ObjectiveTo systematically review the pharmacoeconomic studies of negotiated drugs in the Chinese National Reimbursement Drug List (NRDL). MethodsPubMed, EMbase, The Cochrane Library, CNKI and WanFang Data databases were electronically searched to collect the pharmacoeconomic studies of negotiated drugs in the Chinese NRDL from January 1, 2012 to January 1, 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, the qualitative systematic review was performed. ResultsA total of 59 (33.9%) drugs were evaluated in 124 pharmacoeconomic studies. Only 23 (13.2%) drugs were evaluated in 29 (23.3%) pharmacoeconomic studies prior to the negotiation. Besides, 75 (60.5%) of the negotiated drugs were supported by evidence of economic superiority than the comparison. ConclusionThe pharmacoeconomic studies on drugs which listed in the NRDL is insufficient. Future pharmacoeconomic studies should perform to provide more substantial support for the national drug negotiations.
ObjectiveTo analyze the limitations and challenges for the use of real-world data in the decision making of drug reimbursement through literature review and provide standard process and guideline for the real-world study supporting drug reimbursement. MethodsBy summarizing the relevant policies, regulations, and guiding principles of major drug regulatory agencies worldwide, the study analyzed the applicable conditions, framework, and reimbursement mode for using real-world evidence in the decision making of drug reimbursement. ResultsThe study found that the health technology assessment departments of major developed countries and Asian countries have used real -world evidence to evaluate the drug efficacy and safety. The application scope of real-world data for reimbursement decision included describing the treatment process of the disease, assessing economic burden, verifying economic models, and evaluating the efficacy and safety of drugs. Some developed countries including the United Kingdom and the United States had released guidelines or frameworks of the real-world study for reimbursement decision. The process and framework of using real-world data in reimbursement decision could be divided into three models: coverage with evidence development, outcome-based contract, and re-assessment. ConclusionReal-world data has been widely used in the process of health technology assessment. To adapt to the development of the pharmaceutical industry and to meet the needs of clinical patients, it is urgent to standardize the process of collecting real-world data and formulate the scope and process of using real-world data in the reimbursement process.