Cost-Effectiveness as Part of the German AMNOG Process Analyzing the 2025 SVR Proposal and Its Implementation Challenges
Author(s)
Stefan Walzer, MA, PhD1, Bjoern Schwander, BSc, MA, RN, PhD2, York Francis Zoellner, PhD3.
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2AHEAD GmbH, Bietigheim-Bissingen, Germany, 3Hamburg University of Applied Sciences, Hamburg, Germany.
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2AHEAD GmbH, Bietigheim-Bissingen, Germany, 3Hamburg University of Applied Sciences, Hamburg, Germany.
OBJECTIVES: The 2025 SVR (Council of Experts) report advocates the structured integration of cost-effectiveness analysis (CEA) into Germany’s early benefit assessment framework (“AMNOG process”), proposing routine use of cost-utility metrics across selected products. This shift aims to enhance pricing transparency and comparability, representing a potential paradigm change in a system traditionally focused solely on clinical benefit. The objective is to assess potential benefits and identify challenges related to the implementation of such proposal within the German context.
METHODS: A focused policy review was conducted based on Chapters 2 and 5 of the 2025 SVR report. Literature on HTA frameworks in other European markets (e.g., NICE, HAS, ZIN) was analyzed to extract implementation models. Barriers to integration within the German context—legal, methodological, and political—were identified through comparative institutional analysis.
RESULTS: The SVR recommends a “defined selection” of drugs be subject to CEA using indication-independent metrics, such as cost per QALY. While such approach could increase pricing consistency and international alignment, several implementation hurdles remain: (1) Germany lacks an official cost-effectiveness threshold; (2) there is institutional fragmentation between IQWiG (which can perform CEAs), G-BA (not part of added benefit assessment) and GKV-SV (does not use them for pricing); and (3) public and political resistance persists, due to concerns over rationing and equity.
CONCLUSIONS: Embedding CEA into AMNOG bears potential to enhance systematic value assessment, it requires methodological standardization, wider public debate (e.g. citizen council) and clear communication. A pilot-based, gradual introduction—limited to high-cost products or selected therapeutic areas—could be a feasible first step. Success will depend on political alignment and early stakeholder engagement to address ethical, technical, and institutional concerns.
METHODS: A focused policy review was conducted based on Chapters 2 and 5 of the 2025 SVR report. Literature on HTA frameworks in other European markets (e.g., NICE, HAS, ZIN) was analyzed to extract implementation models. Barriers to integration within the German context—legal, methodological, and political—were identified through comparative institutional analysis.
RESULTS: The SVR recommends a “defined selection” of drugs be subject to CEA using indication-independent metrics, such as cost per QALY. While such approach could increase pricing consistency and international alignment, several implementation hurdles remain: (1) Germany lacks an official cost-effectiveness threshold; (2) there is institutional fragmentation between IQWiG (which can perform CEAs), G-BA (not part of added benefit assessment) and GKV-SV (does not use them for pricing); and (3) public and political resistance persists, due to concerns over rationing and equity.
CONCLUSIONS: Embedding CEA into AMNOG bears potential to enhance systematic value assessment, it requires methodological standardization, wider public debate (e.g. citizen council) and clear communication. A pilot-based, gradual introduction—limited to high-cost products or selected therapeutic areas—could be a feasible first step. Success will depend on political alignment and early stakeholder engagement to address ethical, technical, and institutional concerns.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE227
Topic
Economic Evaluation, Health Policy & Regulatory