Original research drug crisis! Negotiation drugs and generic drugs included in local medical insurance

Today, three countries, including tegrilol tablet and bortezomib for injection, have negotiated that generic drugs will officially enter the payment scope of basic medical insurance in Tianjin, and Zhengda Tianqing and Shenzhen xinlitai will benefit first National negotiated generic drugs entered the local medical insurance yesterday (October 17), Tianjin Social Security Center issued a notice on issues related to the inclusion of national negotiated generic drugs such as tegrilol tablets in the payment scope of medical insurance It is clear in the notice that since October 18, 2018, generic drugs negotiated for three countries including tegrilol tablet will be included in the payment scope of Tianjin basic medical insurance, work injury insurance and maternity insurance Previously, on August 15, 2018, Tianjin issued a notice on issues related to the payment management of drug generic medical insurance According to the notice, at present, the payment standard of generic drugs is temporarily implemented according to the actual market price, but shall not exceed the payment standard of corresponding negotiated drugs If the generic drug specifications are inconsistent with the negotiated drugs, the payment standard shall be calculated according to the notice of the national development and Reform Commission on printing and distributing the drug price difference rules (fgjg [2011] No 2452) As for tegrilol tablet, which was included in the payment scope of Tianjin medical insurance, tegrilol is a new and selective small molecule anticoagulant developed by AstraZeneca, and the first reversible binding, direct acting, oral administration new P2Y12 receptor antagonist In July 2011, it was approved by the FDA of the United States and listed under the trade name of brilinta In December 2012, tegrilo of AstraZeneca entered the Chinese market According to the data of minenet, tegrilo of AstraZeneca has exceeded the market scale of 500 million yuan in China On the evening of August 2, Shenzhen xinlitai announced that it had received the approval document for drug registration of tegrilol tablets approved and issued by the State Drug Administration, and won the first domestic imitation of tegrilol tablets On October 18, it was included in the payment scope of Tianjin basic medical insurance This will undoubtedly have an impact on AstraZeneca's unique tegrilol market The medical insurance payment standard for tegrilol tablets of AstraZeneca is 90mg / tablet, 8.45 yuan, limited to patients with acute coronary syndrome, and the payment shall not exceed 12 months The medical insurance payment standard converted from tegrilol tablet of Shenzhen xinlitai into 90mg / tablet is 5.99 yuan, which is also limited to patients with acute coronary syndrome, and the payment shall not exceed 12 months According to the policy requirements of the state office, the medical insurance payment standards of generic drugs and original research drugs will gradually approach, which will undoubtedly be more conducive to the market performance of generic drugs Needless to say, up to now, more than 30 domestic pharmaceutical companies have submitted applications for registration of tegrilol, 16 of which have been approved for clinical application and are in review status The payment standard is temporarily implemented according to the actual market price of generic drugs except for Tianjin On July 3, 2018, Beijing Municipal Human Resources and Social Security Bureau issued a notice that generic drugs of 36 negotiated drugs are included in the category B drugs in Beijing basic medical insurance, work injury insurance and maternity insurance drug catalog The notice requires that for the payment standard, if the generic specification is consistent with the negotiated drug, the payment standard shall be temporarily implemented according to the actual market price of the generic drug, but shall not exceed the payment standard of the corresponding negotiated drug; If the generic drug specification is inconsistent with the negotiated drug, the payment standard shall be calculated according to the notice of the national development and Reform Commission on printing and distributing the drug price difference rules (fgjg [2011] No 2452) If the calculated payment standard is higher than the actual market price of generic drugs, the actual market price of generic drugs shall be taken as the payment standard On August 21, 2018, Tongchuan City, Shaanxi Province also issued a notice to include generic drugs of national negotiated drugs into the payment scope of basic medical insurance, and manage them according to class B drugs in the national drug catalog The limited payment content shall be implemented in accordance with the provisions of similar drugs in the document of the Ministry of human resources and social security [2017] No 54 On September 30, 2018, the general office of Tianjin Municipal People's government issued the notice on the implementation plan of reforming and improving the supply guarantee and use policy of generic drugs According to the notice, we will establish and improve the dynamic adjustment mechanism of the medical insurance drug catalog in our city, and include eligible generic drugs in the scope of medical insurance reimbursement according to the regulations Improve the generic medical insurance reimbursement policy According to the requirements of the national medical insurance drug catalog management policy, establish and improve the dynamic adjustment mechanism of medical insurance drug catalog in this city, timely update the medical insurance drug catalog to meet the clinical drug demand For the drugs in the city's medical insurance drug catalog, there is no limit to the commodity name or manufacturer, and the eligible generic drugs are included in the scope of medical insurance reimbursement according to the regulations The payment standards for medical insurance drugs should be formulated reasonably, and the generic drugs with the same quality and efficacy as the original research drugs should be paid according to the same standards, so as to promote the alternative use of generic drugs In addition to Tianjin, many provinces and cities across the country have issued similar notices to follow up and implement the opinions on reforming and improving the supply guarantee and use policy of generic drugs issued by the general office of the State Council on March 21, 2018 In general, at present, Beijing has included the generic drugs of 36 negotiated drugs into the payment scope of Beijing medical insurance catalog, and Tianjin has included three According to the requirements of the documents of the state office, not only this, but also the generic drugs and the original research drugs with the same quality and efficacy will be paid according to the same standards It can be seen that it is only a beginning for generic drugs of negotiated drugs to be included in the local medical insurance catalogue With the maturity of various conditions, more generic drugs will achieve the same medical insurance payment status as the original research drugs, and the impact on the original research drugs will be further intensified at that time.