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
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
Prof. Dr. Eva Susanne Dietrich
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
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 |
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