LAWLEY Pharmaceuticals has confirmed it will seek judicial review of the Pharmaceutical Benefits Advisory Committee (PBAC) decision to not recommend female-specific testosterone AndroFeme 1 for PBS listing (PD 12 Feb).
The testosterone cream was approved by the Therapeutic Goods Administration (TGA) in 2020 for the treatment of distressing low libido in postmenopausal women, medically termed hypoactive sexual desire dysfunction (HSDD).
With last week's publication of the public summary documents outlining the rationale for the PBAC's decision, Lawley's medical director Michael Buckley said he considered the PBAC's refusal to be "scientifically and logically flawed", and ultimately "inequitable to women".
"The PBAC provided no opposing science, no contrary safety data, no logic and not a shred of evidence to validate this negative decision," Buckley said.
"It's obviously not a pricing issue as we were requesting up to 75% less per day than what the PBS currently pays for some of the eight testosterone products on the PBS for men," he added.
An application for judicial review has been lodged with the Federal Court of Australia.
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