What changes have been brought about by the three major reform directions of the new drug price policy?

have not yet found openings to exploit! The era of low profit of generic drugs will officially come! Recently, the office of the State Medical Insurance Bureau, together with the national development and Reform Commission, the national health and Health Commission, the general office of the State Administration of market supervision, and the comprehensive Department of the State Drug Administration, solicited opinions on the notice on doing well in drug price management at this stage (hereinafter referred to as the "notice"), which means that the new drug price policy is about to be launched This is a new change in drug price management since the guidance of the general office of the State Council on improving the centralized drug purchase in public hospitals (GBF [2015] No 7, referred to as "No 7 document") was issued in 2015, and it is also another major reform after the State Medical Insurance Bureau took over the centralized drug purchase from the national health and Health Commission since its establishment in 2018 According to the notice, in addition to narcotic drugs and the first category of psychotropic drugs, the prices of chemical drugs, Chinese patent medicines, biochemical drugs, Chinese herbal pieces and hospital self-made preparations are all subject to market regulation, and the prices match the costs and supply The highest ex factory (port) and retail prices for narcotic drugs and category I psychotropic drugs will continue to be implemented Among them, the shortage of drugs is directly linked to the Internet Drug shortage allows enterprises to adjust their own prices and directly hang on the Internet They are not allowed to intervene for the reasons of low historical prices and low surrounding prices This means that the policy of "for drugs that are clinically necessary, in small quantities and in short supply in the market, they will be produced and purchased at a fixed price through national bidding" in No 7 document will be changed And the low-cost drug policy will have a major change The medical security department will no longer make and publish the list of low-cost drugs according to the price or cost If it is necessary to set up supporting price and purchase support policies for the characteristics of drug supply and use, the list of contents formulated and published by the industrial policy department and the competent department of the industry shall be taken as the benchmark This means that the notice of the national development and Reform Commission on improving the price management of low-cost drugs (fgjg [2014] No 856) policy will become history To solve the price conflict between low-cost drugs and "volume purchase", according to the policy of the national development and Reform Commission at that time, for the drugs (low-cost drugs) with low daily average cost within the current government guidance price range, the highest retail price set by the government shall be cancelled Within the standard of daily average cost, the specific purchase and sale price shall be set by the manufacturer and operator according to the drug production cost, market supply and demand and competition The standard of daily average cost of low-cost drugs formulated in 2014 is: no more than 3 yuan for western medicine and no more than 5 yuan for Chinese patent medicine However, in the implementation of the policy, the actual price of low-cost drugs is far lower than the daily average cost standard set by the national development and Reform Commission In the past, the commonly used low-cost drugs were centralized on the Internet and purchased directly by the hospital To cancel the low-cost drug policy is actually to solve the conflict between the policy of volume purchase of generic drugs and the policy of low-cost drugs Low price drugs shall not be purchased online again, and the specific purchase and sale prices shall not be set by the producers and operators according to the drug production cost, market supply and demand and competition The only thing that can go online and allow companies to adjust their prices on their own is the shortage of drugs The shortage of drugs should not be overcharged The difference between the ex factory price and the online price should not be huge (3 times or more) In addition, information such as drug production capacity, shortage reason, cost information, tax paid ex factory price certificate should be provided Therefore, in the future, it's almost impossible to earn high profits through drug shortage In the future, it is not impossible for the shortage of drugs to return to the designated production The benefits of women's and children's specialty drugs may not be written in the draft for comments, but there may be no more online procurement and return to market-oriented drugs, as well as non patent women's and children's specialty drugs, emergency (rescue) drugs and basic infusion These drugs are also likely to return to the era of "volume purchase" price competition The favorable price policy for women's and children's specialty drugs may also come to an end In the first batch of pilot list of generic drug volume procurement, there is montelukast, a specialty drug for women and children The "volume procurement" of generic drugs can include the specialty drugs for women and children The second batch of "volume procurement" of generic drugs is expected to be fully launched in the second half of 2019 Is there a market for improved drugs with reasonable price differential relationship? The notice also mentioned that the payment standard of medical insurance should be set according to the common name and adjusted dynamically If there are differences in dosage forms, specifications and packaging of the same kind of drugs, a reasonable price difference relationship shall be maintained in accordance with the principle of equal treatment costs, taking into account the clinical effect, cost value, technical level and other factors According to the notice issued by the national development and Reform Commission in 2011 on printing and distributing the rules of drug price difference, the price difference of oral tablets is common tablets, chewable tablets, lozenges (including soluble tablets), enteric coated tablets, dispersible tablets and effervescent tablets, among which the price difference between ordinary tablets and effervescent tablets is the largest, the price difference between them is 1.3 times In terms of injection, the large volume injection is based on the specification of 50ml, and the small volume injection and ordinary powder injection cost 4.5 yuan more per bottle According to the catalogue of national basic medical insurance, work injury insurance and maternity insurance drugs (2017 Edition), ordinary tablets (tablets, enteric coated tablets, coated tablets, film coated tablets, sugar coated tablets, extract tablets, dispersive tablets, scratch tablets), hard capsules, soft capsules (rubber pills), enteric coated capsules belong to the "oral regular release dosage form"; slow-release tablets, slow-release coated tablets, controlled-release tablets, slow-release capsules Controlled release capsule belongs to "sustained release controlled release dosage form"; injection, injection, solution for injection, injection for intravenous drip, suspension for injection, sterile powder for injection, intravenous injection, water injection, emulsion for injection, emulsion injection, powder injection, injection, sterile powder injection and freeze-dried powder injection belong to "injection" After the implementation of the differential price policy, most of the effervescent tablets are not under the protection of the medical insurance catalog, so should the price of non-medical insurance products be limited by the differential price policy? How to calculate the difference ratio between oral regular release dosage form and sustained release controlled release dosage form? For the emulsion for injection and emulsion injection, are they all included into the small volume injection category according to the filling volume specification, with the same price as the ordinary injection? All of these problems must be faced in the implementation of the policy Especially improved drug products In order to prove that the clinical value of the improved drug product is better or not inferior, the improved drug should be compared with the original product dosage form The clinical investment is more than 10 million yuan Moreover, the cost of sustained-release and controlled-release dosage form is higher from the production line input to the production cost Under the new differential pricing policy, if the price difference between the slow-release controlled-release dosage form and the oral regular release dosage form is not significant, it will hit the enthusiasm of enterprises to invest in the research of improved new drugs The national drug price monitoring system has established "under competitive varieties" big test price monitoring + cost monitoring "notice" It is mentioned that the national drug public procurement market will be built relying on the provincial drug centralized procurement platform, and price information monitoring at home and abroad will be carried out In addition to price monitoring, the cost monitoring system should also be improved, especially the working mechanism of drug price cost investigation, which mainly aims at the varieties with abnormal price changes, excessive price differences with the same kind and insufficient competition The notice, the key object of the punishment measures, also refers to the punishment measures, aiming at the drugs with abnormal increase, large price difference between regions, serious poor distribution, large price difference between online and offline, and large scope of early warning for many times in a row The daily management will be strengthened by means of letter talks and interviews If the enterprise refuses to adjust without reason, it shall be punished seriously by means of credit punishment, joint law enforcement and other means according to the seriousness of the case This means that enterprises need to maintain the price stability, and keep the price between different regions in a certain period of time However, for some bargaining products, the system is filled in by the hospital, which may lead to the situation of wrong filling, missing filling and disorderly filling in by the hospital, so it is difficult for the enterprise to maintain the price Especially after the system is fully integrated, the historical data can be tracked If an enterprise wants to maintain the price by not participating in the bidding, it may only lose the market "Price" and "distribution" double credit exploration and establishment of Credit Incentive and penalty mechanism is a highlight of this reform The credit mechanism aims at, in addition to the price credibility, whether the distribution is timely, etc Enterprises with high credit score may win the bidding first, and enterprises with low credit may lose the qualification of bidding or even cancel the qualification of medical insurance payment After the establishment of a complete set of price monitoring system focusing on "uncompetitive products", the costs and profits of the pharmaceutical industry are basically clear, and the price survey will also focus on the products with insufficient competition (i.e exclusive products), and new drugs and exclusive traditional Chinese medicine injections will also be included in the survey The Ministry of finance's recent investigation on the cost of domestic pharmaceutical enterprises shows that there are no perfect enterprises, and it is expected that enterprises with more problems will face fines Summary price is a very key factor in product project approval This reform of the health insurance bureau means that the price of generic drugs will return to the market competition, and that the price war is still inevitable It remains to be seen whether online purchasing can improve the enthusiasm of enterprises to participate in the small number of manufacturers and the shortage of clinically necessary drugs The research and development enthusiasm of improved new drugs will be affected by the price difference policy Source: medical economic news Author: boundary