OBJECTIVE： To introduce high-value drug insurance access mechanism in Australia， and to provide suggestion for improving orphan drug medical insurance access in China. METHODS： By literature study and policy analysis， access principle， risk-sharing mechanism and restricted use principle of high-value drug insurance access in Australia were summarized and analyzed， so as to evaluate the effects of high-value drug insurance access mechanism. RESULTS & CONCLUSIONS： The inclusion of high-value drug in Australian National Formulary considers not only the cost-effectiveness ratio， but also the drug’s clinical efficacy， irreplaceability and the social principles； risk-sharing mechanism and restricted use principle achieve a good balance between the accessibility of patient’s medication and the sustainability of health insurance fund； remarkable results are achieved in guaranteeing patient’s medication and strengthening basic medical insurance. It is recommended to perfect orphan drugs medical insurance access standard， introduce risk-sharing mechanism and standardize the use of orphan drugs and reimbursement in China.