A new round of health care negotiations is opening the door to these new varieties or big opportunities

" domestic needle 700,000 yuan, Australia 41 Australian dollars (about 203 yuan), Japan free. "Recently, a rare disease drug for spinal muscular dystrophy (SMA), Nosine sodium, has caused controversy because of the wide difference in the actual price paid by patients at home and abroad.Unidentified "melon-eating masses" have accused foreign pharmaceutical companies of "discriminatory pricing", but I do not know that the core of the huge contrast is actually health insurance reimbursement. Because the drug is already included in the drug benefit scheme in Australia, the actual government purchase of a single drug costing up to A$110,000 costs patients only A$41. The same is said of Japan, which is basically fully reimbursed.But at home, why is the patient's out-of-pays price so high? The reason is simple: one of the conditions for the 2019 National Health Care Negotiations is that the drug must be approved by December 31, 2018, and nosinas entered in February 2019 and does not meet the terms of the negotiations. The more essential reason is that the urgent need for a wide range of patients, represented by SMA, to be included in health insurance with similar scarce class 1 new drugs/exclusive varieties needs to be addressed urgently.Obviously, "how to put more and better drugs into health care" has become the current health insurance bureau every day thinking about the key issue, this "public opinion storm" no doubt also gave the health insurance bureau a wake-up call, may have to speed up the progress! And that's obviously what it does.For example, on August 17th, the Health Insurance Administration published the 2020 National Health Insurance Drug Catalog Adjustment Work Programme and the 2020 National Health Insurance Drug Catalog Adjustment Reporting Guidelines. There is a "significant" improvement from the draft two weeks ago: extending the time frame for the inclusion of drugs from the end of 2019 to August 17, 2020, when new generic drugs are approved for sale.In addition, compared with previous years of health insurance negotiations, 2020 health insurance negotiations will be particularly adopted enterprise self-declaration system, on the one hand, to give new drug enterprises the opportunity to choose their own, reduce the price of access to health insurance, can reduce a lot of unnecessary costs;For example, the Medical Insurance Bureau recently issued "on the establishment and improvement of basic medical insurance outpatient co-payment guarantee mechanism guidance (draft for comments)", the original into the individual account of the unit payment part, all into the medical insurance co-ordination funds for outpatient-related reimbursement. It is estimated that if the opinion is implemented in 2021, or will bring more than 500 billion yuan of health insurance co-ordination fund increments for outpatient reimbursement, but in fact, after the expansion of medical insurance, the original funds can be used to release the original funds covered drugs, so as to include more qualified new drugs, to achieve market-wide expansion.Jin Chunlin, director of the Shanghai Center for Health and Health Development Research, said in an interview with the media, "the adjusted formal plan, clear 7 cases into health insurance pointed out the conditions and direction, but also with the previous policy to connect and maintain the same, that is, to encourage the direction of biomedical innovation, the pursuit of catalog varieties optimization, price appropriate, improve efficacy, the pursuit of value of medical care." "

01 price-for-volume, the effect is remarkablethe Health Insurance Bureau has taken a big step forward, in September will enter the expert review process. So what kind of drugs would be more popular?There is no doubt that it is the most cost-effective drug. In 2019, the health-care bureau will stage a lively "soul negotiation" with the ultimate goal of negotiating on behalf of the public to obtain the most cost-effective medicines. From the past successful negotiations of products, the health insurance bureau identified the cost-effective may come from: patients widespread, clinically urgent need, efficacy has obvious advantages, price can be reduced space.At the same time, the health insurance bureau has been trying to innovate, such as last year's PD-1 products, are in 2018 in the domestic market of a new class of drugs, adaptive disorders are quite extensive, the price is not low. The cost of treatment for the year after the negotiation of O-drugs and K-drugs was about $2.3 million, the cost of xindili monoanti was about $170,000, and the price of Tripri monoanti was about $100,000. After negotiations, although only one domestic PD-1 product (Xindili mono-resistance) entered the health insurance catalog, but the price lower than the original price of 63.7% (from January 1, 2020), greatly reducing the burden on patients. Public data show that The First Half of this year, Xindili monoantigen achieved sales of 921 million yuan, if all of the health insurance channels, roughly equivalent to 7,350 patients received the drug treatment.It is worth noting that the half-year sales of Xindili monoanti-in-health insurance are close to the full-year sales of 2019 and also close to the sales of the original O-drug in China in 2019. As a result, the "price-for-volume" effect of the health care negotiations has been seen. So, this year Insight database compiled the list of possible health care negotiations, including O-drug, K-drug, Hengrui's Karry Pearl single resistance, Junshi's Ripley single-resistance, and Baiji Shenzhou's Terrelly Pearl single-resistance in the PD-1 products gathered, industry analysts expect this year there will be a battle that can not be underestimated.In the case of full competition, especially Hengrui, Baiji such a strong commercialization ability of the players come in, whether it is the new drug companies, or the family deep-rooted Merca East and BMS, are pressure, but also through the driving force of health insurance price reduction. What's more, O-drugs have been dumped by K-Drugs this year: first-half sales of O-drugs were $3.419 billion, up -6% YoY, and K-Drugs' cumulative revenue was $6.672 billion, up 38%.For example, Oghidini was approved to enter the Chinese market in March 2017, entered the health care list through negotiations in 2018, achieved sales of 2.135 billion yuan in China's sample hospitals (hospitals with more than 100 beds) in 2019, and by the first quarter of this year, with a growth rate of 463.5 percent, "empty" the TOP10 drug list of 100-bed hospitals.Patients are also very concerned about the health care negotiations. After last year's PD-1 health care negotiations, many patients left messages expressing gratitude to the government, "expecting PD-1 to become a good medicine that ordinary people can afford", but also said "expecting K medicine into health insurance price reduction", and "hope that more targeted drugs will be included in health care as soon as possible." From the patient's expected variety, most belong to the obvious treatment advantages, scarcity, treatment costs are high class 1 new drugs, disease areas cover liver cancer, lung cancer, stroke, slow-blocking lung, ischemic heart disease and other major diseases.

02 relax the window, innovation-orientedLooking back at the history of health care negotiations, both in terms of drug access, patient expectations, and corporate awareness of health care negotiations, has risen to a level.   From the end of October 2018, 17 anti-cancer drugs have achieved price-for-volume negotiations, and by 2019 the health care negotiations will be conducted on 77 varieties, including 22 anti-cancer drugs such as pyridoxine, apatinistini, arotetini, and Xindili monoanti.   Health insurance negotiations are increasingly showing the direction of encouraging innovation, on the one hand, accelerate the introduction of clinically urgently needed imported drugs, on the other hand, vigorously support domestic innovative drugs, especially the obvious advantages of the first class of new drugs, from the optimization of the review and approval process to commercial listing. During last year's negotiations, eight of the 12 major domestically produced innovative drugs were negotiated, including Apatini, Sidabenamine, Nenosa, pyridoxine, Rosasta, pyridoxine, Xindili monoanti, and recombinant cytokine gene-derived proteins.   Then to this health care negotiations to open the approval period, pull a long window at the same time again released the medical insurance authorities on the approval of innovative drugs: to encourage eligible just approved for the market of a new class of drugs declared, in accordance with the two years of medical insurance practice innovation attempts, this time may be put into some newly listed new drugs as a pilot.   However, some industry experts said, ???The world's new? Drugs, including mechanism innovation, breakthrough treatment methods, first-class drugs, etc., to obtain new drug approvals based on a limited, controlled clinical trial environment, still need to be obtained? The real world? General and special population efficacy and safety data for further evaluation, there is a certain risk of drug use.   Taking into account incentives for innovation, the introduction of advanced and innovative treatments for patients, and safety considerations, expert choices may tend to be met at the same time: innovative and proven (e.g., included in major national science and technology projects, national key research and development programs, and new drugs conducted by the National Center for Clinical Medicine Research and approved by the central management), strong data support (e.g., other authoritative treatment guidelines recommend endorsement varieties), scarcity (e.g., the field has been approved in recent years to market drugs with significant advantages).   From the field of disease, liver cancer, lung cancer, stroke, slow-blocking lung and other major diseases because of the broad coverage of the patient population, the application variety selectivity, reference is relatively higher, so a greater probability of being favored. For example, stroke. On August 24th, the China Stroke Report 2019 was published. According to the report, the stroke death rate in China in 2018 was 1.4949 per 100,000, accounting for 22.3% of the total death rate of the chinese population, and has become the leading cause of premature death and disease burden. In such a major area, only a few of these new drugs are currently covered by health insurance, and the choice of supply is much smaller than the patient's needs.   In fact, the dynamic adjustment of the medicare catalog, but also for the Health Insurance Bureau to include innovation, "cage for birds" to provide operational space. On June 17, the State Health Insurance Administration and other three departments issued a "notice on doing a good job in 2020 urban and rural residents of basic medical security." Among them, it is clearly required that by the end of June 2020, the national key monitoring varieties will be removed from the catalogue, and the completion of 40% of the provincial supplement varieties digestion. With the orderly promotion of the three medical associations, the increase of medical insurance co-ordination funds, the future medical insurance bureau for the absorption of innovation may also be normal, for pharmaceutical companies, innovation will increasingly become the key to victory.
(E drug manager)