Chinanews client, Beijing, December 8th (Reporter Zhang Ni) In the past few days, drugs such as mannitol sodium capsules and noxinarine sodium injection have entered the new version of the medical insurance catalog and have aroused great attention.
Covering a wide range and falling prices...The adjustment of the medical insurance drug catalog involves the vital interests of tens of thousands of Chinese families.
Why can new drugs enter the catalog?
How many barriers does a drug have to pass through if it wants to enter medical insurance?
Data map: In a specialized hospital for Alzheimer's disease in the suburbs of Beijing, an elderly patient with the disease is basking in the sun in a wheelchair.
Photo by Cui Nan issued by China News Service
Why can "Nine Phase One" be included in the medical insurance catalog?
Recently, the adjusted "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2021)" was announced, and a total of 74 drugs were added to the list.
Included in the medical insurance list this time includes a new drug for the treatment of Alzheimer’s disease, Mannite Sodium Capsules (trade name: Phase 9). The drug was approved for marketing in 2019 and participated in medical insurance negotiations in 2020, but the negotiation failed at that time. .
The "Nine Phase One" entry into medical insurance has caused concern and it is inseparable from the wide range of audiences.
According to the Global Health Estimates Report 2019 released by the World Health Organization in 2020, in the past 20 years, among the top ten causes of death in the world, Alzheimer's disease and other forms of dementia alone have been among the top ten causes of death in the world.
In China, the number of patients with Alzheimer's disease is also very large.
So as a new drug, why can "Nine Phase One" be included in medical insurance?
Recently, the National Medical Insurance Bureau responded to this issue.
The relevant person in charge of the Medical Management Department of the National Medical Insurance Administration said that taking Ganlut Sodium Capsules as an example, the drug was included in the scope of support for the "Major New Drug Creation and National Science and Technology Special Project".
In 2020 and 2021, the application was successful, and both passed the expert review.
The failure of negotiations in 2020 was not included in the catalog.
In this year’s adjustments, after 32 experts’ review, an average score of 70.47 was obtained, and the drug was qualified to negotiate according to the rules.
Through negotiation, a 66.92% price reduction was included in the catalog.
Through negotiation of price cuts and medical insurance reimbursement, the burden of medication for patients will be significantly reduced.
Data map: Photo by Yu Danfei, automatic medicine dispenser
How many barriers does it take for drugs to enter the medical insurance catalog?
It is not an easy task for drugs to enter the medical insurance catalogue, and they have to withstand the multiple tests of efficacy and price.
From the perspective of the effectiveness of drugs, the National Medical Insurance Bureau has clarified several requirements.
First of all, the drug must pass the review of the drug regulatory authority and be approved for marketing.
Article 7 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" stipulates that the drugs included in the national "Drug List" should be chemical drugs, biological products, and Chinese patent drugs (ethnic drugs) that have been approved by the national drug regulatory authority and obtained a drug registration certificate.
In recent years, the national medical insurance drug catalogue has been adjusted, mainly for drugs newly approved for marketing in recent years.
Second, the company must submit materials that can prove the effectiveness of the drug.
In the stages of application, review, and negotiation, the National Medical Insurance Administration organizes relevant companies to submit data and corresponding evidence in terms of validity and other aspects as required.
In order to ensure the authenticity of the materials, the materials submitted by the enterprises shall be publicized during the declaration process and shall be supervised by the whole society.
The drug administration, health and health departments are requested to provide drug support materials to provide support for the review.
Finally, the drug must be able to pass expert review.
According to the adjustment rules, the drugs that meet the application requirements and are successfully declared need to undergo multiple rounds of demonstrations by experts in pharmacy, clinical medicine, pharmacoeconomics, and medical insurance management.
It needs to be pointed out that since most of the drugs currently included in the adjustment scope are newly approved drugs, many of which are even marketed that year, the expert review mostly relies on the data collected during the clinical trial of the drug.
In future work, the National Medical Insurance Administration will encourage companies to carry out real-world research on drugs, and will rely more on real-world research data in catalog adjustments.
In addition, medicines must be able to withstand "soul bargaining", because negotiators must strive for more favorable prices for the common people within the range that the medical insurance fund can bear and the enterprise can accept.
The negotiation base price is calculated by experts organized by the medical insurance department to form the highest price that the medical insurance fund can bear, that is, the negotiation base price, which serves as the basis and bottom line for the negotiation experts to carry out negotiations.
According to the current negotiation rules, on-site negotiations are jointly participated by the enterprise side and the medical insurance side, and the enterprise side is negotiated by the authorized negotiating representative, and the medical insurance side is led by the negotiation team leader, and the negotiation result is determined on the spot.
First, the company will make a quotation, and the company will have two opportunities to make a quotation and confirm it.
If the price after the second confirmation of the company is higher than 115% (exclusive) of the negotiated base price of the medical insurance party, the negotiation fails and it will be automatically terminated.
If the price after the second confirmation of the company is not higher than 115% of the base price negotiated by the medical insurer, it will enter the negotiation link between the two parties.
The price agreed by both parties must not be higher than the negotiated base price of the medical insurance party.
Taking this negotiation as an example, 67 kinds of exclusive drugs outside the catalogue were successfully negotiated, with an average price reduction of 61.71%.
The National Medical Insurance Agency said that the ultimate success of the negotiation depends on whether the bottom lines of the medical insurance party and the enterprise side overlap.
From a practical point of view, the responsibility of the medical insurance negotiator is to use the negotiation mechanism to guide the enterprise to quote the lowest price it can accept.
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