Price reduction without quality reduction! The average price of centrally procured heart stents has dropped to around 700 yuan.

On November 20, the Medical Network reported that on November 5, China conducted its first centralized procurement of high-value medical consumables in Tianjin, targeting coronary stents. After the centralized procurement, 10 products, both domestic and imported stents, were selected, with the average price dropping from around 13,000 yuan to about 700 yuan, a decrease of approximately 93%. It is expected that patients will be able to use the selected coronary stents in January next year.

Stents support a new life

Every year, about 1 million patients with coronary heart disease in China receive coronary stents, and their quality of life improves due to the stents.

Hearing that the price of coronary stents has dropped to around 700 yuan, Li Qiang kept telling his son, 'What a loss!' His son hurried to comfort him: 'It's not a loss! At that time, 70% of the three coronary arteries were blocked; it was necessary to do it for survival!' After thinking about it, Li Qiang felt it made sense, as future stent placements would be cheaper. At this time, it had just been a little over a month since Li Qiang had his stent placed.

Li Qiang, 59, lives in Henan. During a health check at work in September, he discovered symptoms of a heart attack. The doctor kept him hospitalized. Li Qiang said he felt fine, with no pain or discomfort, and stubbornly returned home against medical advice.

That night, his brother-in-law, who is a doctor, learned about this and quickly called to persuade Li Qiang to stay in the hospital. His son, who works in Beijing, rushed back to Henan overnight and took his father to the hospital for a coronary angiography the next day. The angiography results showed extensive atherosclerosis in the heart, and surgery was necessary to open the blocked vessels. Since the local hospital could not perform the surgery, his son took him to a large hospital in Beijing.

On September 18, Li Qiang was admitted to the hospital. The coronary angiography showed that all three coronary arteries were blocked. 'With 70% blockage in your vessels, this must have started at least five years ago,' the doctor said after reviewing the results. Li Qiang felt a chill down his back. Upon reflection, he remembered that one night last year, around July or August, he did feel discomfort in his heart, but after lying down all night, he thought he was fine the next day and didn't pay much attention.

After weighing his options, Li Qiang chose to have a stent placed instead of bypass surgery, reasoning that 'the incision would be smaller, and recovery would be better.' A few days later, in two separate surgeries, Li Qiang had 1 and 5 stents implanted, all of which were imported. Among them, 5 were drug-eluting coronary stents from two different brands, priced at 17,000 yuan and 17,320 yuan respectively, and 1 was a platinum-chromium alloy biodegradable sirolimus-eluting coronary stent, priced at 18,800 yuan. The total cost for the stents alone exceeded 100,000 yuan, and with additional costs for balloons, catheters, guidewires, as well as angiography, examinations, and surgery, the total cost reached 220,000 yuan. After reimbursement from health insurance and critical illness supplementary insurance, Li Qiang had to pay about 100,000 yuan out of pocket, which was a bit of a burden for him.

On September 30, Li Qiang was discharged from the hospital. From then on, he took 11 different medications daily, including diabetes medications he had been taking for years and antithrombotic medications after the stent placement. After the stent was placed, his son noticed changes in Li Qiang. He stopped smoking, stopped drinking white liquor, and changed his previously sedentary habits. Now, Li Qiang counts his steps while walking, carefully plans his diet, and records his blood sugar, blood pressure, and blood lipid levels.

"After the stent was placed, my chest feels very comfortable, and I feel refreshed. But it is indeed expensive, and I am afraid of re-narrowing. I have to quit smoking and drinking as per the doctor's advice and change my lifestyle. I hope that when I return for a check-up in a year, there will be no deterioration," Li Qiang said.

Du Jin from Inner Mongolia had a stent placed at Anzhen Hospital in Beijing two years ago.

"From then on, my life changed because of the stent," Du Jin said. Three days after being discharged, Du Jin returned home to Hohhot, Inner Mongolia, and reported to the surgeon through the Good Doctor Online platform, uploading his heart rate and blood pressure check results. He only felt at ease after the doctor replied 'normal.' Since then, Du Jin has consulted the doctor multiple times about blood pressure and other issues and has followed up online. Due to timely communication with the doctor and strictly following medical advice, Du Jin's recovery after surgery has been good, and he has regained confidence in life.

Every year, about 1 million patients with coronary heart disease in China receive coronary stents, and their quality of life improves due to the stents. A small stent supports a new life for patients.

Coronary heart disease, simply put, is the blockage or narrowing of the coronary arteries that supply nutrients to the heart, leading to symptoms such as angina and myocardial ischemia, commonly known as a heart attack.

The main treatment methods for coronary heart disease include medication, surgical bypass, and percutaneous coronary intervention. Percutaneous coronary intervention refers to the stent placement procedure, which involves inserting a coronary stent into the coronary artery through a catheter to support the narrowed section and restore smooth blood flow.

In 1986, French doctors Jacques Puel and Ulrich Sigwart successfully performed the world's first coronary stent surgery. Due to its short treatment duration, minimal trauma, significant efficacy, and few complications, it has been favored by many clinical doctors and patients.

In clinical applications, cardiac stents have continuously improved, evolving from bare stents to drug-eluting stents and biodegradable stents, with materials constantly evolving and performance optimizing. Currently, coronary stent intervention surgery is recognized as a safe and routine treatment method.

For more than a decade after the birth of coronary stents, patients in China relied on imported stents, which were extremely expensive. Coupled with the auxiliary materials and examination costs during surgery, getting a stent was like buying a small car.

In 1999, China finally produced its own coronary stents, leading to a decrease in prices. However, the unit price of imported stents still ranged from 20,000 to 30,000 yuan, and many patients needed more than one stent, making coronary stents still seem unaffordable.

In recent years, the prevalence of cardiovascular diseases in China has been continuously rising, with the total number of cases ranking first in the world, leading to an increasing number of patients needing reliable coronary stents. The 'China Cardiovascular Disease Report 2018' released by the National Center for Cardiovascular Diseases shows that the prevalence of cardiovascular diseases in China is in a continuous upward phase, with 290 million patients. In 2016, the mortality rate from cardiovascular diseases was the highest, surpassing cancer and other diseases, with 2 out of every 5 deaths caused by cardiovascular diseases. From 2013 to 2016, the average number of stents implanted in coronary heart disease patients remained around 1.5, with a case growth rate of 13%.

Due to the excessively high prices, many patients have given up on getting coronary stents and opted for conservative drug treatment. For those who have given up on stent placement, the blocked coronary arteries are like ticking time bombs, constantly threatening their lives.

Medical reform tackles the 'hard bones'.

High-value medical consumables are different from drugs; they lack a stable structure, making it difficult to design a system similar to drug consistency evaluation.

November 5, 2020, is the day when the national organization for centralized procurement of cardiac stents opens bids. With two hours left until the bid opening, many company representatives are anxiously waiting outside the venue.

The seemingly calm venue is brewing a huge wave of reform.

This is the first time our country has conducted national-level centralized procurement for high-value medical consumables, which are expensive. Unlike drugs, high-value medical consumables do not have a stable structure, making it difficult to design a system similar to drug consistency evaluation. Although the usage is increasing, the lack of uniform standards makes it hard to compare quality and price, creating difficulties in procurement. The industry generally views this as a 'deep water zone' of reform, a tough 'hard bone' to chew.

From April last year to November this year, the National Medical Insurance Administration conducted extensive research and market analysis, encouraging local pilot programs and clarifying the principle of one product, one policy for centralized procurement. After screening, they found that cardiac stents with mature technology and strong alternatives were more suitable. Among them, cardiac stents featuring chromium alloy and rapamycin and its derivatives are clinically advanced and were identified as procurement products. The procurement rules were designed to be based on product registration certificates, allowing medical institutions to report their own quantities, leveraging the scale and linkage effects of centralized and volume-based procurement to encourage companies to lower prices.

At 10 a.m., the opening of product price information for companies begins. According to the rules, the shortlisted price must be less than 1.8 times the market's lowest bid price, and those above 1.8 times the lowest bid must be below 2850 yuan. The 2850 yuan threshold comes from the lowest bid price in last year's pilot volume-based procurement in Jiangsu Province.

The reason for determining this bidding price range is that the National Medical Insurance Administration found in preliminary research that the price of drug-eluting stents in our country is higher than that in other countries. In some countries without centralized procurement, the price of the same brand of stents is around 2000 yuan, while the price drops to 1000 yuan or even lower with volume-based centralized procurement.

Under the carefully designed rules, price becomes the only competitive factor. Under the power of national-level centralized volume effects, all selected products reported prices below 1000 yuan, mostly concentrated around the 700 yuan range.

A drug-coated stent system (rapamycin) reported the lowest price of 469 yuan. This product previously had a listed price of 13,300 yuan and was only approved for market release at the end of 2017. Why would such an advanced product be willing to drop from over 10,000 yuan to 469 yuan?

In response, the head of Blue Sail Medical Group stated that centralized procurement clearly has a significant attraction for market demand, with hospital procurement needs reaching 100,000 units. After winning the bid, they will also receive no less than 10% of the remaining quantity, and the market demand is expected to rise. Coupled with policies such as prepayment of medical insurance, shortened settlement cycles, and ensuring hospital usage, this provides companies with clear expectations.

This means that the original sales and distribution models will undergo disruptive changes, significantly reducing corporate sales costs and improving operational efficiency. The head believes that national centralized volume procurement is a milestone on the path of deepening medical reform, which helps reduce the burden on patients while standardizing the industry environment and reconstructing the industry ecosystem, allowing companies to focus on their core business.

Centralized volume procurement is not a standalone policy but a mechanism. It is organized by the state, with multiple departments such as medical insurance, health, and quality supervision working together. For example, strengthening quality supervision throughout the process, allowing hospitals to retain budget surpluses, assessing hospital usage, and any discovered kickback cases will affect centralized procurement, ensuring that the selected prices are implemented, allowing the public to truly access high-quality and reasonably priced products. At the same time, it forces the pharmaceutical industry to innovate, cutting unreasonable distribution costs and shifting focus to research and innovation, said Zhong Dongbo, director of the Pharmaceutical Pricing and Bidding Procurement Department of the National Medical Insurance Administration.

According to Yang Yazhen, deputy director of the National Medical Insurance Research Institute, this is the market guiding role of centralized volume procurement, which lowers prices and gives companies clear expectations. Only by choosing reasonable profits and bidding farewell to distorted prices can they win the market.

Stent prices drop without compromising quality.

Procurement based on registration certificates ensures the stability of product quality. Simultaneously adjusting medical service prices to motivate medical personnel.

Li Qiang calculated that out of the six stents he used, five were selected for price reduction, and the remaining one has a selected product that can be substituted. Li Qiang said that when the stent was placed, he never expected the price could drop to around 700 yuan. However, he is also very puzzled: after the price drop, is the quality reliable?

In fact, the principle of one product, one policy is to ensure that price reductions do not compromise quality. In the centralized procurement of cardiac stents, procurement is based on registration certificates to ensure the stability of product quality, and medical institutions report their own demand.

Compared to drug centralized procurement, this is an innovation in cardiac stent procurement. The use of selected products also gives medical institutions great autonomy, ensuring that selected products meet clinical needs and ensuring product quality, said Chang Feng, a professor at China Pharmaceutical University.

At 10:48 a.m. on November 5, when Zhang Tiejun, deputy director of the Tianjin Medical Insurance Bureau and director of the National Joint Procurement Office for High-Value Medical Consumables, announced the proposed selection results, three clinical experts relaxed their brows.

Among the top 10 commonly used coronary stents, 7 were selected. These products are mainstream products commonly used in hospitals, and there is no issue of suitable alternative products, said Yang Weixian, deputy director of Fuwai Hospital of the Chinese Academy of Medical Sciences. Most selected products have been used for over 5 years, with some exceeding 10 years, and their safety and effectiveness have been clinically verified.

According to one company, cardiac stents are highly regulated medical devices. Any changes in major raw materials, production processes, or technologies require 'type testing' by third-party national testing agencies and 'application for changes' from the drug regulatory authority. Moreover, each stent has a unique identification number, and all products are traceable throughout the process.

Cardiac stents are products implanted in the human body, just like human organs, and cannot be taken lightly. No company can have a lucky mindset on this principled issue, said a relevant person in the company.

On November 11, the National Medical Products Administration issued a notice on strengthening quality supervision of selected coronary stents in national centralized volume procurement, requiring localities to strengthen supervision to ensure the quality and safety of coronary stents in centralized volume procurement. Companies must establish and improve the traceability system for coronary stent products and effectively carry out product recall and tracking work. Local drug regulatory departments must conduct at least one comprehensive supervision inspection of selected companies each year and strengthen monitoring of adverse events related to coronary stent products.

Some are concerned that the significant price drop of cardiac stents may affect hospital revenue. Will the costs for patients undergoing surgery increase?

In 2019, our country has fully implemented a zero markup policy for consumables. When various regions canceled the markup policy, they simultaneously adjusted the prices of medical services, reflecting the costs and technical labor value of medical institutions through these adjustments. Currently, performing a coronary stent surgery requires at least three charge items: coronary angiography, balloon dilation, and stent placement. For example, in Beijing, coronary angiography costs 1000 yuan, balloon dilation costs 1350 yuan, and stent placement costs 3300 yuan, totaling 5650 yuan, not including other examination and treatment income. At the same time, to further motivate medical institutions, the medical insurance department has clearly stated that a portion of the surplus from centralized procurement medical insurance will be allocated to medical institutions. This means that the price reduction of heart stents will not affect hospital income.

After the price reduction of stents, the total burden on patients will also significantly decrease. It is estimated that for employees' medical insurance and residents' medical insurance patients who have stents implanted, the out-of-pocket expenses will drop to below 2500 yuan.

To encourage medical institutions to use the selected heart stents, the centralized procurement office has already established relevant support measures for the implementation of subsequent procurement volumes, such as allowing medical institutions to retain part of the annual medical insurance budget surplus.

The Tianjin Chest Hospital ranks fourth in the country for the annual usage of heart stents. The hospital director, Guo Zhigang, believes that the price reduction of heart stents not only does not affect hospital income but also enhances the hospital's image, increases patient trust, and improves doctor-patient relationships.

This centralized procurement of heart stents is expected to save 10.9 billion yuan. Experts suggest that various regions should utilize the space and opportunities provided by the results of centralized procurement to promote reforms in medical staff salary systems, hospital compensation mechanisms, etc., to motivate medical staff and better ensure the implementation of procurement results.

Zhong Dongbo revealed that our country will summarize the good experiences of centralized procurement of coronary stents and begin to select products with high usage, high prices, serious inflation, and significant public concern as the next batch for centralized procurement. Following a one-product-one-policy approach, thorough technical analysis, market research, and expert validation will be conducted to formulate suitable procurement rules. It is expected that as each product matures, it will be gradually included in centralized procurement, allowing the public to access higher quality and lower-priced products.