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    Home > Medical News > Medical World News > New edition of medical insurance Catalogue: set up new standards for market access

    New edition of medical insurance Catalogue: set up new standards for market access

    • Last Update: 2019-11-06
    • Source: Internet
    • Author: User
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    With the release of the national basic medical insurance, work injury insurance and maternity insurance drug catalogue (hereinafter referred to as nrdl) in 2019, the National Medical Insurance Bureau has completed the first stage of this year's update of the medical insurance catalogue, including the transfer in of conventional access drugs without negotiation, transfer out of some drugs and administrative adjustments In the coming second phase, although the first drug negotiation this year will determine the main path of Western medicine medical insurance payment, in addition to setting the pace of nrdl biennial update, there are still many aspects worthy of close attention 1 Small scale adjustment will become the new normal: compared with 133 new Western medicines in nrdl 2017, only 47 new Western medicines are added in nrdl 2017 However, the adjustment range is reasonable The 2017 version of the medical insurance catalog is the first adjustment after eight years since 2009, and this adjustment is only two years away from the previous one According to the preset speed adjusted every two years, nrdl will continue this fine-tuning mode in the future At the same time, the price negotiation for the newly approved new drugs once a year will become the main way for them to enter the market 2 Large scale transfer of chronic disease drugs to multinational enterprises: the beneficiaries of this catalogue include many multinational enterprises Their innovative drugs for autoimmune diseases, diabetes and hypertension (including combination therapy) have been directly transferred into this year's nrdl, such as two newly approved rheumatoid arthritis drugs, i.e Romero (toshizumab) and Johnson Simpson (golimumab) In addition, anticancer drugs and rare disease drugs have entered the stage of price negotiation, not reflected in the regular access 3 The national health and Health Commission and the health insurance bureau coordinate and promote: the national health and Health Commission (NHC) and the National Health Insurance Bureau (NHSA) cooperate to ensure the effective implementation of the reform Through consultation, 20 national key monitoring drugs for rational use announced by the health and Health Commission on July 1, 2019 were all transferred out of the medical insurance catalogue In addition, the medical insurance bureau also strictly implements the policy of restricting the prescription right of Western medicine by the health care Commission, and the western medicine without assessment cannot issue the prescription of Chinese patent medicine and Chinese herbal pieces 4 The authority of provincial adjustment has been withdrawn: the announcement of the state health insurance bureau indicates a major market change, that is, all regions are not allowed to increase the list of class B drugs by themselves, which also shows that the future drug listing is completely under the unified jurisdiction of the state level, and it is very difficult for pharmaceutical enterprises to hope to make up for the loss of failing to enter the national health insurance catalog through the supplement of provincial health insurance catalog In 2019, the number of nrdl regular access drugs released increased to 2643, only 4.3% higher than that in 2017, including 1322 western drugs; and a total of 148 new drugs were added (see Table 1 in the full report) The newly added drugs cover the priority national essential drugs, children's drugs (38 drugs) and chronic diseases drugs (36 drugs) such as diabetes, etc., and the treatment drugs for major diseases such as cancer and rare diseases have basically all entered the price negotiation The new nrdl is expected to be implemented from January 1, 2020 5 Drugs transferred out: about 50% of the drugs transferred out of the new nrdl are related to the lack of market recognition effectiveness, and other drugs are transferred out due to low clinical value, better alternative treatment means, obvious abuse and other reasons In July of this year, the national health and Health Commission released the first batch of national key monitoring rational drugs catalog (chemical and biological products) to publicize the varieties with unreasonable drug use According to the insiders, the health and Health Commission finally persuaded the state health insurance bureau to transfer all 20 key monitored varieties with a market value of about 50 billion yuan out of the medical insurance catalog (see Table 4 below for the complete list) 6 Adjustment of class a drugs: there are 75 drugs adjusted from class B to class A (class a drugs are reimbursed 100%), most of them are traditional Chinese medicine, and the total number of class a western medicine is less than 4 last year Table 5 (see the complete report) is the western medicine adjusted from nrdl class B to class a this year Seven Cancellation of the provincial supplementary Catalogue: on July 22, the state health insurance bureau issued the opinions on the establishment of the management system of the list of medical insurance benefits (Draft for comments), which pointed out that the state uniformly formulated the national basic medical insurance drug catalogue, and all regions strictly followed the national basic medical insurance drug catalogue, in principle, they are not allowed to make their own catalogue or use alternative methods to increase the drugs in the catalogue 。 It means that after the new version of the national health insurance catalog is published, all provinces and cities should keep the same with it, and there is no provincial health insurance supplement catalog In addition, each overall planning area may, in accordance with national regulations, formulate medical insurance payment standards for drugs, medical service items and facilities and for various payment methods If the State formulates payment standards in a unified way, the provisions of the State shall prevail In principle, the policies and measures issued in the past that do not conform to the list shall be cleaned up and standardized within three years, and shall be connected with the national policies, and priority shall be given to the key monitoring and rational use of drugs issued by the health care Commission 8 Diabetes drugs: in the adjustment of the medical insurance catalog, the most drugs were adjusted in the digestive tract and metabolism, with 12 drugs transferred in (see Table 2), of which most were hypoglycemic drugs Novo Nordisk's new generation of ultra long acting basic insulin analogue, Novo Nordisk (degu insulin injection), which was just approved for marketing in China in September 2017, quickly won the market In this catalog adjustment, Novo Nordisk was transferred as the only injection to be used as the second-line treatment for type 2 diabetes with poor control of other long-acting insulin drugs In addition, seven kinds of oral compound hypoglycemic drugs, including all common DPP-4 inhibitors and metformin combination therapy, were added in the adjustment of the medical insurance catalogue, respectively, jienoda (cigliptin metformin tablets), anligo (shagliptin metformin sustained release tablets) of AstraZeneca, obinin of bringlingham and yiheli (metformin wiggliptin tablets) of Novartis 。 It should be noted that this routine access does not cover glucagon like peptide-1 receptor agonists for the treatment of type 2 diabetes Novartis Nordisk's lilaluptide entered the 2017 health care catalog after price negotiations AstraZeneca and Sansheng's BCP, Sansheng's BCP, Sanofi's BCP, as well as Shanghai Renhui's self-developed benaluptide will all go through price negotiations to obtain medical coverage Dulaglutide, a new type of diabetes drug in Lilly, was just approved in China in February, so it will take some time to be included in the medical insurance The following three SGLT2 inhibitors approved for marketing in 2017 are also expected to enter the price negotiations: dapagliflozin from AstraZeneca, empagliflozin from bringlingham and canagliflozin from Johnson & Johnson 9 Arthritis drugs: in the Chinese market, the performance of monoclonal antibodies for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases is poor, but this situation will be improved after the new version of medical insurance adds two kinds of arthritis drugs Both of Roche's yamelo (trozumab injection) and Johnson's hinproni (gelimummab injection) were approved for listing in China on the same day in December 2017, and were included in the new nrdl through regular access without negotiation However, these two drugs are largely limited by the scope of medical insurance payment: yamelo is only used for the second-line treatment of systemic juvenile idiopathic arthritis and RA, Simpson is used for the treatment of RA and ankylosing spondylitis patients who do not respond to other treatments, and severe plaque psoriasis patients In July this year, Roche began to prepare to include yamelo in the medical insurance In the provincial bidding, the price of yamelo was reduced from 1925 yuan (80mg: 4ml) to 830 yuan, a decrease of 57% The sharp price cut of yamero has made the biosimilar drug yisaipu (recombinant human type II tumor necrosis factor receptor antibody fusion protein) of Sansheng Guojian Pharmaceutical Co., Ltd feel more pressure, and its market share of more than 60% of RA may not be guaranteed.
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