On December 3, the 2021 National Medical Insurance Drug Adjustment Catalog was officially finalized.
In this adjustment of the medical insurance drug catalog, a total of 74 new drugs have been added to the catalog and 11 drugs have been removed from the catalog.
’s newly added drugs include 7 directly added non-exclusive drugs and 67 new negotiated drugs, with the latter having an average price reduction of 61.71%. As of press time, the original prices of the new drugs and their prices after entering the medical insurance catalog have not been announced.
It is reported that the above-mentioned newly included drugs cover tumors, chronic diseases, anti-infections, rare diseases, women and children, etc., involving a total of 21 clinical groups.
After adjustment, the total number of drugs in the National Medical Insurance Drug Catalog in 2021 is 2,860, including 1,486 Western medicines and 1,374 Chinese patent medicines. There are still 892 types of traditional Chinese medicine pieces in the catalog. The new version of the medical insurance drug catalog will be implemented on January 1, 2022.
The annual medical insurance drug catalog is adjusted, and the inclusion of rare disease drugs (also known as "orphan drugs") in medical insurance has attracted special public attention.
This is because, although the incidence rate of rare diseases is low, due to our country's huge population base, there are many patients with rare diseases. It is estimated that the number of rare disease patients in my country is about 16.8 million.
On the other hand, the diagnosis and treatment of rare diseases are more complex and the treatment effects are unclear. In addition, domestic rare disease drugs are relatively scarce, expensive and dependent on imports, making it difficult to meet the treatment needs of patients with rare diseases.
The huge patient base, the urgent need for medication, and the generally high drug costs have made the inclusion of rare disease drugs in medical insurance something that relevant patients and even the public are looking forward to.
This year, 7 rare disease drugs have been included in the medical insurance catalog, including human coagulation factor IX for the treatment of hemophilia, icatibant acetate injection for the treatment of hereditary angioedema, and spinal muscular atrophy. (SMA)'s nosinaxin sodium injection , fampridine sustained-release tablets for the treatment of multiple sclerosis , agalsidase α concentrated solution for injection for the treatment of Fabry disease, Iloyu for the treatment of hypolipidemia Monoclonal antibody injection , clofenac soft capsules for the treatment of thyretin amyloidosis cardiomyopathy.
Among them, Nosinaxin Sodium Injection, which treats SMA, costs nearly 700,000 yuan per injection and 4.2 million yuan for 6 injections per year. It is regarded as the first high-value rare drug to receive an "admission ticket" from medical insurance.
In addition, agalsidase α concentrated solution for injection to treat Fabry disease has also attracted widespread attention due to its annual cost of html worth one million .
If calculated at an average price reduction of 61.71%, the annual costs of these two drugs will be reduced to 1.6 million yuan and 380,000 yuan respectively.
These two drugs are developed and produced by foreign pharmaceutical companies Biogen Idec and Takeda (Takeda) respectively.
In 2016, nosinaxin sodium was approved by the US Food and Drug Administration (FDA), becoming the world's first specific drug for the treatment of SMA. Three years later, in 2019, Nosinaxin Sodium Injection was approved for marketing in China.
At that time, this drug was the only drug for the treatment of SMA in China, and the patient had to pay for it all out of his own pocket. Last year, Nosinasen sodium caused controversy because "a shot in China costs 700,000 yuan, while abroad it costs 280 yuan."
According to the "White Paper on the Survival Status of SMA Patients in China ", there are currently about 30,000 SMA patients in China. After Noxinaxin Sodium is included in the medical insurance, the market penetration rate and share of the drug will be greatly increased.
Takeda’s agalsidase α concentrated solution for injection (Ripga) was approved to enter China in August last year, and the drug was included in the “Second Batch of Urgent Clinical Overseas Drugs.”
The high domestic price and the large and urgent demand from patients have become important driving forces for the entry of the above-mentioned rare drug into medical insurance.
However, due to the high cost of research and development of rare disease drugs, it is indeed something that pharmaceutical companies need to carefully consider and consider if they significantly reduce prices and include them in medical insurance. Allowing pharmaceutical companies to have a reasonable profit range to avoid dampening their enthusiasm for innovative drugs is also a consideration in the price negotiation process.
According to the " First Batch of Rare Diseases" catalog jointly released by the National Health Commission, and other five departments in 2018, my country has officially recognized 121 rare diseases. So far, among the 121 rare diseases, more than 50 drugs are marketed in China with corresponding indications, and more than 40 drugs are included in the medical insurance drug catalog.
In addition, the pace of domestic rare disease drugs being approved for marketing is also accelerating. Since the beginning of this year, a total of 9 new drugs for rare diseases have been approved for marketing in my country, such as Kyowa Hakko Kirin’s brosumab, Takeda’s icatibant acetate and velaglucerase α, and Janssen’s dimethyl fumarate. , Biogen's Fampridine, Roche's Rispran Oral Solution Powder and Satrolizumab, etc.
Everyone has equal rights to life and health. At the negotiation site for this year's medical insurance drug catalog, Zhang Jinni, a negotiator from the National Medical Insurance Bureau and director of the Drug Equipment Procurement and Construction Management Division of the Fujian Provincial Medical Insurance Bureau, said that "no small group should be abandoned" and companies should use it when making quotations. The utmost sincerity.
ZAKER News produced by
text / edited by Xiong Yue
/ Chopin
