China's National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MOHRSS) have released the 2020 Edition of the National Reimbursement Drug List (NRDL) on Dec. 28, 2020, which will take effect on Mar. 1, 2021.
119 out of 162 drugs were negotiated and successfully added to the 2020 NRDL with an average price cut of 50.64%. Twenty-nine medicines were also removed for limited clinical value or because approval was revoked by the National Medical Products Administration (NMPA). The list is now made up of a total of 2,800 medicines, including 1,426 western ones and 1,374 Chinese ones.1
1. The 2020 NRDL adopts application system for the first time
In previous NRDL adjustments, all drugs with market authorization can enter the review procedure. This year is different as only drugs belonging to one of the following categories can apply for being listed in NRDL.
1.1 Application Scope
（1） Therapeutic drugs for respiratory diseases related to novel coronavirus pneumonia（COVID-19）;
（2） Drugs included in the 2018 National Essential Drug List 2；
（3） Drugs included in the list of urgently needed overseas new drugs3, and the lists of generic drugs4 and pediatric medicines5 that are encouraged to be developed by relevant government departments;
（4） Drugs included in the National Centralized Procurement List；
（5） Drugs that got marketing authorization after Jan. 1, 2015;
（6） Drugs with major changes in functions and indications after Jan. 1, 2015；
（7） Drugs included in five or more provincial-level reimbursement drug lists.
1.2 Conditions for Application
NHSA set these categories according to three conditions:
（1） Drugs that can meet the clinical demands. For example, drugs for the treatment of COVID-19, drugs urgently needed in clinical settings or encouraged to be copied by generic drugs, and drugs on the National Essential Drugs List or National Centralized Procurement List.
（2） Drugs that can better connect the NRDL review and the new drug approval, such as medicines newly appearing on the market or newly approved with modified functions or indications.
（3） Drugs that are continually used in clinical settings. For instance, medicines that are on five or more provincial-level drug reimbursement lists.
2. Price Negotiation for Listed Products
It is also the first time for the NRDL adjustment to include price re-negotiations for the products that are already on the list. The review panel selected 14 kinds of exclusive medicines with high price or a large share of the fund for price reduction negotiation. The annual sales amount of each of these drugs is more than one billion yuan. They were all kept in the list with an average price cut of 43.36%.
3. Emphases on drugs for COVID-19, Cancer, and Rare Diseases
The NRDL adjustment this year paid close attention to the support for drugs treating novel coronavirus pneumonia. Interferon alfa, ribavirin, chloroquine phosphate, and all the other medications listed in the latest Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia 6 have been included in the 2020 NRDL.
The 2020 NRDL added 17 anticancer drugs, including four domestically produced programmed cell-death protein 1 (PD-1)- inhibitors – Sintilimab, Tislelizumab, Toripalimab, and Camrelizumab.7
Drugs for treating rare diseases are another heated issue. Novartis's Gilenya and Mayzent for multiple sclerosis (MS) are included in the 2020 NRDL. In addition, several other rare disease drugs such as Ambrisentan for pulmonary hypertension, Deutetrabenazine for Huntington's Disease (approved in May 2020), etc. are also included.
Besides, the 2020 NRDL indicates NHSA's support for new drugs by embracing medicines that received market approval before Aug. 17 this year, such as Almonertinib Mesylate Tablets developed by Hansoh Pharmaceutical Group.
4. Comments from Pharma Company Representatives
The new antidiabetic drug Morus alba's polyhydroxylated alkaloids, developed by Beijing Wuhe Bo'ao Pharmaceutical Co., Ltd., entered the NRDL just after getting approved this year. Although the price of the drug dropped once it was launched, we feel NHSA's support for new drugs and are willing to sell the products with a small profit margin, said Yuesheng Huang, chairperson of the company.
The NRDL negotiation and supporting policies are meant to promise companies predictably more immense sales volume with lower prices, said Bin Huang, vice-president of AstraZeneca China. The policies leave reasonable profit space so that companies can innovate and develop sustainability, he added.
Bin Huang took Tagrisso for example, which is AstraZeneca's third-generation drug for non-small cell lung cancer. The drug experienced two NRDL negotiations with modified indications in 2018 and 2020. Now it is much less expensive in China compared to other countries and regions.8