Tuesday, 02 January 2024 12:17 GMT

Single-source drug launches in GLOBE/GUARD European reference markets fall 27% in first 17 months since MFN EO, reveals GlobalData


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(MENAFN- Cision) Some 27% fewer new pharmaceutical active ingredients (i.e. new single-source brands) were launched in the European reference markets under the GLOBE and GUARD MFN Medicare demonstration models in the 17 months after President Donald Trump published his Most Favored Nation (MFN) executive order (EO), compared to the prior 17-month period, according to the latest analysis of POLI data by GlobalData, a leading intelligence and productivity platform.
Over the same period, there were 17% fewer single-source brands launched in the countries the US plans to benchmark prices against under the voluntary GENEROUS MFN Medicaid model. Across European markets, new single-source drug launches dropped by 14%.
Alex Watt, Managing Analyst, Price Intelligence (POLI) at GlobalData and one of the stud’’s authors, comment“: “We first analyzed brand launch trends in Europe pre- and post-MFN EO in March and identified a worrying trend of European new active ingredient launch declines during the first 10 months following the MFN EO. We have now repeated the analysis to include a longer timeframe, comparing brand launch numbers in the 17 months since the MFN EO to the launches in the 17 months immediately preceding it. The results show the launch decline trend is sustained, although not as steep as it was in the first 10 months pos” EO.”
In March 2026, GlobalData reported a decline for single-source brands priced for the first time in its POLI database in the 10 months after MFN EO (12 Ma– 2025 – 12 March 2026) compared to the 10-month period preceding the EO. The decline was 43% for single-source presentations (39% by number of single-source brands) for the countries referenced under GLOBE and GUARD, 37% for presentations (36% for brands) for the countries referenced under GENEROUS, and 35% for presentations (32% for brands) for all European countries.
Milena Izmirlieva, Head of Health Economics and Market Access Research and Analysis at GlobalData, explains the difference in trend o“served: “The US MFN initiative, which is essentially international reference pricing (IRP), encourages companies to delay or forego launches in order the prevent referencing. In the first 10 months after the MFN EO, companies were reacting to an unpredictable US pricing policy, and the countries to be referenced by the US was confirmed for GENEROUS only in October 2025 and for GLOBE and GUARD - in December 2025.
“It is possible that companies were delaying launches more widely in the first 10 months due to the uncertainty. Once companies knew that launch of the MFN demonstration models was not imminent and that there were plenty of exemptions, launch delays have continued, but at a slightly more m”derate pace.”
As part of the POLI data analysis, GlobalData also examined drug withdrawals in Europe over the same time period. Watt explains“the findings: “The average number of brands with at least one presentation withdrawn was 26% higher during the 17-month period since the MFN EO than during the preceding 17-month period for Europe as a whole, and 9% higher in the countries whose prices will be referenced under GENEROUS. For the GLOBE and GUARD reference countries, there was a 2% decline in the number of brands experiencing withdrawals. The data indicates that while brand presentations continue to be withdrawn across Europe, withdrawal numbers are not higher in the countries whose prices the US plans to reference under GLOBE and GUARD over the 17-month review period because these two models are not yet in effect.”
GlobalData focused its analysis of launch and withdrawal trends on Europe because all countries referenced under GENEROUS and 14 of the 17 markets referenced in GLOBE and GUARD are in Europe*. As a result, the most significant adverse consequences of the MFN initiative are expected to be observed in Europe.
Izmirlieva continues“ “Companies are particularly likely to try to prevent referenc–ng – usually by delaying launches or withdrawing products from low-priced reference markets so that prices are not available for referencing. This is even more likely when a high-priced country, such as the US, references prices from countries with lower GDPs and wants to reference the lowest list price among them. It is very unusual for a high-priced market to reference the lowest price from a basket to lower-income countries, according to my research relying on Glob’lData’s detailed 75 IRP 360 profiles, which I presented at the ISPOR Europe conference in Novemb”r 2025.”
Izmirlieva c“ncludes: “GlobalData warned a year ago about the risk of launch delays and product withdrawals in Europe if the US went ahead with its MFN plans. Our data confirms that this risk has materialized and that launch delays have persisted over the first 17 months since”the MFN EO.”
GlobalData also conducted an analysis of the year-on-year (YoY) trend in Europe for single-source brand launches and withdrawals for the 12-month period after the MFN EO. The results of this analysis can be accessed on the GlobalData report store here: Tackling Drug Prices in the US (White Paper).
* The US references prices from Denmark, France, Germany, Italy, Switzerland, and the UK under the voluntary GENEROUS model for Medicaid drugs, which was launched in January 2026. The countries whose prices the US plans to reference under the mandatory GLOBE and GUARD models, which will apply to Medicare Part B and Medicare Pard D drugs, respectively, are Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the UK.

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