Optimal Global Value of Information Trials: Better Aligning Manufacturer and Decision Maker Interests and Enabling Feasible Risk Sharing

• Published in: PharmacoEconomics Vol. 31; no. 5; pp. 393 - 401
• Main Authors: Eckermann, Simon, Willan, Andrew R.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing AG 01.05.2013; Adis International; Springer; Springer Nature B.V
• Subjects: Biological and medical sciences; Biomedical Technology - economics; Clinical trial. Drug monitoring; Clinical trials; Cooperative Behavior; Costs; Decision Making; Design; Diffusion of Innovation; Drug Industry - economics; Drug Industry - organization & administration; Economic aspects; Economy. Management; Ethics; Expected values; General pharmacology; Health Administration; Health and social institutions; Health care expenditures; Health care industry; Health Economics; Humans; Information sharing; Informed Consent; Jurisdiction; Medical sciences; Medical technology; Medicine; Medicine & Public Health; Methods; Opportunity costs; Pharmacoeconomics and Health Outcomes; Pharmacology. Drug treatments; Public Health; Public health. Hygiene; Public health. Hygiene-occupational medicine; Quality of Life Research; Randomized Controlled Trials as Topic - ethics; Randomized Controlled Trials as Topic - methods; Reimbursement; Research Design; Research Subjects - psychology; Review Article; Risk management; Risk sharing; Risk Sharing, Financial; Technology adoption; Translational Medical Research - economics; Translational Medical Research - organization & administration; Australia; United Kingdom > UK; Opportunity Cost; Risk Sharing; Relative Treatment Effect; Threshold Price; Local Trial; Jurisdiction; Decision maker; Sharing; Decision making; Health economy; Risk factor; Manufacturer; Clinical trial; Value of information; Public health; International
• DOI: 10.1007/s40273-013-0038-5
• ISSN: 1170-7690; 1179-2027

Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of their performance over time. Such arrangements rely on prospective information regarding the incremental net benefit of the new technology, and its use in practice. However, once the new technology has been adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of positive while uncertain incremental health and net monetary benefit. Informed patients in these cases would likely be reluctant to participate in a trial, preferring instead to receive the new technology with certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials. Consequently, efficiently designed global trials better align the interests of decision makers and manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local trials, up until the point that current evidence is globally sufficient.