The outcome of the national talks will be announced!

On December 2, the State Food and Drug Administration issued an announcement stating that it has recently passed the priority review and approval procedure to approve the import registration application of the clinically urgently needed rare disease drug for injection stuximab
.
Stuximab was once included in the list of China's "First Batch of New Drugs Urgently Needed Overseas" due to rare disease drugs
.
In January 2021, the domestic marketing application for the drug was accepted by CDE and was included in the priority review procedure
.
The accelerated listing of Stuximab fully demonstrates China's determination and strength in accelerating the introduction of high-quality innovative drugs for rare diseases
.
In recent years, with the continuous deepening of medical reforms, China’s innovative drug review and approval system has been gradually improved, and the speed of new drug approval has been greatly improved, allowing innovative drugs to quickly benefit Chinese patients.
At the same time, "orphan drugs" and innovative drugs for rare diseases are also covered by annual medical insurance.
The key coverage of the catalog adjustment can better meet the reasonable medication needs of the insured patients
.
A reporter from the "Medical Insurance Economic News" was informed that the results of the new round of medical insurance catalogue negotiations will be released tomorrow (December 3), which innovative drugs "running" will enter the medical insurance, and whether the negotiations for major diseases are successful will soon be announced
.
Review and approve reforms and speed up the launch of innovative drugs.
In recent years, the country’s policy dividends for encouraging drug innovation have continued to increase, and drugs that are urgently needed for clinical use have been approved for marketing
.
According to the data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs were approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
Record
.
With the continuous improvement of the review and approval environment, the continuous optimization of China's pharmaceutical innovation environment has achieved significant results
.
The acceleration of the launch of new drugs, in the eyes of the industry, is mainly due to the gradual improvement of my country's innovative drug review and approval system, and the speed of new drug approval has been greatly improved, further paving the way for the innovation and transformation of enterprises
.
In recent years, the State Food and Drug Administration has fully implemented the spirit of the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" and the "Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance and Innovation and Development of Traditional Chinese Medicine" and other documents, and established and improved medicines to speed up the market.
Registration procedures, continuous improvement of the indication team review, project manager, technical dispute resolution, review information disclosure and other systems, the efficiency of review and approval has been greatly improved, and the reform of the drug review and approval system has been further advanced
.
In addition, in the new version of the "Administrative Measures for Drug Registration", a chapter "Procedures for Accelerating the Marketing Registration of Drugs" has been added, and four accelerated channels have been established for China to encourage innovation and meet urgent clinical needs-breakthrough therapeutic drugs, conditional approval, Prioritize review, approval, and special approval to accelerate the launch of innovative drugs with high clinical value and improve the availability of drugs
.
Thanks to the continuous acceleration of the review and approval of new drugs, a number of innovative drugs "ran into" the 2021 medical insurance negotiations as soon as possible
.
What is different from previous years is that the 2021 medical insurance negotiations will further relax the time threshold in the scope of review for new drugs that are newly listed or have new indications
.
Western medicines and proprietary Chinese medicines not included in the medical insurance catalogue, including medicines for the treatment of respiratory diseases related to new coronary pneumonia, medicines included in the National Essential Medicines List (2018 Edition), approved from January 1, 2016 to June 30, 2021 New generic drugs on the market and approved drugs with major changes in their indications or functional indications are included in the 2021 medical insurance catalog review scope
.
The data shows that 93.
02% of the non-catalog products that passed the preliminary formal review this year are new drugs that will be on the market after 2016
.
It is worth noting that there are 20 domestically-made innovative drugs for the first time in the national talks
.
Including PARP inhibitors, BTK inhibitors, ALK inhibitors, ADC drugs (antibody coupling drugs), etc.
, involving many listed pharmaceutical companies such as Hengrui Pharmaceuticals, BeiGene, Rongchang Biological, Betta Pharmaceuticals, and Zejing Pharmaceuticals
.
The list of medical insurance drugs is updated every year, and anti-cancer drugs are attracting attention
.
For example, this year’s focus on PARP inhibitors is relatively high.
A total of 4 drugs participated in the negotiation, namely AstraZeneca’s Olapali, Zai Lab’s Nirapali, Hengrui Medicine’s Fluzoparib, and Baekje Pamipalli from China
.
Among them, the first two new indications participated in the negotiation, fluzoparib and pamipali entered the primary list for the first time, and the results of the negotiations are worth looking forward to
.
"Every advance must be discussed" to allow patients to use new drugs and good drugs.
In addition, in recent years, the medical insurance catalogue has adjusted the use of rare diseases as one of the key points.
The number of drugs included in the catalogue has increased and the coverage of rare diseases has expanded
.
Data show that the 2009 version of the medical insurance catalog contains 22 drugs for rare diseases, covering 13 rare diseases; the 2017 version of the medical insurance catalog contains 30 drugs for rare diseases, covering 15 rare diseases; the 2019 medical insurance catalog contains 39 rare diseases Drugs for diseases, covering rare diseases of 19 diseases; the 2020 version of the medical insurance catalog contains 45 drugs for rare diseases, covering rare diseases of 22 diseases
.
According to industry insiders, medical insurance is an important system for people’s livelihood.
In the previous adjustments to the medical insurance catalog, the National Medical Insurance Bureau has always firmly grasped the basic medical insurance function of Medicines for medical needs are included in the catalog, allowing patients to use new and good medicines more quickly
.
Through the access negotiation of the medical insurance catalogue, a new mechanism for the dynamic adjustment of the medical insurance drug catalogue has been established.
Many new drugs and good drugs are included in the catalog, realizing a win-win situation for patients, enterprises, and medical insurance
.
Since the normalization of medical insurance negotiations, the negotiation of drugs for rare diseases has also become a hot spot in the market
.
According to industry sources, the substantial price reduction of Bojian's SMA treatment drug (spinal muscular atrophy) Noxinagen Sodium Injection has been successfully negotiated, and Takeda's Fabre medication agalsidase α injection concentrated solution has been successful
.
If the above two drugs succeed in bargaining, they will become the pioneers of high-value rare disease drugs entering medical insurance.
They have very important significance for clinical treatment and industrial development.

.
However, the final result of medical insurance negotiations still needs to be subject to the results announced by the National Medical Insurance Bureau
.
Guided by the principle of focusing on people's health and ensuring more fairness and accessibility, the annual national medical insurance negotiations have contributed to encouraging innovation in medicine, reducing the burden on patients, and improving the availability of medicines
.
Judging from the first three rounds of negotiations led by the National Medical Insurance Administration, the average drop was over 50%
.
In August 2018, the National Medical Insurance Administration issued the "Notice on Issuing the Scope of Special Negotiations for Anti-cancer Drugs and Medical Insurance Access in 2018".
Through special negotiations on anti-cancer drugs, 17 drugs were transferred to the medical insurance catalog with an average price drop of 56.
7%.
, Which greatly alleviated the medication problems of cancer patients in our country
.
The subsequent second and third rounds of medical insurance negotiations not only allowed more life-saving innovative drugs and exclusive varieties to enter the medical insurance catalogue, better met the basic drug needs of the insured people, and promoted the innovative development of the pharmaceutical industry, but also Achieved an average drop in drug prices reached 60.
7% and 53.
8%
.
On December 2, the National Medical Insurance Bureau held a video conference on improving the medical insurance and rescue system for major diseases in Beijing
.
The meeting requested that the overall requirements of the "Opinions of the General Office of the State Council on Improving the Medical Insurance and Relief System for Major and Major Diseases" should be accurately grasped, and the construction of a unified and standardized medical assistance system should be the main line, the support mechanism should be improved, and the protection efficiency of the system should be enhanced
.