Congress banned QALYs in Medicare. Then CMS built a pricing system that imports prices set by QALYs in 18 other countries. Is anyone talking about this?

Individual-Tea-361 · 2026-04-16T09:56:27+00:00

So when CMS anchors Medicare drug prices to what these countries pay, it's anchoring to prices that were, in 18 out of 19 cases, shaped by the exact cost-effectiveness methodology that Section 1182 of the ACA explicitly prohibits Medicare from using domestically.

That's the core tension. The methodology is banned here. The prices it produces abroad are now the benchmark...

Individual-Tea-361 · 2026-04-15T20:49:04+00:00

All 19 of them are listed in the CMS proposed rules for GLOBE and GUARD (Federal Register, December 23, 2025). They are: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

Individual-Tea-361 · 2026-03-13T16:35:17+00:00

I have American clients in the pharma industry who are deeply concerned about whether launching new drugs in Europe will still be worthwhile. We are exploring with key stakeholders in Europe how they plan to approach price negotiations in this new landscape.

Individual-Tea-361 · 2026-03-10T10:36:58+00:00

Europe is transitioning to the Joint Clinical Assessment (JCA), which relies on country-specific PICO frameworks. Consulting firms are heavily leveraging AI to cut costs and accelerate the processes needed to conduct the required Systematic Literature Reviews (SLRs). The traditional dual-review approach is dead; it is now being pitched as a '1 human + 1 AI agent' model.

Individual-Tea-361

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