Opdivo reattempts reimb expansion for first-line liver·lung cancer

Application submitted late last year... Expected to be presented to the Cancer Disease Deliberation Committee in April

Remained non-covered since initial listing... Attention focused on the expansion of immunotherapy options

Immunotherapy Opdivo is set to reattempt reimbursement listing for liver and lung cancer in Korea.

According to industry sources, Ono Pharmaceutical Korea’s PD-1 inhibitor Opdivo (nivolumab) is expected to be submitted to the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Deliberation Committee in April.

Last October, Opdivo failed to secure coverage criteria from the Cancer Disease Deliberation Committee for first-line treatment of hepatocellular carcinoma and non-small cell lung cancer. At that time, reimbursement criteria were only established for pleural mesothelioma.

Ono immediately resubmitted applications for reimbursement expansion for the two indications, which will be reviewed again next month.

Opdivo is essentially one of the earliest immuno-oncology drugs introduced, alongside Keytruda (pembrolizumab). However, it has remained a non-reimbursed indication for first-line NSCLC for an extended period. Discussions on reimbursement for first-line NSCLC have been ongoing since 2021.

In hepatocellular carcinoma, Opdivo is indicated in combination with the CTLA-4 inhibitor Yervoy (ipilimumab). This combination regimen has demonstrated the longest survival data among first-line treatment options for hepatocellular carcinoma.

The Opdivo + Yervoy combination showed a median overall survival (OS) of 23.7 months in the phase III CheckMate-9DW trial, which included patients with unresectable or advanced hepatocellular carcinoma who had not received prior systemic therapy. This represents a 21% reduction in the risk of death compared to the control group treated with ‘Lenvima (lenvatinib)’ or ‘Nexavar (sorafenib),’ which showed a median OS of 20.6 months.

It remains to be seen whether Opdivo, which has faced a rocky road from its initial listing to the reimbursement expansion, will be able to expand its prescription scope this time.