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How to Evaluate Drug Procurement Reform’s Effectiveness? (AI Translation)

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2023年2月12日,山东滨州市黄山街道, 一家医保便民药店的工作人员给购药居民配备集采的“ 零差价”药品。图:董乃德/ 视觉中国
2023年2月12日,山东滨州市黄山街道, 一家医保便民药店的工作人员给购药居民配备集采的“ 零差价”药品。图:董乃德/ 视觉中国

文|财新周刊 周信达

By Caixin Weekly's Zhou Xinda

  以2018年末“4+7”城市试点为起点,一场由国家医保局操刀的药品和耗材集中带量采购(下称“集采”),已历经5个年头和13个批次,签约品种陆续进入续约期。这场震动全行业的大调整至今已发展为常态化制度,新的挑战也不断涌现。

Starting with the "4+7" city pilot program at the end of 2018, a centralized volume-based procurement of pharmaceuticals and medical consumables, orchestrated by the National Healthcare Security Administration, has spanned five years and 13 batches. The contracted products are gradually entering the renewal phase. This sweeping adjustment, which has impacted the entire industry, has now evolved into a regularized system, continually presenting new challenges.

  价格变动是最直接的成果,也带来药企市场份额的洗牌。药品共纳入374个品种、1653个药品,其中国产仿制药占比达到96%,平均降幅超过53%。高值耗材降价更为猛烈,四批耗材平均降幅82%,冠脉支架从上万元到不足千元的“灵魂砍价”至今影响深远。

Price changes are the most direct outcome, leading to a reshuffle in the market share among pharmaceutical companies. A total of 374 categories, encompassing 1,653 drugs, were included, with domestic generics accounting for 96% and an average price reduction exceeding 53%. The price drop in high-value medical consumables was even more drastic, with an average reduction of 82% across four batches. The "soul-bargaining" reductions brought the price of coronary stents from over 10,000 yuan to less than 1,000 yuan, leaving a lasting impact.

  集采的另一重目标瞄准公立医院结构变革,通过结余留用费用为医疗服务价格、薪酬体系等多项改革腾挪空间,尤其面对医保基金整体紧平衡,要使医保战略购买价值最大化。今年6月,国务院《深化医药卫生体制改革2024年重点工作任务》继续强调,落实集采医保资金结余留用政策,完善激励约束机制,促进医疗机构如实填报采购量并合理优先使用中选产品。

Another key objective of centralized procurement is to target structural reforms in public hospitals by utilizing savings from retained costs to open up space for adjustments in medical service prices, salary structures, and several other reforms. Given the overall tight balance of the healthcare fund, it is crucial to maximize the strategic purchasing value of medical insurance. In June this year, the State Council's "Key Tasks for Deepening the Reform of the Medical and Health System in 2024" continued to emphasize the implementation of policies that allow for the retention of savings from centralized procurement with medical insurance funds. The plan also aims to improve incentive and restraint mechanisms, promote medical institutions to accurately report procurement volumes, and reasonably prioritize the use of products selected through centralized procurement.

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Caixin is acclaimed for its high-quality, investigative journalism. This section offers you a glimpse into Caixin’s flagship Chinese-language magazine, Caixin Weekly, via AI translation. The English translation may contain inaccuracies.
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How to Evaluate Drug Procurement Reform’s Effectiveness? (AI Translation)
Explore the story in 30 seconds
  • China's centralized procurement system led to a significant price reduction of pharmaceuticals and medical supplies, with average drug prices dropping by 53% across nine batches and high-value consumables by 82% over four batches.
  • The system aims to reform public hospitals by reallocating savings for medical service price adjustments and salary restructuring, despite challenges in fund allocation at the hospital level.
  • Concerns remain over the impact on drug availability, as domestic generics replace original brands, and hospitals prioritize bulk procurement, affecting patient choice and market dynamics.
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Explore the story in 3 minutes

The "4+7" city pilot program initiated China's centralized volume-based procurement for pharmaceuticals and medical consumables in late 2018, greatly impacting the industry by mandating significant price reductions and market share realignments.[para. 1][para. 3] Over five years and 13 procurement batches, the initiative aimed to curtail pharmaceutical and consumable prices, achieving an average price cut of 53% for medicines and 82% for medical consumables, like coronary stents. This was achieved through "soul-bargaining" efforts that brought stent prices down from over 10,000 yuan to below 1,000 yuan.[para. 1][para. 2]

A crucial intention behind centralized procurement is structural reform in public hospitals, leveraging saved costs to adjust medical service prices, personnel salaries, and more.[para. 2] The strategy emphasizes maximizing the strategic purchasing value of medical insurance, reflected in initiatives like improved incentive mechanisms for medical institutions and refined procurement reporting and prioritization practices.[para. 3][para. 4] Despite these objectives, hospitals struggle to implement specific plans and might misallocate funds for operational deficits, reducing incentives to utilize procured items.[para. 3][para. 4][para. 5]

In its sixth year, the expanded scope of group purchasing now includes previously untouched areas like biosimilars and in vitro diagnostic reagents. Provincial inter-regional alliances handle new extensions, tackling challenges like maintaining market stability, price level stability, and clinical medication stability amid varying renewal outcomes and potential fragmentation risks.[para. 5][para. 6][para. 7] Completion rates for centralized procurement form part of hospitals' performance metrics, sometimes leading to underreporting and deliberate understatement of drugs needed to avoid penalties.[para. 8][para. 9][para. 10]

Throughout this process, multinational companies have retracted from aggressive price reductions during group procurement phases,[para. 11][para. 12] pointing to long-term concerns over profitability and the loss of business appeal prevalent in past price-cutting strategies.[para. 11][para. 12] However, for many pharmaceutical companies, navigating the complex, regularly revised procurement landscape has stirred notable industry reshuffles, showcasing the challenges of meeting regulatory demands juxtaposed against achieving competitive pricing and product quality.[para. 12][para. 13][para. 14]

Moreover, centralized procurement has inadvertently driven some patients to report difficulty accessing original brand drugs due to increased generic usage. The reform's pressure to meet centralized selection targets alters clinical drug use structures, making original drugs less affordable and/or accessible to patients regardless of personal or clinical preference.[para. 14][para. 15]

The issue of patient choice under collective procurement reflects the core challenge of balancing cost, access, and quality. Consistency evaluations, although a fundamental requirement, lack long-term and detailed post-market studies to effectively assure generic drug quality similar to original products.[para. 15][para. 16] Efforts to initiate rigorous testing and consistent evaluation standards may provide more comprehensive data to balance costs and efficacy, allowing patients better decision-making opportunities based on clinically reliable evidence rather than just price considerations.[para. 16][para. 17]

Moving forward, the focus shifts toward optimizing procurement rules to better accommodate quality alongside pricing, potentially involving scaling reward mechanisms for superior quality, efficacy, and innovation value.[para. 17][para. 18][para. 19] Additionally, forming an integrated strategic plan in alignment with health insurance payment adjustments, fostering fair competition and transparent pricing, becomes critical to sustaining the initiative's ongoing practicality and addressing stakeholder reservations.[para. 20][para. 21]

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Who’s Who
Beijing Chunli
北京春立
In 2015, Liu Feng underwent a left knee replacement at Gansu Provincial Hospital, choosing Beijing Chunli's medical consumables, with pre-reimbursement surgical expenses exceeding 40,000 yuan.
Tianjin Zhengtian
天津正天
Tianjin Zhengtian was mentioned in the article as the supplier of medical consumables used during Liu Feng's right knee replacement surgery. The surgery, which utilized Tianjin Zhengtian's products, resulted in reduced hospitalization time to one week and a total cost decrease of approximately 15,000 yuan compared to previous procedures.
CSPC Pharmaceutical Group
石药
The article mentions that CSPC Pharmaceutical Group, along with Huaren Pharma, was involved in a bidding process where they appealed against the use of national monitoring prices, citing reasons such as price increases due to raw materials and high manufacturing costs, which made it challenging to adhere to the national monitoring prices for their products.
China Resources Sanjiu
华润三九
China Resources Sanjiu is mentioned in the context of raising concerns about national monitoring prices. In September, companies including CR Sanjiu appealed against price monitoring in Yunnan's drug procurement platform, citing issues like increased raw material costs and high production demands that made supplying at the monitored price unfeasible.
Chongqing Huasen Pharmaceutical
重庆华森制药
Chongqing Huasen Pharmaceutical's chewable tablets of aluminum magnesium carbonate had about a 30% market share before the second batch of centralized procurement. Subsequent batches saw competition from companies like CR Sanjiu. Facing a divided market share, Huasen advocated for a milder pricing approach during renewals.
China National Pharmaceutical Group Taiji
国药太极
China National Pharmaceutical Group Taiji's Xiao Jin Pill was not selected in the first batch of Chinese medicine centralized procurement due to unfamiliarity with the rules. It later became a backup product in the Guangdong Six Province Alliance, and with uncontrollable raw material price increases, its sales declined by over 20% in the past year. The company hopes for favorable terms in future centralized procurement rounds.
Hansoh Pharmaceutical Group
豪森
Hansoh Pharmaceutical Group secured the supply qualification for Apixaban tablets (2.5mg*14 tablets) during the third batch of national procurement. However, in a recent procurement by the Su-Shan Alliance, other companies like Lepu Pharmaceuticals and Qilu Pharmaceutical became suppliers, indicating increased competition and changes in supply dynamics for Hansoh.
Lepu Pharmaceutical
乐普药业
Lepu Pharmaceutical was mentioned as one of the companies that has gradually passed consistency evaluations for the apixaban tablets (2.5mg*14 tablets), alongside companies like Chia Tai Tianqing, CSPC, and others, securing contracts in the pharmaceutical procurement renewals led by the Su-Shan Alliance.
Chia Tai Tianqing Pharmaceutical
正大天晴
Chia Tai Tianqing Pharmaceutical (正大天晴) is mentioned in the context of being one of the companies that secured the supply position for the drug Apixaban (2.5mg*14 tablets) during the Su-Shan Alliance follow-up procurement. This was after multiple companies, including them, passed the consistency evaluation, indicating its involvement in the ongoing centralized drug procurement efforts in China.
Qilu Pharmaceutical
齐鲁制药
Qilu Pharmaceutical is mentioned as one of the companies that participated in the follow-up procurement of drugs like Apixaban tablets after initial national centralized procurement rounds. It was among the companies providing this medication in alliance renewals, as local provinces organize continued selection processes for drugs after the initial agreements expire.
Changzhou Pharmaceutical Factory
常州制药厂
Changzhou Pharmaceutical Factory is mentioned as one of the companies that gained the selection for producing the same specification of apixaban tablets (2.5mg*14 tablets) in a subsequent procurement by the Jiangsu-Shanxi alliance. This was after Luye Pharma was acquired for production capability following the initial selection in the 2020 national procurement.
Novo Nordisk
诺和诺德
The article mentions Novo Nordisk in the context of insulin price adjustments during follow-up centralized procurement. It notes that in a recent procurement round, 14 insulin products, including those from Novo Nordisk, experienced price increases compared to the initial procurement phase, highlighting ongoing adjustments in the pharmaceutical industry's centralized purchasing process.
Eli Lilly
礼来
Eli Lilly, a multinational pharmaceutical company, quoted prices far above the maximum limit in the ninth round of centralized procurement, effectively opting out of selection. Earlier this year, due to strategic adjustments, Eli Lilly withdrew Atomoxetine Hydrochloride capsules from the Chinese market. This reflects a shift in focus from generic pricing battles to emphasizing innovation and participation in national health insurance negotiations for new drugs.
Bristol-Myers Squibb
百时美施贵宝
Bristol-Myers Squibb's original drug entecavir (Baraclude) was compared with Chia Tai Tianqing's generic version in a real-world study. The study, involving over 13,000 patients, found no significant statistical differences in efficacy and safety between the original and generic drugs. This was part of the evaluation of selected drug efficacy and safety under China's centralized procurement policy.
UCB
比利时药企优时比
The article mentions UCB, a Belgian pharmaceutical company, which sold its mature business in China for $6.8 billion, focusing on neurology and allergy diseases, along with its production base in Zhuhai. This sale is part of a strategic adjustment in response to the changing pharmaceutical market dynamics influenced by China's centralized bulk-buying program.
Luye Pharma
绿叶制药
Luye Pharma was mentioned in the article in the context of being outbid by Bayer's BayAspirin during the second national drug procurement in 2020. Bayer secured supply rights for 16 provinces with the lowest price of 0.18 yuan per tablet, surprising the industry. This reflects the competitive nature of the procurement process and the pressure on companies to lower prices.
Sino-American Shanghai Squibb Pharmaceuticals
中美华东
The article does not provide specific information about Sino-American Shanghai Squibb Pharmaceuticals. It generally discusses the impacts of drug procurement policies in China, particularly focusing on national pharmaceutical companies and their strategies in response to centralized purchasing.
Bayer
拜耳
In the article, Bayer's Glucobay (Acarbose tablets) was discussed. In the 2020 second round of centralized procurement, it won supply rights in 16 provinces at a low price of 0.18 RMB per tablet. However, despite this strategy, sales decreased significantly due to the price cut. Later, Acarbose was absent from several follow-up procurements, and there were even reports of supply shortages, highlighting challenges with "price-for-volume" strategies.
Fuwoze
富沃思
Fuwoze, a Chongqing orthopedic medical device company, is concerned about cost compression due to precision requirements in production. Their production uses imported machines to maintain technical accuracy, making further cost reductions challenging under the price constraints imposed by the centralized procurement system in China.
AI generated, for reference only
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