The National Healthcare Security Administration (NHSA) has released a notification disclosing the drugs that have passed the preliminary formal review stage for potential inclusion in this year’s adjustment to the National Reimbursement Drug List (NRDL). The public feedback window is open from August 18 to 24, 2023, allowing stakeholders to provide input on the shortlisted drugs.
Application Overview and Selection Process
The NHSA received a total of 629 applications for consideration between July 1 and July 14, 2023, with companies seeking inclusion for 570 different drugs by molecule name. A total of 390 molecules passed the selection phase, marking a slight increase from the number considered during last year’s update.
Shortlisted Drugs and Price Negotiations
The 390-strong shortlist includes 226 drugs that have never been previously listed on the NRDL (212 western medicines and 14 Chinese patent medicines), with 184 being exclusive drugs and 42 non-exclusive. The former group will enter the price negotiation process, while the latter will engage in price bidding. Additionally, 164 already NRDL-listed drugs (136 western medicines and 28 traditional Chinese medicines) will be up for consideration, including 149 exclusive drugs renewing existing NRDL contracts and 15 non-exclusive drugs.
Focus on Cutting-Edge Therapies
Focusing on more advanced therapies in the market, of the seven antibody drug conjugate (ADC) therapies approved in China, three already have NRDL coverage, while the remaining four have all been included in this year’s review. These include Pfizer’s Besponsa (inotuzumab ozogamicin), Gilead’s Trodelvy (sacituzumab govitecan), Roche’s Polivy (polatuzumab vedotin), and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan).
New PD-1 Drug and CAR-T Therapies
The only new PD-1 drug that passed the formal review was CStone’s Cejemly (sugemalimab). Two chimeric antigen receptor (CAR) T cell therapies passed the preliminary formal review, namely Kite’s Yescarta (axicabtagene ciloleucel) and Juno’s relmacabtagene autoleucel. The preliminary formal examination round places less emphasis on pricing, allowing CAR-T therapies with annual costs far exceeding the Basic Medical Insurance (BMI) maximum ceiling (of around RMB 300,000 per year) to gain inclusion. For such drugs to eventually enter the NRDL, another review procedure is required, followed by negotiations. Notably, Yescarta has previously been included following the formal review stage in 2021 before failing to progress further.-Fineline Info & Tech
