Market access – reimbursement / pricing

In the Europe as well as international market, the Health Technology Assessment (HTA) was designed to assess the health technologies impact based on the medical benefit, the risk for the patient and the economic management for the heath system.

The industrial development and the market access of a new medical device depends on many regulatory steps. As early as possible, steps should be prepared. This anticipation allows an appropriate strategy design to demonstrate the new device interest based on medical and economic arguments. Indeed, the understanding of the reimbursement / funding environment, specific for each device and market, is an crucial step in the market access.

The CE mark exigencies based on European Directives do not regulate the medical device market access issues in the European countries area. The reimbursement management remains a “national concern” for each country. Although most of the health system in Europe are moving on the care spending activities management, payment and/or reimbursement of a device, these health systems work more and more on the actual benefit assessment of a medical device.

 

AD-DM Consulting supports your market access and reimbursement projects, with the:

–        Development of a profound and customized Reimbursement Roadmaps including the coverage, coding, payment in key European markets

–        Review and identification of the Health Technology Assessment (HTA) expectations

–        Development and building of strong key opinion leaders and learned society relationships

–        Contribution of the clinical data planning, study design and clinical study management

–        Management of economic and budget impact modeling / value

–        Writing, proofreading and submission of the both medical and economic dossiers to the Healthcare Authorities

–        Pricing strategy and negotiation