LFU:online

Students understand fundamentals of health-technology and pharmaco-economic evaluation of medicinal products, reimbursement by social security funds

• HTA: definition, history and development of HTA, overview of HTA process, key principles of HTA & HTA Framework, international and national HTA institutions, EU HTA regulation and its national implementation, HTA methods, basics in literature research for systematic reviews, GRADE from evidence to decision, Horizon Scanning, AdHopHTA, Impact of HTA, Innovation & HTA
• Legal basis - subsidiarity principle and transparency directive Healthcare systems in the EU
• Healthcare systems in the EU
• Organization (Bismarck/Beveridge/private)
• Decision-making
• Marketing authorization vs reimbursement
• Pharmacoeconomic evaluations: cost/benefit, cost/effectiveness, cost/utility, cost minimization
• Overview of pharmacoeconomic guidelines in the EU
• reimbursement policies: Pricing transparency, parallel trade, reference pricing and rebates, financial managed entry agreements, Outcome-based managed entry agreements
• Real-world evidence – methodology, use and pitfalls
• exercise: Application of the HTA core model and evaluation of pharmacoeconomic studies using checklists

lecture will provide important basics applied by students in a practical part to specific questions

active participation in practical course demonstrating understanding of theoretical principles and critical reasoning