Will Balversa make progress toward reimb in Korea this year?

Passes CDDC review in May after adding THOR trial results

Attention is focused on whether the first targeted anticancer therapy option is reimbursed and whether coverage will be increased

Attention is focused on whether progress will be made in the insurance reimbursement listing process for ‘Balversa,’ the first targeted therapy for bladder cancer.

 

According to industry sources, Janssen Korea’s FGFR inhibitor for urothelial carcinoma, Balversa (erdafitinib), passed review by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) this past May.

 

Discussions are now underway for its submission as an agenda to the Drug Reimbursement Evaluation Committee later this year.

 

The specific indication under review for reimbursement is ‘treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations, whose disease has progressed during or after at least one prior systemic therapy including a PD-1 or PD-L1 inhibitor.’ At the time of its original domestic approval in 2022, Balversa’s indication was,“Treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR2 or FGFR3 alterations, whose disease has progressed during or after at least one platinum-based chemotherapy, or within 12 months of receiving neoadjuvant or adjuvant chemotherapy, including platinum-based chemotherapy.” However, immune checkpoint inhibitors targeting PD-1 and PD-L1 have been approved for use in the first- and second-line settings since then, creating a need to demonstrate Balversa’s efficacy in patients pretreated with these agents.

 

This unmet need was addressed by the publication of results of the Phase III THOR trial, which compared Balversa to chemotherapy in patients with FGFR3/2-altered metastatic urothelial carcinoma who had progressed following 1–2 lines of therapy, including immunotherapy.

 

The study demonstrated an overall survival (OS) benefit with Balversa.

 

According to the THOR trial results, during a median follow-up period of 15.9 months, the median overall survival (mOS) in the Balversa treatment group was 12.1 months, representing a 36% reduction in the risk of death compared to 7.8 months in the chemotherapy group.

 

Based on these results, the U.S.

 

FDA approved the conversion of Valbessa's designation to full marketing approval in January, with the approval conditions set under more limited terms than the initial approval.

 

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Valbessa's indications.

 

Janssen Korea has additionally submitted the THOR study results to the Ministry of Food and Drug Safety (MFDS) in Korea.

 

These developments culminated in the positive opinion from the Cancer Disease Deliberation Committee in May.

 

Whether Balversa will secure reimbursement within the year and become an accessible treatment option for Korean patients remains to be seen.

 

Meanwhile, bladder cancer has been one representative cancer that has had no targeted therapy options available.

 

Balversa became the first targeted anticancer drug for bladder cancer through its novel mechanism that inhibits FGFR (Fibroblast Growth Factor Receptor).

 

FGFR is one of the biological signals involved in cancer cell growth and is associated with multiple cancer types.

 

FGFR alterations are particularly common in bladder cancer, observed in approximately 20-30% of patients.