Abstract:
Background: Access to precision medicine is limited due to many factors such as precision medicine technology of each country, high-cost technology that requires high finance, limitations on knowledge and competency of personnel and access to precision medicine. Each country manages access to precision medicine differently. The existing evidences of precision medicine reimbursement policy were limited. Objective: To explore reimbursement decision of precision medicine focusing on diagnostic tests and factors associated with reimbursement decision among high-income and upper-middle-income countries. Methods: A targeted review of literatures was conducted through PubMed, MEDLINE, Embase, Cochrane Library, and hand-searching. The study included 13 selected precision medicine and eight selected countries. Content analysis was used. Results: Two precision medicine tests; HER2/neu and BCR-ABL gene, were reimbursed in all countries, while EGFR mutation test was reimbursed in all high-income countries. Among pharmacogenetic tests for severe ADR screening, only HLA-B*15:02 and HLA-B*57:01 were more likely to reimburse in high-income countries than upper-middle-income countries. Most of pharmacogenetic tests for dose adjustment were not reimbursable, except for TPMT gene test which was more likely to get reimbursed among high-income countries. Genetic risk predictors for cancer development, BRCA1 and BRCA2 gene test was covered by most high-income countries. Factors positively affected reimbursement decision were purpose of precision medicine test, health care budget, regulatory agency’s recommendation, carrier gene frequency in ethnic groups, and economic evaluation. Conclusion: Access to precision medicine is still limited in upper-middle-income countries. Criteria for precision medicine reimbursement decision should be established.
