-109.
  • 8. Steidle C, Schwartz S, Jacoby K, et al. AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab 2003; 88: 2673-2681.
  • 9. McNicholas TA, Dean JD, Mulder H, et al. A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function. BJU Int 2003; 91: 69-74.
  • 10. Swerdloff RS, Wang C, Cunningham G, et al. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 2000; 85: 4500-4510.
  • 11. Wang C, Berman N, Longstreth JA, et al. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: application of gel at one site versus four sites: a General Clinical Research Center Study. J Clin Endocrinol Metab 2000; 85: 964-969.
  • 12. Handelsman DJ, Liu PY. Klinefelter’s syndrome — a microcosm of male reproductive health. J Clin Endocrinol Metab 2006; 91: 1220-1222.
  • 13. Herlihy AS, Halliday JL, Cock ML, McLachlan RI. The prevalence and diagnosis rates of Klinefelter syndrome: an Australian comparison. Med J Aust 2011; 194: 24-28.
  • 14. Liverman CT, Blazer DG, editors. Testosterone and aging: clinical research directions. Washington, DC: The National Academies Press, 2004. http://www.nap.edu/catalog.php?record_id=10852 (accessed Feb 2012).
  • 15. Conway AJ, Handelsman DJ, Lording DW, et al; Endocrine Society of Australia. Use, misuse and abuse of androgens. The Endocrine Society of Australia consensus guidelines for androgen prescribing. Med J Aust 2000; 172: 220-224. <MJA full text>
  • 16. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2006; 91: 1995-2010.
  • 17. Nieschlag E, Swerdloff R, Behre HM, et al. Investigation, treatment and monitoring of late-onset hypogonadism in males: ISA, ISSAM, and EAU recommendations. Int J Androl 2005; 28: 125-127.
  • 18. Bhasin S, Cunningham GR, Hayes FJ, et al; Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536-2559.
  • 19. Wang C, Nieschlag E, Swerdloff R, et al. Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA, and ASA recommendations. J Androl 2009; 30: 1-9.
  • 20. Wu FC, Tajar A, Beynon JM, et al; EMAS Group. Identification of late-onset hypogonadism in middle-aged and elderly men. N Engl J Med 2010; 363: 123-135.
  • 21. Handelsman DJ. An old emperor finds new clothing: rejuvenation in our time. Asian J Androl 2011; 13: 125-129.
  • 22. Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med 2010; 363: 109-122.
  • 23. Shabsigh R. Testosterone therapy in erectile dysfunction. Aging Male 2004; 7: 312-318.
  • 24. Buvat J, Lemaire A. Endocrine screening in 1,022 men with erectile dysfunction: clinical significance and cost-effective strategy. J Urol 1997; 158: 1764-1767.

Author

remove_circle_outline Delete Author
add_circle_outline Add Author

Comment
Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Responses are now closed for this article.