Affordability | Payer's budget |
Therapy cost/price |
Therapy payment/reimbursement |
Assessment of value | Criteria |
Non-patient related health benefit |
Patient-related health benefits |
Development of therapy | Intellectual property |
Manufacturing |
Non-clinical |
Positioning |
Resources |
Ethical/social factors | Patient's convictions |
Patient's perception |
Socioeconomical |
Evidence generation | Trial design |
Trial conduct |
Trial outcomes |
Postauthorisation |
Operational implementation | Infrastructures |
Patient burden |
Healthcare professionals |
Regulatory hurdles | Marketing authorisation application process |
Quality standards |
Pricing regulations |
Parallel access |