HONG KONG – China has added more than 300 new drugs to the National Reimbursement Drug List (NRDL) in its latest revision released Friday – the first since 2009.

The changes aim to enhance treatment access for cancer, hepatitis, hemophilia and other major diseases, while pharmaceutical companies with their drugs on the list could see sales skyrocket.

On Feb. 23, the secretary of the insurance division of the Ministry of Human Resources and Social Security (MHRSS), Chen Jinfu, announced the changes to the NRDL. The 2017 version includes innovative drugs that have been on the market in the past 10 years and commonly used drugs for the treatment of severe mental illnesses, diabetes and other major diseases.

The 2009 version of the list included 2,196 drugs, among them 1,164 kinds of Western drugs and 1,032 patented Chinese medicines. The new NRDL has added 339 additional types of drugs, for a total of 1,297 Western-style drugs and 1,238 Chinese medicines, an increase of 15 percent.

“For pharmaceutical companies, the market performance of drugs newly added or removed from the latest NRDL will become clear within one year. Once a company’s drugs are included in the NRDL, a rapid increase in demand for the drugs is inevitable,” said Li Zhong, an industry analyst with China Shineway Pharmaceutical Group Ltd.

“The 2009 version of the NRDL saw dozens of drugs reach over ¥1 billion [US$145.6 million] in sales. The new NRDL means that China’s ¥1.5 trillion pharmaceutical market is about to be reshuffled,” Li added.

Drugs included on the NRDL are accessible through state insurance schemes and are thus sponsored by the government, making them more affordable to the public. Patients using new drugs approved for sale since the last update of the list in 2009 have had to bear the burden of the cost without reimbursement. Reimbursements for drugs on the list can be as high as 80 percent.

“The update will improve access to medicines for Chinese patients,” said Li.

Compared with the 2009 list, 91 children’s medicines have been added to the new NRDL.

Drugs for leukemia, lung cancer and other tumor types may also be added into the scope of the list after negotiations with pharmaceutical companies. The 2017 version also takes into account drugs for work injuries, such as the new botulinum toxin type A injection and tetrandrine for pneumoconiosis.

The new NRDL divides medicine into three categories: Western medicine, Chinese patent medicine and Chinese herbal medicine. The medical sector generally categorizes organic chemicals, inorganic chemicals and biological products as Western medicine; antibiotics fall into that group.

Chinese patent medicine, on the other hand, is made of Chinese herbal ingredients in the form of pills, creams and other formulations. Chinese herbal medicines are processed raw medicinal ingredients.

“Other than a small number of drugs with low clinical approval or which are not covered by reimbursement, the vast majority of approved chemical drugs and biological products from 2008 to the first half of 2016, as well as common treatments for cancer, severe mental illness, hemophilia and other major diseases, have been included in the new NRDL,” said Li.

In terms of drugs that boast high clinical value but are relatively expensive, the MHRSS intends to include 45 drugs in negotiations to reduce drug prices, and then to include the drugs into the scope of the NRDL.

Nearly half of the 45 drug types to be negotiated are tumor-targeting drugs for leukemia, gastric cancer, colorectal cancer and other common tumors. The other drugs treat cardiovascular and cerebrovascular diseases, rare diseases and other major diseases.

According to industry experts, drug companies have spent months lobbying the government to get their drugs on the NRDL.

Glaxosmithkline plc agreed to reduce the price of its hepatitis B drug, Viread (tenofovir disoproxil), by 67 percent, expecting a major volume boost in return.

In May 2016, the National Health Commission issued the results of the first batch of national drug price negotiations.

Notably, prices have decreased more than 50 percent for chronic hepatitis B first-line treatment drug Viread, Zhejiang Beida Pharmaceutical Industry Co. Ltd.’s non-small-cell lung cancer targeted therapy drug icotinib and Astrazeneca plc’s locally advanced or metastatic non-small-cell lung cancer product Iressa (gefitinib). Chen announced that based on expert review, the three drugs have been included in the new NRDL. Also on the new list is Shire plc’s Advate (octocog alfa) for hemophilia.

Further adjustments may not happen for eight years.

“The adjustment cycle for the NRDL is indeed long, but the future will see a consistent and effective drug access mechanism that promotes innovation in the pharmaceutical industry,” said Chen.

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