Impact-Messung nationaler Gesundheitstechnologiebewertungen
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Rationale: Increasing costs of health technologies and scarce public funds have prompted public authorities in Austria, other European countries, and elsewhere to require Health Technology Assessments (HTAs), especially for innovative, high-cost medicines, prior to deciding on reimbursement for their use. HTAs are systematic evaluations of properties, effects and/or impacts of health care technology including medicines, medical devices but also organizational structures in which medical services are delivered. HTAs include medical, social, ethical and economic dimensions. In the last decade a trend towards the adoption of HTAs is noticeable. Even countries that traditionally did not require any assessments for reimbursement are moving towards cost-effectiveness analyses. However, it is not given that HTA reports are actually considered within the reimbursement decision process. Objectives: The overall objective of this proposal is to examine the combined effects of adoption of evidence-based decision-making (incl. HTA) and the levels of governmental involvement on funding decision of high-cost prescription medicines. In specific the study has three aims: 1) describe the evolution of national evidence-based reimbursement decision- making including HTA strategies in the four case study countries under the light of different governmental environments; 2) compare differences between the four case study countries with respect to procedural frameworks and aspects considered around uncertainties within the reimbursement decision-making processes on the example of four medicines; 3) determine the impact of evidence-based reimbursement decision-making (incl. HTA) and other factors (such as patent expiry) on pricing / managed entry access schemes. Methodology: On the example of four countries (Brazil, Germany, New Zealand and United States of America) I will evaluate the evolution of evidence-based decision making and different government involvement in funding decisions by performing a systematic literature search. Further, I will assess the decision making process on the example of four medicines in each of the four case study countries. For this purpose I will follow the analytical framework by van Herck (2013) and perform semi-structured interviews with different stakeholders in the case study countries. In a final step, I will look at the medicine price development of the four different medicines in the four case study countries. If possible, I will also consider claims data. It is of particular interest to understand if any new forms of funding such as managed entry agreements have been introduced for those medicines. Significance: To utilize HTA effectively in the Austrian healthcare system, policy makers need to know the impact of HTA. Learning from other countries experience in implementing evidence-based decision making especially for challenging questions such as very high cost medicines is of core interest and may benefit future funding decision-making in Austria.
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