To create samples for the whole country? Wuhan's new purchasing plan with capacity

"To provide replicable promotion experience for the implementation of centralized drug procurement in the national medical insurance overall planning area." Wuhan has put forward such a goal in its work plan of centralized drug procurement with quantity On December 1, Wuhan issued four copies of detailed rules for drug volume purchasing: classification method of Wuhan drug volume purchasing catalogue (Draft for comments), quality stratification method of Wuhan drug volume purchasing (Draft for comments), quality scoring method of Wuhan drug volume purchasing (Draft for comments), the first batch of drug volume purchasing in 2019 in Wuhan The detailed rules of construction, for the "4 + 7" after the volume procurement mode, created a new sample Wuhan's plan adds a lot of innovative measures to the volume purchase mode, such as evaluating the quality through various dimensions, such as proposing to divide the groups according to the volume, and proposing different price reduction ranges, etc A drug administration expert commented on this: Wuhan's volume purchase plan aims to explore where the price of high-quality drugs is appropriate to squeeze water in a proper way under the circumstances of non-state centralized purchase, which not only does not damage the level of clinical drug use, but also allows the substantial price reduction of the original research drugs, so as to make a demonstration for other provinces and regions in the country and simply follow But not long ago, Hu Jinglin, director of the State Medical Security Bureau, gave full affirmation to the exploration of non evaluated drugs' centralized procurement in Wuhan when investigating the drug use guarantee and centralized procurement of drugs in outpatient service of hypertension and diabetes in Wuhan, Hubei Province, and encouraged all regions to explore and establish a normalized centralized procurement system, and to study the scope of procurement to high-value medical consumables and non excessive medical consumables Evaluate the development of drugs For the quality problems that have been concerned by the purchasing industry before, in last year's "4 + 7", consistency evaluation was used as the evaluation threshold This time, Wuhan adopted the rules of quality stratification and quality evaluation, and included multiple evaluation indexes First of all, Wuhan city has carried on the quality stratification to the medicine The first level of quality is the national first-class new drugs during the monitoring (protection) period, patent drugs beyond the protection period, national secret prescription Chinese patent drugs, national first-class protected varieties of traditional Chinese medicine, etc., and the second level of quality is other GMP certified drugs and other imported drugs Secondly, for the quality score, Wuhan will carry out comprehensive evaluation score according to different groups, including enterprise evaluation, product evaluation, quality evaluation and supply evaluation Specifically, the evaluation of enterprises accounts for 30 points in total, including two dimensions First, according to the relevant statistics of the Ministry of industry and information technology, the higher the enterprise ranking in the industry, the higher the score; second, the higher the R & D cost ranking, the higher the score In this dimension, enterprises with large R & D investment and large revenue are more advantageous It is worth noting that the highest score in the industry is 20 points, and the lowest score is 5 points, while the overseas production enterprises are all 10 points The product evaluation accounted for 35 points, and the evaluation indexes included output, API guarantee, patent, export volume and bad record This indicator shows the support for innovation, the scale and the dividend of the capacity of self-produced API, and the varieties with quality problems are also treated differently The quality evaluation accounted for 28 points, including both objective evaluation and expert evaluation For example, the index of clinical efficacy is evaluated by experts according to the literature of clinical efficacy evaluation, or by experts according to the quality and efficacy of clinical medication experience In addition, in this dimension, there are adverse reactions monitoring, drug quality sampling and so on The highest proportion is the quality standard, and the current quality standard is 10 points higher than the new pharmacopoeia standard Finally, the evaluation of supply accounted for 7 points, including market share, supply stability and experts' evaluation of the supply situation of the declared enterprises since 2018 It is worth noting that Wuhan also implemented a one vote veto system for enterprises with major quality and safety accidents or serious violations of laws and regulations within three years All in all, Wuhan city has carried out a very detailed system design for the volume procurement at the prefecture and city level Many problems criticized in the previous drug bidding have also been taken into account The volume procurement mechanism after "4 + 7" has been improved, which is good for large enterprises with stable production capacity, high investment in research and development, sufficient clinical literature, self-produced APIs and no quality problems In terms of price, Wuhan has also carried out innovative design The list of drugs purchased this time shall be selected and determined by the expert group from the drugs other than those purchased by the state and province through negotiation and centralized volume purchase, and this time it is also divided into quality levels, which means that there are some varieties with large clinical dosage but not evaluated How to determine the number of shortlisted declaration enterprises? In short, experts conduct comprehensive evaluation according to different groups through four dimensions of enterprise evaluation, product evaluation, quality evaluation and supply evaluation The same bidding group is ranked from high to low according to the scores For example, when the number of qualified drugs declared is less than or equal to four, all enterprises can enter the bidding It is worth noting that this document specifies the shortlisted reduction, which is formulated by the expert group according to the relationship between quality stratification and the actual use in 2018 The proportion of actual consumption of different quality levels of the same generic name in 2018 is more than 50%, which is listed as group A, and the proportion less than 50% is listed as group B In addition, the decline rate of group A is not less than 20% on the basis of the national lowest price, and that of group B is not less than 10% on the basis of the national lowest price Popular explanation: the shortlist reduction is "admission ticket" The shortlist reduction set by the two dimensions of quality and volume price relationship makes the selected enterprises take into account two quality levels In addition, it is impossible for the enterprises to be selected without price reduction, while No 7 document has no clear requirements In principle, if the price is greatly reduced, the market share will be high And the decline will be another 10% - 20% at the lowest price in the country If it is spread out from Wuhan, it will promote another round of price reduction Group A and group B enterprises agree to be shortlisted, get "tickets" and get the qualification of subsequent quotation After being shortlisted, if there are two or more enterprises with the same generic name, the same dosage form and the same specification in the same group, they shall be selected by competitive quotation; if there is only one enterprise, they shall be negotiated by volume This means that if there are more than two shortlisted enterprises, they will enter the stage of competitive quotation At this time, they not only face the bidding object, but also need to consider and evaluate the quotation of competitors After bidding, select the lowest price If the price is the same, the one with higher comprehensive score will be shortlisted If the comprehensive score is the same, the one with higher product quality score will be shortlisted After obtaining the supply qualification through bidding, the detailed rules also clearly stipulate how much quantity can be obtained, that is, each bidding group's winning enterprise takes the effective quotation corresponding to the maximum share of the gradient quotation as the winning price and gives the quantity according to the corresponding gradient Generally, the quotation corresponding to the largest share is the lowest quotation Group A with a large amount of shares will quote in accordance with the gradient of 50%, 70% and 80% of the bargaining base of varieties, while group B with a small amount will quote in accordance with the gradient of 20%, 40% and 50% of the bargaining base of varieties Each price reduction gradient of group A and B shall not be less than 5% of the bidding price It is worth noting that if group B enterprises want to get more than 50% of the consumption, the reduction of their quotation is at least 50% of the reduction of the selected enterprises in group A, which is effective In short, group A and group B need to obtain increment through gradient price reduction competition, and increment cannot be obtained without price reduction or invalid price reduction Before centralized procurement expansion, there was no clear provision According to the lowest price enterprise, first select the province, then the second and third enterprises, and then select circularly without price reduction In addition, if there is only a bidding quotation or a bidding quotation but the gradient quotation is invalid, the selected enterprises in group A will obtain 30% of the supply of the bargaining base, and B The selected enterprises in the group get 10% of the supply After the gradient quotation is given, if the total amount of the two groups is less than 50% of the agreed amount, the enterprises not selected will negotiate according to the bidding quotation from the lowest to the highest If the price accepted by the bargaining enterprise is lower than the selected enterprise, the remaining purchase amount will be borne by the enterprise.