China National Healthcare Security Administration: Every small group should not be abandoned
China National Healthcare Security Administration: Every small group should not be abandoned
China National Healthcare Security Administration: Every small group should not be abandoned
2021-12-08
In the world, there are some rare diseases, also known as "orphan diseases", which refer to diseases with a very low incidence and are rare. It is precisely because rare diseases are rare, but there are generally low investment in scientific research, low diagnosis rate, lack of effective treatment methods, and most rare disease patients and families still face "the disease has no cure", "the cure has no medicine", and "the medicine has no insurance." At the same time, drugs for rare diseases are priced very high because of the high R&D investment cost and small market, and some even reach the sky-high price of one million yuan.


The Chinese government pays attention to the medication protection of each small group. In order to cope with these problems, the medication of rare disease patients has gradually become the focus of attention in the adjustment process of the national medical insurance drug list. Since the normalization and adjustment of the national medical insurance drug catalogue at 2019, and with the reform and development of the national medical and health system, the drug review and approval process has been continuously optimized. In 2019 and 2020, a variety of high-value drugs have been approved in China. Drugs for rare diseases have entered the medical insurance list through negotiation, and the total number has reached 45.


On December 3, 2021, the National Medical Security Administration held a press conference to announce the results of the adjustment of the National Medical Insurance Drug List in 2021. A total of 74 new drugs were added to the list. Among them, 7 drugs for rare diseases were shortlisted, even including drugs for rare diseases with a price tag of one million yuan.


Specifically, the rare disease drugs that have entered the medical insurance list through negotiations this time are human coagulation factor IX, icatibant acetate injection, Nusinersen Sodium Injection, fampiridine sustained-release tablets, and agalsidase α. Concentrated solution for injection, eloyuumab injection, and clofenac soft capsules are used to treat hemophilia, hereditary angioedema, spinal muscular atrophy, multiple sclerosis, Fabry disease, hypolipidemic, and thyroid Prime protein amyloidosis cardiomyopathy.


Among them, Nusinersen Sodium Injection and Agalase Alpha Injection Concentrated Solution are both famous for high-priced rare disease drugs, and their manufacturers are Biogen from Netherlands and Takeda from Japen. It is reported that before medical insurance negotiations, the price of Biogen’s Nusinersen Sodium Injection was as high as 700,000 yuan per injection, and the annual cost of Takeda’s concentrated agarase α injection solution was generally at the level of one million yuan. As of now, the specific price of new drugs entering the medical insurance catalog has not been announced. As for the price reduction rate, the announcement when it is implemented in 2022 will be announced later.


In a November negotiation between the Medical Insurance Bureau and the manufacturer that was greatly admired on the Chinese Internet, Mrs. Zhang from the Medical Equipment Procurement Supervision Office of the Medical Insurance Bureau fondly proposed that every small group should not be abandoned, and hope that the company make effort, more effort, more and more effort, exchange price for quantity, enter the medical insurance catalog, so that orphan patients can use the medicine, and also guarantee the income of the enterprise by quantity. 


The industry predicts that with the continuous optimization and reform of the drug review and approval process in the future, rare disease drugs will accelerate their listing, and the pace of being included in the national medical insurance catalog will increase year by year. Affected by this, more and more patients with rare diseases and their families will see new hope.


Product Catalog