Ten measures are favorable for innovative medical devices

September 12, 2024  Source: https://mp.weixin.qq.com/ 33

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Recently, the Guangzhou Municipal Health Commission of Guangdong Province issued the "Ten Measures of the Guangzhou Municipal Health Commission to Support the High-quality Development of Innovative Drugs and Devices", covering the entire process of product research and development-hospital use-payment expansion.

 

The notice proposes to urge medical institutions to hold at least one working meeting of the medical device-related committee every quarter, and hold a meeting within one month after the publication of the "Guangzhou Innovative Drug and Device Product Catalog", and promptly include innovative drugs and devices in the medical institution's drug or device catalog as needed, so as to achieve "all-out allocation" and give priority to selection. Encourage qualified medical institutions to accelerate the application of innovative medical devices such as active surgical instruments, passive implantable devices, medical software, medical imaging, radiotherapy, surgical robots, etc., and orderly promote the iterative upgrade of medical institutions' equipment and facilities.

 

Adjust the "Evaluation Indicators and Scoring Methods of Pharmaceutical Affairs of Guangzhou's Third-level Public Medical Institutions" and "Performance Assessment Indicators of Guangzhou's Municipal and District Third-level Public Hospitals", add national negotiation drugs, innovative drugs, and innovative medical device allocation rates as assessment indicators, and promote the accelerated entry of innovative medical devices into hospitals from the institutional level.

 

At the payment level, assist the medical insurance department to establish special funds for innovative drugs and equipment and a diversified payment mechanism to support the development of innovative drugs and equipment, support commercial insurance companies to develop inclusive commercial health insurance products covering innovative drugs and equipment, explore drug and equipment liability insurance in the clinical trial link; eliminate the impact of national negotiated drugs, innovative drugs, and innovative diagnosis and treatment projects on relevant indicators such as per capita drug costs and per capita medical costs.

 

Previously, the "Several Measures for Guangzhou Medical Insurance to Support the Development of Innovative Medicines" issued by the Guangzhou Medical Insurance Bureau also mentioned that innovative drugs and equipment and innovative medical technologies should be included in the city's medical insurance payment scope in a timely manner according to regulations; support the application of special case payments for cases using innovative drugs and equipment and innovative medical technologies.

 

Due to large investments, long cycles, and high technical barriers, the development of innovative drugs and equipment is highly dependent on policy support. In recent years, various places have taken measures that are favorable to innovative drugs and equipment, and heavy financial support is being implemented one after another.

 

Beijing officially announced that by 2026, the total scale of the pharmaceutical and health industry will reach 1.25 trillion yuan (the operating income of the pharmaceutical industry will reach 240 billion yuan), and fixed asset investment will exceed 10 billion yuan per year. The development goals include 30 new approved innovative medical devices.

Shanghai proposed that for products that enter the special review procedures for innovative medical devices in the country and Shanghai, a maximum of 3 million yuan in support will be given in accordance with regulations; for the above products that obtain registration certificates for the first time and are put into production, a maximum of 8 million yuan in support will be given in accordance with regulations, not exceeding 40% of the R&D investment. The cumulative support amount for each unit is up to 30 million yuan per year. The investment of real money guarantees the enthusiasm for the research and development of innovative medical devices, but if commercial transformation is to be achieved, supporting assistance in pricing, admission to hospitals, payment and other links is still needed.

On September 10, the State Council Information Office held a series of themed press conferences on "Promoting High-quality Development", and put forward opinions on the charging access of new technologies, new equipment and new consumables:

For major innovative projects that optimize the diagnosis and treatment of major diseases or fill the gaps in diagnosis and treatment, a green channel will be opened to speed up the review; for improved innovative projects, the current price items will be improved to achieve compatibility and quickly meet the reasonable charging needs; for other new price items, the acceptance and review progress will be accelerated to fully meet the reasonable charging needs of new technologies, new equipment and new consumables at different innovation levels.

Shanghai, Hainan, Guangzhou and other places have also issued clear documents to encourage innovative pharmaceutical and medical device companies to negotiate prices with medical institutions independently, while ensuring professionalism, and also respecting objective market laws.

In terms of admission to hospitals, in addition to Guangzhou, Shanghai also requires that the admission of innovative pharmaceuticals and medical devices should not be affected by reasons such as the total medical insurance budget, restrictions on the drug catalog, and the proportion of drug consumption; Beijing proposes to promote the research and development of medical devices through ordering, first purchase, etc., and accelerate the application of innovative products in hospitals.

 

Based on the reform of medical payment methods, medical institutions are relatively cautious in the use of high-priced technologies. So far, many places have reserved green channels for innovative devices in the payment link to promote their commercialization and complete the closed loop. Hainan will include innovative drugs and medical devices purchased by designated medical institutions across the province in the scope of direct settlement; Beijing will include qualified innovative drugs and medical devices and related technical services in the scope of payment excluded from CHS-DRG payment; Zhejiang has introduced incentives for innovative medical technologies, and the total incentive amount will be determined according to a certain proportion of the total DRG settlement amount this year.

 

With the implementation of various major measures, the ecology of the innovative medical device industry has changed. Relying on the support of the whole chain, the pace of innovation of domestic medical devices will continue to accelerate.

By editor
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