OBJECTIVES: With a significant proportion of the world’s population and considerably high GDP growth rates, China represents an attractive opportunity for commercialization of orphan drugs for rare diseases. However, funding for orphan drugs remains challenging due to conflicting priorities with coverage of essential drugs. We aimed to understand the current coverage policies for orphan drugs in China and evaluate the impact they have on pricing and market access.  METHODS: Secondary research of government legislation at the national and provincial level to identify specific policy and decision making criteria for coverage of orphan drugs and rare diseases. We selected 8 orphan drugs and scored them based on a pre-defined set of access drivers (incidence of the disease, severity of the condition, therapeutic alternatives, level of innovation, affordability, etc.).  We analyzed the scores to identify any correlation with the pricing and reimbursement status. RESULTS: Since 2009, a fast-track approval process for drugs related to some rare diseases has been in effect with a separate regulation specifying that these drugs are eligible for reduced clinical trial requirements. Provincial coverage for orphan drugs remains low, however, Shanghai has recently implemented a specialist program for the coverage of 12 rare diseases providing funding of ~$32,200 per patient per year. Furthermore, at the national level, a “Bill of Rare Diseases” is currently under review including proposals for the establishment or reimbursement mechanisms and assistance networks for the treatment of rare diseases. Scores for access drivers were minimally correlated with pricing and reimbursement status. CONCLUSIONS: Our results demonstrate that, although there is considerable market opportunity supported by variable legislation to facilitate orphan drug coverage, pricing and market access remains challenging and is not necessarily related to individual product value. Therefore, pharmaceutical companies seeking access for orphan drugs should consider selective programs, designed to improve affordability and patient access.