Regulatory and Economic Aspects in Oncology
Book information
Description
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. Front Matter ....Pages i-vii Introduction and Overview (Evelyn Walter)....Pages 1-5 Cost of Cancer: Healthcare Expenditures and Economic Impact (Bengt Jönsson)....Pages 7-23 Oncology from an HTA and Health Economic Perspective (Clement Francois, Junwen Zhou, Michał Pochopien, Leila Achour, Mondher Toumi)....Pages 25-38 Heterogeneous Recommendations for Oncology Products Among Different HTA Systems: A Comparative Assessment (Szymon Jarosławski, Eve Hanna, Monique Dabbous, Lylia Chachoua, Mondher Toumi)....Pages 39-55 Patient-Reported Outcomes in Oncology, Beyond Randomized Controlled Trials (Mondher Toumi, Szymon Jarosławski, Christos Chouhaid, Bruno Fallissard, P. Auquier)....Pages 57-65 Patient-Reported Outcomes in Health Economic Decision-Making: A Changing Landscape in Oncology (Mandi Pratt-Chapman, Afsan Bhadelia)....Pages 67-83 Approaches to Capturing Value in Oncology (Evelyn Walter)....Pages 85-108 Orphan Drugs in Oncology (Daria Korchagina, Szymon Jaroslawski, Guy Jadot, Mondher Toumi)....Pages 109-142 Recent Developments in Health Economic Modelling of Cancer Therapies (William Green, Matthew Taylor)....Pages 143-151 Drug Pricing and Value in Oncology (Patricia M. Danzon)....Pages 153-167 Regulatory and Evidence Requirements and the Changing Landscape in Regulation for Marketing Authorisation (Francesco Pignatti, Elias Péan)....Pages 169-187 Prioritization not Rationing in Cancer Care (Nikolaus Knoepffler, Jürgen Zerth, Martin O’Malley)....Pages 189-205
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