Impact Assessment of Health Technology Assessment policies

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.

The aim of my research is two folded: to provide evidence on the economic burden of cancer medicines for patients and society and to explore sustainable ways from a health systems perspective to fund medicines including the development of value measures. Through the Erwin Schroedinger Stipend by the Austrian Science Fund I was able to expand my research and provide evidence on the fact that all high-income countries are struggling with publicly funding medicines. Due to extra-ordinary drug price increases and an increased demand for medicines as a result of an aging population, health systems are confronted with the ethical challenge of setting priorities in health care. Decisions have to be taken on who will have access to which medicines at which price. In my research, I approached key decision makers in different high-income countries to understand their decision-making process. In another study, I focused on the US health care system, which is highly fragmented and based on mainly private health insurance. In this study, I was mainly interested to explore how the topic of high-drug prices has been discussed over the last 30 years as setting of drug prices is not allowed in the US. I could show that the problem of high-drug prices is more relevant today than it was before. This is mainly due to the fact that many more people are struggling to pay for healthcare. In another research, I focused on the assessment of the economic burden and the out-of-pocket spending of breast cancer medicines on privately insured patients in the US. On the one hand side, I could show that there are great disparities between African American women and Caucasian women with regard to time to death; and on the other side my study provided evidence that women are struggling to pay for their cancer medicines. Through this research, I became interested in understanding and comparing methods that aim at measuring the value of new cancer medicines. I compared different countrys approaches and it was interesting to find out that some countries involve patient preferences in their approach while other countries base their methods solely on evidence from clinical trials. Overall, this Erwin Schroedinger Stipend has enabled me to expand my research to gather more evidence on the (un)affordability of medicines in the US and in other high-income countries. The aim of my research is to take this evidence and to engage in dialogues with all stakeholders including patients, providers, payers, governments and pharmaceutical industry to find common solutions to this problem.