OBJECTIVES : China implemented an annual National Reimbursement Drug List (NRDL) pricing negotiation mechanism to determine new drugs reimbursement coverage in 2017. The mechanism has evolved over the past 3 years. The 2019 negotiation has resulted in 70 new drugs being added to NRDL through negotiation. This study aims to analyze the outcomes of the 2019 NRDL price negotiation, and to analyze factors influencing the price-cut in negotiations.

METHODS : Secondary research was conducted to retrieve information including NRDL payment standard, lowest tendering price before negotiation, and patient assistance programs (PAP). International reference price (IRP) in the reference country/region basket was obtained from IQVIA MIDAS database®. Where price data was available, we analyzed potential influencing factors of price-cut.

RESULTS : More drugs (70 in 2019, 17 in 2018 and 36 in 2017) with larger price-cut (60.7% in 2019, 44% in 2017 and 56.7% in 2018) were added through 2019 negotiation. The majority (52/70) were western drugs in oncology (n=7, average price-cut 64.8%), rare diseases (n=6, average price-cut 42.6%), cardiovascular diseases (n=3, average price-cut 45.8%), diabetes (n=6, average price-cut 56.1%) and infectious diseases (n=8, average price-cut 69.1%), etc. Of 52 western drugs, 44.2% (23/52) were approved recently (in 2018), indicating a much shorter time between launch and NRDL listing. IRPs were found for 33 drugs, we found that 29 (87.9%) had negotiated prices lower than the IRPs (average 47% lower than their lowest IRPs). For the 15 drugs with PAPs, 12 (80%) had negotiated prices lower than their PAP-converted prices. For the 7 oncology drugs, we conducted a correlation analysis to examine clinical outcomes (improved progression-free-survival) and % price-cut, but no correlation was found.

CONCLUSIONS : The negotiation mechanism is becoming a regular practice in China NRDL updates for innovative medicines, with wider coverage and higher price-cut. IRP and PAP-converted price appeared to be key factors in the negotiation.