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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 11 Benefit, Efficiency, Reimbursement

SGB V, IQWiG, G-BA, GKV-SV, market access, RA & HTA, European developments

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 20 hours ca. 20 hours Study paper 3
Module leader
Prof. Dr. Eva Susanne Dietrich

Module contents

Introduction

  • Background
  • Overview of the legal basis

General methods of IQWiG

  • Patient-relevant medical benefit or harm
  • Specific methodological aspects of benefit assessments
  • Information procurement and assessment
  • Case studies

Dossier preparation and assessment

  • Dossier structure
  • Case studies

Benefit assessment by the Federal Joint Committee

  • Consultation in the context of the (early) benefit assessment
  • Decisions of the G-BA
  • Data collection accompanying the application
  • EU-HTA
  • Case studies

Pricing according to AMNOG

  • Framework agreement
  • Rebate negotiations, reimbursement amount
  • Arbitration board

Drug expenditure control according to the AMNOG

  • Rebate agreements, target agreements, pay-for-performance agreements, etc.

Further development of the organisation of cost-effectiveness and pricing of medicinal products

  • Targets and willingness to pay

Reimbursement of medicinal products

  • Organisation and basic principles of SHI
  • SHI control instruments for the supply of medicines
  • Case studies

Cost-benefit assessment

  • Legal framework
  • Cost-benefit assessment process
  • Methodological requirements for the cost-benefit assessment

EU-HTA

  • Legal basis
  • Status of the discussions
  • Interaction with AMNOG process
  • DiGA

Study plan

Part 1
Thursday 24.07.2025 von 14:00 - 18:45 Uhr Wissenschaftszentrum Bonn
Friday 25.07.2025 von 08:30 - 18:30 Uhr Wissenschaftszentrum Bonn
Saturday 26.07.2025 von 08:00 - 16:00 Uhr Wissenschaftszentrum Bonn
Submission of study paper Monday, 25.08.2025  

Lecturer

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Documents

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