Regulatory and Economic Aspects in Oncology. - Institute for Pharmaeconomic Research Vienna, Austria | Springer Nature Switzerland AG | 2019. - 205 Pages Includes References. - Recent Results in Cancer Research. .


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.

ISBN: 978-3-030-01206-9 978-3-030-01207-6 (eBook)

ISSN: 0080-0015 2197-6767 (electronic) = Regulatory and Economic Aspects in Oncology. additional benefit analysis approach approval ASCO benefit-risk cancer drugs cancer patients cell Chronic Clin Oncol Clinical and Economic clinical benefit clinical trials compared cost of cancer cost-effectiveness countries criteria decision decision-making drug prices economic evaluation effectiveness efficacy EMA endpoints erlotinib ESMO estimates ethical European Medicines Agency evidence extrapolation France G-BA Germany health economic health technology assessment healthcare expenditures HRQL HRQOL HTA ICER imatinib impact increase incremental cost-effectiveness ratio indication indirect costs interventions limited lung cancer marketing authorisation measures methods models Multiple myeloma NICE oncology oncology drugs orphan designation orphan drugs orphan medicinal products overall patient-reported outcomes payers perspective PFS pharmaceutical prioritization PROs QALY QoL quality-adjusted rare diseases recommended Regulation EC regulatory reimbursement relevant Renal cell carcinoma Slomiany specific studies Substantial/IV survival curves symptoms therapeutic Toumi toxicity treatment tumour USA value frameworks Value Health

LCCN: 2018957057

Subjects--Personal Names: --Medical / Administration, Medical / Clinical Medicine, Medical / Oncology / General, Oncology, Public health administration, Cancer -- Treatment -- Cost effectiveness -- Economic aspects -- Government policy, Health administration, Medical economics, Medicine -- Practice.