How to design the cost‐effectiveness appraisal process of new healthcare technologies to maximise population health : A conceptual framework

This paper presents a conceptual framework to analyse the design of the cost‐effectiveness appraisal process of new healthcare technologies. The frameworkcharacterises the appraisal processes as a diagnostic test aimed at identifyingcost‐effective (true positive) and non‐cost‐effective (true negative) technologies.Using the framework, factors that influence the value of operating an appraisalprocess, in terms of net gain to popula tion health, are identified. The frame-work is used to gain insight into current policy questions including (a) howrigorous the process should be, (b) who should have the burden of proof, and(c) how optimal design changes when allowing for appeals, price reductions,resubmissions, and re‐evaluations.The paper demonstrates that there is no one optimal appraisal process and theprocess should be adapted over time and to the specific technology underassessment. Optimal design depends on country‐specific features of (future)technologies, for example, effect, price, and size of the patient population,which might explain the difference in appraisal processes across countries. Itis shown that burden of pro of should be placed on the producers and that theimpact of price reductions and patient access schemes on the producer's pricesetting should be considered when designing the appraisal process