Politics, Policy & Law

Updated plan for China’s reimbursement increases pricing pressure on checkpoint inhibitors

The final plan for China’s update of its National Drug Reimbursement List would allow drugs approved this year to be included and could increase pricing pressure on eligible PD-1/PD-L1 inhibitors.

With drugs approved this year now eligible for reimbursement, China’s updated plan for the National Drug Reimbursement List plan could increase pricing pressure on eligible PD-1/PD-L1 inhibitors.

The National Healthcare Security Administration released the final plan for the update Monday, revising the selection criteria to include drugs approved by the National Medical Products Administration (NMPA) before Aug. 17.

The NHSA’s draft plan, released earlier this month, did not include drugs approved this year (see “China’s Updated Reimbursement List”).

The change could increase pricing pressure on PD-1/PD-L1 inhibitors, according to Goldman Sach’s Ziyi Chen, citing the eligibility of anti-PD-1 antibody camrelizumab (SHR-1210) from Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) for reimbursement for three “large” indications — non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) and esophageal squamous cell carcinoma — under the new plan. Under the draft rules, the addition of camrelizumab to the NRDL would have been limited to treatment of classical Hodgkin lymphoma (cHL).

At least seven additional PD-1/PD-L1 drugs could be added to the NRDL this year, including the anti-PD-L1 antibody Tecentriq from Roche (SIX:ROG; OTCQX:RHHBY), which gained eligibility under the final plan. Tyvyt sintilimab from Innovent Biologics Inc. (HKEX:1801) and Eli Lilly and Co. (NYSE:LLY) is the only anti-PD-1 mAb already on the list. 

Brukinsa zanubrutinib from BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) is likely to benefit from the change, Chen said in an analyst note, adding that inclusion on the NRDL could position the Btk inhibitor to compete with Imbruvica ibrutinib from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ), which is already on the list and is up for price re-negotiation this year.

Brukinsa was approved in June to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL). Imbruvica was added to the NRDL for the same indications in 2017 (see “Insurance Coverage for 17 Cancer Therapies”).

The new plan also limits the inclusion of therapies for COVID-19-associated respiratory disease to those in the seventh version of COVID-19 treatment guidelines issued by China’s National Health Commission.

NHSA plans to complete the update this year, with a final list slated for November or December. Eligible sponsors will be able to submit applications to the agency this month and next. It said it will launch an online application system soon.

TARGETS
Btk – Bruton's tyrosine kinase

PD-1 (PDCD1; CD279) – Programmed cell death 1 

PD-L1 (B7-H1; CD274) – Programmed cell death 1 ligand 1