Medical insurance access based on the whole life cycle of drugs

Before, drug access was divided into three parts: hospital access, bidding access and medical insurance access, which were separated from each other and not closely linked Medical insurance access was relatively less important With the reform of medical policy, especially for innovative drugs, medical insurance access becomes more and more important From 2000 to 2019, China has carried out a total of five adjustments to the medical insurance catalog From the perspective of change trend, the interval between the adjustment of medical insurance catalogue is becoming shorter and shorter From 2017, the medical insurance negotiation and access system began, and a considerable number of drugs were transferred out in 2019 This also means that China's medical insurance fund is in the stage of "releasing cages and changing birds", so as to make room for more and more valuable drugs This also means that enterprises can no longer wait for the drug to be listed before considering whether to enter the medical insurance, but should consider clearly in the drug research and development stage Of course, this is both an opportunity and a challenge for enterprises On October 31, Ms Chu Minhua, vice president of research and Development Institute and President of Research Institute, was invited by GBI to prepare for medical insurance access? What do you do? How do you do it? Shared her analysis and insights So far, the state has organized three health insurance price negotiations, and the fourth is in progress In 2016, the first healthcare negotiation successfully negotiated three drugs, with tenofovir ester successfully reducing 67%, and exetinib and gefitinib both reducing more than 50% In 2017, the second price negotiation organized by the Ministry of human resources and social security successfully negotiated 36 kinds of drugs, with an average decrease of 44% in the price of drugs, and the highest decrease of 70% In 2018, 17 special negotiations on anticancer drugs were successfully included, with an average drop of 56.7% in drug prices, with the highest drop of more than 70% A total of 70 drugs will enter the negotiations in 2019 According to previous news, the results will be announced in November Enterprises should understand the relevant policies and the logic behind them According to the first three medical insurance negotiations, the state first started from the clinical needs of drugs, and the policy was inclined to the use of drugs for major diseases such as cancer and rare diseases, slow diseases, children's drugs, emergency rescue drugs and clinically necessary drugs Next is the clinical efficacy of drugs Every year, there are new dosage forms of drugs Whether there is an innovative mechanism for drugs, clear efficacy and safety are the focus of consideration Thirdly, in terms of drug pricing, we should calculate whether the drug has pharmacoeconomic value according to its value, economics, health output and treatment value, and also consider the overspending pressure on medical insurance fund if the drug is included Finally, in terms of medical insurance management, drugs should be easy to fund management, not be abused clinically, and limit the payment for indications As mentioned above, we can't wait for the drug to be listed before we consider whether it will be included in the medical insurance However, from the time of drug research and development, the reform of medical insurance access actually runs through the whole process from discovery to listing On the one hand, the State encourages innovative drugs, which can be reflected in a number of policies in recent years "Major new drug creation project" encourages the development of new treatment mechanism, treatment of serious life-threatening diseases, rare diseases and children's drugs In terms of approval, it also includes accelerated approval of innovative drugs, tacit approval of 60 day clinical trials, and conformity evaluation of generic drugs China's accession to the International Conference for the technical coordination of human drug registration (ICH) in 2017 has also become an important manifestation of the international community's support for China's drug God review and approval reform The newly revised Drug Administration Law also puts forward the system of listing license holder, which further clarifies the main responsibility All of these reflect that the review and approval of drugs in China are subject to strict policy supervision On the other hand, the medical insurance bureau hopes to improve the efficiency of fund use and the level of medical insurance In addition to the dynamic adjustment of the medical insurance catalogue, the special provincial purchase of anticancer drugs, the special negotiation on the access of innovative drugs to medical insurance, the centralized purchase of "4 + 7" national drugs, the issuance of the list of key monitoring rational drugs and the reform of insurance payment mode, etc all reflect the determination of the state to use the medical insurance fund more effectively and to include more good drugs for life and emergency into the medical insurance For enterprises, the post marketing strategy of drugs should be considered at the time of research and development, prepare relevant approval materials as early as possible, and establish the concept of the whole life cycle However, the time to prepare access data is very limited, so in the top-level design of drugs, the preparation process of access data should do the following: ① Play the role of key opinion leader (KOL) The enterprise shall contact KOL as early as possible and consult with the main researchers of relevant drugs; ② Focus on product innovation For example, whether there is an innovative mechanism for drugs, whether it is a global initiative, etc; ③ Grasp the clinical unmet needs From the data submitted in the past, in the epidemiological investigation, all enterprises are well prepared However, the data of disease burden, outpatient / inpatient / non-medical cost related expenses, and patients' quality of life are generally missing It is suggested that the above data should be collected simultaneously in phase III clinical trials of drugs; ④ It emphasizes the clinical value of drugs The core value of drugs is still clinical value Enterprises should consider how to show the advantages of drugs to medical insurance experts in an easy to understand way; ⑤ Plan drug positioning and pricing Because the payment of medical insurance has the limitation of indications, which indication to choose to enter medical insurance should be considered in advance The wide indication of drugs is a double-edged sword, which means that the number of potential drugs is large, but at the same time, the pressure of medical insurance fund is also large;