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Regulation

China’s updated reimbursement list likely to see COVID-19 therapies, more anti-PD-1s

Process will conclude by year-end, allows companies to submit own drugs for first time

August 8, 2020 12:25 AM UTC

Monday marks the final day the public can comment on a draft plan for China’s next National Drug Reimbursement List, which could be updated to include countermeasures for COVID-19-associated respiratory disease as well as more PD-1/PD-L1 inhibitors. The National Healthcare Security Administration’s proposal seeks to set a timeline that could see the process completed by November and will allow companies for the first time to submit their own drugs for consideration.

Previously, a panel selected the drugs eligible for inclusion.

Sponsors of at least six PD-1/PD-L1 drugs are eligible to vie to join Tyvyt sintilimab from Innovent Biologics Inc. (HKEX:1801) and Eli Lilly and Co. (NYSE:LLY) on the NRDL. The anti-PD-1 mAb, which is approved in China for classical Hodgkin lymphoma (cHL), joined the list in 2019 (see “Tyvyt Edges Out PD-1s”).

Three of the six mAbs hail from domestic companies BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160), Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) and Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180).

But negotiations are unlikely to create significant price competition among the domestic PD-1 inhibitors this time around, according to an analyst note from Goldman Sach’s Ziyi Chen, who noted that only “smaller” indications -- melanoma and cHL -- are eligible for addition.

Medicines approved by the National Medical Products Administration (NMPA) in 2015-19 are eligible for inclusion on the NRDL, as well as older drugs that were on five or more provincial insurance lists by YE19, drugs on the 2018 national essential list and the 32 generic and off-patent originator drugs included in China’s last round of centralized procurement (see “Second Round of Centralized Procurement”).

Beginning Sept. 1, the NRDL will be revised annually in accordance with interim NHSA medical insurance measures released earlier this summer, which stated that drugs added to the list will be priced via negotiation or bidding in the country’s centralized procurement program. In the past, drugs with comparable pricing and similar safety and efficacy to NRDL-listed drugs have not been subject to price negotiation. The change could add pricing pressure to long-covered drugs with limited competition (see “China’s Proposed Annual NRDL Revisions”).

The NHSA will complete the draft guidelines by the end of August, with eligible sponsors able to submit applications this month and next. The final list will be released in November or December. The agency last updated the list last December, with the 52 newly-added innovative molecules accepting an average price cut of nearly 61%.