Major routes for orphan drugs to be incorporated into the reimbursement system of UK and the enlightenment to China

In order to provide enlightening experience for the establishment of reasonable and diversified orphan drugs into the reimbursement system in China, the official websites of the National Institute for Health and Care Excellence(NICE)and the National Health Service(NHS)in the UK were inspected, collecting and summarizing the relevant documents, on the inclusion of orphan drugs into the reimbursement system. Relevant literatures were analyzed with theoretical studies on the accessibility of medicines for patients with rare diseases. In the NHS system, the inclusion of orphan drugs into the reimbursement system in the UK can be achieved mainly through seven routes, with three routes that are evaluated by NICE(MTA, STA and HST)and four are directly managed by the NHS(specialized commissioning, CDF, IFRs, CtE). Through the analysis of the inclusion of orphan drugs into the reimbursement system and the various problems in the UK, we have found some enlightening experience for the establishment of the reimbursement system for orphan drugs in China.