Just now! The State Health Insurance Administration issued the latest instruction on “Centralized Procurement of Innovative Instruments”
2022-10-20
01 .How to purchase innovative medical devices?
On October 12, the National Healthcare Security Administration(NHSA) again responded to the purchase of innovative medical devices. It is reported that in the recent centralized procurement of spinal consumables, the 3D printing spinal products will be selected by the enterprise.
In this regard, the National Healthcare Security Administration said that: considering that 3D printing products are still in the initial stage, the market competition is not sufficient, and the product characteristics are more complex, some products have the characteristics of personalized customization, and its cost and efficiency are difficult to compare with those of mass production products. At the same time, for 3D printing products not participating in centralized purchase, the online price will be standardized in the subsequent work.
The National Healthcare Security Administration further clarified that for innovative products such as 3D printing orthopedic consumables, taking into account the technical characteristics, production costs, use conditions, clinical efficacy and other characteristics, it will adopt the “one product, one policy” approach to determine appropriate procurement rules and improve the market-oriented price formation mechanism.
In addition, in September of this year, the National Health Insurance Bureau also clearly pointed out in the relevant reply that is still difficult to implement the method of centralized procurement of innovative health devices, because the clinical use of innovative health devices is not yet mature， and the amount of use is difficult to estimate temporarily.
In August this year, the National Healthcare Security Administration also mentioned in the relevant reply that it was studying and improving relevant policies to guide all regions to timely include qualified innovative medical consumables into the scope of health insurance payment according to procedures.
2.How is the approval progress of innovative medical devices?
So far, the State Drug Bureau has approved 180 innovative medical devices to be listed on the market.
In 2021, 35 products were approved, a significant increase compared with last year, most of which are domestic products.
Industry insiders believe that from the perspective of national policy, innovative medical devices have a very rare opportunity for development. “both regulatory and policy support, including the relevant assessment of hospitals, are vigorously encouraging the development of innovative medical devices, and the capital market is also very concerned.”
The green channel at the regulatory level, priority approval, pre- approval, and the registrar system are all helpful to the development of innovative medical devices. At the same time, various regions provide support and subsidies to companies that carry out innovative medical device research and development, which is a rare window period in general. “
The data shows that, by the end of 2021, 351 medical devices in China have entered the special review procedure for innovative medical devices, of which 134 innovative medical devices from 113 enterprises have been approved for listing; Active products account for 44%, negative products account for 38%, and IVD products account for 18%.
It is noteworthy that the industry’s definition of “innovation” is becoming clearer.
In the Special Approval Procedure for Innovative medical devices (Trial), for medical devices with core technology invention patents, international leading, domestic pioneering, and significant clinical application value, priority should be given to handling innovative medical devices without lowering standards and procedures.
In 2018, NMPA revised and issued the Special Review Procedure for Innovative Medical Devices, determining that the application time for special examination of innovative medical devices shall not exceed 5 years from the date of patent authorization announcement.
In July this year, the Beijing Health Insurance Bureau issued a trial policy of CHS-DRG payment for new drugs and technologies and new devices approved can apply for DRG payment exclusion.
In the document, there are strict restrictions on what is “new”, that is, “new generic drugs/medical devices approved by the drug regulatory department for marketing within three years (including the year of application and the previous two natural years, the same below); new medical devices that can be charged separately due to price adjustment within three years”, can apply for exemption of CHS-DRG payment.
Some industry experts argue that the only innovation that health care can support is a technological change or a real benefit to patients. “New drugs and new technologies have innovative value, and some policy support should be given at the initial stage of listing.
However, any product has its own economic cycle, and the consumption of products will be enlarged when they are mature. In the long run, the prices of drugs and consumables must have phased changes. “
