Takeda's Zejula expands insurance coverage as 1st-line maintenance therapy for HRD-positive ovarian cancer

Takeda Korea said Monday that coverage for its poly (ADP-ribose) polymerase (PARP) inhibitor, Zejula (niraparib), has been expanded to include first-line maintenance therapy for patients with homologous recombination deficiency (HRD-positive) ovarian cancer, effective as of Oct. 1.

The Ministry of Health and Welfare has revised the criteria for insurance coverage to include maintenance therapy for patients with advanced HRD-positive epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer who have responded partially or completely to first-line platinum-based therapy.

This change makes Zejula the only single-agent PARP inhibitor eligible for insurance coverage as first-line maintenance therapy for HRD-positive ovarian cancer patients in Korea.

Previously, insurance coverage was limited to maintenance therapy for patients with advanced BRCA mutation-positive epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer who responded to first-line platinum-based therapy, as well as for those with BRCA mutation-positive recurrent high-grade serous ovarian cancer.

"Despite Zejula’s proven benefits in improving progression-free survival (PFS) for HRD-positive ovarian cancer patients, including those with BRCA mutations, insurance coverage in Korea has so far only applied to BRCA-mutated cases, leaving HRD-positive patients facing significant financial hurdles," said Professor Kim Jae-won of Seoul National University Hospital’s obstetrics and gynecology department.

HRD-positive ovarian cancer makes up about 50 percent of all ovarian cancer cases, with roughly 20 percent of those involving hereditary or somatic BRCA 1/2 mutations. This insurance expansion now offers better access to treatment for HRD-positive patients who were previously ineligible due to the lack of a confirmed BRCA mutation.

Zejula has shown substantial improvements in PFS, regardless of biomarker status. In the phase 3 PRIMA study, which assessed Zejula’s efficacy as a first-line maintenance therapy, HRD-positive patients treated with the drug had significantly longer PFS compared to the placebo group. At the final clinical cutoff, the median PFS for HRD-positive patients was 24.5 months with Zejula, versus 11.2 months for the placebo group (HR 0.52; 95% CI, 0.40-0.68; P<0.001).

In the primary analysis of the PRIMA study, Zejula demonstrated a favorable safety profile, with most adverse reactions manageable through dose adjustments. Long-term follow-up results over 3.5 years confirmed that the safety profile remained consistent, with no new safety concerns identified.

Additionally, the phase 3 PRIME study conducted with Chinese patients affirmed Zejula's clinical efficacy for ovarian cancer patients responding to first-line platinum-based chemotherapy. The findings revealed that the median PFS for HRD-positive patients receiving Zejula had not yet been reached, while the placebo group had a median of 11.0 months (HR 0.48; 95% CI, 0.34–0.68).

Professor Kim hailed the insurance coverage expansion for HRD-positive patients using Zejula as "welcome news for both medical professionals and patients," noting it will “mark a new turning point in the treatment landscape for ovarian cancer in Korea,” allowing more patients to access first-line maintenance therapy.

Moon Hee-seok, CEO of Takeda Korea, expressed satisfaction with the expanded coverage, which now enables HRD-positive patients—making up about half of all ovarian cancer cases in Korea—to benefit from this treatment. “Given the significant efficacy of PARP inhibitors in HRD-positive ovarian cancer patients,” he said, “Takeda Korea has been actively working to ensure that more patients can receive treatment with Zejula.”