Rolling original research? There are three barriers to the consistency evaluation of generic drugs

September 29, 2018 is a key year for quality consistency evaluation of generic drugs On the way to cross the border and charge, the real swords and bayonets are red! According to incomplete statistics, up to now, there have been 97 drugs that have passed the consistency evaluation These new expensive drugs have the trend of staying behind, suppressing the original research and controlling the market share However, through the consistency evaluation, the burden of generic drugs is not easy, and there are three more hurdles to be crossed ▍ the first hurdle: centralized purchase of drugs in 2017, the policy of the great heat in the pharmaceutical market was to replace business tax with value-added tax and two vote system, while in 2018, the national drug pilot purchase became a great heat According to relevant documents, the selection scope of the joint procurement of the national drug pilot is all the generic products that have been evaluated for consistency A total of 33 varieties were involved And the mode of the national pilot procurement is basically determined, that is, the national organization, the pilot city joint procurement, using the Shanghai technology platform operation On the whole, there is no accident for the drugs entering the pilot joint purchase negotiation Basically, they start to reduce prices at 10 points If there is no drug in conformity assessment, only the remaining 30-40% of the market space can be divided If this trend continues, drug companies that originally expected to raise drug prices through consistency evaluation must be prepared for price reduction in order to gain market share In the same way, this price reduction stimulation will also be transmitted to the original king of uncrowned - the original research drug In the era of the highest retail price, the original research drugs enjoy the preferential treatment of independent pricing, while the quality stratification of drug bidding and purchasing is high, and the low-level generic drugs kill each other   Now, the original research drug has lost the Amulet of exclusive group, and the era of "high price and middle elevation cost open road" has been destroyed Under the constraint of "price reduction survival, price for quantity" mantra, the original research drug is helpless to be carried into the rolling price reduction trend, and the market sales structure will also change dramatically in the environment of quality improvement and price reduction, which is in line with the "low price, low rate" of sunshine ”The time has come Therefore, whoever can pass the consistency evaluation first can have the first chance Once the drug purchase cycle is missed, although in some provinces and cities, the market share can be directly sold through online bargaining (such as GPO in Guangzhou), but the market share has already been divided into seven to eight percent What is left to him, except for his great merits, I'm afraid there are not many sales ▍ the second hurdle: medical insurance payment standard Remember that at the end of 2015, a guiding opinion on the formulation of basic medical insurance drug payment standard (Draft for comments) circulated in the industry almost clearly showed that the goal of establishing payment standard according to the common name in the future will remain unchanged, and a standard will be unified in the future After three years, according to the current comprehensive relevant policies, in the future, products with large price difference between the original research drug and the imitated drug will be given a transition period of 2-3 years to gradually realize the convergence of medical insurance payment price At this point, I can't help thinking about a problem Now the centralized purchase of drugs is no longer "centralized" Group purchase, inter provincial and regional alliance purchase, regional purchase, single variety with quantity purchase and other purchase methods have gradually broken the drug price into pieces Who will be the standard for the same medical insurance payment standard in the future? Based on the original research? Or generic?   Thinking of this, I can't help thinking of the successful experience of a province The biggest possibility is that in three years' time, all the products of various dosage forms and specifications of the original generic drugs that have passed the consistency evaluation will be packaged into a group, the benchmark products will be selected as the representative of the standard dosage forms and specifications, and then the medical insurance payment standard of the benchmark products will be fixed, and the corresponding difference ratio will form their respective medical insurance payment prices The actual bid price and online price, ha ha, with the measurement of medical insurance payment standard, I'm afraid that the drug price will not fall?! ▍ the third key: hospital prescription habits In the context of closer drug prices, generic drugs through consistency evaluation will find that, although they have the official confirmation aura of equality with the original research drugs, in fact, the original research drugs have been basically tested by strict clinical trials, with strong safety and effectiveness According to the relevant materials of "is bioequivalence consistent with clinical equivalence" published by dingxiangyuan, "generic drugs are consistent with clinical equivalence" Compared with the original research drug, the clinical efficacy is affected by many factors, only the pharmacokinetic parameters are similar, which can not guarantee the clinical equivalence Doctors and patients all think that compared with the original research drug, although the generic drug is bioequivalent, the clinical efficacy may be different From the perspective of clinical use, if there is no significant difference between the price of the drug through the consistency evaluation and that of the original research drug, why should we abandon the use of the original research drug with clinical basis and change it into a strange generic drug   On June 25 this year, in the announcement on receiving the application of new drug information published on the official website of a major hospital in China, the drugs that had passed the consistency evaluation at that time were definitely blocked outside the door, which undoubtedly sent a clear signal to the industry If we want to replace the original research, there are only two ways for generic drugs: one is to reduce prices substantially; the other is to improve their own technology level, which really proves Better than the original drug No matter what kind of medicine, whether it has complete and sufficient safety, whether the quality is stable is an important measure of "no difference" Whether the medical institutions need it or the patients bury it or not is the basis of "closer distance" Consistency evaluation is a necessary choice to keep the market, but related pharmaceutical companies should take a long-term view From the perspective of national policy, the consistency evaluation will greatly improve the level of China's generic drugs, "try our best to solve the situation that China's generic drug industry is large but not strong," how small and scattered is poor ", but the fundamental intention is to grasp both the research and development of generic drugs and the creation of new drugs From this point of view, ironmaking needs to be more hard Through consistency evaluation, only passing scores are obtained In order to win the favor of the market, it is necessary to have the determination and confidence of half a century people, and consolidate their own foundation, so as to stride over the three hurdles and win the future.