Drug procurement "national first standard" came drug companies or face different situations


On November 15, the full text of the "4+7" Cities Drug Centralized Purchasing Document was published. With the consent of the Central Committee for Comprehensively Deepening Reform, the State organized a pilot centralized procurement of medicines, and the scope of the pilot area is Beijing, Tianjin, Shanghai, Chongqing, as well as Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, Xi'an, and other 11 cities (referred to as the "4 + 7 cities"). According to the procurement documents, the first batch of banded procurement catalog totaled 31 varieties, including cefuroxime tablets, escitalopram oxalate tablets, and resuvastatin calcium tablets that have been full of three enterprises through consistency evaluation.

Unlike the previous provincial bidding and purchasing in some provinces, the NHPA did not enter the procurement on its own this time, but acted as a rule maker and supervisor. The purchaser of this band purchasing is "4 + 7 cities" composed of purchasing alliance, that is, the pilot region to appoint representatives to form a joint purchasing office, on behalf of the pilot region of public health care institutions to implement centralized purchasing, the daily work and the specific implementation of the Shanghai Municipal Medicine Centralized Bidding and Purchasing Services Management Institute to undertake.

Late arrival of the "first national standard"

According to the procurement documents, the declared enterprise refers to the provision of drugs and accompanying services of the domestic drug manufacturers, imported drugs, the domestic general agent is considered to be the same as the manufacturer, and commitment to declare the varieties of the annual production and marketing capacity to meet the requirements of the number of procurement.

Declared varieties refers to the procurement of varieties within the scope of the catalog to obtain the domestic registration of valid approvals of listed drugs, specifically including the original drug and the State Drug Administration issued a generic drug quality and efficacy consistency evaluation of reference preparations, through the State Drug Administration of the generic drug quality and efficacy consistency evaluation of generic drugs, according to the "State Food and Drug Administration on the issuance of the reform of the registration and classification of chemical drugs program" in accordance with the new chemical drugs. Announcement of the State Food and Drug Administration on the Publication of Chemical Drug Registration Classification Reform Program", and the generic drugs approved according to the new registration classification of chemical drugs.

At the same time, the procurement documents require that enterprises have valid registration approvals for the designated specifications of the varieties in this procurement, and when declaring varieties, each variety must contain all the main specifications produced by the enterprise.

The procurement program, known as the "first national standard" by industry insiders. This is the first since the establishment of the National Health Insurance Board at the level of the Central Reform Commission adopted the document, but it can be said to be "late". As early as early August, the National Health Insurance Bureau was established less than two months ago, began around the national organization of centralized drug procurement pilot, to four municipalities, seven sub-provincial cities and cities with plans to seek advice. September 11, the National Health Insurance Bureau held a forum on the national pilot drug procurement work in Shanghai. SSE previously reported that the document will organize four municipalities directly under the central government, seven sub-provincial or planned cities in the Mid-Autumn Festival before the National Day to organize a "band procurement" pilot, the goal is to pass the consistency of the evaluation of the varieties of 33 varieties of the common name, including over the patent period of the original drug, the reference preparation and through the evaluation of the generic drug.

According to data from the Ministry of Commerce, the size of the pharmaceutical market in these 11 cities accounted for about 29% of the country in 2017, and the size of urban public hospitals' medication accounted for 67.7% in the first half of 2018. Data from the Southern China Institute of Pharmaceutical Economics show that the varieties selected for this pilot procurement list had terminal sales of nearly 80 billion yuan in 2017 in China's public healthcare institutions, which, together with sales in the terminals of China's urban retail pharmacies, totaled nearly 100 billion yuan. Looking at the sales of individual varieties, there are five that exceeded 5 billion yuan, with clopidogrel bisulfate tablets, whose original manufacturer is Sanofi, leading the way with 11.479 billion yuan in sales.

Competitiveness of API companies to improve

From the official documents, the first batch of band purchasing catalog includes 31 varieties. Comparison with the 33 varieties previously rumored on the Internet found that cefazolin sodium/sodium chloride injection and paclitaxel injection were removed, and the procurement volume of the relevant varieties showed a different degree of reduction.

Among them, the maximum procurement volume of clopidogrel oral normal-release dosage form 293.8 million tablets, atorvastatin oral normal-release dosage form 20mg procurement volume 156.7 million tablets, clopidogrel oral normal-release dosage form 25mg procurement volume amounted to 183.2 million tablets, the three varieties are more than 100 million tablets in size; as well as amlodipine oral normal-release dosage form, Amoxicillin oral normal-release dosage form, and other varieties have been clarified in the procurement volume.

From the consistency evaluation of enterprises, Zhejiang Huahai Pharmaceuticals led the way with seven varieties, China Biopharmaceuticals, Yangzijiang are four varieties, Shiyao Group shortlisted three varieties. These companies are expected to be the big winners in this round of procurement due to the large sales of the varieties involved.

Some industry analysts said that, overall, in the new round of pharmaceutical change, the importance and competitiveness of API companies gradually increase, by entering the field of preparations or and preparations and joint mode of enterprises to improve the value chain discourse. API industry will be driven by the previous price "class cycle" industry, to new products, new technologies and new orders to obtain the growth of the industry.

The band purchasing of 31 varieties of drugs, so far, there are 5 varieties of consistency evaluation of manufacturers reached 3, respectively, ralsuvastatin calcium tablets (10mg), amlodipine benzenesulfonate tablets (5mg), cefuroxime tablets (250mg), tenofovir disoproxil fumarate tablets (300mg), montelukast (3g). Analysts said that the five varieties of fierce competition, will be taken to bidding procurement, the lowest bidder, the winning bidder is faced with greater pressure to reduce prices, the estimated price reduction of 40%. Even the staff of the relevant listed companies directly to the reporter said, will "first wait and see, and then action".

On the market about "once the only low price is to take", manufacturers may cut corners, cost control, affecting the efficacy of "doubts, some experts said, this round of pilot drugs with volume purchasing exclude drugs that have not passed the consistency of quality and efficacy evaluation, is committed to ensuring the safety and efficacy of drugs, so that patients can use the medicines. Drug safety and efficacy, so that patients use generic drugs in the quality and efficacy of a better guarantee. At the same time, it can also reduce the burden of patients' medication through the substitution between generic drugs and original research drugs.

Where should the original research drug companies go from here?

Although the national pilot program of volume purchasing still allows the sale of non-winning varieties in medical institutions under the condition of meeting the number of winning varieties, and gives the original research drug enterprises a transition period of 2 to 3 years, but some staff members of the original research drug enterprises told the reporter that the program is committed to the winning varieties further expanding the amount of 60% to 70% of the use of medical institutions, so the loss of interest is the original research drug varieties will have to face the problem of the end! .

From the varieties of original research manufacturers, Pfizer involved in the varieties of four, by the impact of the larger, AstraZeneca, Sanofi, Schweppes have three varieties, Eli Lilly, GlaxoSmithKline, Merck Sharp and Dohme each have two varieties.

According to the Southern China Institute of Pharmaceutical Economics data statistics, the pilot procurement list selected varieties in 2017 in China's public medical institutions terminal sales share, the original drug market share of more than 50% of the number of varieties there are 11. Once the original drug varieties are not successful in winning the bid, it means that its corresponding market share will quickly shrink to 30% to 40%, and the previous financial and material resources invested in the pilot region for the expansion of the volume may also be abandoned.

Even if the original varieties of drugs successfully won the bidding, also means that the expected maximum 50% price reduction, its single product profits are bound to fall dramatically, "move the amount or price" will become a band purchasing under the dilemma faced by foreign pharmaceutical companies. In Shanghai, the third batch of band purchasing, the winning varieties of imported originator drugs are absent, the main reason is that pharmaceutical companies do not want to lead to a market for a chain of price reductions across the country.

It can be seen that the size of the scope of drug sales, in the pilot program of volume purchasing, or will directly determine the size of the degree of impact on the pharmaceutical enterprises.

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Drug procurement "national first standard" came drug companies or face different situations

On November 15, the full text of the "4+7" Cities Drug Centralized Purchasing Document was published. With the consent of the Central Committee for Comprehensively Deepening Reform, the State organized a pilot centralized procurement of medicines, and the scope of the pilot area is Beijing, Tianjin, Shanghai, Chongqing, as well as Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, Xi'an, and other 11 cities (referred to as the "4 + 7 cities"). According to the procurement documents, the first batch of banded procurement catalog totaled 31 varieties, including cefuroxime tablets, escitalopram oxalate tablets, and resuvastatin calcium tablets that have been full of three enterprises through consistency evaluation.