Abstract
The objective of this study is to assess the acceptance of morbidity endpoints by the Institute for Quality and Efficiency in Healthcare (IQWiG) within the early benefit assessment in Germany. The analysis focuses on morbidity endpoints (ME) for oncology substances compared to non-oncology substances: (1) how many ME have been accepted? (2) In how many cases has IQWiG determined an additional benefit based on ME? All benefit assessments published by the Federal Joint Committee (G-BA) between 01/01/2011 and 11/01/2016 have been considered (n=158). Of those, 97 were excluded from the analysis due to one of the following reasons: orphan drug designation, no dossier submitted or incomplete evaluation by the IQWiG (due to missing data). Data analyzed: number of accepted ME as proportion of all submitted endpoints; additional benefit based on accepted ME; percent of assessments in which at least one ME was accepted. In total, 24 oncology and 37 non-oncology assessments have been included into the analysis. For the 24 oncology assessments, a total of 101 ME had been submitted. IQWiG accepted hereof 34 ME (≈34%). Accepted ME include: pain, skeletal-related complications, health state and symptoms. The IQWiG determined an additional benefit for ten assessments based on ME (10/24≈42%). For the 37 non-oncology assessments, 163 ME had been submitted. IQWiG accepted 106 (≈65%) including: strokes, cardiovascular events and relapse-related events. For non-oncology substances, IQWiG determined an additional benefit for 19 assessments based on ME (19/37≈51%). At least one endpoint was accepted in 88% of oncology assessments and in 100% of benefit assessments in all other indications. Though the rate of accepting ME in oncology indications is numerically lower (34% vs. 65%), the derivation of an additional benefit based on ME in oncology assessments is comparable (43% vs. 51%).
Published Version
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