HRD testing remains still not reimbursed for Korean ovarian cancer patients

Although the importance of homologous recombination deficiency (HRD) testing in ovarian cancer patients has been emphasized recently, there is still a discrepancy between diagnosis and treatment in clinical practice in Korea.

According to the recently published Pan-Asian adapted ESMO Clinical Practice Guideline (ESMO-PAGA) by the European Society for Medical Oncology, HRD status, along with BRCA, is a key biomarker in determining the treatment direction for ovarian cancer. However, in Korea, HRD diagnostic tests remain uncovered by insurance, while treatments prescribed based on this information are covered by insurance, creating a contradictory structure.

While pharmaceutical companies are temporarily operating HRD testing cost support programs, these initiatives are likely to cease once the funds are exhausted, raising concerns about sustainability and equity without institutional reforms.

ESMO-PAGA publishes ovarian cancer guidelines reflecting Asian reality

The ESMO-PAGA guidelines, published in June, provide region-specific recommendations for the diagnosis and treatment of epithelial ovarian cancer in Asia. Developed by 20 experts from 10 Asian countries, including South Korea, the guidelines are an adaptation of the 2023 ESMO European guidelines to reflect the realities of Asia. They emphasize the importance of precise diagnosis and personalized treatment for patients with high-grade ovarian cancer.

In particular, the guidelines strongly recommend evaluating both BRCA1/2 mutations and HRD status during the diagnostic stage. This is critical for predicting the efficacy of PARP inhibitors and selecting appropriate treatment candidates. The guidelines classify this as “Level I, Grade A,” indicating that it has received the highest level of evidence and the highest recommendation grade, with 100 percent agreement from experts across Asia (Refer to Table).

However, these scientific standards are out of sync with the clinical reality in Korea.

In Korea, BRCA1/2 PCR testing is covered by health insurance, but NGS-based genomic testing to assess HRD status is not covered. This situation directly conflicts with the “diagnosis-based personalized treatment” structure recommended by the guidelines.

That’s because it is practically impossible to select eligible patients for treatment or determine maintenance therapy strategies without accurate HRD information.

Such misalignment between diagnosis and treatment has become more prominent with the expansion of insurance coverage for the PARP inhibitor “niraparib (Zejula in trademark name).” Following the expansion of reimbursement criteria for niraparib in October of last year, patients with HRD-positive status are now eligible for insurance coverage for first-line maintenance therapy, regardless of their BRCA mutation status.

In other words, while the treatment is covered by insurance if the patient is HRD-positive, the costs of the HRD test required to diagnose this condition must be borne by the patient out of pocket.

Pharma firm’s support for testing costs is a ‘temporary step’, unable to guarantee sustainability

To fill this gap, Takeda Pharmaceutical Korea, which holds the rights to niraparib, has been operating its own HRD test cost support program since 2024. Through the “FIRST Campaign,” the company covers the full cost of HRD tests for ovarian cancer patients. However, the program is only temporary and will automatically end when funds are exhausted.

Moreover, relying on a private company's voluntary program for the sustainability of the diagnostic system is criticized as inconsistent with the basic principles of public healthcare.

Diagnosis and treatment must be part of a continuous medical process. Experts agree that diagnostic tests determining the indications for treatment should be included in the reimbursement system, given that the treatment itself has been reimbursed. In particular, for cancers like ovarian cancer, which have a poor prognosis and are difficult to diagnose early, accurate and rapid molecular diagnosis is a decisive factor in survival rates.

The guidelines emphasize that HRD diagnosis is the starting point for treatment decisions in patients with high-grade non-mucinous ovarian cancer. However, the Korean reimbursement system still does not recognize this starting point institutionally.

The irony of “diagnosis at the patient's expense, treatment covered by insurance” not only undermines the immediate effectiveness of treatment but also raises questions about the coherence of the national cancer management system.

Experts say it is now time for a policy shift toward ensuring sustainable and equitable access to diagnostic testing, rather than temporary support measures.