New MFN deals raise the stakes for Australia’s delayed HTA reform

Four months after the US Trump administration concluded what was expected to be the final tranche of drug-pricing agreements with 17 of the industry’s biggest players, the most favoured nation (MFN) drug-pricing campaign has moved into its second phase.

At the negotiating table are companies with increasingly global footprints, extending well beyond the traditional U.S. and European pharmaceutical powerhouses. The latest cohort includes CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, UCB, Alcon, Astellas Pharma, BeOne Medicines and BridgeBio.

Broadly, the MFN campaign seeks to align U.S. prescription-drug prices with those paid by selected high-income comparator countries. The administration has been working toward MFN pricing by drawing on net prices paid in Australia, Canada, Denmark, France, Germany, Italy, Japan, Switzerland and the U.K.

The financial commitments attached to the latest agreements are substantial. Collectively, the nine companies have pledged at least $19.6 billion in near-term investment in U.S. drug development and manufacturing, taking the cumulative investment attached to MFN agreements to $668 billion.

For CSL, the agreement dovetails with a recently disclosed plan to invest $1.5 billion in expanding its manufacturing footprint near Chicago.

“These agreements provide a sustainable and stable access framework to important medicines for people living with rare diseases and serious conditions while strengthening the manufacturing capabilities, supply infrastructure and scientific innovation required to deliver those therapies reliably,” Diego Sacristan, CSL’s commercial chief, said in a statement.

A new analysis has documented a steep fall in new medicine launches over the past 12 months, adding fresh pressure to an already contentious debate over delays surrounding implementation of the Health Technology Assessment (HTA) Review.

Researchers examined pharmaceutical launches using an updated GlobalData extract, comparing product launches across two matched 12-month periods, from May 2024–2025 and May 2025–2026, across three cohorts.

The findings are difficult to dismiss as an isolated market fluctuation. New medicine launches declined across every reference cohort examined.

Within the 19-country GLOBE/GUARD basket, which includes Australia, launches fell by 30%. The decline was even sharper across 11 EU member states, where launches dropped 38%. By comparison, U.S. launches declined by 11% over the same period.

For Australia, the implications are particularly acute. The domestic market is confronting compounding reports of Pharmaceutical Benefits Scheme (PBS) negotiation withdrawals, alongside the removal of medicines that had previously secured reimbursement from established access pathways.

Negotiations on the Strategic Agreement between the government and Medicines Australia are continuing, placing the pharmaceutical sector under pressure to determine whether it can secure implementation of the HTA Review recommendations and whether those reforms can be delivered in a way that reconciles Australia’s domestic pricing architecture with the expectations created by the MFN regime.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.