PBAC's latest decision on Testosterone: Not recommended (2025). Considered for Treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women who have failed appropriate education and correction of modifiable biopsychosocial factors according to ISSWSH process of care.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
10
first 2011
Submissions
10
2011 → 2025
Eligible population
Postmenopausal women (naturally or surgically postmenopausal) aged 18 years or older with hypoactive sexual desire dysfunction (HSDD) that has failed appropriate education and correction of modifiable biopsychosocial factors according to ISSWSH process of care.
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Change in sexual interest and satisfaction
Pivotal trial size
34 patients
Key trials
El-Hage, 2007
Comparator
placebo
Economic model
Cost-minimisation
ICER note
No economic analysis was presented. A cost minimisation approach was proposed comparing price to existing PBS-listed testosterone 5% cream, but this was a cost comparison rather than an ICER.
Why PBAC said no
Reasons cited in the latest PSD: superior comparative effectiveness not adequately supported by clinical data, claim of non-inferior safety not adequately supported, lack of long-term safety data (trial only 2 years), high risk of use outside restriction in premenopausal women and those not meeting clinical criteria, no economic analysis presented
Submission history
Nov 2011: Deferred · Authority Required
Aug 2013: Recommended with restriction · Restricted
Jul 2014: Recommended with restriction · Authority Required
Mar 2015: Recommended · Authority Required
Mar 2015: Recommended · Authority Required
Jul 2015: Recommended with restriction · Restricted
Nov 2015: Noted · Restricted
Nov 2018: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required