Experts say that the quality of generic drugs needs to be improved, and policies such as drug bidding and medical insurance payment need to be improved
For some time, the measures against anticancer drugs have continued, and some pharmaceutical companies have begun to downgrade The purchase price of cancer drugs, Sichuan Province has also become the first province to announce special negotiations on anticancer drugs. For anti-cancer drug manufacturers, whether it is a special negotiation or a drug price negotiation that has been going on for nearly three years, it is a starting point for many companies to change the market price. More importantly, high-quality generic drugs are also expected to enter the market. , further pull the price down. However, at the generic level, the supporting policies for drug bidding, medical insurance payment, and hospital access after the consistency evaluation have yet to be implemented.
Policy-driven anticancer drugs began to cut prices
Recently, drug downloading platforms in several provinces have reported news of drug price cuts.
On June 29, the Hubei Provincial Public Hospital Drug (Consumables) Supply Security Platform issued a notice saying that in response to the national tax reform policy, according to the enterprise application, Pfizer will be downgraded by 15 varieties and 20 products. The price dropped by 3.4%-10.2%.
On July 4th, Beijing Pharmaceutical Centralized Purchasing Service Center issued a reminder that Pfizer and Xi’an Yangsen and other companies have passed the price reduction function of Beijing Pharmaceutical Sunshine Purchasing, among which there are many anti-cancer drugs. Taking crizotinib (Secret) as an example, the drug is mainly used for the treatment of non-small cell lung cancer. In August 2011, it was approved by the US Food and Drug Administration for approval. Originally priced at 53,400 yuan of crizotinib (250mg specifications), each box will be reduced by 2078 yuan, the price cut is 3.9%.
It is worth noting that the exclusive anti-cancer drugs outside the medical insurance catalogue, the medical insurance access negotiations are also in progress.
On July 12, the National Medical Insurance Bureau stated that it will carry out special centralized procurement of anticancer drugs on a provincial basis.
As of now, Hubei, Gansu, Beijing, Sichuan, Shandong and other provinces have begun to adjust the price of anticancer drugs. Sichuan is the first province to announce special negotiations on anticancer drugs. Launched on July 13th.
In the list of 103 anti-cancer agents previously announced by the Ministry of Finance, 82 have been included in the medical insurance catalogue (2017 edition) and 36 negotiating varieties, and these varieties will also become special concentrated procurement of anti-cancer drugs. Focus. Among the remaining 21 non-health insurance products, 17 are exclusive varieties (13 are exclusive to foreign companies and 4 are domestically exclusive), which may be the focus of this access negotiation.
The past high-priced anticancer drugs are expected to enter the medical insurance catalog, and patients can clearly benefit from it. Li Yan, chief physician of the Department of Digestive Oncology, Beijing Cancer Hospital, said that whether medical insurance reimbursement is the primary consideration for many cancer patients when choosing drugs, not efficacy. “Some drugs, the sooner they are used, the better control of the tumor, the quality of life of the patient will also increase. With the delay in use, the drug’s potency ratio will decrease.”
Consulting company Latitude Health predicts that this round of national will-led “operations” is expected to reduce the price of imported anti-cancer drugs in the national medical insurance catalog by 10%, and the import of anti-cancer drugs outside the catalog may be reduced by up to 50%, which is why they are included in the country. Prerequisites for the medical insurance catalogue.
The key to changing the price of medical insurance is negotiating
In April 2017, the Ministry of Human Resources and Social Security decided to include the 2017 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue Negotiations A list of 44 varieties in the range. Among them, the number of anti-tumor and immunomodulator varieties is 22, which becomes an absolute “leading role”. In the earlier national drug price negotiations in 2016, GlaxoSmithKline’s first-line treatment for chronic hepatitis B, tenofovir (Wreid), Zhejiang Beida’s non-small cell lung cancer targeted therapy drug ectinib (Kemena) and AstraZeneca’s gefitinib (Iressa) prices fell by 67%, 54%, and 55%, respectively.
Into the medical insurance directory, companies certainly have their own abacus. An industry insider told reporters that whether or not to enter the medical insurance catalogue has always had an important impact on pharmaceutical manufacturers and capital markets.
The price change for the market does not seem to appear quickly. Take the domestic famous anticancer drug manufacturer Beida Pharmaceutical as an example. Its self-developed ectinib belongs to the national class 1 new drug, and it is also the first small molecule targeted anticancer drug with independent intellectual property rights in China. After Ekentini entered the new national basic medical insurance catalogue, the monthly average drug cost dropped from 12,000 yuan to 5,500 yuan, and the price reduction rate reached 54%. Although the sales volume increased, the revenue and net profit of Beida Pharmaceutical in the first three quarters of 2017 were year-on-year. There was a decrease of 2.42% and 34.03% respectively, but Beida Pharmaceuticals expressed optimism about the market prospect of ectinib.
The aforementioned industry insiders also said that whether the price can be changed to the market, but also the situation of competing products entering the medical insurance catalogue. The wider the coverage of medical insurance, the more difficult it is to reduce the price for the market, in the same disease. In the field, the more types of drugs involved in the negotiations, the smaller the sales bonus that can be released.
For some exclusive varieties, the effect of price cuts on the market is obvious. In July 2017, Roche Herceptin was included in the National Health Insurance Catalogue, which is a first-line treatment for breast cancer treatment. Currently, there is no substitute for the same ingredients and the same effect. The demand for Herceptin in the country is also short-term. There has been a surge, and since March of this year, Herceptin has been out of stock in many hospitals across the country. Roche said that it has applied to the China National Food and Drug Administration to transfer Herceptin, which supplies the Chinese market, from the existing production base to a higher-capacity production base in order to solve the problem of drug shortage.
A number of supporting mechanisms for generic drugs are waiting to be implemented
The majority of the 36 negotiated drugs mentioned above are imported drugs. After the expiration of their patent period, domestic anti-cancer generic drugs are also It is expected to be included in the medical insurance drug list. Generally speaking, the price of a generic drug can reach 70% of the original drug, and with the increase of similar generic drug manufacturers, the price of drugs will continue to decline, and it is expected to reach 30% or even lower of the original drug. Taking the thymus method (immunomodulation preparation) for injection in Hainan Shuangcheng Pharmaceutical as an example, the patent period of the original drug has passed, and the original drug and the generic drug of Shuangcheng Pharmaceutical have also passed the EU approval. There is no big difference in the above. The imported drug sold for 600 yuan after the expiration of the patent, and the price of the generic drug of Shuangcheng Pharmaceutical was only 80 yuan, a difference of 7.5 times.
The level of generics is the key. He Ping, deputy dean of the Qilu Pharmaceutical Group Pharmaceutical Research Institute, said that improving the level and quality of Chinese generic drugs is the only way. There are problems of “extensive research and development and industrialization” in China’s generic drugs, the quality is uneven, and the low level of repetition is serious; innovative drugs are still in the primary stage, and there are insufficient basic research, talents and experience, and they are hot. Seriously follow the trend.
In February 2016, the Opinions on the Evaluation of the Quality and Efficacy of Generic Drugs issued by the General Office of the State Council pointed out that in the Catalogue of Essential Medicines (2012 edition), before October 1, 2007 A total of 289 varieties of chemical generics and oral solid preparations approved for marketing should be completed before the end of 2018.
Guo Yunpei, president of the China Pharmaceutical Enterprise Management Association, publicly stated that the implementation of the consistency evaluation is a supplementary course. “Only if this course is completed, there is reason to fully say that the foundation has been laid.”
At the enterprise level, after the consistency evaluation, it also faces a series of links such as bidding and procurement. Wang Chengdong, chairman of Hainan Shuangcheng Pharmaceutical Co., Ltd. said, “The government needs to improve the supporting policies for high-quality generic drugs, so that the generic drug industry can be truly brought into a benign development track, including drug bidding and medical insurance after consistency evaluation. Payment, hospital admission and many other aspects of the policy.”
Shi Luwen, director of the Department of Pharmacy Management and Clinical Pharmacy, Peking University School of Pharmacy, also said that to really make the product work, from bidding, procurement and the entire medical insurance Reimbursement and entry into the hospital require the construction of corresponding supporting mechanisms.