IQWiG and LSE Authors Say EU Joint Clinical Assessments Could Become a Basis for US Price Talks
- To mark the first Joint Clinical Assessment under the EU HTA Regulation, Huseyin Naci of the London School of Economics and Beate Wieseler, head of drug assessment at Germany’s IQWiG, published a New England Journal of Medicine perspective on 26 September 2026. IQWiG publicised it on 28 September.
- Joint assessments run in parallel with EMA marketing authorisation, moving HTA earlier in a drug’s life. Wieseler said running approval and HTA together gives companies a greater incentive to run high-quality studies with relevant comparator arms from the start.
- The authors say patient access will still depend on national price negotiations, and that industry questions whether joint assessments will speed access. The answer depends on how far member states converge on the comparators they require.
- They argue joint assessments could be used outside Europe, including in the US, where no transparent process links clinical benefit to price and private payers already rely on bodies such as ICER.
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The piece is about who sets the evidence bar, and it lands the same week Germany’s health ministry proposed lowering it.
- Two German voices, opposite directions. IQWiG’s drug assessment head argues for strong comparative evidence from the outset; the health ministry’s AMNOG 2.0 key points would accept best-available evidence for five approval routes. Germany must give due consideration to joint assessments in its national process, so both standards will meet in the same dossiers.
- A US role would raise the stakes of the comparator choice. US prices already reference Europe: Lilly’s MFN basket includes France, Germany, Italy and Denmark. If US payers began citing joint assessments, Europe’s judgement of clinical benefit would travel alongside its prices, and the comparators chosen in Brussels would become a US pricing input.
- ICER shows how early benchmarks bite. This week the FDA approved AbbVie’s Juvmo with ICER’s value range already set before launch. A European assessment published at approval would give US payers a second independent anchor before any price is named.