CAR-T (a cell therapy drug), ADC (antibody conjugated drug)... Patients are eagerly anticipating these innovative drugs. However, some innovative drugs are still difficult to use even after being approved for market. The research and development cost of innovative drugs is high, with some priced as high as millions of yuan, which patients cannot afford. Some innovative drugs are difficult to purchase in medical institutions after approval, and the problem of "difficult medication" for innovative drugs has become a focus. Recently, multiple documents supporting the development and application of innovative drugs have been released intensively, bringing good news to innovative drugs. How can innovative drugs no longer be difficult to use? On July 8th, reporters from Science and Technology Daily interviewed several experts on this matter. Question 1: How can the pricing of innovative drugs be lowered? Innovative drug research and development requires a large investment, a long chain, and a low probability of success. The pricing after listing is higher than that of generic drugs, which is reasonable. ”Professor Liu Bao from the School of Public Health at Fudan University told reporters that currently, CAR-T products listed in China are priced as high as 1.29 million yuan per injection. Even if there may be price adjustments in the future, it is difficult for ordinary families to afford them all by themselves. The R&D investment is large, we need to find ways to reduce it. ”Liu Bao said that clinical trials are one of the largest stages of research and development investment for innovative drugs before they are launched. To incentivize the research and development of innovative drugs, relevant departments have introduced a series of policies to compress the research and development cycle and review time through measures such as conditional approval and priority review and approval, and reduce the cost of innovative drug research and development. For example, on the basis of optimizing the pilot work of clinical trial review and approval for innovative drugs, the National Medical Products Administration proposed on June 16 to complete the review and approval of clinical trial applications for three types of innovative drugs within 30 working days. To significantly reduce research and development costs, relevant departments continue to promote the use of artificial intelligence and big data technology for innovative drug development. The "Several Measures to Support the High Quality Development of Innovative Drugs" (hereinafter referred to as the "Measures") issued by the National Healthcare Security Administration and the National Health Commission propose to support the use of medical insurance data for innovative drug research and development, develop data products that meet the needs of innovative drug research and development, and improve innovation efficiency. Professor Deng Yong from the School of Humanities at Beijing University of Traditional Chinese Medicine analyzed that medical insurance data covers key information such as disease spectrum and clinical medication demand, which can accurately guide enterprises and institutions to focus on the research and development of valuable and effective innovative drugs, avoiding homogeneous competition; At the same time, it can also enable research and development entities to better understand the existing drug usage and clinical demand gaps, accelerating the development of urgently needed innovative drugs. Question 2: What if innovative drugs cannot be purchased in hospitals? Previously, some patients found that some innovative drugs covered by medical insurance cannot be purchased or used in hospitals. "Medical institutions will have many considerations on the use of innovative drugs," said Lv Lanting, associate professor of the School of Population and Health of Renmin University of China. In response to this issue, the Measures propose five measures to support the clinical application of innovative drugs, such as promoting the accelerated entry of innovative drugs into designated pharmaceutical institutions. The use of some innovative drugs is much more complex than simply taking medication or receiving injections, and even requires the addition of supporting medical services. ”Liu Bao gave an example that CAR-T is customized for individual patients and involves many personalized medical services. Gene therapy and targeted therapy also have similar issues. Liu Bao believes that although the "Measures" propose that some innovative drugs can be excluded from disease settlement, which reduces usage restrictions, it is still difficult to fundamentally bridge the "last mile" if an incentive system for the use of innovative drugs cannot be formed in medical institutions. Regarding the difficulty of introducing innovative drugs into hospitals, Lv Lanting stated that the "Measures" support the inclusion of innovative drugs in the medical insurance drug list, which is beneficial for hospitals to select drugs with more clinical efficacy and cost-effectiveness based on their own actual situation. In addition, the Measures also propose to promote the construction of cloud platforms. Regarding this, Deng Yong stated that if a trading platform for innovative drugs can be established, it will open up a "new channel" for the circulation and use of innovative drugs, making it convenient for the public to access them. Three questions: How can innovative drugs achieve sustainable and high-quality development? Partial innovative drugs are conditionally approved for market, which requires them to undergo confirmatory clinical trials to obtain more clinical data and verify their safety and efficacy after being approved for market. ”Liu Bao explained that some innovative drugs are launched based on alternative clinical endpoints, which require verification through longer observation periods after listing, which is in line with international practice. Innovative drugs have not yet formed a stable volume and there is insufficient accumulation of clinical data. ”Lv Lanting stated that the clinical use of innovative drugs still requires experience accumulation. Therefore, the Measures propose to strengthen real-world research on innovative drugs. This indicates that the National Healthcare Security Administration and the National Health Commission will work together to promote the evaluation of the real-world clinical efficacy of innovative drugs, which is not only conducive to screening innovative drugs that are effective for patients and providing more support, but also conducive to enhancing doctors' and the public's understanding of the efficacy of innovative drugs, and promoting global understanding of the effectiveness of innovative drug use in China, "said Lv Lanting. Deng Yong also stated that observing the effectiveness of innovative drug use in a wider population and actual clinical scenarios, providing more evidence for drug improvement and clinical application, will not only enhance public confidence in the safety and effectiveness of innovative drugs, but also contribute to drug regulation and approval. (New Society)