The article is from the public number: Economic Observer (ID: eeo-com-cn) , author: according to Qu Yin, Liu, from the title figure: vision China


November 28, 2019 National Health Insurance Negotiation ResultsCome out. The reporter learned at the press conference that 150 drugs were negotiated into 97, all of which were included in the category B drug list.

70 of the 97 successfully negotiated drugs are new drugs, most of which are newly marketed in recent years and have high clinical value, involving cancer, rare diseases, hepatitis, diabetes, multidrug-resistant tuberculosis, rheumatic immunity, Cardio-cerebral vessels, digestion and other more than 10 clinical treatment areas.

From the perspective of key areas, all 5 basic drugs were successfully negotiated, 22 anticancer drugs, 7 drugs for rare diseases, and 14 chronic diseases. (including diabetes, Hepatitis B, rheumatoid arthritis, etc.) medication, 4 children medication negotiations were successful, and the directory structure has been further optimized.

The average price of a drug that has been successfully negotiated has fallen by 60.7%. The average decline in the three types of hepatitis C treatment medications was more than 85%, and the average decrease in treatment medications such as tumors and diabetes was about 65%. Twenty-seven of the 31 renewed drugs were successful, with an average price drop of 26.4%.

In 2019, the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drugs Catalog included a total of 2,709 medicines. Compared with the 2017 version, 218 drugs were imported, 154 drugs were transferred, a net increase of 64.

Only one finalist of the star cancer drug PD-1

On the official website of the Medical Insurance Bureau, the list of drugs negotiated during the agreement period (1) Western medicine, the market focus PD-1 monoclonal antibody is only Cinda Bios (01801 .HK) (brand name: Daboshu) was shortlisted. The list shows that the payment standard for Xindili mAb is 2843 yuan (span class = “text-remarks” label = “Remarks”> (10ml: 100mg / bottle) . In addition, Medicare payments are limited to patients who have relapsed or refractory classic Hodgkin lymphoma after at least second-line chemotherapy.

CindaBio’s Xindilizumab was approved for listing in December last year, and officially started selling on March 9 this year. The price is 7838 yuan. (10ml: 100mg/ Bottle) . According to the drug donation plan announced by Cinda Bio, the annual treatment cost for patients after the drug donation plan is about 160,000 yuan. Cinda Bio’s 2019 Interim Report shows that in the first half of the year, sales of Sintilizumab were approximately 332 million yuan.

Cinda Bio has a high willingness to reduce the price of Xindilizumab. The Minsheng Securities research report shows that there is fierce competition for relapsed or refractory classic Hodgkin’s lymphoma indications. Hengrui Medicine and BeiGene have related products, and Xindilizumab faces greater sales pressure.

In addition, in the case of little difference in clinical results, the annual treatment cost of Xindilizumab is about 50,000 yuan higher than that of Carrelizumab of Hengrui Medicine. Monoclonal antibodies are under pressure in terms of price and sales strength.

The objective response rate of tislelizumab from BeiGene in classic Hodgkin lymphoma indications (ORR) And complete relief (CR) The data is better than that of Xindilizumab, and it is expected that after listing of Tislelizumab, Dilitumab caused greater sales pressure.

Analysis of Minsheng Securities Research Report states that there is only one PD-1 monoclonal antibody in medical insurance, which has little impact on PD-1 monoclonal antibody manufacturers, because from the current sales data of four listed products and the PD-1 field From the perspective of unmet clinical needs, the profitability of pharmaceutical companies can be guaranteed.

13 key questions from National Medical Insurance Bureau

The National Medical Insurance Bureau conducted a detailed interpretation of the core issues such as the objectives of the medical insurance negotiations, the number of drugs negotiated, the results of the negotiations, changes in the patient’s personal burden, and the payment standards of the negotiated drugs.

I. What are the general ideas and goals of the National Medical Insurance Drug Negotiation and Access Work in 2019?

In order to implement the decision-making arrangements of the Party Central Committee and the State Council, the National Medical Insurance Bureau has seriously carried out the adjustment of the National Medical Insurance Drug Catalogue in 2019. This adjustment is generally divided into two stages: regular access and negotiated access.

Negotiation access just concluded is the largest ever since the establishment of the medical insurance system. This negotiation always adheres to the basic starting point of maintaining the health of the insured, adheres to the basic functional positioning, adheres to overall planning, and adheres to an open, fair, and impartial expert review system.The requirement of “do your best and do your best” establishes the adjustment idea of ​​”emphasizing the key points, complementing the shortcomings, optimizing the structure, and encouraging innovation”;

Under the premise of ensuring that the fund is affordable, the National Medical Insurance Bureau will give full play to the institutional, policy, and market advantages of the overall management of urban and rural medical insurance, negotiate and reach agreements with relevant companies, and improve the basic medical insurance drug security capabilities and Level, the goal of improving the efficiency of the use of medical insurance funds is conducive to better meet the basic medication needs of the insured and improve the sense of gain for the broad masses of people.

Second, what is the number of drugs entering the negotiation process?

Negotiations on access to medical insurance medicines are only for exclusive medicines that were marketed in China before December 31, 2018. During the routine access phase of the medical insurance drug catalog, experts reviewed and voted to propose 128 negotiated drug alternatives. After confirming the negotiation intention with the enterprise, 119 drugs were finally identified as new negotiated varieties. In addition, 31 of the varieties negotiated in 2017 need to be negotiated again to determine whether they can renew their contracts. The two add up to a total of 150, and the number of new negotiated drugs and the total number of negotiated drugs have reached record highs.

III. What is the result of this national medical insurance drug negotiation? (What is the negotiation success rate? Successfully negotiated drugs How much is the quantity, type, treatment area, and price?)

Of the 150 negotiated drugs, 70 of the 119 new drugs were successfully negotiated, including 52 western medicines and 18 Chinese patent medicines, with an average price decrease of 60.7%. The average decline in the three types of hepatitis C treatment medications was more than 85%, and the average decrease in treatment medications such as tumors and diabetes was about 65%. Twenty-seven of the 31 renewed drugs were successfully negotiated, with an average price drop of 26.4%.

The drugs that have been successfully negotiated are mostly new drugs that have been marketed in recent years and have high clinical value, involving more than 10 clinical trials including cancer, rare diseases, hepatitis, diabetes, multidrug-resistant tuberculosis, rheumatic immunity, cardiovascular and cerebrovascular disease, and digestion Treatment area.

After regular access and negotiated access, the adjustment of the national medical insurance drug list in 2019 was fully completed, and 2,709 drugs were finally included. Compared with the 2017 version of the catalog, 218 drugs were imported, 154 drugs were transferred, and a net increase of 64 drugs. After this adjustment, the support capabilities in key areas have been further improved, and the basic medical insurance support capabilities have reached a new level.

Fourth, the catalogue adjustment plan mentioned that priority will be given to non-medical insurance products in national essential medicines, treatment of major diseases such as cancer and rare diseases, treatment of chronic diseases such as hypertension and diabetes, and medication for children. What about access to drug negotiations?

This negotiation has always focused on the clinical treatment needs of the insured patients, focusing on tumors, rare diseases, chronic diseases, and children’s medications. All essential drugs that entered the negotiation process have been successfully negotiated.

The closely watched PD-1 tumor immunotherapy drugs and oral medicines that can cure hepatitis C have entered the list for the first time. Lung cancer, rectal cancer, breast cancer, etc. have more choices of targeting and chemotherapy drugs. Bosentan, The successful negotiation of medicines such as Maggot and other rare diseases such as pulmonary hypertension and C-type Nimanpick disease have eliminated the dilemma of no cure in the list, diabetes, hepatitis B, rheumatoid arthritis, multidrug-resistant tuberculosis, chronic Patients such as obstructive pneumonia have more high-quality new drugs to choose from.

From the perspective of key areas, all 5 basic drugs have been successfully negotiated, 22 anticancer drugs, 7 drugs for rare diseases, 14 chronic diseases. (including diabetes, Hepatitis B, rheumatoid arthritis, etc.) medication, 4 children’s medication negotiations were successful, the directory structure was further optimized, and the expected goals were achieved.

5. What is the process of the national medical insurance drug negotiation and admission process?

The first is to formulate a negotiation plan and collect relevant data. After fully listening to the opinions and suggestions of various parties and repeatedly demonstrating, the “Work Plan for Negotiation and Access to the Medical Insurance Drug List in 2019” was formulated. Collect and summarize relevant data through multiple channels, such as local medical insurance departments, enterprises, and drug recruitment platforms, to lay a solid foundation for negotiations.

The second is to estimate the floor price for negotiations. The authoritative experts and backbones in pharmacoeconomics and medical insurance management will be drawn up nationwide, and the pharmacoeconomics group and fund measurement group will be established respectively, and grouped and calculated in parallel according to the key points of measurement technology to form a negotiated floor price.

The third is to strengthen communication with enterprises. Organize two rounds of centralized communication, introduce the general arrangement of the negotiation work, the factors to be considered for the calculation of specific drug negotiations, the negotiation rules, and the requirements for submitting information, guide them to form reasonable expectations, and fully listen to the opinions and suggestions of the enterprise. Establish a communication mechanism to respond to the concerns of the enterprise in a timely manner, and organize experts to demonstrate it if necessary.

Fourth, conduct on-site negotiations. Formulate negotiation rules and procedures, and clarify negotiation details,