Pharmacy Daily | Pharma taking PBAC to court over knockback

PERTH-BASED Lawley Pharmaceuticals has lodged an application in the Federal Court of Australia seeking judicial review of the decision by the Pharmaceutical Benefits Advisory Committee (PBAC) in Nov 2025 to not recommend listing of AndroFeme 1, a transdermal testosterone cream formulated for post-menopausal women, on the PBS (PD 06 Jan).

The only female-specific formulation for hypoactive sexual desire dysfunction (HSDD) with marketing authorisation anywhere in the world, AndroFeme was registered in the Australian Register of Therapeutic Goods in Nov 2020 and is presently available as a private prescription.

Pointing out that men have access to several PBS-subsidised sexual dysfunction products, Lawley's founder, CEO and pharmacist, Michael Buckley, said: "This rejection means women will pay between 14 to 16 times more for treatment than their male counterparts pay for the treatment of similar sexual dysfunction conditions."

"This decision is an astounding rejection of the physical, mental and sexual needs of post-menopausal women," he added.

While the public summary documents for the PBAC's decision are not yet available, comments from the Nov 2025 PBAC meeting outcomes outline its concerns around safety and efficacy.

The PBAC considered the clinical evidence comparing testosterone with placebo presented in the submission was not strong, with trial participants not representative of the proposed PBS listing and inconsistent definitions of sexual dysfunction used.

The PBAC also noted that inappropriate use of testosterone is associated with adverse effects including the potential for androgenisation if testosterone levels are not carefully monitored.

"Overall, it considered the clinical data did not show that testosterone was more effective than placebo, or as safe, for the relevant patients."

Lawley said that the PBAC non-recommendation was affected by jurisdictional error because it made its decision in a procedurally unfair way, failed to have regard to a mandatory consideration under the National Health Act 1953 (Cth), and made a decision that involved irrational or unreasonable findings.

Lawley also contended that the PBAC failed to deal with a substantial, clearly articulated argument that the listing of AndroFeme 1 was required to redress inequitable access to sexual dysfunction products for women.

"To not challenge the decision would be tantamount to endorsing the PBAC's flawed approach and accepting that Australian women do not deserve cost-effective access to the kind of product that Australian men can obtain cheaply and easily," Buckley concluded. KB