Strategy integration of pharmaceutical enterprises under the new normal of the industry

Source: Sina pharmaceutical's overall acceleration of drug access on April 10, 2017 and the increasingly mature control of medical insurance funds are the basic characteristics of the pharmaceutical industry under the new normal The synergy of policy focus brought by the three medical linkage also means that the strategies of drug registration, pricing, reimbursement, admission, market and sales of pharmaceutical enterprises need to be integrated and coordinated 1、 The overall acceleration of drug access is a significant feature of the reform of the medical and health system in 2016-2017, which is reflected in the acceleration of drug review and approval: the original AstraZeneca drug oxitinib mesylate was approved by CFDA in 7 months, only 16 months after the first approval of the drug in the world; the acceleration of drug reimbursement access: The update of the national basic medical insurance drug catalog has made up the old deficit since 2009, and clearly proposed to establish a dynamic adjustment mechanism of the drug catalog, so that the whole industry is happy Before that, it took up to 10 years for foreign new drugs to be listed in China for review and approval, and nearly 7 years for reimbursement access - many imported original research drugs were close to patent expiration when they were reimbursed The current series of reforms mean that China's drug access is speeding up and integrating with international practices - in Taiwan, Japan, Hong Kong and other markets, new drugs are usually completed within three years from registration application to reimbursement access The acceleration of new drug listing means that patients can benefit from new diagnosis and treatment methods in time, and the acceleration of reimbursement access means that the medical insurance drug catalog is expected to gradually change from cost control means to the list of rights of insured patients 2、 The acceleration of drug access and the maturity of medical insurance fund control mode complement each other Under the new normal, medical insurance funds all over the country are facing the income pressure brought by the slowdown of economic growth and the expenditure pressure brought by the aging society "Strict control" is not only the premise of "wide access", but also the requirement of "wide access" Specifically, it includes: the maturity of total amount control and index decomposition system at the level of hospital and department; the reform of medical insurance payment mode makes medical behavior need "profit from performance", rather than "bonus from investment"; the intelligent monitoring of medical insurance makes the "advance warning" and "in-process control" in medical supervision implemented by medical insurance; The payment standard of medical insurance affects doctors' prescription and patients' willingness to pay by adjusting the payment amount of medical insurance fund (at present, the payment standard of medical insurance in Fujian and Tianjin is lower than the provincial bidding price); more products in the same treatment field are included in the scope of medical insurance reimbursement, so as to promote market competition; In the future, with the gradual completion of the "evaluation of the consistency of quality and efficacy of generic drugs", generic drug substitution will further play the role of fee control in the reform of medical insurance payment standards and payment methods The reform of medical insurance fee control can be described as a ten-year sword Take Tianjin as an example - if the pharmaceutical enterprises didn't feel the sales pressure at the beginning of the reform, in the 2013 diabetes pay per head pilot (breaking through the list of Medicare drugs, DPP-4 inhibitors were reimbursed in the pilot hospital), they tasted the sweetness of "light list"; In 2015, when the intelligent monitoring system of medical insurance was upgraded, it began to feel that "heavy supervision" brought unprecedented sales pressure (especially the drugs ranked first in the sales of large hospitals) - medical insurance monitored doctors' prescriptions in real time through the information system, and it was difficult to deal with super indications and large prescriptions in the system; In 2016, the renewal of medical insurance synonym database broke the pattern that the original medical insurance payment price was equal to the provincial bid winning price The new products included in the synonym database were determined according to the maximum payment standard of drugs within the original synonym payment range, which was no higher than 130% The reimbursement payment standard of some original research drugs was only 130% of the generic generic generic generic generic generic generic drugs, far lower than the provincial bid winning price The path of Tianjin's medical insurance reform policy is shown in the following figure: Third, pharmaceutical enterprises need to integrate strategies in all aspects The acceleration of drug access and the change of the environment for medical insurance fee control will change the original market competition pattern, and the era of simply relying on catalog to drive sales will never return Along with the improvement of patients' access to drugs, the life cycle of drugs in the Chinese market will gradually integrate with developed countries All of these challenges the integration of a series of strategies such as drug registration, pricing, reimbursement, admission, market and sales.