Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development
- 22 March 2010
- journal article
- review article
- Published by Wiley in British Journal of Pharmacology
- Vol. 159 (7), 1367-1373
- https://doi.org/10.1111/j.1476-5381.2009.00550.x
Abstract
The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals.Keywords
This publication has 11 references indexed in Scilit:
- Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force ReportValue in Health, 2007
- Cost-effectiveness as an outcome in randomized clinical trialsClinical Trials, 2006
- Analysis Sans Fronti??resPharmacoEconomics, 2006
- Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force ReportValue in Health, 2005
- Collection of Health-Economic Data Alongside Clinical Trials: Is There a Future for Piggyback Evaluations?Value in Health, 2005
- How Much Should Medicare Pay For Drugs?Health Affairs, 2004
- Investment decisions in pharmaceutical R&D projectsDrug Discovery Today, 2003
- Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices—Modeling StudiesValue in Health, 2003
- Cost-Effectiveness League TablesPharmacoEconomics, 2003
- Oregon: The Ups and Downs of Oregon's Rationing PlanHealth Affairs, 1993