OBJECTIVES: Information regarding health technology assessment (HTA) requirements for orphan drugs in Asia Oceania is limited. The aim of our study was to compare HTA evidentiary requirements for standard and orphan drug appraisals among 7 Asia Oceania countries/regions. METHODS: A literature and policy review was conducted to identify standard and orphan drug HTA requirements and processes for the following countries: Australia, Japan, South Korea and China (further divided into regions including Mainland China, Hong Kong, Singapore and Taiwan to capture the diverse healthcare markets included in the country). A modified Hutton Framework was used to descriptively assess the HTA and reimbursement processes in these 7 countries/regions. RESULTS: Authorities in Asia Oceania are currently in various stages of HTA and reimbursement process development for standard and orphan drugs. Of the 7 countries/regions studied, Australia is the only country with distinct orphan drug HTA evidentiary requirements and processes compared to standard drugs. Cost-effectiveness evidence is required as part of South Korea’s standard HTA review, but incremental cost-effectiveness ratio (ICER) thresholds are more lenient for orphan drugs. In Hong Kong, orphan drugs are assessed by an independent expert review committee, and appraisal criteria weigh heavily on patient characteristics and perceived benefit. Several countries/regions include health economics in their standard HTA review: Taiwan (budget impact, comparative effectiveness) and Singapore (cost-effectiveness); both countries/regions have similar evidentiary requirements for orphan and standard drugs. Japan is in early stages of developing HTA procedures and requires minimal economic evidence in standard and orphan drug assessment. Mainland China does not have a centralized HTA process for standard and orphan drugs. CONCLUSIONS: Most Asia Oceania countries/regions are still developing their HTA policies. Due to lack of distinct orphan drug HTA procedures in Taiwan, Singapore, Mainland China, and Japan, obtaining reimbursement for drugs may require additional efficacy or health economic analyses.