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The 5th medical insurance adjustment negotiations in that, the directory adjustment gradually dynamic November 11, the National Health Insurance Administration issued on the 2020 National Health Insurance Drug Catalog adjustment "expert review" results query announcement, through expert review, this stage of work has been completed.
next step, the health care bureau will continue to "negotiate access" and other related work.
according to the 2020 National Health Insurance Drug Catalog Adjustment Work Programme released by the Health Insurance Administration in August, this year's catalog adjustment is divided into five stages: "preparation", "enterprise declaration", "expert review", "negotiating access" and "publishing results".
the "Enterprise Declaration" phase, which was added to the Programme last year, for the first time, the Enterprise Declaration Guidelines were issued, and the information was reviewed in a formal manner and the drugs that passed the formal review were made public.
in particular, the Programme changed the deadline for the adjustment of the scope of the drug catalogue from the end of 2019 to the number of drugs approved by 17 August 2020 inclusive.
means that new drugs with full clinical value but not yet on the market can enter the health insurance list in less time.
now, the health-care directory adjustment cycle has been shortened from the past seven years to two years, until the current one-year adjustment once.
With the further reform of the medical insurance system, the adjustment of the catalogue will be more rational and scientific, and in the future, China's new drugs hope to be approved and talked about as soon as possible, in order to achieve a seamless interface between drug supervision and medical insurance.
October 2015, with the approval of the State Council, 16 ministries (bureaus) such as the Health and Family Planning Commission have established departmental coordination mechanisms to organize and carry out the first batch of pilot national drug price negotiations.
, the dynamic adjustment of the national health insurance catalogue began.
in the past five years, China has gradually established a dynamic adjustment mechanism for the scope of basic medical insurance drugs, optimized the structure of drugs in the catalogue, and at the same time, the negotiation and access to patented drugs, exclusive production of drugs and other high-value drugs continued to advance.
data source: National Health Insurance Administration, Ameda industry research and adjustment scope: including high values, excluding low values, health insurance adjustments have to review the 2015-2016 six-month negotiations, selected by experts for hepatitis B, non-small cell lung cancer, multiple myeloma treatment drugs as pilot varieties, are patented varieties; For the special negotiation of anti-cancer drugs, the varieties are essential for the treatment of solid tumors and hematomas, 2017 and 2019 catalog adjustment, in addition to drug negotiation access, also includes the regular adjustment of the catalog (transfer in, transfer out);
2015-2020 National Health Insurance Directory Adjustment Scope: Data Source: Health and Family Planning Commission, Ministry of People's Social Security, National Health Insurance Administration issued health insurance catalog adjustment related policies, Ameda industry research collated data sources: Health and Family Planning Commission, Ministry of Human Resources, National Health Insurance Bureau issued health care catalog adjustment related policies, Ameda industry research Collated data sources: Health and Family Planning Commission, Ministry of Human Resources, the National Health Insurance Bureau issued the health insurance catalog adjustment related policies, Ameda industry research finishing in addition to the inclusion of good clinical efficacy, reasonable price of new drugs, but also need to regularly eliminate the clinical value is not high, can be replaced by the old varieties, "in and out" is also an important means of catalog structure optimization, can improve the use of health insurance funds.
The National Health Insurance Administration, in interpreting the 2019 Directory Adjustment Work Programme, has indicated that if the drug regulatory authorities have revoked all approval numbers under the generic name or revoked the Imported Drug Registration Certificate, the drug regulatory authorities prohibit the production, sale and use of such products will be transferred directly out of the catalogue;
Previously, the transfer-out mechanism (draft for comments) was also emphasized during the 2016 catalog adjustment, but in fact, in the 2017 health-care catalog, the final transfer of varieties are basically "banned by the state drug regulatory authorities to produce, sell and use" varieties, and the number of transferred varieties is limited.
2019 catalog adjustment and transfer mechanism, but also consider the varieties in clinical use, medical insurance drug requirements, a total of 150 varieties, a greater intensity.
including the "first batch of national key monitoring of rational drug use drug catalog" of calf serum protein, mouse neurogrowth factors, Changchun citin and other drugs.
2017 vs 2019 Health Care Catalog part of the varieties: Data source: 2017, 2019 Health Insurance Catalog, Ameda Sample Public Hospital Database According to the Ameda Sample Public Hospital Sales Data, in 2019 transferred out of the catalog of varieties, according to the general name, The forefront of the country's key monitoring drugs have a better market sales performance.
of health insurance directories is focused on improving the efficiency of the use of health insurance funds and using limited resources to maximize the clinical benefits of patients.
of these varieties also shows that in the process of optimizing the structure of medicines in the medical insurance catalogue, the auxiliary drugs with unclear clinical efficacy will face a crisis.
Negotiating varieties: the number of year-on-year increase, the price reduction is stable 2015-2019 health care negotiations variety number and price reduction range: data sources: Health and Family Planning Commission, Ministry of People and Social Affairs, the National Health Insurance Administration issued the results of the health insurance catalog negotiations, The Emmys industry research and finishing for health care negotiations access work, health insurance funds played a "strategic buyer" role, "quantity exchange" to promote a significant decline in drug costs.
results of the negotiations, it can be seen that a number of world-renowned "noble drugs" issued a "civilian price", imported drugs are basically the lowest price in the world.
, however, there were slight differences in the decline in varieties in different therapeutic areas, such as the average decline in cancer drugs by more than 40 per cent among successfully negotiated varieties in 2017.
in the 2019 negotiations, for the first time, the Health Care Administration introduced competitive negotiations on hepatitis C drugs, with prices falling by an average of more than 85 percent, and drugs for cancer and diabetes by more than 65 percent.
, through the negotiation of the introduction of clinical high-value varieties, to ensure that patients have access to drugs at the same time, and strive to save the cost of national health insurance drugs.
July 2020, the State Administration of Health Insurance issued the Interim Measures for the Administration of Drug Use in Basic Medical Insurance, further clarifying the establishment and improvement of the dynamic adjustment mechanism, which in principle is adjusted once a year.
the same time, the Measures clearly define the requirements related to the transfer of medical insurance catalogues into and out of varieties, and lay an important mechanism guarantee for the transfer and transfer of catalogues.
past, the medical insurance catalog adjustment is slow, the interval is long, the new drug can not be approved in time to be included in the scope of reimbursement, to a certain extent, also inhibited the development of new listed varieties.
the future, dynamic adjustment of medical insurance catalogue can be quickly and effectively incorporated into clinically urgently needed, clinically effective, safe and reasonably priced products, and can effectively eliminate products that are at a disadvantage in multi-dimensional value assessment.
further regulate the use of medicine and dynamic adjustment in China's medical insurance catalogue, which will help to improve the efficiency of the use of medical insurance funds.
also from the pharmaceutical industry, but also conducive to promoting the development of China's pharmaceutical innovation.
, the adjustment of the national health insurance catalogue gradually became normal.
whether it is innovative pharmaceutical enterprises or generic pharmaceutical enterprises, they need to assess their own and variety of the situation, conduct adequate market research, understand the basic market situation, formulate appropriate market access strategies, and strive to maximize the interests of enterprises.