Reimbursement Landscape in Europe
The purpose of this step is to understand the current reimbursement environment in Europe, relevant for your medical device. To do so, we will:
- Clarify the relevant type of coding systems and guidelines, applicable for the specific device or to any comparable products, issued on a national level or by regional health agencies, in each of the European countries. Clarify the reimbursement status in the reimbursement catalogs of supplementary health insurance providers.
- Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms.
- Identify the main decision makers, lay out the typical path towards obtaining national, regional or local reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in Europe.
Reimbursement Planning for European Decision Makers
According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for European decision makers, such as national payer organizations, health technology Assessment (HTA) entities and the ministries of health in each EU country. This includes the development of:
- Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers and would serve as the basis for the Economic Model.
- Economic Model: Highlights the economic benefits of the new device from the perspective of European decision makers. May identify specific outcomes data that should be added to future clinical study protocols.
- Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
- Decision Makers' Feedback: Conduct interviews with the identified European decision makers, utilizing Mediclever's network of local clinicians, payer representatives and other stakeholders, to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.
Implementation
Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:
- Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
- Reimbursement Applications: Work with the relevant medical societies, scientific research institutes and academic centers to apply for new reimbursement mechanisms, such as add-on funding on top of DRG rates, allocated budgets for specific technologies/devices or participation in national/regional innovation programs.
- Pilot Projects: Initiate pilot projects with regional health insurance companies, both public and private, to generate data relevant for their patient population.
- Other Funding Options: Apply for other or interim funding options such as grants, charity funds and specific interim reimbursement mechanisms.
