The value of medical devices caries with it less certainty than pharmaceuticals for a variety of reasons. As described in Kovács et al. (2022) medical devices:
often have multiple applications, frequently, undergo product modifications and during their product lifecycle, multiple incremental technological innovations take place affecting both clinical and economic consequences of their adoption into the clinical settings. In addition, their effectiveness usually depends not only on features of the device itself (e.g., reliability, accuracy), but also on features of their operators (e.g., on their skills and experience) and the institutional environment (e.g., size, availability of multidisciplinary teams) in which the device is used.”
There is even a large learning by doing literature on how medical devices and surgical procedures may improve over time as providers gain more experience with a medical device or a specific procedure type.
The clinical trial evidence for medical devices is also less robust as randomized controlled trials are not required, in part because it is not practical to have a blinded control arm for many medical devices.
A paper by Kovács et al. (2022) aims to create a framework for coverage with evidence development for Central and Eastern European countries. Central and Eastern Europe is an interesting context as most medical devices are first adopted in Western Europe and Central and Eastern European countries often have smaller budgets than those in Western Europe. In fact, the Kovacs paper notes 5 important differences between Westerns and Central/Eastern European countries in terms of MD HTA processes:
- Patients and governments have less financial resources in
- Health status is on average worse
- Reliance on public funding and provision of health care is predominant
- Pricing decisions are often “driven by principles and requirements of influential WE [Western European] countries”
- Human and financial resources for formal HTA processes are generally insufficient in the majority of CEE countries (Poland and Hungary are exceptions)
Despite these challenges, the Kovacs paper provides a number of recommendations for implementing coverage with evidence development (CED) for medical devices in Central and Eastern European countries. The authors reach these conclusions through structured interviews with 25 decision-makers from 22 European countries including 4 from Central and Eastern European countries (Bulgaria, Hungary, Poland, Slovakia).
The recommendations include collaborating with other countries (joint implementation), using another CED scheme structure and applying to their country, setting reimbursement decisions based on the results of another country’s CED decisions to inform their country, and using real-world data from another country’s CED to inform reimbursement decisions in their country. A summary of these recommendations are in the table below.
|Joint implementation of CED schemes|| • Collaboration of multiple centers in multiple countries and adherence to similar protocols for patient care need to be organized|
• Participating countries should agree on a set of common outcomes and data collection methods, complemented by local
• Use of shared database and joint analysis of data is advised,
while decision-making should remain at the national level
|Transferring the structure of an existing CED scheme and adjusting it to local context||• The transferability of a scheme, that is, the relevance of collected outcomes, the decision rule, the length of the CED scheme, the stopping rule and the feasibility of data collection should be assessed and adapted to the local context|
|Reimbursement decision is linked to outcomes from an ongoing CED scheme in another country||• The appropriateness of the design and timing of the scheme, and the accessibility of detailed data for applying it to conditional reimbursement locally, needs to be assessed|
• If patient level data are not directly accessible, the relevance of the outcome measure(s) collected and the decision rule in the local context must be assessed
• Locally relevant decision rules need to be developed and additional effect modifying factors need to be considered (differences in learning curve, patient population and organizational background)
|Real-world evidence from completed CED schemes in another country|| • The feasibility of transferring real-world evidence from early|
technology adopter countries need to be explored using a