Reimb for ovarian cancer treatment lacks full coverage

Reimbursement for Zejula has been expanded to cover HRD-positive ovarian cancer as of October 2024

It has been pointed out that the mandatory testing, which is still non-reimbursed, impose burdens on patients

The Korean Society of Gynecologic Oncology prepares to propose their opinions to the gov't…"Institutional support is necessary"

Despite expanded reimbursement for homologous recombinant deficiency (HRD)-positive ovarian cancer, HRD-related tests remain non-reimbursed.

 

The Korean medical community has taken the initiative to resolve this issue.

 

Sources reported that the Korean Society of Gynecologic Oncology is collecting evidence to propose reimbursing the HRD tests to the Ministry of Health and Welfare (MOHW).

 

HRD is the loss of homologous recombination repair, which is one of the DNA repair processes.

 

When a patient tests positive for HRD, cancer cells are unable to repair DNA damage effectively.

 

In particular, mutations in BRCA1/2 genes, commonly occurring in breast cancer and ovarian cancer, cause HRD.

 

The HRD prevalence in ovarian cancer is clinically reported to be about 50%.

 

The Korean Society of Gynecologic Oncology focuses on the HRD tests because of expanded reimbursement for the ovarian cancer treatment Zejula.

 

The National Health Insurance reimbursement criteria for Zejula expanded since October last year to the treatment of HRD-positive ovarian cancer.

 

Previously, reimbursement of Zejula was approved for patients with BRCA mutations-associated ovarian cancer who responded to platinum-based therapy in first-line treatment.

 

Due to expanded reimbursement, Zejula is now the only PARP (Poly ADP-ribose Polymerase) inhibitor with insurance coverage for first-line maintenance therapy in HRD-positive ovarian cancer patients.

 

Product photo of Zejula

About seven months after the reimbursement expansion, prescriptions for Zejula have continued to increase.

 

Ovarian cancer patients take two 100 mg tablets once daily, and among conventional ovarian cancer treatments, Zejula is the only one with a once-daily dosing regimen.

 

In particular, since long-term PFS extension benefits have been confirmed in the PRIMA trial and follow-up observational studies, increased prescriptions following reimbursement expansion were expected.

 

The issue lies in the HRD-positive status that is central to the reimbursement expansion.

 

Since the reimbursement criteria are for HRD-positive ovarian cancer treatment, confirming HRD positivity is essential.

 

However, unlike Zejula being reimbursed, the HRD tests remain non-reimbursed.

 

The HRD test requires a next-generation sequencing (NGS)-based gene panel assay, for which the patient must bear approximately KRW 2.5 million in costs.

 

In contrast, BRCA1/2 mutation testing has relatively greater accessibility through national programs and partial health insurance coverage, creating a gap between the two tests.

 

In other words, patients seeking a reimbursed prescription for Zejula must pay out-of-pocket for an expensive and non-reimbursed test.

 

The Korean Society of Gynecologic Oncology has also recognized this issue and plans to propose a policy measure to address it.

 

A society official stated, "From a patient's perspective, it is difficult to understand that a non-reimbursed test is required in order to prescribe a reimbursed drug," and added, "We are planning to review Korea's testing infrastructure and foreign precedents and convey related opinions to the MOHW." The society's proposal on HRD testing is scheduled to be submitted to the MOHW and the Health Insurance Review & Assessment Service (HIRA) as early as the first half of the year.

 

However, whether they will lead to substantive discussions on formal reimbursement remains to be seen.

 

Considering that the prevalence of HRD in ovarian cancer reaches about 50% and that most patients require testing before treatment, the real-world issue of financial burden persists.

 

A Korean Society of Gynecologic Oncology representative added, "To improve treatment outcomes for ovarian cancer patients, the introduction and utilization of HRD testing are necessary.

 

Therefore, institutional support will be necessary."