Shortages of hormone replace therapy (HRT) patches: PBS subsidy and substitution of Estradot, Estraderm MX and overseas alternatives The current shortages of HRT patches remain ongoing, with the shortage of some brands extended until December 2025. The shortages are due to manufacturing reasons or an increase in demand for alternate brands. For up-to-date information, please refer to the Therapeutic Goods Administration (TGA) website. To address the shortages, the TGA has approved the supply of overseas-registered alternatives under section 19A (s19A) of the Therapeutic Goods Act 1989 which allows medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply.

The Department of Health and Aged Care has temporarily listed on the PBS a number of
HRT patches approved under s19A. The table on the following page summarises the s19A HRT patches that are available on the PBS and whether substitution is allowed.

PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument (SSSI)
The Department has enabled pharmacists to substitute Estradot, Estraderm MX and s19A Estradiol Transdermal System (Sandoz, USA) patches under the PBS without needing a new prescription provided conditions are met in accordance with the TGA SSSI. At this time, the s19A Estramon is not included as a PBS substitute in the SSSI, due to the difference in pack size compared to Estradot and Estraderm MX. For full information on this PBS arrangement, please refer to the PBS website.

1 April 2025 designated brand list – minimum stockholding requirements
The 1 April 2025 designated brand list is available on the designated brand web page. The list includes a current and projected list of designated brands that are subject to the minimum stockholding requirements.

PBS Website Update
The Schedule of Pharmaceutical Benefits has been updated. New, Amended and Deleted items can be found on the Summary of Changes page.