The 2023 National Reimbursement Drug List (NRDL), published by China’s National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MHRSS) on December 13, 2023, came into effect on the first day of 2024.
The updated 2023 NRDL includes a total of 3,088 drugs, with 126 new additions and the removal of one drug, Elbasvir and Grazoprevir Tablets.
The revised NRDL encompasses various categories of drugs, including
1,698 chemical drugs and biological products
1,390 Chinese patent medicines
892 traditional Chinese medicine pieces for decoction
The 126 newly added drugs can be classified into different therapeutic areas as follows:
21 drugs for tumor treatment
17 drugs for covid-19 treatment and anti-infection
15 drugs for diabetes, psychotropic drugs, and autoimmune diseases
15 drugs for rare diseases (among them, Avapritinib Tablets are also used for tumor treatment
59 drugs for other therapeutic areas
Out of the 126 newly added drugs, 121 went through price negotiation, resulting in an average reduction of 61.7%. The remaining 5 drugs were directly selected for inclusion in the NRDL.
1. Highlights of the 2023 NRDL
1.1 Innovative drugs
Apart from essential medicines, innovative drugs are an emphasis in NRDL adjustment. The 2023 NRDL includes 23 domestic first-class innovative drugs, including 16 chemical drugs, 3 biologics, and 4 Chinese patent medicines.
Table 1: Domestic Class 1 innovative drugs added to the 2023 NRDL
Drug name | Company | Therapeutic area | |
1 | Vorolanib Tablets | Anti-tumor and immunomodulation | |
2 | Glumetinib Tablets | Anti-tumor and immunomodulation | |
3 | Befotertinib Mesylate Capsules | Anti-tumor and immunomodulation | |
4 | Linperlisib Tablets | Anti-tumor and immunomodulation | |
5 | Iruplinalkib Tablets | Anti-tumor and immunomodulation | |
6 | Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets | Systemic anti-infection | |
7 | Alfosbuvir Tablets | Systemic anti-infection | |
8 | Omadacycline Tosilate Tablets | Systemic anti-infection | |
9 | Leritrelvir Tablets | Systemic anti-infection | |
10 | Simnotrelvir Tablets/Ritonavir Tablets (Co-packaged) | Systemic anti-infection | |
11 | Deuremidevir Hydrobromide Tablets | Suzhou Wangshan Wangshui Biomedical | Systemic anti-infection |
12 | Keverprazan Hydrochloride Tablets | Digestive system and metabolism | |
13 | Retagliptin Phosphate Tablets | Digestive system and metabolism | |
14 | Anaprazole Sodium Enteric-coated Tablets | Digestive system and metabolism | |
15 | Dorzagliatin Tablets | Digestive system and metabolism | |
16 | Pegmolesatide Injection | Blood and hematopoietic system | |
17 | Efbemalenograstim alfa Injection | Anti-tumor and immunomodulation | |
18 | Telpegfilgrastim Injection | Anti-tumor and immunomodulation | |
19 | Zuberitamab Injection | Blood and hematopoietic system | |
20 | Shenge Spleen-strengthening Capsules (Shenge Bushen Jiaonang) | Nervous system | |
21 | Desmodium styracifolium (Osb.) Merr. Flavonoids Capsules (Guangjinqiancao Zonghuangjian Jiaonang) | Urinary system | |
22 | Huzhen Qingfeng Capsules (Huzhen Qingfeng Jiaonang) | Musculoskeletal system | |
23 | Icaritin Soft Capsules (Yinyanghuosu Ruan Jiaonang) | Tumor |
Since 2015, NRDL is adjusted almost every year, innovative drugs are more likely to get into NRDL than before. Over 80% of the innovative drugs are enrolled into NRDL within two years from marketing approval.
1.2 Rare disease drugs
Another highlight is that the 2023 NRDL includes 15 more orphan drugs for rare diseases.
Table 2: Rare disease drugs added to the 2023 NRDL
Drug name | Therapeutic area | Indication | |
1 | Efbemalenograstim alfa Injection | Anti-tumor and immunomodulation | Generalized myasthenia gravis in adults who are acetylcholine receptor antibody-positive |
2 | Satralizumab Injection | Anti-tumor and immunomodulation | Neuromyelitis optica spectrum disorder |
3 | Eculizumab Injection | Anti-tumor and immunomodulation | 1. Paroxysmal nocturnal hemoglobinuria (PNH) 2. Atypical hemolytic uremic syndrome (aHUS) 3. Refractory generalized myasthenia gravis (AChR) |
4 | Siltuximab for Injection | Anti-tumor and immunomodulation | Castleman disease |
5 | Afatinib Dimaleate Tablets | Anti-tumor and immunomodulation | Unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
6 | Spesolimab Injection | Anti-tumor and immunomodulation | Generalized pustular psoriasis flares in adults |
7 | Selumetinib Hydrogen Sulfate Capsules | Anti-tumor and immunomodulation | Neurofibromatosis type I (NF1) |
8 | Tetrabenazine Tablets | Nervous system | Huntington's disease |
9 | Ozanimod Hydrochloride Capsules | Nervous system | Relapsing forms of multiple sclerosis (MS) |
10 | Pitolisant Hydrochloride Tablets | Nervous system | Narcolepsy in adults |
11 | Vigabatrin Powder for Oral Solution | Nervous system | Infantile spasms |
12 | Sirolimus Gel | Skin disease | Tuberous sclerosis complex |
13 | Eliglustat Tartrate Capsules | Digestive system and metabolism | Type 1 Gaucher disease |
14 | Nitisinone Capsules | Digestive system and metabolism | Tyrosinemia type I |
15 | Calcitriol Oral Solution | Digestive system and metabolism | 1. Postmenopausal osteoporosis 2. Chronic renal failure, especially renal osteodystrophy in patients receiving hemodialysis 3. Postoperative hypothyroidism 4. Idiopathic hypoparathyroidism 5. Pseudohypoparathyroidism 6. Vitamin D-dependent rickets. 7. Hypophosphatemic vitamin D-resistant rickets, etc. |
Related: Catalog of Rare Diseases in China
2. Review of China’s NRDL negotiations
China’s NRDL negotiations were initially piloted in 2015 and have since occurred on an almost annual basis. During these negotiations, pharma companies lower drug prices in order to secure a place on the NRDL.
As a result of these price cuts and subsequent reimbursements by the national basic healthcare insurance fund, NRDL-listed drugs become affordable for a larger number of patients, potentially leading to increased sales volumes in public hospitals and designated drugstores.
Table 3: China’s NRDL negotiations
Year | Number of drugs that entered negotiation | Number of drugs added to NRDL + drugs staying in NRDL via contract renewal | Negotiation success rate | Average price reduction rate |
2015 (pilot) | 5 | 3 | 60% | 58.7% |
2017 | 44 | 36 | 81.82% | 44% |
2018 | 18 | 17 | 94.44% | 56.7% |
2019 | 150 | 97 (70+27) | 64.67% | 60.7% |
2020 | 162 | 119 (96+23) | 73.46% | 50.64% |
2021 | 117 | 94 (67+27) | 80.34% | 61.71% |
2022 | 147 | 121 (108+13) | 82.31% | 60.1% |
2023 | 143 | 121 | 84.6% | 61.7% |
Contact BaiPharm if you would like more details about China’s NRDL.
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