ABSTRACT
Payers are increasingly concerned about the continued growth in health-care costs globally, coupled with limited health-care resources. They are responding by taking active measures to control costs to assure that health-care budgets are allocated in a way to maximize health-care provisions. Presently, for new pharmaceutical products, payers are asking two related economic questions: (1) Does the new product represent good value, and (2) can they afford it? The first question can be addressed using cost-effectiveness analysis, whereas the question about affordability is approached by evaluating the budget impact of the new therapy on the health-care system. These are both important questions and directly influence the access that patients have to new medicines and vaccines. This interest is growing in a number of countries and is often referred to as the “fourth hurdle” for pharmaceutical
CONTENTS
25.1 Introduction .............................................................................................. 313 25.2 Evaluating Cost-Effectiveness ................................................................ 314 25.3 Multinational Health Economic Evaluation ......................................... 315
25.3.1 Generalizability and Transferability ....................................... 316 25.3.2 Heterogeneity ............................................................................. 316 25.3.3 Statistical Framework ................................................................ 317 25.3.4 Statistical Model ......................................................................... 318
25.4 Illustrations ............................................................................................... 320 25.4.1 Assessment of Treatment with Lisinopril and Survival ....... 320 25.4.2 Scandinavian Simvastatin Survival Study ............................. 322
25.5 Concluding Remarks ............................................................................... 325 References ............................................................................................................. 328
product market access, following safety, efficacy, and manufacturing quality. The purpose is to guide decision makers toward interventions that are likely to offer maximum health gain. A number of textbooks have been written on the general frameworks and methods for the economic evaluation of healthcare programs (Drummond et al. 1997; Drummond and McGuire 2001).
