Syllabus
· Funding and organization of health care, focus on pharmaceuticals
· HTA (Health Technology Assessment) characteristics, definition
· Health economics and pharmacoeconomics
· Regulatory processes: marketing authorization vs. reimbursement and patient access
· Clinical evidence interpretation (clinical studies, meta-analyses, indirect comparisons)
· Evidence hierarchy, sources of evidence-base medicine
· Range of clinical outcomes: from surrogates to QALY (Quality-Adjusted Life-Year)
· Pharmacoeconomic modelling: reasons, approaches, methods
· Integrations of various evidence types (clinical, economic) in complex HTA report
· In practice lessons the abovementioned topics are discussed and exercised using real-world model examples in pharmacotherapy of osteoporosis and diabetes.
Annotation
The aim is to make students familiar with the complex evaluation of health interventions (technologies), namely drugs, concerning their relative/comparative efficacy, safety and cost-effectiveness. These aspects are integrated within HTA (Health Technology Assessment), which represents an important objective tool for fair and balanced definition and understanding of the added value of drugs (and health technologies in general).
In developed countries across the globe, HTA systems are commonly applied as a part of regulatory and decision-making processes, including pricing and reimbursement of health technologies and/or their inclusion and positioning in national formularies, guidelines, or therapeutic standards.
In the Czech Republic and other European countries the environment in terms of HTA development is under cultivation. The demand for knowledge and methods in this healthcare areas has been growing both at the site of public authorities (e.g. ministry of health, drug agency), 3rd party payers i.e. insurance funds, healthcare providers and healthcare (pharmaceutical, medical devices) industry.
The topics presented and discussed will focus on current HTA practices and they also follow-up on particular chapters taught in social pharmacy subject.