"Science and Technology Innovation Board**" on February 6 (reporter Xu Hong).On the eve of the Lunar New Year, the pharmaceutical industry once again ushered in a blockbuster favorable policy.
It is reported that the National Health Insurance Administration's "Notice on Establishing a Mechanism for the Formation of the First Listing of Newly Listed Chemical Drugs and Encouraging High-quality Innovation" (hereinafter referred to as the "Consultation Draft") solicited opinions through relevant industry associations. At the same time, the relevant person in charge of the Procurement Department of the National Health Insurance Administration also gave a detailed interpretation of the considerations behind the formulation of the "Draft for Comments" in an interview with **.
According to the "Draft for Comments", the National Health Insurance Administration has comprehensively summarized the experience of the operation of the formation mechanism of the first batch of new crown drugs, after in-depth research, multi-party argumentation, and extensive listeningExplore and implement the formation mechanism of the first release of newly listed chemical drugs based on independent quantitative evaluation
Among them,"The higher the self-assessment score, the higher the value of drug innovation, the higher the degree of freedom of the first launch of newly listed drugs", "the self-score is high-grade, and the stability period of the first release is given 1-5 years, and it will not be included in the centralized procurement during the stability period, and in principle, it will not interfere with the network".and other protection measures are considered by the industry to support "true innovation".
Affected by this, the Hong Kong stock drug and biotechnology index rose all the way intraday on the 6th, closing up nearly 5% on the day. The A-share pharmaceutical sector also rose all the way, with WuXi AppTec rising 7% intraday, Hengrui Pharmaceutical rising more than 9%, and Rongchang Biotech and Mabwell Biotech on the Science and Technology Innovation Board 20cm up and down.
"One province is connected to the network, and the whole country is passing".
The new regulations for the first release of drugs were originally introduced in the midst of the epidemic to promote the marketing of new crown drugs as soon as possible.
At the beginning of January 2023, the National Healthcare Security Administration issued the Guidelines for the Formation of Novel Coronavirus Drugs (Trial) (hereinafter referred to as the "Guidelines"), which includes a total of 13 requirements, and the specific measures can be summarized into 6 aspects, including:
Change the original mode of separate acceptance by provinces and repeated submission of materials by enterprises, and the first batch of new crown drugs will be accepted and used nationwide; It is clear that the applicant shall make a special explanation of the raw material cost, R&D expenses, period expenses, innovation and economy of the first issuance, etc., with the purpose of opening up the first constituent elements and promoting the development of the enterprise based on factors such as production and operation costs and market supply and demand.
Since then, including Junshi Biosciences, Simcere Pharmaceutical, Zhongsheng Pharmaceutical, and Merck, etc., the new crown ** drugs developed by these domestic and foreign pharmaceutical companies have all passed the new regulations for initial public issuance after being approved for marketing.
After a new drug is launched, there will be a process of hanging the net. According to the past, it was necessary to go to the network one province by another, and the rules of each province were different, so the time experienced in the middle would be relatively long, because only after the realization of each province could the drug be sold. ”
However, during the epidemic, because it is necessary to ensure that the new crown medicine can be used as soon as possible, a relatively special online procurement policy has been implemented. We first negotiated a first issue with the Price Procurement Division of the Medical Insurance Bureau, and then the Price Procurement Division issued a document to the provinces, and then the provinces were listed on the network in accordance with the determined **In this way, the time for the drug to enter the terminal is greatly shortened。An industry insider who has participated in the listing of new crown drugs told the reporter of the Science and Technology Innovation Board.
Therefore, if the newly listed chemical drugs are implemented once the initial release formation mechanism is implemented, in the eyes of the enterprise, the most intuitive advantage isIt improves the efficiency of drug hanging"This province is linked to the network, implemented nationwide, and the enterprises of the province are running everywhere, and one province is going to hang. Some business people said so.
In addition, according to the interpretation of the relevant person in charge of the National Health Insurance Bureau's ** Recruitment DepartmentThe first ** network service model is a new channel in parallel with the previous network connection model。Enterprises can choose to follow the initial listing mechanism, and enjoy the convenience of centralized initial issuance, green channel and other services while undertaking certain information disclosure obligations and accepting peer review and social supervision; You can also choose to continue to hang up the network according to the old mechanism and give up the relevant service conveniences.
"Differential treatment of real and false innovations".
Another highlight of the Draft for Comments is that:It is proposed that the first listing will try to implement a classification management model based on quantitative evaluation, stratify newly listed chemical drugs, and give policy support in echelons.
Specifically, the National Health Insurance Administration has uniformly formulated the enterprise self-assessment scale (hereinafter referred to as the "self-assessment scale") for the first ** classification, which provides guidance for enterprises to evaluate the innovation quality of newly listed drugs from the dimensions of pharmaceutical material basis, clinical value, and evidence-based evidence strength.
The first-time applicant enterprises will self-evaluate the drug against the scale, the maximum number of points that can be obtained for corporate self-assessment (pharmacy points + clinical value points + evidence-based evidence points) is 150 points (60 + 60 + 30), andAccording to the score, it is divided into three levels: high [90-150], medium [50-90], and low [0-50].
The higher the self-assessment score, the higher the value of drug innovation, and thus the greater policy support will be obtained, including:
1. For newly listed drugs with high self-assessment points, the specific composition of the first release is not required in principle;
2. For newly listed drugs with high self-assessment points, the applicant company can grasp the economy of the first listing on its own, and do not make specific information requirements;
3. For newly listed drugs with high self-evaluation points and centering, enterprises can apply for the first launch from the date of receiving the "Notice of Acceptance" of the marketing authorization application officially issued by the Center for Drug Evaluation of the State Food and Drug Administration, but the newly listed drugs with low self-evaluation points can only be declared after the approval of the State Food and Drug Administration.In addition, newly marketed drugs with high self-assessment points and middle can obtain a stable period of 1-5 years for the first launch according to the approval status (formal approval, conditional approval). During the stability period, it can be temporarily excluded from centralized procurement, and in principle, it will not face restrictive measures.
In this regard, a person from a pharmaceutical company who has been concerned about the policy for a long time told the reporter of the "Science and Technology Innovation Board" that this is right"The difference between true and false innovation" is a great benefit to "real innovation".
Deppon Pharmaceutical commented that the "Draft for Comments" is another innovative measure to enhance the high-quality development of innovative drugs, evaluate the innovation and clinical value of drugs in multiple dimensions, support high-quality innovation with clinical value, and tilt policy resources such as online and procurement to true innovation and high-level innovation, so as to avoid pseudo-innovation and low-water "innovation" hitchhiking and crowding out high-quality innovation space.
However, although for newly listed drugs, especially those with high-quality innovative drugs with clinical value, the marketing access of products under the new regulations will become easier and faster.
But at the same time, some industry insiders told the reporter of the "Science and Technology Innovation Board".In order to truly achieve rapid sales of innovative drugs after they are launched, it is also necessary to dredge other links, including hospitals, medical insurance access, etc.
The listing of drugs is not equal to the access of the hospital market, because the access of the hospital market is actually one of the biggest problems plaguing innovative pharmaceutical companies. ”
In addition, the first listing of drugs on the network is not equal to medical insurance access, and if it is not included in the medical insurance catalog, it will greatly affect the access to the hospital market. The other party said.