Advice on market access strategy

Compilation of the (country-specific) reimbursement dossier

Development of risk sharing procedures and conditional reimbursement schemes (managed entry schemes)

Coordination and monitoring of applied reimbursement procedures and assessment of effectiveness of reimbursement measures. (includes the analysis of the pharmaceutical and health care costs and estimations of event impact)

•Feasibility analyses
• product characteristics
• product development
• the local market access environment (which recognises comparators, target population and value requirements), …

Description of reimbursement options and links to product reimbursement modalities

Mapping of a stakeholder environment (insurance companies, academia, members of the medical and pharmaceutical communities…)

Involvement at hearings in line with the recommendations of the reimbursement committee

Organisation of Delphi panels to obtain input for budget-impact analysis and cost-effectiveness models

Relative effectiveness assessments and health technology assessments – incorporating EUnetHTA recommendations

Integration of relative effectiveness elements in the clinical development plan