Author丨Zhu Ping, Xi Lei Ye, Li Jiaying
Editor丨Xu Xu
Source丨Visual China
On December 13, the results of the adjustment of the national basic medical insurance, work-related injury insurance, and maternity insurance drug catalogue in 2023 were announced, with a total of 126 drugs newly added to the national medical insurance drug catalogue and 1 drug transferred out of the catalogue. After the adjustment, the total number of drugs in the catalogue has increased to 3,088, including 1,698 Western medicines, 1,390 Chinese patent medicines, and 892 Chinese herbal decoction pieces. The new version of the National Reimbursement Drug List will be implemented from January 1, 2024.
At present, a new drug price system that is in line with the mainland's national conditions and covers all therapeutic fields has been initially established, and imported drugs have basically given the lowest prices in the world. Through negotiation of price reduction and medical insurance reimbursement, the burden on patients has been reduced by more than 600 billion yuan.
Throughout the six rounds of adjustment of the medical insurance drug catalog, new therapeutic drugs have replaced some of the original drugs with inaccurate efficacy and inflated prices, further improving the level of drug protection for insured personnel and standardizing the management of medical insurance drugs. Innovative drugs from domestic and foreign companies have been included in the National Medical Insurance Catalogue to provide patients with different treatment options for the same target.
In order to promote the implementation of new medical insurance drugs, the National Health Insurance Administration first adjusted the payment scope of some drugs, revised the drug description, etc., and returned the right to choose drugs to medical personnel. In terms of follow-up implementation, measures such as the direct connection of negotiated drugs to the network, the adjustment of information systems, and the improvement of management policies such as dual channels not only ensure that the prices of negotiated drugs are adjusted as scheduled according to the agreement, but also further improve the accessibility and fairness of drug use.
The medical insurance catalogue has been greatly optimized
The 21st Century Business Herald reporter learned that in 2023, 126 new drugs will be added to the medical insurance catalog, including 21 drugs for tumors, 17 drugs for new crown anti-infection, 15 drugs for chronic diseases such as diabetes, psychiatry, rheumatism and immunity, 15 drugs for rare diseases (among which avatinib tablets are also drugs for tumors), and 59 drugs for other fields. At the same time, 1 drug that is about to be withdrawn from the market was transferred.
Huang Xinyu, director of the Department of Pharmaceutical Service Management of the National Health Insurance Administration, introduced at the press conference that after this adjustment, the total number of drugs in the medical insurance catalog will increase to 3,088, including 1,698 Western medicines and 1,390 Chinese patent medicines, and the level of protection in key areas such as chronic diseases, rare diseases, and children's drugs has been further improved. Overall, the results of this catalogue adjustment are in line with expectations.
A total of 143 drugs participated in the negotiation/bidding of this catalogue adjustment, of which 121 had a success rate of 84.6% and an average price reduction of 61.7%. Both the success rate and the price reduction are about the same as in 2022. Combined with the negotiation of price reductions and medical insurance reimbursement factors, it is expected to reduce the burden on patients by more than 40 billion yuan in the next two years.
Most of the drugs are newly launched in recent years and have high clinical value. Among them, 100 drugs were used for tumors, and 93 drugs were used for chronic diseases such as hypertension, diabetes, and mental illness. Before 2017, there was not a single tumor targeted drug in the medical insurance catalog. Nowadays, a large number of new mechanisms and new target drugs have been included in the catalogue through negotiation, and up to now, the mainland medical insurance drug catalogue contains 74 tumor-targeted drugs. This allows patients to have a diverse choice of targeted drugs across generations in many therapeutic areas.
Chen Wen, a professor at Fudan University and head of the pharmacoeconomics expert group for the adjustment of the 2023 National Medical Insurance Drug Catalog, said that after six rounds of adjustments, the National Health Insurance Administration has added a total of 744 drugs to the medical insurance catalog, of which 446 have been added through negotiation, covering all 31 therapeutic areas in the catalog. A total of 395 drugs with uncertain efficacy, easy clinical abuse, and clinically eliminated or about to be withdrawn from the market have been released.
From the perspective of clinical use, the proportion of drugs in the catalogue in medical institutions has increased year by year. According to the monitoring of some sample hospitals by the Chinese Pharmaceutical Association, from 2018 to 2022, the proportion of the amount of medical insurance drugs used in the average total drug use of the sample hospitals increased to 86.73%. The medical insurance catalogue guides the "upgrading" of clinical drugs in mainland China through "spitting out the old and absorbing the new", and most therapeutic areas have been on par with the international mainstream drugs, and the level of medical insurance drug protection has achieved a leap.
In addition to better serving clinical practice, the update of the National Medical Insurance Catalogue can further promote the development of innovative drugs. Huang Xinyu, director of the Department of Pharmaceutical Management of the National Health Insurance Administration, said that under the premise of adhering to the "basic guarantee", the National Health Insurance Administration will include innovative drugs in the medical insurance catalogue and accelerate clinical application to vigorously support the development of innovative medicine. As of the end of October 2023, the cumulative expenditure of the medical insurance fund for negotiated drugs during the agreement period has reached 244.7 billion yuan, driving the sales of related drugs to 354 billion yuan.
In order to support the innovation and development of pharmaceutical products in mainland China, the National Health Insurance Administration has adopted a variety of incentive measures, such as establishing a full-process innovative drug support mechanism such as coverage, declaration, review, calculation, and negotiation. This year, a total of 25 innovative drugs participated in the catalogue negotiations, with a success rate of 92%. Compared to the overall level, the success rate was 7.4 percentage points higher, and the average decline was 4.4 percentage points lower. In addition, in order to improve the negotiation and renewal rules for the development of innovative drugs, the state supports some drugs to go overseas, and negotiates some drugs in accordance with the principle of enterprise voluntariness, and the price is kept confidential. For example, 230 negotiated drugs in this year's drug catalogue have implemented price secrecy.
It is worth noting that the adjustment period of the national medical insurance catalogue has been shortened. The National Health Insurance Administration has established a dynamic adjustment mechanism for the medical insurance catalogue to adapt to the access of new drugs, shortened the adjustment period from the original maximum of 8 years to 1 year, and changed the catalogue access method from the expert selection system to the enterprise declaration system. The time from the approval of new drugs to the catalogue has been shortened from more than 5 years to more than 1 year, and 80% of innovative drugs can enter the NRDL within two years after listing.
The R&D achievements of domestic innovative pharmaceutical companies may be expected to accelerate the expansion of the in-hospital market with the help of their rapid inclusion in the national medical insurance catalog. Taking BioPro Biotech as an example, its first domestically developed Category 1 innovative biological product targeting CD20, Zebetumab Injection, Areximab ® Injection, was approved by the National Medical Products Administration (NMPA) for marketing on May 17, 2023, filling the gap of self-developed innovative monoclonal antibody drugs in Zhejiang Province. Nearly 6 months after its approval, the drug entered the National Medical Insurance List, providing a new treatment option for patients with B-cell lymphoma.
Steadily promote the implementation of policies
The adjustment of the payment scope of medical insurance is related to the rationality of clinical drug use and the safety of the fund, and the National Health Insurance Administration has made a steady adjustment.
For the new access catalogue and the drugs renewed this year, in principle, it will be determined according to the situation declared by the enterprise. For the original varieties in the catalog, according to the general idea of "ensuring the basic scientific and reasonable, reducing and restricting the same kind, and progressing in a balanced and gradual manner". Taking into account the actual clinical situation, clinical needs, and the affordability of the medical insurance fund, the National Health Insurance Administration has formulated a work plan for adjusting the specifications in batches, and adjusted the payment scope of some drugs according to the plan in this year's work.
Revise the unreasonable individual drugs in the original catalogue to make them conform to the drug instructions and the actual clinical situation. In the future, the National Health Insurance Administration will steadily promote the adjustment work according to the clinical drug situation, the payment ability of the medical insurance fund, and the management ability of medical insurance, in accordance with the established ideas and plans. On the premise of ensuring the safety of the fund and promoting the rational use of drugs, the payment scope of medical insurance drugs will be adjusted step by step in batches, and more drug options will be returned to medical staff.
In order to further optimize the adjustment workflow of the national drug list and standardize the working mechanism, this year, the National Health Insurance Administration has made improvements in five aspects: work rules, evaluation evidence requirements, evaluation methods, communication between the government and enterprises, and information system functions. Among them, in terms of review, four groups of experts, including clinical experts, pharmaceutical experts, medical insurance experts, and pharmacoeconomics experts, jointly reviewed and evaluated the effectiveness, safety, fairness, innovation and other dimensions of drugs, so as to make the drug catalog more compatible with the actual medical insurance management of clinical drugs.
It is worth noting that in the field of cancer treatment, the new version of the National Medical Insurance Catalogue includes a variety of innovative drugs suitable for different disease courses.
For example, Eli Lilly's anti-tumor CDK4 & 6 inhibitor Weixuan (abeciclib tablets) combined with endocrine therapy (tamoxifen or aromatase inhibitors) is used for the first time in the adjuvant treatment indication of adult patients with early breast cancer who are hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high recurrence risk, and Ki-67≥20%. At the same time, the two major indications of HR+, HER2- advanced endocrine sensitivity and advanced endocrine resistance of the drug were renewed, covering both early and advanced breast cancer populations. At the same target, another large multinational company, Novartis' innovative breast cancer treatment drug Carilon ® (rebociclib succinate tablets) was selected into the new version of the National Medical Insurance Catalog.
In order to benefit the masses as soon as possible, the National Health Insurance Administration will take a series of measures to promote the implementation of the catalogue. Ensure that the negotiated drug price is adjusted as scheduled in accordance with the agreement, and realize the listing of the network, and make basic preparations for the landing of the catalog. Through linkage with medical institutions, the newly added drugs in the catalogue are included in the list in a timely manner to improve the level of drug security. Further improve the management policies such as dual channels, strengthen the management after the entry of the catalog, and strengthen the monitoring of the data of the drugs in the catalog, especially the use and payment of negotiated drugs. In the future, doctors and patients can learn about the list of drug allocation institutions submitted by relevant enterprises through the inquiry channel on the WeChat official account and official website of the National Health Insurance Administration, so as to inquire and purchase negotiated drugs.
SFC
Editor of this issue: Li Yutong, Xi, Song Jiayao
Yu Minhong: Apologize to Dong Yuhui!
A key step for 5G!The first judgment of a Chinese court
What is the signal that banks are intensively holding symposiums for real estate companies?