Coverage and Reimbursement of Personalized Drugs
Franz Hessel,
Programme Director,
SRH University
Healthcare systems all over the world are facing an economic pressure due to an increasing demand for healthcare and limited financial resources. Beyond the proof of efficacy and safety for approval purposes third party payers' decision processes for financing health technologies - often described as ‘fourth hurdle’ - are present in many countries. For these reimbursement decisions real-life effectiveness and budget impact estimations are taken into consideration additionally.
Genetically stratifying, so-called personalized medicine approaches are more and more implemented in oncology as well as other medical disciplines. These approaches show an improved medical efficacy often combined with economic consequences.
This talk describes the challenges of the evaluation of personalized drugs for reimbursement decisions on pharmaceuticals and accompanying biomarker tests in selected countries such as US, UK and Germany and the challenges for drug as well as test manufacturers to successfully access the market of reimbursed technologies.
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