How could the shift in regulatory sequence affect Eli Lilly and Company's market access?
New regulatory sequence may alter pricing and market entry for Eli Lilly's products The procedural change, where Therapeutic Goods Administration (TGA) approval now precedes listing on the Pharmaceutical Benefits Scheme (PBS) for new medicines, alters the established pathway for market entry in Australia. Since the TGA is responsible for evaluating products and conducting price negotiations to determine market access, this shift changes the timing and structure of those negotiations. This could affect how quickly and under what financial terms Eli Lilly and Company can bring its therapeutic goods to the Australian market.
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How it reaches Eli Lilly and Company
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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.
The full event1independent outlet -
The TGA evaluates pharmaceutical products, including conducting price negotiations to determine market access in Australia. A change in the sequence of TGA approval and PBS listing alters the timing and structure of these critical negotiations for companies like Eli Lilly and Company.
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The facts so far
As reported. Each one links to where it comes from.
- TGA approval now precedes PBS listing for new medicines.illawarramercury.com.au
- The TGA evaluates Eli Lilly's products, including price negotiations, to determine market access in Australia.illawarramercury.com.au
- The federal government subsidises the cost of approved treatments listed on the PBS for eligible patients.illawarramercury.com.au
Why it matters
For Eli Lilly and Company, market access in Australia is heavily dependent on the TGA's evaluation and the subsequent PBS listing, which determines if the government will subsidise the cost of its products. Any structural change to this pathway, such as altering the sequence of approval and listing, directly impacts the company's operational timeline and the financial viability of its market entry strategy.
This process is standard for high-cost therapeutic goods in Australia, where the Pharmaceutical Benefits Advisory Committee (PBAC) recommends subsidisation based on clinical need and cost-effectiveness. The change in sequence means that the regulatory hurdle and the financial negotiation hurdle are now structured differently, affecting all pharmaceutical companies seeking Australian market access.
What we don't know yet
- How will the new sequence affect the timeline for price negotiations between the TGA and pharmaceutical companies?
- Will the change in sequence alter the criteria used by the PBAC when assessing the need for subsidisation?
What would change this answer
Reporting
- illawarramercury.com.auSunday
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Brind's analysis is written by AI from the reporting linked above and can be wrong. This explainer is a possibility worth considering, not a forecast: steps marked as Brind's reasoning are not stated in the reporting. It is not investment advice; do your own research.