TABLE 1.

Published Reports Evaluating Incremental Benefit of New Drugs

Published	Author	Drugs	Years	Region	Findings
1991	Kaitin et al18	218	1978-1989	United States	15% rated “1A” (important therapeutic gain) by FDA
2002	Prescrire 19	2,100	1987-2001	France	3% “bravo” (0.3%) or “real advance” (2.8%)
2005	Morgan et al20	1,147	1990-2003	Canada	6% offered “substantial improvement” or were the first effective drug
2006	Motola et al21	176	1995-2004	Europe	31% offered “major benefit”
2010	van Luijn et al22	122	1995-2005	Europe	10% had evidence of statistically significant superiority
2012	Prescrire23	994	2002-2011	France	2% “bravo” (0.2%) or “real advance” (1.5%)
2018	Lexchin24	509	1995-2016	Canada	11% were therapeutically innovative
2019	Wieseler et al25	216	2011-2017	Germany	26% offered “major” (0.5%) or “considerable” (25.5%) added benefit
2019	Rodwin26	680a	2009-2016	France	5% offered “major” (1.6%) or “important” (3.9%) improvement
2021	DiStefano et al27	122	2018b	United States	15%-27% offered more than low added therapeutic benefit

^a Estimate based on disclosed average of 85.7 drugs per year.

^b DiStefano et al identified 122 “ultra-expensive” drugs based on Medicare Part D spending in 2018.

FDA = US Food and Drug Administration.