PBAC says NO!

The outcome of the November 2025 meeting of the Pharmaceuticals Benefits Advisory Committee (PBAC) has determined that AndroFeme® 1 testosterone cream for the treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women not be recommended for PBS listing. The PBAC Outcome statement can be viewed at the PBS website.

Lawley is very disappointed and aggrieved by the PBAC decision not to recommend the listing of AndroFeme^® 1 on the PBS and disagrees with the grounds on which the PBAC reached that decision.

Among other things, Lawley believes that the PBAC has strayed beyond its jurisdiction by inappropriately reevaluating matters of efficacy and safety that are properly within the statutory and policy remit of the Therapeutic Goods Administration (TGA). Many of the concerns expressed by the PBAC relate to clinical evidence which was extensively evaluated and accepted by the TGA (the body properly tasked to undertake that evaluation) when the product was approved for registration in the Australian Register of Therapeutic Goods for the precise indication of HSDD for which PBS listing is now being sought.

Lawley also believes that the PBAC’s economic analysis is fundamentally flawed and does not properly recognise the significant value of AndroFeme^® for postmenopausal Australian women who suffer from HSDD, who, unlike their male counterparts who have access to eight subsidised testosterone therapies, presently have no access to subsidised treatment for their condition.

Lawley presently intends to pursue all available options to overcome the PBAC’s recommendation to refuse PBS listing, including availing itself of the Department’s own Independent Review process and seeking judicial review of the decision in the Federal Court of Australia.