TestosteroneAndroderm
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.
Decisions on record
- Meeting Nov 2025 Not recommended Hypoactive sexual desire dysfunction in postmenopausal women
- Meeting Jul 2024 Noted Androgen deficiency no PSD
- Meeting Mar 2021 Recommended Testosterone deficiency
- Meeting Nov 2018 Recommended Androgen deficiency; Micropenis; Pubertal induction; Constitutional delay of growth or puberty
- Meeting Jul 2015 Recommended Androgen deficiency
- Meeting Mar 2015 Recommended Androgen deficiency
- Meeting Mar 2015 Recommended Androgen deficiency
- Meeting Mar 2012 Recommended Testosterone replacement therapy no PSD
1 earlier decision
- Nov 2011 Deferred Testosterone replacement therapy
Access path
- TGA registered · Androderm
TGA label narrower than the PBS population
- Nov 2011Recommended · restricted
vs testosterone transdermal gel
- Aug 2013Recommended · restricted
Evidence: RCT → Registry
- Jul 2014Recommended
Evidence: Registry → Other
- Mar 2015Recommended
Evidence: Other → Cost-minimisation
- Mar 2015Recommended
Evidence: Other → Cost-minimisation
- Jul 2015Recommended
Evidence: RCT → Other
- Nov 2015Noted
- Nov 2018Recommended · restricted
Evidence: Other → Single-arm
- Mar 2021Recommended
Comparator changed: testosterone 1% gel → testosterone 1% gel 50 mg
- Nov 2025Not recommended
superior comparative effectiveness not adequately supported by clinical data, claim of non-inferior safety not…
From the public summary
7.1 The PBAC did not recommend testosterone 1% cream for the treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women. The PBAC questioned the clinical place of testosterone in therapy, noting the difficulty in defining the medical condition and an appropriate scope of testosterone use.PSD · Nov 2025
7.2 The PBAC considered the primary reason for this outcome was due to the clinical evidence provided in the submission from the pivotal trial and the meta-analysis.PSD · Nov 2025
6.44 The submission did not present an economic analysis of testosterone against the proposed comparator of placebo.PSD · Nov 2025
6.45 The submission proposed a ‘cost minimisation approach’ (CMA) for the listing of testosterone 1% cream, comparing the price to an existing PBS listed product, testosterone 5% cream (AndroForte 5). The submission stated that this was based on the lowest cost per day that the government is willing to pay for male testosterone products, which it estimated as between $1.07 (for AndroForte 5) and $2.63 (for Testogel pump pack) per day.PSD · Nov 2025
6.40 The submission described testosterone 1% cream as superior in terms of effectiveness compared to placebo. The evaluation considered that this claim was not adequately supported by the evidence presented, because the only trial presented was small (N=36), used a higher dose (10 mg/day) than proposed (5 mg/day) for initial treatment, and enrolled only menopausal women who had undergone hysterectomy and did not meet the diagnostic criteria for the …PSD · Nov 2025
The PSCR stated that the TGA considered “the dosage recommendations were made on the basis of the totality of available evidence, i.e. that a 5 mg dose will deliver testosterone in female physiological concentrations in most patients, with 10 mg reserved for patients who remain symptomatic and have not exceeded female physiological levels of testosterone by more than 50% after a 12-week trial”.PSD · Nov 2025
6.3 The comments from consumers and health care professionals described a range of benefits of treatment with testosterone 1% cream including improved energy levels, mood, self-esteem and quality of life, improved relationship health, improved libido, wellbeing, bone and muscle health, enhanced cognition, reduced fatigue, and the potential for deprescribing of antidepressants and antipsychotics.PSD · Nov 2025
6.4 The PBAC noted that comments from AMS indicated that “the only evidence-based indication for the use of testosterone in women is for the treatment of HSDD” and that “other purported benefits reported in some social media outlets are without scientific basis”. The PBAC noted that the AMS supported an Authority Required (streamlined) listing.PSD · Nov 2025
Cost-effectiveness
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.
The PBAC noted that while some women may benefit from testosterone, it considered on balance that the claim of superior comparative effectiveness was not adequately supported by the data. PBAC · 2025
Decision context
PopulationPostmenopausal 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.
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Not recommended | placebo | — | RCT · Change in sexual interest and satisfaction |
| Mar 2021 | Recommended | testosterone 1% gel 50 mg | — | Cost-minimisation · Cost-minimisation |
| Nov 2018 | Recommended · restricted | testosterone 1% gel | — | Single-arm · Surrogate |
| Nov 2015 | Noted | — | — | Other |
| Jul 2015 | Recommended | — | — | Other |
| Mar 2015 | Recommended | testosterone 1% gel sachets | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Recommended | testosterone 1% gel (Testogel) | — | RCT · Surrogate |
| Jul 2014 | Recommended | — | — | Other |
| Aug 2013 | Recommended · restricted | — | — | Registry |
| Nov 2011 | Recommended · restricted | testosterone transdermal gel | — | RCT · QoL | other (serum total testosterone within the normal range) |
Consumer voice
Consumer and healthcare professional input described multiple benefits of testosterone 1% cream including improved energy, mood, libido and quality of life, though some commenters raised concerns about off-label use, cost barriers, and safety risks in younger populations. Organisations were divided, with some supporting listing for HSDD with safeguards while others opposed broader access.
the only evidence-based indication for the use of testosterone in women is for the treatment of HSDD Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to postmenopausal women who have failed appropriate education and correction of modifiable biopsychosocial factors per ISSWSH.