The head from the National Healthcare Security Administration (NHSA) told China Central Television (CCTV) on August 7 that steady progress has been made in the new round of negotiations on cancer drugs. After 60 oncology clinicians voted and enterprises approved, 18 drugs were finally included in the negotiation scope, all of which feature high clinical value and high innovation and benefiting patients a lot for the treatment of hematologic and solid tumors. The negotiations will be completed by the end of September.

The anticancer drugs included in the special negotiations cover non-small cell lung cancer, colorectal cancer, renal cell cancer, melanoma, chronic myelogenous leukemia, lymphoma, and multiple myeloma. However, most of these drugs are still in the exclusive patent protection period, making it very difficult to negotiate.

According to Xiong Xianjun, head of the working group under the NHSA, of the 18 varieties, 16 are imported drugs, and two are innovative drugs made at home. We have to push forward price negotiations. Through negotiations with enterprises to reach agreements to reduce the price, and finally enterprises can accept the price negotiated. At the same time, we have to ensure that the drug reimbursement funds can cover it, and the common people can afford it.

According to the NHSA, prices of 17 cancer drugs included in the medical insurance in 2017 dropped sharply during negotiations for inclusion in the National Drug Reimbursement List. The average decrease is 57%, which is generally at the lower level in the world. RMB 15.9 billion has been covered by drug reimbursement funds.

According to Xiong Xianjun, head of the medical security department of NHSA, last time the price reduction of cancer drugs is 57%. After the reduction, these drugs were included in the National Drug Reimbursement List which can also reimburse part of the expenses of drugs for patients. In fact, the double burden is too heavy for people.

Since May 1 this year, China's government has implemented a tax reduction policy on imported cancer drugs, but the people have not yet experienced the decline in drug prices, which is mainly because imported drugs are generally in stock for several months, and the result of the tax policy adjustment on the terminal price is not prompt, according to pharmaceutical companies. At the same time, the procurement cycle in the province is usually 1-2 years, and the procurement price for hospitals has not changed during the contract period. The NHSA requires 12 enterprises involved in national drug negotiations in the early stage to re-calculate drug prices. After the review by fiscal taxation experts, supplementary agreements on the adjusted drug reimbursement standards or online procurement prices have been signed with enterprises.

Establishing evaluation system for including drugs in medical insurance system

China's medical insurance has covered more than 95% of the population, but the medical insurance can only provide the basic medical security. Experts suggest that China should establish a comprehensive evaluation system for drugs included in the medical insurance system. The scope of the evaluation should not only cover the efficacy and safety of drugs, but also the affordability of the whole society and the economic benefit ratio of imported drugs. Only in this way can China ensure the safety and sustainability of medical insurance funds and bring down the burden of medical care for ordinary people.

Professor Shen Lin, Vice President of Peking University Cancer Hospital said that not all imported drugs are good. Professor Shen believed that the evaluation system focusing on whether the drug is necessary and irreplaceable should be established and the efficacy or security is not the only factor. Meanwhile, the affordability of the whole society and the economic benefit ratio should also be assessed.

Professor Shen said that efforts should be accelerated to launch imported drugs for rare diseases and tumors with specific targets in domestic market through preferential policies such as trial waiver. However, in the case of China's high incidence of malignant tumors and immune system diseases, and different disease spectrum, disease characteristics, and genetic characteristics, various clinical problems will occur if the drugs are directly marketed without clinical trials.

Professor Shen said it would arouse a lot of trouble if we just apply these research from western people directly to Chinese people. We've actually encountered a lot in clinical practice. In fact, the dose and the application of the drug should be altered. And once the drug has entered the market, it's going to produce issues because all do not know much about it.

Experts suggest that a green channel aiming at common and frequent diseases in China can be opened for foreign pharmaceutical companies, so that they can quickly conduct clinical trials in China. After the trials, the drugs can be launched in the market with the sample data of Chinese people. And only in this way can the drug safety be guaranteed.

Professor Shen urged to hold an open view to these foreign pharmaceutical companies and shorten the review and approval time for the application of clinical trials to encourage these companies to do so, and then the results shall be assessed later. This conforms to the scientific attitude.

Accelerating efforts to improve the quality and innovation home-made drugs and make the drug R&D more innovative

One of the ends of China's tax reduction policy on imported cancer drugs is to force domestic pharmaceutical companies to accelerate innovation. In the long run, the innovation and quality of domestic drugs is the key to ensuring that domestic patients can timely get access to good drugs and new drugs.

In 2017, 36 drugs were included in the national health insurance system through negotiations, including 17 cancer drugs such as Herceptin. Take Herceptin as an example, its price has been reduced from RMB 20,000 to RMB 7,600 through negotiations. After medical insurance reimbursement, patients can buy it for around RMB 1,500. After the drug price dropped, the number of patients using it increased significantly.

On August 4, the CNDA held a symposium on pilot centralized drug procurement to discuss the issue to replace the original drugs with generic ones passing consistency evaluation. It focuses on the sheer quantity procurement of drugs that have passed consistency evaluation, so as to drive drug prices to drop. Since 2015, China has launched the generic drug consistency evaluation. For the approved generic drugs, the quality consistency evaluation should be conducted in time and batches according to the principle of consistency with the quality and efficacy of the original drugs. The quality and efficacy of the generic drugs should be same as that of the original ones.

According to Shi Luwen, Director of Department of Pharmaceutical Administration and Clinical Pharmacy, Peking University School of Pharmaceutical Sciences (SPS), consistency evaluation can promote the transformation and upgrading of enterprises, get rid of drawbacks caused by backward production capacity, and greatly improve the quality of the generics.

According to statistics, 138 anticancer drugs have been on the market in China, with a total cost of about RMB 130 billion in 2017. To reduce the cost of cancer drugs, it is equally important to support and encourage domestic drug R&D and innovation. In 2008, China launched the major science and technology project of "major new drug creation". By the end of 2017, more than 1,700 projects had been approved.


Shi said that more than 95% of Chinese drugs are generic ones. It is a long way to realize such transformation though now it is an optimal time for generics to turn to innovative drugs. It is necessary to build a comprehensive system to cover the production, R&D, circulation, and supervision of drugs, talents pool, fiscal tax policy, relevant reimbursement policy, and talent evaluation method.

(Quoted from CCTV News)