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The role of real-world evidence in health technology assessment decision-making: harmonization of standards and evaluation of effective frameworks for reimbursement decisions a systematic literature review
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This study examines how international HTA bodies harmonize evidence requirements for Real World Evidence (RWE) and identifies effective methodologies for reimbursement decisions. By comparing leading European agencies (NICE, HAS, IQWiG), it highlights discrepancies in RWE acceptance, patient involvement, and economic evaluations. Through case studies in oncology approvals and cost-effectiveness analyses, findings emphasize the need for standardized criteria, transparency, and structured frameworks like Managed Entry Agreements (MEA). This research contributes to the broader thesis by advocating for global harmonization to enhance healthcare decision-making and accessibility.
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Health technology assessment Decision making Standarts Frameworks Real world evodence Reimbursement decisions