UPDATE: On Sept. 1, 2023, China National Healthcare Security Administration (NHSA) issued the list of drug products that have passed the preliminary review for entering the 2023 National Reimbursement Drug List (NRDL).
The list covers 386 products, including blockbuster drugs such as Fosun Kite’s Yescarta, the first CAR-T product approved in China, and Daiichi Sankyo’s Enhertu, which was approved in February this year for breast cancer treatment.
As planned by NHSA, the drugs on the preliminary list will be further evaluated by experts before the end of this September. The price negotiations between NHSA and the companies are schedule to take place during September to November this year. Thus, the 2023 NRDL will possibly be published near the end of this year.
Previously: China Adds 111 Drugs to 2022 National Reimbursement Drug List
On Mar. 1, 2023, China starts to implement the 2022 National Reimbursement Drug List (NRDL) issued by the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security in Jan. 2023. NRDL is a list of drugs fully or partially reimbursed by the national basic health insurance.
After bidding or price negotiation between NHSA and pharmaceutical companies, 111 drugs entered the 2022 NRDL and 3 drugs were delisted. The average price cut reached 60.1%.1
Among the newly added drugs, 56 are for chronic diseases (diabetes, hypertension, psychoactive disease, etc.), 23 for tumor, 17 for anti-infection, and 7 for rare diseases.
The adjusted NRDL now covers 2,967 drugs, including 1,586 western (chemical/biological) drugs and 1,381 Chinese patent medicines.
1. 2022 NRDL Highlights
1.1 Two COVID-19 Drugs Admitted into NRDL
As China recently experienced a surge in COVID-19 cases, antiviral drugs for COVID-19 treatment were a focus in the price negotiation.
Pfizer’s Nirmatrelvir/Ritonavir (Paxlovid) with high public attention did not enter NRDL. The quote for Paxlovid was too high, according to NHSA in an announcement on Jan. 8, 2023. Paxlovid currently costs 1,890 yuan (about 278 USD) for one course.2 Now the drug is temporarily covered by basic health insurance until the end of March this year.
MSD’s Molnupiravir (Lagevrio) and Genuine Biotech’s Azvudine made the list. Mulnupiravir has already been included in China’s national medical procurement platform with its price of 1,500 yuan per bottle containing 40 capsules for one course.3 Azvudine for treating HIV is priced at 11.58 yuan / 3 mg tablet. In the case for treating COVID-19, the Azvudine tablet is 1 mg. As calculated, each bottle costs around 175 yuan, and one course will be no more than 350 yuan.4
1.2 Seven Rare Disease Drugs Added to NRDL
Rare disease drugs, also known as orphan drugs, are also a highlight in NRDL negotiations. In the candidate list for 2022 NRDL, there were 19 drugs held by companies, including Sanofi, Novartis, Roche, Takeda, and BeiGene, for rare diseases, such as Fabry disease, Pompe disease, etc. After the negotiation, the following seven rare disease drugs entered the NRDL.
Seven Rare Disease Drugs Added to 2022 NRDL5
Hereditary angioedema (HAE)
Risdiplam Powder for Oral Solution
Spinal muscular atrophy (SMA)
Dimethyl Fumarate Enteric Capsules
Multiple sclerosis (MS)
Neuromyelitis optica spectrum disorders (NMOSD)
Riluzole Oral Suspension
Amyotrophic lateral sclerosis (ALS)
Pulmonary hypertension (PH)
2. Review of China’s NRDL Negotiations
Started in 2015, China’s NRDL negotiations take place annually. In the negotiations, pharma companies lower drug prices to get into NRDL. Because of price cuts and reimbursements, NRDL-listed drugs become affordable to more patients and probably increase their sales volumes.
For pharmaceutical companies aiming for expansion in the China market, it is significant to evaluate NRDL’s impacts on their products. BaiPharm collects all seven rounds of NRDL’s information for your reference. Contact BaiPharm if you would like more details.
China’s NRDL Negotiations
Number of Drugs for Negotiation
Number of Drugs Added to NRDL + Drugs Staying in NRDL via Contract Renewal
Average Price Cut
Procurement term within 2016-2017
Starting from 2023/03/01
(Starting from 2023/04/01 for Azvudine and Qingfei Paidu Granules)
Contact BaiPharm for pharma regulatory consulting services.