As an important auxiliary means of pharmacoeconomics evaluation, budget impact analysis can effectively measure the affordability of medical insurance fund, and plays a significant role in the process of medical insurance access negotiation, adjustment of medical insurance reimbursement directory and establishment of payment price. The quality of budget impact analysis data has a great impact on the analysis results and the scientific decision-making. When the existing data cannot meet the requirements of the paper, relevant software is needed to carry out Delphi method to ensure the data accuracy. Infopoll is a powerful, easy-to-use application that designs consultation questionnaires by providing multiple question choices and multiple forms of answer settings, as well as detailed statistical charts for results analysis. This paper introduces how to obtain the data of budget impact analysis based on Delphi method using Infopoll software, and analyzes the main results in detail.
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.