New drug price regulation policy in the US and its impact on willingness to pay thresholds
Historically, prices for innovative drugs in the United States have been much more leniently regulated than in most other high-income countries. For a long time, the country lacked a unified national mechanism directly linking the price of a drug to its clinical and economic value.
An attempt to change this model was made back in 2020 year, when the US administration proposed implementing the MFN (Most-Favored-Nation) model for the Medicare Part B program. However, the initiative was stopped by the courts and subsequently withdrawn by the Centers for Medicare and Medicaid Services (CMS).
A new phase of policy began on May 12, 2025, when the White House issued an executive order
Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.
Its key idea is to bring prescription drug prices in the US in line with comparable developed countries, so that American patients do not pay more for their drugs than patients abroad.
MFN's policy involves the use of international price benchmarks. The following countries are considered as reference countries:
It is the prices in these healthcare systems that actually become the external reference point for the American pricing rate.
Practical implementation began in 2025–2026.
In July 2025, the White House announced measures to bring American prices in line with the best international prices, and on January 1, 2026 the five-year GENEROUS model for Medicaid was launched.
It assumes voluntary participation of states and manufacturers and provides for additional discounts on outpatient drugs.
However, this policy raises a deeper question:
If the US begins to focus on the prices of reference countries, does this mean that it is actually beginning to focus on lower willingness to pay thresholds?
For the analysis, 6,876 cost-per-QALY economic evaluations were examined from the Tufts CEA Registry (1979–2023):
All thresholds were converted to a comparable form - as a multiple of GDP per capita.
Main conclusion
The American scientific literature systematically uses higher willingness-to-pay thresholdsthan in countries that the administration considers price benchmarks.
The probability that a study uses a threshold greater than 1 GDP per capita was:
This means that US studies are significantly more likely to assume that the healthcare system can afford a higher level of spending for additional medical efficiency.
Distribution of Thresholds Used
MFN Countries
Furthermore, in MFN countries, there has been a shift toward stricter thresholds over time, while in the US, economic assessments across all periods more often use values above 1 GDP per capita.
After 2020, thresholds ≤1 GDP have already become predominant in MFN countries.
Why this matters
The publication shows that the new US policy may mean not only the import of lower drug prices, but also the import of stricter value chains benchmarks for health care systems.
If the United States begins to look to countries where economic evaluation uses lower willingness-to-pay thresholds, this may lead to a revision of the acceptable level of spending on additional medical efficiency.
The original publication can be found at:Health Affairs Scholar Cost-Effectiveness Thresholds Used in the United States versus Most Favored Nations
An attempt to change this model was made back in 2020 year, when the US administration proposed implementing the MFN (Most-Favored-Nation) model for the Medicare Part B program. However, the initiative was stopped by the courts and subsequently withdrawn by the Centers for Medicare and Medicaid Services (CMS).
A new phase of policy began on May 12, 2025, when the White House issued an executive order
Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.
Its key idea is to bring prescription drug prices in the US in line with comparable developed countries, so that American patients do not pay more for their drugs than patients abroad.
MFN's policy involves the use of international price benchmarks. The following countries are considered as reference countries:
- United Kingdom
- France
- Germany
- Italy
- Canada
- Japan
- Denmark
- Switzerland
It is the prices in these healthcare systems that actually become the external reference point for the American pricing rate.
Practical implementation began in 2025–2026.
In July 2025, the White House announced measures to bring American prices in line with the best international prices, and on January 1, 2026 the five-year GENEROUS model for Medicaid was launched.
It assumes voluntary participation of states and manufacturers and provides for additional discounts on outpatient drugs.
However, this policy raises a deeper question:
If the US begins to focus on the prices of reference countries, does this mean that it is actually beginning to focus on lower willingness to pay thresholds?
For the analysis, 6,876 cost-per-QALY economic evaluations were examined from the Tufts CEA Registry (1979–2023):
- 3,488 studies from the US
- 3,388 studies from MFN countries
All thresholds were converted to a comparable form - as a multiple of GDP per capita.
Main conclusion
The American scientific literature systematically uses higher willingness-to-pay thresholdsthan in countries that the administration considers price benchmarks.
The probability that a study uses a threshold greater than 1 GDP per capita was:
- 88.4% — US
- 68.3% — MFN countries
This means that US studies are significantly more likely to assume that the healthcare system can afford a higher level of spending for additional medical efficiency.
Distribution of Thresholds Used
MFN Countries
- 34.1% — ≤1 GDP
- 44.1% — 1–3 GDP
- 3.1% — >3 GDP
- 19.1% — ≤1 GDP
- 57.3% — 1–3 GDP
- 5.7% — >3 GDP
Furthermore, in MFN countries, there has been a shift toward stricter thresholds over time, while in the US, economic assessments across all periods more often use values above 1 GDP per capita.
After 2020, thresholds ≤1 GDP have already become predominant in MFN countries.
Why this matters
The publication shows that the new US policy may mean not only the import of lower drug prices, but also the import of stricter value chains benchmarks for health care systems.
If the United States begins to look to countries where economic evaluation uses lower willingness-to-pay thresholds, this may lead to a revision of the acceptable level of spending on additional medical efficiency.
The original publication can be found at:Health Affairs Scholar Cost-Effectiveness Thresholds Used in the United States versus Most Favored Nations
