Ono Pharmaceuticals' colorectal cancer drug Braftovi (encorafenib) has been recognized as appropriate for reimbursement by the Pharmaceutical Benefits Evaluation Committee 18 months after it passed the Health Insurance Review and Assessment Service (HIRA)'s Cancer Disease Review Committee.

The committee also recognized GSK's endometrial cancer drug Jemperli (dostalimumab) and Roche's optic neuromyelitis drug Enspying (satralizumab) as appropriate for reimbursement. On the other hand, BMS Pharmaceuticals received conditional approval for two of its new treatments -- ulcerative colitis drug Zepocia (ozanimod) and anemia drug Reblozyl (luspatercept).

Besides, the committee decided to reconsider AstraZeneca's neurofibromatosis drug Koselugo (selumetinib), reserving its decision.

HIRA released the results of the committee’s eighth meeting for this year on Thursday.

The committee recognized the appropriateness of Braftovi for treating patients with “metastatic colorectal cancer with confirmed BRAF V600E mutation.”

Braftovi is a targeted anticancer drug used in combination therapy with cetuximab. Ono Pharmaceuticals immediately applied for reimbursement to HIRA after winning approval from the food and drug safety ministry in August 2021. It passed the cancer review in January of the following year, but the reimbursement discussion had been stalled for the past year and a half.

Braftovi is the only drug that has been recommended as a first-line treatment for BRAF V600E-mutated colorectal cancer in the world's leading guidelines after demonstrating a survival benefit over the widely used irinotecan/FOLFIRI + cetuximab combination in phase 3 clinical trial.

However, cetuximab is not covered in the same treatment regimen as Braftovi in the Korean clinical setting, so the combination of irinotecan/FOLFIRI + cetuximab, which was set as the control arm in the clinical study, is not used, and bevacizumab + FOLFOX/FOLFIRI is mainly used instead.

Therefore, the review panel requested additional data from the pharmaceutical company to demonstrate the benefit of Braftovi + cetuximab over Bevacizumab + FOLFOX/FOLFIRI in the domestic setting, which took time and delayed the reimbursement discussion.

While the HIRA and the pharmaceutical company were arguing over the submission of the supplementary data, patients who could not afford the cost of Braftovi, which is over 12 million won ($9,230) per month, filed a petition to request an immediate reimbursement.

Braftovi’s benefits are still subject to drug price negotiations with the National Health Insurance Service for up to 60 days and a decision by the Health Insurance Policy Review Committee.

GSK's anti-PD-1 immuno-oncology drug Jemperli has been on very fast progress to reach the niche within about half a year of its approval by the food and drug safety ministry in December 2022.

Jemperli is indicated for the treatment of patients with "recurrent or progressive mismatch repair deficient (dMMR)/high microsatellite instability-high (MSI-H) endometrial cancer who are on or have shown progression after prior platinum-based systemic chemotherapy."

Since the beginning of this year, GSK has provided free access to Jemperli through its Expanded Access Program (EAP) at 16 major medical institutions and will continue to do so until reimbursement.