Zejula's expanded reimbursement boosts treatment access for ovarian cancer patients in Korea

Takeda Korea’s PARP inhibitor Zejula (ingredient: niraparib) has emerged as a significant advancement in the treatment of ovarian cancer with the recent expansion of its reimbursement coverage, marking a pivotal step in improving patient access to therapy.

During a press conference to commemorate 100 days since the expansion of reimbursement criteria for Zejula to include first-line maintenance monotherapy in homologous recombination deficiency (HRd)-positive ovarian cancer, local experts stressed their belief that the drug, which has consistently demonstrated efficacy and safety in long-term studies, will see wider adoption in clinical practice as a result.

The expanded reimbursement, which took effect in October 2024, now makes Zejula the only reimbursed PARP inhibitor in Korea for first-line monotherapy in HRd-positive ovarian cancer patients. Previously, Zejula’s reimbursement was limited to BRCA-mutated ovarian cancer patients who responded to platinum-based chemotherapy.

HRd, a key biomarker in ovarian cancer, is a pathway associated with impaired DNA damage repair. It is closely linked to BRCA1/2 mutations and is present in over 50 percent of ovarian cancer cases, according to clinical data.

Experts at the press conference emphasized the importance of HRd testing as a tool to guide personalized treatment strategies.

Professor Kim Jae-weon of the Department of Obstetrics and Gynecology at Seoul National University Hospital described HRd as a critical factor in determining the course of treatment.

"HRd, along with BRCA mutations, is a cornerstone in ovarian cancer treatment strategies," he said. "HRd testing is essential for tailoring therapies, and its relevance is becoming increasingly recognized in clinical practice."

Kim stressed that Zejula has shown significant clinical benefits in HRd-positive ovarian cancer patients.

The phase 3 PRIMA study, which included 6.2 years of follow-up data, demonstrated that patients receiving Zejula had a median progression-free survival (PFS) of 24.5 months, compared to 11.2 months for those in the placebo group.

Notably, at the five-year mark, the number of patients surviving without disease progression in the Zejula group was double that of the placebo group. Furthermore, the PFS benefits remained statistically significant over the long term.

In addition to its efficacy, Zejula offers advantages in terms of treatment accessibility and patient adherence.

Unlike other PARP inhibitors, which have a two-year reimbursement limit, Zejula’s reimbursement coverage extends indefinitely until disease recurrence.

This allows patients to continue treatment without financial burdens, which is particularly significant for a disease characterized by high recurrence rates.

"Zejula’s extended reimbursement period is a breakthrough, allowing patients to maintain treatment for as long as necessary, which is a substantial benefit compared to other available options,” Kim said.

Professor Lee Jung-Yun of the Department of Obstetrics and Gynecology at Severance Hospital shared his real-world clinical experience, emphasizing that the drug’s once-daily oral dosing has significantly improved patient adherence.

"The simplicity of Zejula’s dosing schedule, combined with its safety profile, enhances treatment continuity and quality of life for patients," he said. “Since the expanded reimbursement was introduced, no severe adverse events have been reported among HRd-positive patients receiving first-line maintenance therapy with Zejula.”

Despite the advancements, Lee noted that some challenges remain.

“Currently, HRd testing is not reimbursed under Korea’s national health insurance, leaving patients to bear the cost, which can reach 2.5 million won ($1,715),” he said. “This financial barrier limits access to precision medicine for many patients.”

Professor Kim called for the inclusion of HRd testing in the reimbursement system.

"If the drug is reimbursed, the diagnostic testing should be as well. HRd testing is critical for identifying patients who will benefit most from therapies like Zejula," he said.