Regulatory and Economic Aspects in Oncology

This book explores topics of importance to all who have an interest in economic methods for assessment of the efficacy and effectiveness of new cancer treatments and in regulatory measures relating to their marketing authorization and pricing. Targeted therapies and modern immunotherapy are placing a substantial strain on health care budgets. Regulation and economic methods to assess the parameters for establishing efficacy and effectiveness are therefore of prime importance. Payer authorities have to determine whether the use of these novel therapies yields clinical benefits that justify their increasing cost. In the simplest terms, cost-effectiveness analyses quantify the ratio between the extent to which an intervention raises healthcare costs and the extent to which it improves health outcomes. Rigorous cost-effectiveness analyses translate all health outcomes into quality-adjusted life years. On the other hand, in order to sustain innovation, price regulations must be coupled with efforts to ensure that drug companies are still able to recoup their investments in high-risk and high-costs research programs. Ultimately, decisions regarding health care expenditures are also a question of society-s willingness to pay.

Dr. Evelyn Walter has been head (and co-founder) of the Institute of Pharmaeconomic Research (IPF) in Vienna since 2003. The IPF's main areas include health economic evaluation, modeling, and expert advice on reimbursement decisions, pharmaceutical pricing and distribution. She first studied Mathematics at Vienna University of Technology, before switching to the Vienna University of Economic Sciences, where she completed a Master's and a doctorate in Economics. She has authored or co-authored some 60 publications, chiefly in refereed journals, and serves as a reviewer for several health economics journals. In Austria, she initiated the "Guidelines for Health Evaluation." She is a Member of the Scientific Advisory Board for the "System of Health Accounts" at Statistic Austria. As a member of ISPOR (the International Society of Pharmacoeconomics and outcome Research) she co-chaired the 17th and 18th Annual European Congresses. Dr. Walter is a Lecturer at the University of Applied Sciences in Burgenland, where she teaches courses on Health Economics, Health Technology Assessment and Pharma Management.

The growing health burden of cancer: a global epidemiological overview.-Cost of Cancer Care: Health expenditures and economic impact.- Innovation in R&D: An answer to cancer.- The Evaluation of Benefits, Harms and Costs of Cancer Screening.- Oncology from a HTA and health economic perspective.- Heterogeneous recommendations for oncology products among different HTA systems: a comparative assessment.- Outcomes in oncology: clinical vs. patient-reported outcome performance measures.- The value of patient-reported outcome in health economic decision making: a changing landscape in oncology.- Approaches to capture value in oncology.- Orphan durgs in oncology.- Recent developments in health economic modeling of cancer therapies.- Drug pricing and value in oncology.- Pharmaceutical price regulation of cancer treatments.- Regulatory and evidence requirements and the changing landscape in regulation for marketing authorization.- Looking for Willingness to Pay (WTP) Threshold for a QALY in oncology.- Equity and patient access to innovative cancer treatments.