On Dec. 28, 2020, the National Healthcare Security Administration (NHSA) and Ministry of Human Resources and Social Security (MOHRSS) issued the 2020 Edition of the National Reimbursement Drug List (NRDL).1 The list covers 55 relevant drugs for 24 rare diseases. In early December 2020, NHSA announced that it would include more rare disease drugs into centralized procurement, in response to a proposal by representatives of the National People's Congress.2
What does it mean for rare disease drugs to enter the NRDL?
The inclusion of drugs in the NRDL means that medical institutions like hospitals will give priority to the use of such drugs. Besides, part of the fees will be covered by the social medical insurance so that more patients will be able to afford the drugs. Hence, getting on the list is conducive to the growth of overall sales and increasing market share in the long run.
Nevertheless, the drugs that made the list sometimes come at a steep price cut. For example, drugs for rare diseases such as Pulmonary Hypertension (PHTN) and Niemann-Pick disease type C (NPC) were included in the NRDL after substantial price reduction. The price of Ambrisentan Tablets, a drug for PHTN, was reduced from 115.97 yuan to 20 yuan per tablet in the centralized procurement list.
China expedites the development and market access of rare disease drugs
Since 2018, China has promulgated a series of policies to provide medical support for about 20 million patients with rare diseases.
On June 8, 2018, the National Health Commission (NHC) and other four departments jointly published China's First Catalog of Rare Diseases, including a total of 121 rare diseases, such as albinism, Kallmann syndrome, Marfan syndrome, and hemophilia.3
In the same year, NHC and the National Medical Products Administration (NMPA) released the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical Settings. The announcement required the Center for Drug Evaluation (CDE) of NMPA to establish a dedicated channel to complete the technical review of drugs for rare diseases within three months of acceptance.4
In 2019, a favorable tax policy for rare disease drugs was jointly announced by four administrators. The policy says that the value-added tax (VAT) for the first batch of 21 rare disease drugs and four active pharmaceutical ingredients will reduce to 3% starting from Mar. 31, 2019, which applies to both domestic and imported.5
On Feb. 25, 2020, the Chinese government unveiled the Opinions on Further Reform of Medical Insurance System, clearly proposing to explore the mechanism of drug guarantee for rare diseases.6
The purpose of these policies is to encourage the research and development of rare disease drugs, and to increase the availability of medicines for the patients in China. International pharmaceutical companies could benefit from those policies if they have the relevant product pipelines and plan to introduce those products into Chinese market.