TGA Approval Precedes PBS Listing for New Medicines
What happened
The Therapeutic Goods Administration approval now precedes listing on the Pharmaceutical Benefits Scheme for new medicines. For example, the drug teprotumumab, approved by the Therapeutic Goods Administration in 2025, has become the first treatment for thyroid eye disease available under the PBS, meaning the federal government subsidizes its cost for eligible patients. This drug is intended to help patients avoid intensive and expensive treatments.
Why it matters
The listing of teprotumumab on the PBS means the federal government subsidizes the cost of the treatment for eligible patients. This regulatory process, where TGA approval is a prerequisite for PBS listing, affects how new therapeutic goods gain market access in Australia.
Who's involved
- Therapeutic Goods AdministrationRegulatory body for therapeutic goods in Australia
- PBSPublic broadcaster and television network that lists subsidized medicines
- BioTechCompany that requires regulatory approval from the Therapeutic Goods Administration to commercialize its therapeutic goods
- Eli Lilly and CompanyAmerican pharmaceutical company whose products are evaluated by the Therapeutic Goods Administration
- Western AustraliaState of Australia where the Therapeutic Goods Administration enforces standards for medical devices
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Eli Lilly and CompanySpeculative
Eli Lilly and Company might see changes in price negotiations with the Therapeutic Goods Administration for its products.
Possible ripples
Who this could reach next, traced step by step from the reporting. Possibilities worth considering, not forecasts.Keep exploring
The entities involved
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Therapeutic Goods Administration
regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia