In order to allocate scarce resources effectively, reimbursement decisions for health technologies should be evidence-based. However, decision-makers are often confronted with the problem that study results are either not applicable to clinical routine or that high quality data is not available at all. Possible consequences of decisions under uncertainty could be high opportunity costs in terms of wasting limited resources or increased risks for patients.
The concept of Coverage with Evidence Development has already been employed in the USA, England and Australia. Despite differences in the terms used, the underlying principle is identical: Reimburse-ment of technologies is tied to the condition of further evidence generation. While providing an opportunity to influence study-designs and outcomes, decision-makers should be enabled to obtain data specifically tailored to meet their needs without restricting access to promising technologies.
Although the three countries investigated show substantial differences, similarities exist in terms of the appliance of Coverage with Evidence Development mostly for new or emerging technologies, the inclusion of evidence generated through a variety of study designs, as well as in the basic refusal of service providers to fund additional research. Further similarities include that several unresolved issues that seem to impact on the successful implementation of Coverage with Evidence Development. Some of the most important ones are questions concerning choice of the best study-design, identification of suitable technologies and of the best point in the life-cycle, consequences for industry and patients and foremost, assurance of funding for additional studies.
Although some differences can be found in the use of Coverage with Evidence Development in the USA, England and Australia, several common factors seem to determine the success of this decision-making tool. Suitable technologies and adequate study-designs should be identified in a clear and transparent process which includes all relevant stakeholders. If, additionally, appropriate funding mechanisms for further evidence generation are in place, Coverage with Evidence Development will prove a valuable means for reimbursement decisions.