NHC to push for reimbursement of orphan disease drugs



The National Health Commission (NHC) held a meeting recently to review progress and consider the next steps in the management of rare diseases and orphan drugs in China.

As noted during the meeting, key progress in recent months included the May 2018 release by the NHC and five other departments of China’s first Rare Disease Catalogue, which designated 121 rare diseases of relevance in China. NHC officials note that the list is seen as sufficient at present, and is comparable in terms of length with neighboring countries such as Japan. The rare disease list is designed to serve as a reference for the development of rare disease management policies by various departments. This has been supported by the National Medical Products Administration (NMPA), which together with the NHC in May 2018 notified that developers of orphan drugs that display no differences when applied in different ethnic groups would be permitted to use foreign data to support a market filing in China.

The next steps for the NHC will be to formulate medical treatment guidance, and establish a nationwide rare disease diagnosis and treatment network as well as a patient registration system. NHC officials have also begun to work with the State Medical Insurance Administration (SMIA) to devise a dynamic Reimbursement Drug List (RDL) listing mechanism specifically for rare disease therapies, following expert review and a negotiations process.
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