Expired original research drugs with bid prices lower than generic drugs may have most of the market

As soon as the bidding result of the second batch of generic volume procurement is proposed, the hot discussion points in the domestic pharmaceutical industry are all focused on the fact that the expired original research drug enterprises can actively participate in the competition of generic volume procurement, and can compete at the lowest price For a long time, there has been a stereotype in the industry that the price of expired original drugs should be higher than that of generic drugs The imitated medicine has gone through three times of purchasing bidding with volume In addition to the "4 + 7" bidding policy, the lowest price is the sole bid winner, and finally AstraZeneca In addition to winning the bid with Shanghai Shiguibao at the lowest price, whether it's the procurement of alliance expansion or the procurement of national quantity, the bid winning of expired original research drugs usually hovers on the passing line - the last ranking shortlisted, reasonable price reduction or as long as no price reduction can win the bid, there will be no price reduction Bayer's acarbose won the bid at the lowest price in the country, breaking the stereotype of the industry on the outdated original research drug companies, but at the same time, there is a new situation - "the price of the expired original research drug and the price of the generic drug have been inverted" In fact, the health care department also acquiesced to this hanging upside down In March 2019, the State Medical Security Bureau issued the opinions on the supporting measures of pilot medical insurance for centralized purchase and use of drugs organized by the state For some drugs with large price difference from the price of the selected drugs, the pilot areas can pay "if the price of non selected drugs is more than twice the price of the selected drugs by the end of 2018, the original price will be reduced by no less than 30% in 2019, and in 2020 or 2021 The price of the selected drugs was adjusted as the payment standard in In principle, if the price of non selected drugs is within 2 times (including 2 times) of the price of selected drugs and the price of selected drugs by the end of 2018, the price of selected drugs shall be the payment standard " At that time, "4 + 7" only won the bid at the lowest price, and the expired original research drugs were basically lost This regulation is mainly based on the medical insurance payment standard formulated for the expired original research drugs, and the industry believes that the price of the expired original research drugs is two times or more than that of the generic drugs Due to the suspicion of monopoly in the exclusive supply of the national market, in case other manufacturers give up production, the exclusive winning enterprise can start the price on its own In order to reduce the risk and avoid the research and development investment drift of the enterprises that invest in the consistency evaluation of generic drugs, from the beginning of alliance procurement, many enterprises have won the bidding, but each province can only supply one enterprise However, if there is no competition among many successful bidders, there will inevitably be a lack of competitive power and low willingness to reduce prices For example, when the alliance purchases with volume, the original research pharmaceutical enterprises will be able to win the bid and enjoy the market without price reduction Only when the "unit comparable price" specified by the national volume purchase is less than or equal to 1.8 times of the lowest "unit comparable price" of the same variety can the potential words be selected, that is, the price of expired original drug research enterprises shall not be higher than 1.8 times of the lowest price of the same variety before they can be selected, which also reflects that the price of expired original drug research enterprises in the mind of the medical insurance bureau shall not exceed 1.8 times of the same variety of generic drugs The original pharmaceutical research enterprise with expired patent has an international advanced production quality management system, which has long been under the supervision of cGMP systems such as the European Union and the United States The quality of the products produced should be better than the products under the 2010 version of China's GMP management system Moreover, the R & D and production management of the efficacy and safety of generic drugs are all based on the original research drug as the learning benchmark, and strive to the direction of "100% replication" of the original research product What's more, the long-term brand cultivation of expired original research drugs, whether it's Chinese doctors or patients, will feel that the quality of expired original research drugs is naturally better than that of generic drugs Under such recognition, it is acceptable that the price of the original drug is higher than that of the generic drug Prior to the volume purchase policy, the expired original research drug enterprises belong to the higher quality level products do not participate in the generic drug competition After the consistency evaluation is approved, the expired original research drug enterprises and the consistency evaluation drugs are regarded as the same quality level However, the patients still think that the quality of the original research is more reassuring For example, the original manufacturer of valsartan API does not have n-nitrosodimethane (NDMA) cytotoxic impurities, but some products of generic manufacturers do not control the impurities well The price of expired original research is lower than that of generic drugs, which means that expired original research drugs are cheaper and better quality products Should they enjoy more drug markets? However, according to the rules of the supply policy, the first ranking enterprises have the priority to choose one area in the supply area After the completion of the priority selection, all the enterprises to be selected shall confirm the remaining areas alternately from the first ranking enterprise Each enterprise to be selected shall select one area at a time and repeat the above process until the completion of the selection and confirmation of all regions This means that even if the original research and development pharmaceutical enterprises win the bidding at the lowest price, they can only split up half of the market So the industry has someone to make complaints about what our province's patients can't enjoy the cheaper raw materials and better drugs, and buy more expensive generic drugs If the gap between the lowest price enterprise and the third enterprise is too large, for example, the price of ABI Longzheng Tianqing is 2800 yuan for 120 pieces in a box, and the final winning price of Jiangxi Shanxiang is 4296 yuan for 120 pieces in a box The former supplies Liaoning, Heilongjiang, Shanghai, Jiangsu, Henan, Hunan, Guangdong, Sichuan, Yunnan, Gansu, Xinjiang (including BINGTUAN), and the latter supplies Beijing Hebei, Shanxi, Fujian, Jiangxi, Hubei, Hainan, Tibet, Shaanxi and Ningxia, why should the latter supply provinces pay more than 1496 yuan for drugs of the same quality? Moreover, if referring to the opinions on the supporting measures for centralized purchase and use of pilot medical insurance organized by the state, "for the original research drugs, reference preparations and generic drugs under the same generic name, in principle, the middle price of centralized purchase shall be taken as the payment standard of the generic drug, and the medical insurance fund shall be settled according to the same payment standard" Is the medical insurance payment price of Jiangxi Shanxiang Province Based on the price of Zhengda Tianqing? Or take Shanxiang's purchase price as the medical insurance payment price, so why do the medical insurance departments in the above provinces spend more expensive price to purchase drugs of the same quality? From the perspective of patients, when the price of expired original research drug is similar to that of generic drug, they may prefer to choose expired original research drug When the expired original drug is cheaper than the generic drug, the price sensitive patients prefer the expired original drug In a word, according to the national drug centralized procurement document issued by joint procurement in December 2019, the final number of enterprises shortlisted shall be determined according to the actual number of enterprises that meet the "qualification of declared varieties", but the maximum number of enterprises shortlisted shall not exceed six, that is to say, no more than six enterprises can have the right to survive, and more than four or more enterprises win the bid Three years of market access The policy that only one manufacturer wins the bid in a province is doomed to make half of the provinces or more provinces unable to use the expired original drugs with lower prices; when the absolute value of generic prices varies greatly, it is also doomed to make half of the provinces or more provinces only use the more expensive generic drugs It is impossible to choose the patients with poor price and quality caused by winning the bid of many enterprises, which may be the price for the sustainable development of domestic enterprises (BIOON Com)