USE OF REAL-WORLD DATA AND REAL-WORLD EVIDENCE TO SUPPORT DRUG REIMBURSEMENT DECISION-MAKING IN ASIA

摘要: A collaboration between global experts and leaders from health technology assessment (HTA) agencies in Asia, the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group seeks to develop non-binding guidance that will provide a framework to generate and use real-world data (RWD)/real-world evidence (RWE) in a consistent and efficient manner for decision-making in Asia. 1 The acronym REALISE signifies our desire to realize (‘to cause to happen or to facilitate’) the potential of RWD/RWE while realizing (‘being aware of’) its strengths and limitations. The issues to be addressed in the guidance document will include but are not limited to:(a) When is it appropriate to consider RWD/RWE for reimbursement decisions?;(b) What types of RWD should we collect?;(c) What are the data sources for collecting RWD?;(d) How should we collect RWD?;(e) Who should collect RWD?;(f) How will RWD be used to generate RWE?;(g) How should we use RWE in decision making?;(h) What are the potential biases and how to deal with these biases?; and (i) What are the ethical considerations in collecting RWD and generating RWE?It is our goal that the proposed guidance document will increase the quality of RWD/RWE collected and used in HTA. However, we recognize that the actual implementation of this guidance document will vary from country to country due to many reasons including capacity constraints, lack of political support, and local legislation. That is, each health system will have its own practical barriers in utilizing RWD and hence, we propose that all recommendations in the guidance …