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. 2022 Jul;23(5):863-878.
doi: 10.1007/s10198-021-01400-2. Epub 2021 Nov 12.

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

Agnes Kisser  1 , Joschua Knieriemen  2 , Annette Fasan  3 , Karolin Eberle  4 , Sara Hogger  4 , Sebastian Werner  5 , Tina Taube  5 , Andrej Rasch  5
Affiliations

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

Agnes Kisser et al. Eur J Health Econ. 2022 Jul.

Abstract

Objective: The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value.

Methods: Identification of all pharmaceuticals undergoing both, EU JCA and German CA between January 2016-June 2020. Qualitative review and data extraction from the assessments, assessment of methodological differences using a hierarchical model. Recommendations for harmonisation were developed and consented with pharmaceutical industry stakeholders.

Results: Differences with potentially major impact: (1) View on differing treatment algorithms and definition of corresponding subpopulations/respective comparators. (2) Clinical relevance of surrogate/intermediate endpoints. Inclusion of different/surrogate morbidity endpoints resulting in different relative effectiveness conclusions. (3) Tolerance of study interventions not used according to marketing authorisation. (4) Different operationalisation and/or weighting of individual safety endpoints leading to differing relative safety conclusions. Differences with potentially minor impact: (1) Disagreement in risk of bias assessment for overall survival and its robustness against study limitations. (2) Use of patient-reported outcome symptom scales as measurements for health-related quality of life instruments.

Conclusion: While many synergies between EU JCA and German CA exist, we identified several aspects in HTA methodology that would benefit of harmonisation and ensure the transferability of future EU JCA to the German HTA process without duplicated evaluation requirements. For those, a set of recommendations was developed.

Keywords: Act on the Reform of the Market for Medicinal Products (AMNOG); EUnetHTA; Health technology assessment; Relative effectiveness assessment.

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Conflict of interest statement

Financial Interests: AK is Pfizer Employee, JK is AbbVie Employee, AMS received funding by LAWG and vfa.

Non-financial interests: None.

Figures

Fig. 1
Fig. 1
(a) The four decision-points during a clinical assessment. (b) The hierarchical approach of the analysis
See this image and copyright information in PMC

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