Shanghai: 12 departments issued documents, innovative medical devices welcome good news

With policy support, the "wind resistance" to the development of innovative devices has been reduced.

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Shanghai optimizes the admission process for innovative devices

Accelerate clinical application

Recently, the Shanghai Municipal Health Commission and other 12 departments issued the "Implementation Plan for Deepening the Reform of the Municipal Medical and Health System by Implementing the Spirit of the Third Plenary Session of the 20th CPC Central Committee and the Fifth Plenary Session of the 12th Municipal Party Committee", which once again clarified the support for innovative drugs and devices.

The document proposes to improve the mechanism to support the development of innovative drugs and medical devices. Promote the reform of the drug and device review and approval system, improve the review capability, efficiency and transparency, and strengthen the protection of drug clinical trial data. Focus on "new and excellent drugs and devices" products, build a communication platform between industry and medicine, and establish an efficient docking mechanism between industry and medicine. Support the development of innovative drugs and devices, improve the price formation mechanism of innovative drugs and devices, optimize the admission process, and accelerate clinical application.

As the innovation engine city of the national biopharmaceutical industry, Shanghai has spared no effort in supporting the development of innovative medical devices in recent years, especially in the admission and payment links.

In terms of admission, Shanghai issued the "Several Measures for Shanghai to Further Improve the Diversified Payment Mechanism to Support the Development of Innovative Drugs and Devices" in July last year, which proposed to accelerate the clinical application of innovative drugs and devices. Adjust and optimize the assessment mechanism of medical institutions. Hospitals shall not restrict the admission of innovative drugs and devices due to reasons such as the number of drug catalogs and the "drug/consumable ratio". For products that have obtained the national medical insurance consumables code and meet the management regulations of the city's additional chargeable consumables catalog, enterprises can directly apply for online procurement, implement one-stop acceptance, reduce the handling links, improve the review efficiency, and accelerate clinical use.

In terms of payment, Shanghai requires that innovative drugs and devices be given priority in DRG/DIP payment, and the payment standards for new technology application cases be raised. There is no control ratio for high-multiplier cases of new technology application, and large-scale new technology applications can be grouped independently. Steadily expand the scope of medical insurance payment for medical service items and medical consumables in the city, and give priority to covering innovative drugs and devices.

Last October, Shanghai added 60 types of consumables to the scope of medical insurance payment, including some innovative consumables such as "optical coherence tomography (OCT) catheters". In December last year, the Shanghai Medical Insurance Bureau and the Shanghai Health Commission issued the "Notice on Reaffirming the Acceleration of the Promotion of the Clinical Application of Innovative Drugs and Devices", further reiterating the relevant policy provisions on accelerating the promotion of the clinical application of innovative drugs and devices.

According to a recent report by Wenhui Daily, Shanghai's basic medical insurance has continuously increased its support for innovative drugs and devices. Innovative drugs and devices have achieved rapid admission to hospitals, and the use of innovative drugs and devices in medical institutions has increased significantly. Innovative technologies are further highlighted in medical insurance payments. In the 2023 version of the DRG payment grouping plan, new technologies and new projects are grouped into 17 groups separately, involving 45,000 cases and a separate payment amount of 500 million yuan.

As of September, Shanghai has approved four domestically produced Class 1 innovative drugs and nine Class III innovative medical devices. The number of approved innovative drugs and innovative medical devices has remained the same as the whole year of 2023.

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Innovative equipment enters hospital, payment resistance decreases

For the development of innovative medical devices, the resistance to breaking the ice in the links of entering hospital, application and payment is relatively large. The positive signal is that the window for innovative equipment is opening. Both the national and local levels have increased their support, and some regions have proposed specific measures to encourage the development of innovative medical devices.

Taking the DRG/DIP reform, which is the most concerned by the industry, as an example, under the new payment method, the application of innovative technologies and innovative products may be restricted.

In July this year, the National Medical Insurance Administration issued the "Notice of the Office of the National Medical Insurance Administration on Printing and Distributing the 2.0 Grouping Scheme for Payment by Disease Group and Disease Type Score and Deepening the Related Work". It is clearly stated that for cases where the use of new drugs and new technologies is not suitable for payment according to the DRG/DIP standards, medical institutions can independently apply for special cases, and the number of special cases is in principle 5% of the total number of DRG discharged cases or 5% of the total number of DIP discharged cases.

In addition, it is proposed to explore the exclusion mechanism, and support qualified new drugs, consumables and new technologies by paying for them according to projects or by weight (points) in the initial stage of application, and then include them in DRG/DIP payment after accumulating enough data in the later stage.

Local levels are also actively promoting measures such as DRG/DIP exclusion payment and special case single discussion to encourage the development of innovative devices. On October 12, the Zhejiang Medical Insurance Bureau issued the "Notice of the Zhejiang Provincial Medical Insurance Bureau on Printing and Distributing the Management Measures for the Incentive Payment of Medical Insurance for Innovative Medical Technologies in Zhejiang Province (Trial)", which clearly stated that qualified innovative drugs and innovative medical service projects (including medical consumables) can be included in the DRG point payment incentive scope after application and certification.

In the review and approval of drugs and equipment, the registration and listing process of innovative medical devices is also expected to be accelerated.

From January to August this year, the State Drug Administration approved 31 innovative drugs and 46 innovative medical devices, an increase of 19.23% and 12.16% respectively over the same period last year.

At the "Promoting High-quality Development" series of themed press conferences held by the State Council Information Office in September this year, it was pointed out that the drug regulatory authorities are planning a package of policy measures to comprehensively deepen drug regulatory reforms in accordance with the deployment of the plenary session, focusing on creating a globally competitive pharmaceutical innovation ecosystem and accelerating the pace of the launch of innovative drugs and medical devices.

At the meeting, it was mentioned that for innovative drugs and medical devices that are key supported by the state, service guidance will be strengthened in review and approval, inspection and verification, etc., and enterprises will be guided to adhere to clinical value-oriented and patient-centered R&D strategies. Improve the accessibility of innovative drugs and medical devices, implement the decision-making and deployment of the Party Central Committee on deepening the coordinated development and governance of the "three medical services", and actively support innovative drugs and devices to enter hospitals and medical insurance.

The golden age of domestic innovative devices has arrived.