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On the evening of June 9th, the National Medical Insurance Administration publicly solicited opinions on the "2021 National Medical Insurance Drug Catalog Adjustment Work Plan" and the "2021 National Medical Insurance Drug Catalog Adjustment Application Guidelines"
.
This means that the adjustment of the medical insurance catalogue and medical insurance negotiations have begun again after a lapse of one year.
According to the draft opinion, the scope of the 2021 National Medical Insurance Drug Catalogue to adjust the application of drugs is mainly outside the medical insurance catalog and within the existing medical insurance catalog
.
According to the document, the adjustment of the National Drug List in 2021 is divided into five stages: preparation, declaration, expert review, negotiation, and announcement of results
Before the end of June this year, new drugs are expected to enter the medical insurance.
A batch of "zombie drugs" will be transferred out
A batch of "zombie drugs" will be transferred out
According to the opinion draft, the drugs outside the medical insurance catalogue are:
1.
From January 1, 2016 to June 30, 2021, new generic drugs approved for marketing by the State Drug Administration;
2.
During the period from January 1, 2016 to June 30, 2021, drugs with major changes in indications or functions and indications approved by the State Drug Administration;
3.
Drugs for the treatment of respiratory diseases related to new coronary pneumonia;
4.
Drugs included in the "National Essential Drug List (2018 Edition)"
.
All Western medicines and Chinese patent medicines outside the catalog that meet the above conditions shall be declared by the enterprise in accordance with the procedures, and shall be included in the scope of review after being approved
In the first half of 2021, the State Food and Drug Administration has approved the listing of many new drugs or new indications.
According to the statistics of the People’s Daily Health Client, a total of 19 new drugs were approved for listing (including new indications) in the first quarter alone, including non-small cell lung cancer, Breast cancer, systemic lupus erythematosus, X-linked hypophosphatemia and many other diseases
.
For example, pratinib and avatinib from CStone Pharmaceuticals; the first class new drug Utidelone injection from Huahao Zhongtian Pharmaceuticals, tatacitrin from Rongchang Biologics, lacosamide tablets from Utimes, Repetinib from Zai Lab
From May 7th to June 6th, more than 10 new drugs were approved by the State Food and Drug Administration
.
Just yesterday (June 9th), Rongchang Biotech's Vidicuzumab, Zejing Biotech's Donafinil Tosylate and other new drugs were also successfully approved for listing
In addition, a number of domestically produced PD-1s have successively harvested new indications, including Hengrui Carrelizumab for Injection (first-line treatment of nasopharyngeal cancer), BeiGene Tilelizumab (squamous NSCLC), and Xinda Deeley bioinformatics mAb (non-squamous NSCLC), Jun is biological Terry Plymouth mAb (recurrent / metastatic nasopharyngeal carcinoma) and the like
.
The medicines in the medical insurance catalogue are the exclusive negotiated medicines whose agreement expires on December 31, 2021, and the payment standard needs to be re-determined in accordance with the agreement; from January 1, 2016 to June 30, 2021, approved by the National Food and Drug Administration , Indications or functional indications have undergone major changes, and the company takes the initiative to declare and adjust drugs that limit the scope of payment
.
In addition, the scope of medicines that have been transferred out of the medical insurance catalog are:
Drugs that have been revoked, revoked or cancelled by the State Drug Administration
.
Taking into account factors such as clinical value, adverse reactions, and drug economics, it is assessed that the risk is greater than the benefit of the drug
.
Focus on drugs that have been listed in the catalog before January 1, 2016 and have no purchase records on the national drug procurement platform from January 1, 2016 to June 30, 2021
The main aspects of the range of drugs for which the payment standards have been adjusted are:
Negotiated drugs that are within the validity period of the agreement and need to re-determine the payment standard in accordance with the agreement
.
According to the company's declaration, it is necessary to adjust the negotiated drugs that limit the scope of payment after expert review
.
Compared with other medicines in the same treatment field, the prices or expenses are obviously higher, and medicines that have occupied a large amount of funds in recent years
.
National Talks on Drugs "Dual Channels" Open to Break the Difficulties of Drug Admission
National Talks on Drugs "Dual Channels" Open to Break the Difficulties of Drug AdmissionIn 2020, the National Medical Insurance Catalogue Negotiation was the largest since the establishment of the medical insurance system.
A total of 162 drugs were negotiated, 119 drugs were successfully negotiated, and the overall price drop was 50.
64%.
The new medical insurance catalogue was officially implemented on March 1 this year.
.
After adjustment, a total of 119 drugs were added to the catalog, and 29 drugs in the original catalog were removed from the catalog
.
The 2020 medical insurance catalog includes a total of 2,800 Western medicines and proprietary Chinese medicines, including 1,264 Western medicines, 1,315 Chinese patent medicines, and 221 medicines negotiated during the agreement period
Looking back at past medical insurance negotiations, the average drop in medicines was more than 50%.
The industry expects that this medical insurance catalog adjustment is no exception, and it may be even more intense
.
Prior to this, the drugs newly included in the medical insurance catalogue all encountered difficulties in hospital admission
.
In order to break this situation and improve the availability of medicines, on May 10, the National Medical Insurance Administration, in conjunction with the National Health Commission, issued the "Guiding Opinions on Establishing and Improving the "Dual Channel" Management Mechanism for National Medical Insurance Negotiation Drugs"
The opinion puts forward a clear focus on including drugs with high clinical value, urgent demand, high cost, and low substitutability into the "dual channel", and at the same time, it is clear that designated retail pharmacies will be included in the scope of medical insurance drug supply guarantee from the national level (payment standards and medical institutions Unification)
.
CITIC Securities predicts that after the nationwide implementation, it is expected to solve the previous problem of "two non-reliance" for some drugs (some drugs are difficult to enter the hospital, and at the same time cannot be reimbursed outside the hospital), greatly encouraging market competition
.
Attachment: 2021 National Medical Insurance Drug List Adjustment Work Plan (Draft for Solicitation of Comments)