Imported drugs have been greatly reduced in price to enter the medical insurance catalogue. The innovation strength of local pharmaceutical companies is facing a big test.


Release time:

2017-09-28

With the release of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)", some imported special drugs have been reduced in price through the medical insurance negotiation mechanism and entered the national medical insurance catalog. The price advantage of domestic competitive drugs is gradually losing. In the future, the medical insurance negotiation mechanism will tend to be normalized, and the competition between domestic and foreign drugs will become more intense, which will further test the innovation strength of domestic enterprises.

On September 1, 513 kinds of drugs were included in the Beijing medical insurance catalogue. In addition to the 477 new drugs added to the national drug list and the 36 drugs negotiated by the state, the Beijing medical insurance list has also been adjusted to increase the number of special diseases in outpatient clinics to 11.

At the same time, a total of 20 provinces (autonomous regions and municipalities) across the country have announced the new version of the medical insurance catalog adjustment or implementation plan. According to the relevant regulations of the Ministry of Human Resources and Social Security, the social security departments of all provinces (autonomous regions and municipalities) shall not transfer the successfully negotiated drugs out of the medical insurance catalog, nor shall they adjust the scope of payment. This means that 36 special drugs must be included in the medical insurance catalogue of all provinces and cities in the country.

It is worth noting that the 36 special drugs negotiated into the health insurance catalogue cover a number of disease areas, and the price reduction is obvious, the domestic competitive drug price advantage is no longer. The industry is worried that the negotiation mechanism will intensify the competition between local enterprises and foreign enterprises in the high-end drug market. In this regard, Peking Union Medical College Hospital Ophthalmology Professor Chen Youxin said frankly: "Whether it is domestic drugs or imported drugs, the inclusion of health insurance is good for patients. From the point of view of negotiations, health insurance negotiations should first consider patients, health insurance funds and enterprises, whether the interests of the three parties can find a balance. Only win-win, the results of the negotiations are valuable."

The pressure of special drugs being included in Beijing's medical insurance fund has increased sharply.

In the first half of this year, the Ministry of Human Resources and Social Security released the 2017 edition of the Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog. In July, it announced a list of 36 national negotiated drugs, including lung cancer, gastric cancer, breast cancer, and colorectal cancer. 15 anti-cancer targeted drugs such as cancer, lymphoma, and myeloma, as well as drugs for chronic diseases such as diabetes, kidney disease, and cardiovascular disease. Through the negotiations of the National Unity Organization, the prices of these drugs have been reduced by an average of 40%, with a maximum reduction of 70%.

According to the regulations, in the implementation of the national health insurance catalogue, the provinces have the authority to adjust the specific payment. Beijing updated the medical insurance directory, the outpatient special disease range expanded to 11. In the adjustment of category B catalogue, 42 new drugs will be added to the reimbursement scope of "radiotherapy and chemotherapy for malignant tumors", including 15 targeted therapeutic drugs and related drugs in the new varieties of national medical insurance catalogue. In addition, Beijing has also included "multiple sclerosis" in the reimbursement scope of outpatient special diseases, and the reimbursement drugs are "recombinant human interferon beta-1b (betairone)". intraocular injection therapy for macular degeneration has also been included in the reimbursement scope of outpatient special diseases, and the reimbursement drugs are "conbercept" and "ranibizumab".

Since China launched drug price negotiations in 2015, the medical expenses of some acute and severe patients involved in the negotiation of drugs have been greatly reduced, and the accessibility of drugs has been greatly enhanced. Take trastuzumab (Herceptin), a targeted drug for the treatment of breast cancer, as an example. Before the negotiation, the average annual drug cost per patient was more than 230000 yuan, which was reduced to about 90000 yuan after the negotiation. After being included in the reimbursement list of outpatient special diseases, the personal burden of retirees was about 10000 yuan, and the burden of medical expenses of patients was greatly reduced. It is estimated that after the implementation of the negotiation mechanism of the 2017 version of the medical insurance catalogue, only a policy adjustment to expand the scope of outpatient special diseases is expected to reduce the burden of medical expenses for patients with serious diseases by about 0.35 billion yuan.

But there are also concerns about whether the health care fund can withstand the problem. In recent years, with the rapid growth of medical expenses, the pressure of medical insurance fund payment in some provinces is increasing. Taking Beijing as an example, due to aging and the high incidence of chronic diseases, the pressure of medical insurance payment has been great. Therefore, Beijing has been lagging behind Qingdao, Jiangsu, Zhejiang and other provinces and cities in the reimbursement scope of high-priced special drugs. With the inclusion of 36 special drugs in the Beijing health insurance catalogue, the pressure on health insurance payments is likely to increase further.

Zheng Bingwen, director of the world social security research center of the Chinese Academy of Social Sciences, pointed out: "at present, China's serious illness medical insurance has gradually achieved full coverage. However, under the circumstances of unbalanced development of medical insurance funds and obvious gap between income and expenditure, China has not opened up new financing channels for serious illness medical insurance expenditure, and can only use the balance of basic medical insurance to pay, This will also bring new burden to the basic medical insurance fund. In addition, the real-time reimbursement of inter-provincial and remote medical insurance promoted by the new medical reform will also increase the pressure on local medical insurance payment to a certain extent, especially for provinces and cities with higher advance costs."

It is understood that in response to the pressure of the medical insurance fund, the Beijing Municipal Human Resources and Social Security Bureau has taken a series of measures to crack down on "big prescriptions" and "excessive prescribing", strictly control the use of the medical insurance fund, and reduce waste.

Domestic drug price advantage weakened to strengthen innovation is imminent

In the past, domestic drugs and similar imported drugs usually win at low prices in the competition. Now imported drugs through the negotiation mechanism to actively reduce prices into health insurance, so that the price advantage of domestic drugs weakened, competitive pressure increased sharply. At the same time, patients have more room to choose Medicare drugs. Take Novartis's ranibizumab 10 mg/ml * 0.2ml injection as an example, the price dropped from 7125 yuan/branch before the negotiation to 5700 yuan/branch, a decrease of 20%. However, the price of domestic similar product Conbercept 10 mg/ml * 0.2ml injection was lowered from 6725 yuan/branch before the negotiation to 5555 yuan/branch, a decrease of 17.40, with a difference of only 145 yuan. After ranibizumab and conbercept are included in the medical insurance, eligible patients only need to pay 30% to obtain drugs, which greatly reduces the economic burden.

Data show that in 2013, Novarb entered the market of public hospitals in key cities in China and was sold at a price of 9800 yuan per unit, with an income of 0.133 billion yuan in public hospitals in key cities in the same year. In 2015, the market size of ranibizumab in China was nearly 0.6 billion yuan. By 2016, the market sales of ranibizumab in public hospitals in key cities in China fell by 2.54 compared with the previous year. One, this has led to intense market competition.

In order to reverse the situation, Novartis took the initiative to lower the sales price of ranibizumab in China before the price negotiation, from 9800 yuan to 7200 yuan each, a drop of 26.54. The industry believes that competition between the two sides will become more intense as ranibizumab and conbercept enter the health insurance catalogue through the negotiation mechanism and fully implement the negotiated price nationwide.

Some people in the industry believe that the advantages of ranibizumab are more reflected in quality and safety when the price is almost the same. Li Hongye, a senior consultant certified by GMP in Europe and the United States, said: "as a biological preparation, the purity of ophthalmic injection and the number of insoluble particles are the key factors that directly affect the quality. Excessive particles in the drug are one of the potential causes of intraocular inflammation caused by intravitreal injection, and the risk of adverse effects is greatly increased."

Professor Wei Wenbin of Beijing Tongren Hospital affiliated to Capital Medical University believes: "At present, in clinical practice, foreign original research drugs and domestic generic drugs are in use, mainly around the price of drug use behavior. With the introduction of the negotiation mechanism of the medical insurance catalog, the price gap between the two is narrowing. I believe that patients will choose drugs that can stand more clinical tests. Domestic enterprises must make real efforts in innovation."

When the reporter combed through the successful negotiation of the medical insurance catalogue, he found that drugs such as cedarben amine, conbercept and apatinib are all special drugs for the creation of major new drugs in the country, which fully reflects the country's attention and support for medical innovation. Therefore, the future competition between local enterprises and multinational pharmaceutical companies should focus more on the word "innovation. Xu Yanjun, deputy director of the Social Security Center of the Ministry of Human Resources and Social Security, said that by introducing a negotiation mechanism, drugs for the treatment of major diseases such as anti-tumor targeted drugs, which are strongly reflected by the society, have been included in the medical insurance catalog, which has greatly improved the level of protection of basic medical insurance. Taking into account the affordability of the medical insurance fund is conducive to guiding reasonable medical behavior and promoting the development and innovation of the pharmaceutical industry, the goal of "three wins" for medical insurance, enterprises and insured persons has been basically achieved.

The formation of China's drug negotiation mechanism memorabilia(Intern reporter An Huijuan collated)

2009.
After the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2009 Edition)" was issued, in response to the "Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical and Health System", the National Development and Reform Commission and other three departments jointly issued the "Reform of Drugs and Medical Services" Opinions on the Price Formation Mechanism ", which clearly mentioned that it will" actively explore the establishment of a negotiation mechanism between medical insurance agencies and medical institutions ".

May 2015
The National Development and Reform Commission, the National Health and Family Planning Commission, the Ministry of Human Resources and Social Security and other departments jointly issued the Opinions on Promoting Drug Price Reform, proposing that the National Development and Reform Commission will no longer set the prices of most drugs, and the drugs paid by the medical insurance fund will be based on the market mechanism by the Human Resources and Social Security Department and relevant departments. And the negotiation mechanism to formulate medical insurance payment standards.

2015-2016
The National Health and Family Planning Commission led the first drug price negotiations in China. In May 2016, the negotiation results were announced: GlaxoSmithKline's tenofovir disoproxil, Beida's icotinib and AstraZeneca's gefitinib successfully negotiated with 67%, 54% and 55% reductions respectively, with an average reduction of 58.7. The National Health and Family Planning Commission said that the results of drug price negotiations are applicable to the procurement and use of public medical institutions (including the military system), while encouraging local health departments to give priority to the procurement and use of negotiated drugs, with a procurement cycle of 2016-2017. Drug price negotiations in 2015 were not attractive to pharmaceutical companies because they did not promise Medicare reimbursement.

February 2017
The Ministry of Human Resources and Social Security issued the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2017 Edition)" (hereinafter referred to as the Drug List) to initiate negotiations on innovative drugs. The drugs to be negotiated are some patented and exclusive drugs with high clinical value but relatively expensive prices determined by expert evaluation.

April 2017
The Ministry of Human Resources and Social Affairs announced the list of 44 drugs to be negotiated, and then set up a special working group and supervision group to undertake specific work and carry out full-process supervision, and organize experts to negotiate with relevant enterprises. Drugs for which appropriate Medicare drug payment standards have been negotiated will be included in the catalogue.

19 July 2017
The Ministry of Human Resources and Social Security issued a notice to formally include 36 drugs such as liraglutide injection into the category B of the drug list, and stipulated that the social insurance authorities of all provinces (autonomous regions and municipalities) shall not transfer the relevant drugs out of the list, nor shall they adjust the scope of payment. The success rate of this negotiation reached 81.8 per cent, and the payment standard determined by the negotiation decreased by an average of 44 per cent compared with the average retail price in 2016, with the highest drop reaching 70 per cent.