The national coronary intervention balloon sampling has entered a critical period! Led by Henan Province, it covers 20 provinces

In the interventional treatment of coronary heart disease, coronary intervention balloons are indispensable "key tools". Nowadays, this consumable has reached a crucial juncture for nationwide volume-based procurement.

On September 11th, the Medical Insurance Bureau of Henan Province released the "Key Points of Centralized Volume-based Procurement Rules for Coronary Intervention Balloon Medical Consumables (Draft for Comment)", indicating that the national joint procurement project led by Henan is about to enter the implementation stage.

Looking back to December last year, the Medical Insurance Bureau of Henan Province had already issued a notice on the centralized maintenance of relevant consumables. The release of this draft for public comment marks that the implementation of joint procurement has entered the "last mile".

In terms of coverage, the provincial lineup of this alliance is huge, with 20 provinces (municipalities and autonomous regions) including Henan, Shandong, Shanxi, Inner Mongolia, Heilongjiang, Jilin, Sichuan, Chongqing, Hunan, Hubei, Guangdong, Hainan, Shaanxi, Gansu, Ningxia, Shanghai, Fujian, Jiangsu and Zhejiang all on the list, almost covering the major medical demand areas in the country.

"Anti-involution" becomes the core highlight! Multiple rounds of quotations and cost commitments, the centralized procurement rules carry profound meanings

This national joint procurement led by Henan Province does not cover all coronary balloons, but focuses on the subcategory of special coronary balloons, specifically including coronary cutting balloons, coronary notches/spinous process balloons, and coronary mastoid balloons.

From the perspective of rule design, the orientation of "guaranteed price and anti-internal competition" is very clear. Multiple provisions not only ensure the cost-effectiveness of medical devices for patients but also set a reasonable profit margin for enterprises.

1.Basic procurement rules: Quantity and price are linked, with stable cycles

•Agreed purchase volume: Determined at 80% of the total demand of the medical institution to ensure that the selected enterprise has stable orders;

•Procurement cycle: Two years from the date of execution of the selected result, with a renewal of the procurement agreement once a year, providing certainty for the enterprise's production planning.

•Quotation range: The declared price must include the product price, delivery fee, supporting tools (delivery + usage fee), and accompanying service fee. Only one price can be declared within the same directory. After being selected, the same enterprise will apply a uniform selected price for all specifications of products under the same directory to avoid "price hikes due to specification splitting".

2.Proposed winning rules: The competition will be conducted in three rounds, taking into account both fairness and efficiency

To ensure full competition and avoid malicious low prices, the rules screen the selected enterprises in three levels:

Source: Henan Provincial Medical Security Bureau

•Rule One: First, sort the quotations from low to high. In case of a tie in quotations, enterprises with no record of bad faith, those with a large procurement demand, and those whose registration certificates were approved earlier will be given priority. If the ranking of affiliated enterprises crosses the "shortlisted/non-shortlisted" boundary, the last-ranked enterprise proposed to be shortlisted will be excluded. In a fully competitive directory, shortlisted enterprises can be selected if their quotations are no more than "1.5 times the minimum declared price". For directories with insufficient competition, the requirement that "the decline rate is greater than or equal to the average decline rate of directories with sufficient competition" must be met to be selected.

•Rule Two: Shortlisted enterprises that were not selected may quote again, but they must meet four conditions simultaneously: ≤ the first quote of the enterprise, ≤ the highest proposed winning price in the same directory, ≤ 80% of the highest valid declared price in the same directory, ≤ 1.3 times the lowest proposed winning price in the same directory.

•Rule Three: For valid enterprises that have not been shortlisted, their re-quotations must meet the following requirements: ≤ the first quotation of the enterprise, ≤ the highest proposed winning price in the same directory, ≤ 80% of the highest valid declared price in the same directory, ≤ 1.2 times the lowest proposed winning price in the same directory.

3.Key terms of "anti-involution" : Hold the cost bottom line and eliminate malicious low prices

Unlike previous centralized procureings, this time it is clearly required that all bidding enterprises must commit to providing quotations no lower than the cost. At the same time, the selected enterprise with the lowest quotation in the same directory needs to explain the rationality of the quotation and publicly issue a statement.

This regulation directly addresses the industry pain point of "snatching orders at low prices and then reducing quality", ensuring the safety of patients' use of medical devices while also creating a fair competitive environment for compliant enterprises.

Coronary special balloons: Domestic production accounts for 50%, and the market is expanding at the right time

Coronary balloons are the "core weapon" in interventional treatment for coronary heart disease - they are inserted into the narrowed area of the coronary artery through a catheter, and can improve blood flow by applying pressure and dilating. They are often used in balloon dilation (PTCA) or in combination with stent implantation. And the "special balloons" in this centralized procurement are even more powerful tools for dealing with complex diseases:

•Cutting balloons: Equipped with micro-blades, for treating complex calcification or fibrotic lesions；

•Notched/spinous balloon: The surface has special protrusions to reduce the damage to blood vessels caused by high-pressure dilation;

• Mastoid balloon: Resistant to high pressure, mainly for the treatment of calcified lesions.

From the perspective of the market pattern, significant progress has been made in domestic substitution.

  As of January 2024, among the over 30 special balloon products approved for marketing by the NMPA, domestic products account for approximately 50%. Companies such as Lepu Medical, Bomai Medical, Dingke Medical, Microport Medical, and Jiwei Medical (Blue Sail) have covered various types including cutting, incisions, spinous processes, and mastoids, and are widely used in coronary and peripheral vascular interventional treatments.

However, the current market size of special balloons is still relatively small, and the penetration rate needs to be improved.

In the previous 2023 "3+N" alliance centralized procurement of the Beijing-Tianjin-Hebei region, the selected price range for related categories was 1,198 to 4,978 yuan, covering 11 regions including Anhui and Xinjiang. The launch of this joint procurement by 20 provinces across the country will further lower terminal prices and expand the scope of use, bringing a "golden opportunity for volume increase" to domestic enterprises.

From the perspective of competition among subcategories, there are differences in the progress of domestic substitution for different types of balloons:

•Coronary artery cutting balloons: Boston Scientific (imported) previously dominated the market, but now domestic enterprises such as Lepu Medical and Bomai Medical are rapidly seizing the market through centralized procurement.

•Notched/spinous balloon: Domestic products have dominated the market, with Lepu, Bomai, Dingke, and Microport collectively holding the majority of the market share.

•Mastoid balloons: The import dependence is relatively high (for instance, the previous winning bid price of Aistarc was 2,952 yuan per balloon), but domestic enterprises such as Lepu and Jiwei have been approved in large numbers in the past two years and are accelerating their penetration.

The implementation of centralized procurement: Patients' burden is reduced, enterprises benefit, and a win-win situation for all parties is expected

The national joint procurement of coronary special balloons led by Henan Province this time is the first large-scale practice of the national policy of "anti-internal competition in centralized procurement", and its impact will radiate to three levels: patients, enterprises and the medical system.

• For patients, the "democratization of advanced life-saving consumables" will become a reality. With the implementation of centralized procurement, the prices of special balloons will further decrease. Patients who were previously hesitant due to the high prices can now use high-quality consumables at a lower cost, reducing their medical burden.

• For enterprises, the logic of "trading price for volume" will be fully realized. Although the selected price may be lower than the market price, the 80% agreed purchase volume and the vast market of 20 provinces can help enterprises rapidly expand sales and reduce marginal costs. Especially for domestic enterprises, they can further reduce the share of imported brands and consolidate their market position through centralized procurement.

• For the medical system, centralized procurement will promote the transparency of consumable prices and the standardization of their usage. The rules clearly state that "medical institutions should give priority to using the selected products to ensure the completion of the agreed volume", while allowing a moderate purchase of other reasonably priced products. This not only guarantees a stable supply but also avoids the practice of "choosing only the lowest price", taking into account both medical quality and cost control.

In addition, this centralized procurement has also established a "dynamic price linkage" mechanism: if a new low price emerges for the same product in the national or other provincial alliance centralized procurement, the unexecuted procurement volume this time will be executed according to the new low price to ensure that the price remains within a reasonable range at all times.

With the advancement of the draft for comments, the national joint procurement of coronary special balloons will soon enter the implementation stage.

This "anti-internal competition" centralized procurement practice will not only change the market pattern of coronary artery consumables, but also provide replicable experience for subsequent centralized procurement of medical consumables, promoting the steady progress of medical security towards the direction of "ensuring basic needs, strengthening the grassroots level, and sustainability".