Multinational Health Panel Challenges Recent Change in How Drug Benefit Is Measured in Germany

Published Aug 31, 2022

Report From ISPOR Clinical Outcome Assessment Special Interest Group

Lawrenceville, NJ, USA—August 31, 2022—Value in Health, the official journal of ISPOR—The Professional Society for Health Economics and Outcomes Research, announced today the publication of a new report from the ISPOR Clinical Outcome Assessment Special Interest Group. The new report cautioned the universal applicability of a recent change by German health technology assessment organization, IQWiG, (Institute for Quality and Efficiency in Health Care), regarding the process of assessing the added benefit of drug interventions. The report, “Is IQWiG’s 15% Threshold Universally Applicable in Assessing the Clinical Relevance of Patient-Reported Outcomes Changes? An ISPOR Special Interest Group Report,” was published in the September 2022 issue of Value in Health.

IQWIG is universally adopting a response threshold of ≥15% of the PRO scale range to assess the clinical relevance of patient-reported outcomes (PROs). “Specifically, patients who report a 15% or greater change in PRO scores are considered responders (meaningful change perceived), and patients not meeting the 15% threshold are considered non-responders (non-meaningful change perceived) for benefit assessment. The authors of this ISPOR report believe that this ≥15% response threshold is incongruent with previously defined and scientifically established thresholds and that PRO scores should be evaluated on a case-by-case basis, rather than using a universal response threshold.

“Validated, established response thresholds are useful and valuable to enhance the transferability of risk/benefit assessments based on PRO measures to assess relative effectiveness for health technology assessment (HTA). They ensure consistent interpretation of PRO effects,” said senior author, Olivier Chassany, PhD, MD, Professor, Assistance Publique–Hôpitaux de Paris, France. “The "15% of the scale" rule certainly eases the review of dossiers for HTA assessors, but I am not sure that this unique threshold applied indiscriminately of the context means something to patients,” said Chassany.

The IQWIG action has already had consequences. The German Federal Joint Committee (G-BA) is the central decision-making body that issues binding directives to ensure the quality of both inpatient and outpatient healthcare services within the German Statutory Health Insurance system. Following the recommendation from IQWiG, it adopted the methodological change in assessing the additional benefit of drug intervention.   

This change also has implications for both clinical and joint clinical assessments in HTA. IQWIG and G-BA are part of the European Network for Health Technology Assessment (EUnetHTA) consortium. “This report is extremely timely. The EUnetHTA-21 guidelines on joint clinical assessment and clinical assessment of endpoints used for relative effectiveness assessment (D4.4 project plan) will be out for public comment in October,” said Chassany.



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2021 impact factor score is 5.101 and its 5-year impact factor score is 6.747. Value in Health is ranked 5th of 87 journals in health policy and services, 7th of 102 journals in healthcare sciences and services, and 19th of 371 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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