The National Healthcare Security Administration (NHSA) released a notification listing the drugs that have passed the preliminary formal review for consideration in this year’s adjustment to the National Reimbursement Drug List (NRDL). The public feedback period is open from September 6 to 12.
Review Results
The NHSA received a total of 537 filings from July 1 to July 14 this year, with companies seeking inclusion for 490 drugs (molecule names). Of these, 344 drugs, or 70%, passed the review. Compared with last year, when 271 out of 474 drugs passed, filings and eligible drugs have increased. Specifically, 60% of ex-NRDL drugs and 91% of already NRDL-listed drugs (seeking coverage for new indications) passed the review. This translates to 199 ex-NRDL drugs passing the review (184 western medicines and 15 Chinese patent medicines), including 158 exclusive drugs and 41 non-exclusive drugs (pending price bidding). Additionally, 145 already NRDL-listed drugs (111 western medicines and 34 Chinese patent medicines) passed, including 123 exclusive drugs (some eligible for simplified renewal) and 22 non-exclusive drugs.
Notable Inclusions
This year’s NRDL update approach and process have changed, with the NHSA optimizing filing procedures for manufacturers and requiring more detailed information about drugs’ efficacy, safety, cost-effectiveness, innovativeness, and accessibility, among other factors. Notably, some high-profile expensive drugs have passed this year’s formal review. For instance, Fosun Kite Biotechnology Co., Ltd’s anti-CD19 chimeric antigen receptor (CAR) T therapy Yescarta (axicabtagene ciloleucel) has passed the review after failing at this stage last year.
Next Steps
The next stages will involve a review to ensure drugs meet filing requirements and are eligible for the next round, followed by a multi-faceted and rigorous review of cost-effectiveness and other factors. Exclusive drugs that pass the review must go through negotiations, while non-exclusive drugs will undergo a competitive bidding process before inclusion for the first time this year.-Fineline Info & Tech
