On the evening of the 17th, the National Medical Insurance Administration announced the "Work Plan for the Adjustment of the National Medical Insurance Drug List in 2020" (hereinafter referred to as the "Plan") and the "Guidelines for the Application of the 2020 National Medical Insurance Drug Catalog Adjustment" (hereinafter referred to as the "Guide"). By the time, drugs for the treatment of respiratory diseases related to new coronary pneumonia can be included in the scope of new drugs proposed in the 2020 drug catalog.
Source: National Medical Insurance Bureau official website
Which drugs can be included in the scope of the proposed new drugs?
The "Plan" shows that, considering the functional positioning of basic medical insurance, the clinical needs of drugs, and the affordability of funds, the scope of adjustment of the drug catalog in 2020 is as follows:
Western medicines and Chinese patent medicines outside the catalog
According to the "Plan", drugs that meet the provisions of Articles 7 and 8 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" and have one of the following circumstances can be included in the scope of new drugs in the 2020 Drug List.
1. Drugs for the treatment of respiratory diseases related to new coronary pneumonia.
2. Drugs included in the "National Essential Drug List (2018 Edition)".
3. Drugs that are included in the list of urgently needed overseas new drugs for clinical use, the list of encouraged generic drugs, or the list of encouraged research and development of children's drugs, and have been approved for marketing by the State Drug Administration before August 17, 2020 (inclusive, the same below).
4. The second batch of nationally organized drugs selected for centralized drug procurement.
5. From January 1, 2015 to August 17, 2020, new generic drugs approved for marketing by the State Drug Administration.
6. During the period from January 1, 2015 to August 17, 2020, supplementary applications were submitted to and approved by the National Food and Drug Administration based on the results of clinical trials, and drugs with major changes in indications, functions and indications.
7. Before December 31, 2019, enter 5 (inclusive) or more provincial-level drugs in the latest edition of the basic medical insurance drug list. Among them, the main active ingredients are included in the "first batch of national key monitoring and rational use of drugs (chemical drugs and biological products)" except.
The "Plan" also stated that all Western medicines and proprietary Chinese medicines outside the list of eligible drugs shall be declared by the enterprise in accordance with the procedures, and shall be included in the scope of the proposed addition after approval. The identification of exclusive drugs is subject to August 17, 2020.
Western medicines and Chinese patent medicines in the catalog
The "Plan" pointed out that drugs in the drug catalog that meet the requirements of Articles 9 and 10 of the "Interim Measures for the Administration of Basic Medical Insurance Medications" and have one of the following circumstances can be included in the scope of adjustment of the 2020 drug catalog.
Which drugs will be transferred out of the scope of the list of drugs?
The "Plan" stated that the scope of the drugs to be transferred out of the catalog includes drugs that have been revoked, revoked or cancelled by the national drug regulatory authority. Taking into account factors such as clinical value, adverse reactions, and drug economics, it is assessed that the risks are greater than the benefits.
The "Plan" also adjusts the scope of payment for standard drugs, which are within the validity period of the agreement and need to re-determine the payment standard negotiated drugs according to the agreement. According to enterprise declaration or expert evaluation, it is necessary to adjust the negotiated drugs that limit the scope of payment. Compared with other drugs in the same treatment field, the price/expense is obviously higher, and in recent years, it has taken up a lot of funds.
The "Plan" also announced the timeline for adjusting the drug catalog. July-August 2020 is the preparatory stage, August-September 2020 is the declaration stage, September-October 2020 is the expert review stage, and October-November 2020 is the negotiation and bidding stage. The results phase will be announced from November to December 2020.
In addition, the "Guide" mentions that the applicant is the marketing authorization holder or the authorized agent of the drug that meets the scope of this guide. The method of declaration is unified online declaration, and paper declaration materials are submitted simultaneously. There is no charge for declaration. The content of the application mainly includes the basic information, cost information, supporting materials, etc. of the declared drug. The specific content and related requirements are subject to the content of the "2020 National Medical Insurance Drug Catalog Adjustment Application System".
Source: Chemical Network
