Detailed Explanation Of 2020 Medical Insurance "Changing Cage For Bird": Drug Declaration Time Limit Extended To Encourage Innovative Drug List

The medical insurance fund "changes the cage for the bird" and encourages innovation to take a more clear step.

On the evening of August 17, the official website of the state medical insurance bureau announced the work plan for the adjustment of the national medical insurance drug list in 2020 and the application guide for the adjustment of the national medical insurance drug list in 2020.

The drug list adjustment is divided into five stages: preparation, declaration, expert review, negotiation and bidding, and announcement of results, which will last from July to the end of the year.

August 17, 2020 is the most important time node in the announced plan, which greatly lengthens the time limit for drug inclusion, which means that more newly approved and qualified drugs can be declared, negotiated and competitive.

The introduction of this plan means that the national health insurance negotiation will be further institutionalized, normalized and transparent. "It is mainly to make the system more solid, more specific, more detailed and more transparent. In particular, the adoption of the enterprise independent declaration system is the biggest bright spot, so as to avoid good drugs from being "strangled" in the evaluation cradle. Secondly, the approval time of new drugs will be extended to August 17, 2020, which will accelerate the time for new drugs to enter the medical insurance system. " Jin Chunlin, director of the Shanghai Health and health development research center, said in an interview with the 21st century economic report that "the conditions and directions of seven cases of medical insurance are specified, which are consistent with the previous policies, that is, to encourage the direction of biomedical innovation, to pursue the optimization of catalog varieties, the appropriate price, to improve the curative effect, and to pursue value medicine."

Speed up the entry of new drugs into medical insurance

Recently, the rare disease spinal muscular atrophy (SMA) and its treatment drug, nosinasheng sodium injection, were hot searched with "70 million injection medicine" and caused public opinion controversy. Bojian, the company that develops and produces the drug, mentioned the time limit of medical insurance negotiation in the previous year when issuing a response statement: the drugs participating in the 2019 national health insurance negotiation must be the drugs approved before December 31, 2018 However, nosinasheng sodium injection was approved in February 2019, which did not meet the requirements. Therefore, it did not participate in the medical insurance negotiation last year.

Bojian said that he has been actively communicating with relevant departments of the state and local governments, calling for the establishment of a multi-party co payment mechanism to further improve the drug access of SMA patients in China.

In the newly released adjustment plan, new drugs approved between December 31, 2019 and August 17, 2020 will no longer have this problem.

According to the above plan, the adjustment scope comprehensively considers the functional orientation of basic medical insurance, clinical drug demand and fund bearing capacity. Western medicine and Chinese patent medicine outside the catalog can be included in the 2020 drug list. The adjustment scope of the proposed new drugs includes seven situations: first, the treatment of respiratory diseases related to new coronavirus pneumonia is included in the diagnosis and treatment plan for new coronavirus pneumonia (Trial Implementation) The second is the drugs included in the national essential drug list (2018 Edition); the third is the drugs included in the list of clinical urgent need overseas new drugs, the list of encouraged imitation drugs or the list of children's drugs that are encouraged to apply for application, and which have been approved by the State Drug administration before August 17, 2020 (including, the same below); and the fourth is the second batch of centralized drug procurement organized by the state Drugs; 5. New generic drugs approved by the State Drug Administration during the period from January 1, 2015 to August 17, 2020; 6. Drugs with significant changes in indications, functions, indications, etc. according to the clinical trial results, the new generic drugs approved by the State Drug Administration during the above-mentioned period (the same 5) shall enter the latest version of more than 5 (including) provinces before December 31, 2019 Drugs in the list of basic medical insurance drugs. Among them, the main active ingredients are listed in the first batch of national key monitoring and rational drug use list (chemical and biological products).

The qualified western medicine and Chinese patent medicine outside the list of drugs shall be declared by the enterprise according to the procedures, and shall be included in the scope to be added after being examined and approved. The identification of exclusive drugs is also subject to August 17, 2020.

"The market and enterprises are more excited to extend the time limit for drug inclusion." Zhao Bing, chief analyst of the pharmaceutical industry of Huajing securities, interpreted this in an interview with the 21st century economic report. Originally, it was as of December 31 of the previous year, "I don't know whether it will be like this in the future or a special case. In the first half of the year, the approval of new drugs was delayed due to the epidemic situation. But the agency has responded to the call. Because in recent years, the drug administration reform and the acceleration of new drug approval are the beginning of significant changes in China's pharmaceutical industry starting from January 1, 2015 mentioned in the document. This batch of new drugs was started according to the new standards, that is, the efficacy and other aspects are actually different from the previous so-called new drugs. This reflects that the National Medical Insurance Bureau encourages the direction of new drugs to remain unchanged, and the overall thinking of medical insurance bureau to include new drugs and good drugs is also unchanged. "

For the new crown drugs, according to the "new coronavirus pneumonia diagnosis and treatment plan (trial version 7)", the drugs involved include antiviral drugs interferon, lopinavir / ritonavir, ribavirin, chloroquine phosphate, abidol, etc., the immune drug tobzumab, and Chinese patent medicines including Xiyanping, Xuebijing, Xingnaojing and other traditional Chinese medicine injections.

According to Jin Chunlin's interpretation of the article, "it is in line with the current actual situation to allow some qualified drugs to be eligible for application, but it still needs expert consultation and consensus, and after negotiation and bidding, there is no problem to be more lenient in the front and stricter in the back."

In the past, the list of medical insurance may remain unchanged for many years. Zhao Bing believes that the plan also reflects the timeliness of the dynamic adjustment of medical insurance. "It is reflected in the relevant drugs included in the new crown pneumonia epidemic situation, and it has also fulfilled the commitment of the medical insurance bureau for the use of medical insurance funds when it was established."

Transfer out risk

In addition to the new drugs, western medicine and Chinese patent medicine in the list are also facing the risk of being transferred out and adjusted this time, which is not once and for all.

First of all, the scope of the drugs to be transferred out of the list, including the drugs whose approval documents have been revoked, revoked or cancelled by the State Drug Administration; and the drugs whose risks are greater than the benefits after comprehensive consideration of the factors such as clinical value, adverse reactions and drug economy.

Perhaps the greater impact is another kind of drugs that "adjust the scope of payment standard drugs": the negotiation drugs that are in the validity period of the agreement and need to be re determined according to the agreement; the negotiation drugs with limited payment scope are necessary to be adjusted according to the enterprise declaration or expert evaluation; compared with other drugs in the same treatment field, the price / cost is significantly higher, and the cost occupies the base in recent years Drugs with more gold.

Jin Chunlin pointed out that first of all, enterprises need to provide more data to prove that their products have better cost and effect. Otherwise, it is difficult for new drugs to be included in the medical insurance, and those already included in the medical insurance may also be removed. "Pharmaceutical economics is very important for the drugs listed in the payment standards that can be adjusted and adjusted. If there are other drug substitutes, as well as the adjustment of the scope of indications and payment standards, it is estimated that the impact will be relatively large, and the enterprises originally in the list can not relax. "

For some hot spots, such as PD-1, only Xinda entered the medical insurance last year. This year's competitors, including Hengrui medicine and Baiji Shenzhou, which were later approved, have attracted more and more attention due to the approved multiple indications.

"The PD-1 rate is likely to enter this year, but at what price is the concern of many people." Zhao Bing believes that the price reduction may be very large, "which also tells us that the hot areas may not be very good, and there are risks in assembling."

This is also a good time for Baiji Shenzhou, where both new drugs are within the time limit. "In terms of business, we have officially launched two drugs this year, one PD-1 and one Btk, with very good sales. At present, the domestic drugs are in a very strong trend Wang Lai, senior vice president of Baiji Shenzhou and head of global research and Asia Pacific clinical development, said in an interview with 21st century economic report.

Referring to 2019, of the 150 negotiated drugs in 2019, 70 of the 119 new drugs were successfully negotiated, with an average price drop of 60.7%. The average decrease rate of three kinds of hepatitis C treatment drugs was more than 85%, and the average decrease rate of treatment drugs for tumor and diabetes was about 65%.

In addition to cancer, chronic diseases and children's medication, rare diseases are also one of the key points. All the essential drugs entering the negotiation process were successfully negotiated. The highly concerned PD-1 tumor immunotherapy drugs and oral drugs that can cure hepatitis C were included in the list for the first time. Bosentan, megestat and other drugs were successfully negotiated, which made patients with pulmonary hypertension, nimanpick disease type C and other rare diseases out of the list There is no cure.

"European and American companies like to make orphan drugs in recent years, and our country encourages them. However, the price of orphan medicine is very expensive, and the number of orphans is too small. In fact, it is impossible to talk about the price of orphan medicine in medical insurance. " Zhao Bing believes that China's medical insurance funds have gone from "low price theory" to "economic and applicable type", rather than "the more new, the more effective, the better" in Europe and the United States. "If any drug wants to reflect the cost performance, it is certain that it is effective, but at the same time, we should pay attention to the price. If a new drug may be effective but expensive, it will not have a large market in China. The original intention of the establishment of the medical insurance bureau is not to control costs or limit the use of medical insurance funds, but to use the funds more reasonably and effectively. The money should be worth spending, which has made great progress. ".

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