Will CDK4/6 inhibitors be reimbursed for early breast cancer?

High survival, but recurrence risk persists for 20 years… highlighting the need for long-term management

Clinical efficacy proven, yet still non-reimbursed… finding balance between access and finances remains a challenge

Despite significant improvements in survival rates for early-stage breast cancer patients, concerns have been raised about how treatment access to reduce long-term recurrence risk remains limited.

In particular, as the clinical value of CDK4/6 inhibitors has been proven in patients at high risk of recurrence, the treatment strategy is clearly shifting beyond simple treatment toward recurrence prevention, yet it has become increasingly clear that reimbursement is failing to keep pace with these developments.

On the 21st, Rep. Mi-hwa Seo of the People Power Party hosted a policy forum titled “The Era of 300,000 Female Breast Cancer Patients: Current Status and Challenges in Recurrence Management,” and intensively discussed recurrence management and treatment access issues for patients with early breast cancer.

On the 21st, experts gathered at the National Assembly Members’ Office Building to discuss measures for managing recurrence in early breast cancer.

Early-stage breast cancer refers to a condition where cancer cells have not spread beyond the axillary lymph nodes, and accounts for approximately 95% of all breast cancer patients.

The 5-year survival rate is high, at 96.6% for Stage 1 and 91.8% for Stage 2, but the problem raised is that, regardless of survival rates, the risk of recurrence remains considerable. In particular, for hormone receptor-positive (HR+) patients, recurrence can continue beyond 5 years after diagnosis and even up to 20 years, underscoring the need for long-term management.

Over the past 20 years, treatment strategies for early breast cancer have centered on surgery, radiation therapy, chemotherapy, and endocrine therapy. However, limitations regarding the inability to sufficiently reduce recurrence rates have been consistently raised.

Professor Hyun-jae Yoo, Sogang University

In response, a research team led by Professor Hyun-jae Yoo at Sogang University conducted a study to quantitatively analyze the socioeconomic burden on early-stage breast cancer patients.

The study was conducted using a combination of surveys and expert advisory interviews with 150 patients aged 19 to 60 who had stage 1 to 3 breast cancer.

The analysis revealed that patients who experienced recurrence incurred approximately KRW 29 million more in total economic losses compared to those who did not.

In particular, indirect medical costs were found to increase by more than KRW 13.3 million on average, and the burden of indirect costs in recurrent patients was confirmed to be about 1.8 times higher.

Professor Yoo explained, “Breast cancer is not a disease that simply ends with treatment, but a disease that affects overall quality of life and social roles after treatment. A treatment strategy that prevents recurrence has important meaning not only for the individual but also from the perspective of social cost.”

Need for treatment centered on high-risk recurrence groups… “unmet need remains”

Given that the risk of recurrence does not completely disappear even in early breast cancer, there is a growing consensus that more aggressive treatment strategies are needed, particularly for high-risk groups.

In particular, it has been pointed out that in patient groups with a high risk of recurrence due to lymph node metastasis or tumor size, such as some late Stage 2 or Stage 3 patients, existing treatment alone has limitations.

In this field, CDK4/6 inhibitor-based therapies are emerging as a new alternative. Novartis’ ‘Kisqali (ribociclib)’ and Lilly’s ‘Verzenio (abemaciclib)’ have demonstrated their efficacy in reducing the risk of recurrence through clinical trials.

Professor Ji-hyun Kim, Seoul National University Bundang Hospital

Professor Ji-hyun Kim of Seoul National University Bundang Hospital emphasized, “CDK4/6 inhibitors are treatments whose efficacy in reducing recurrence and clinical utility have already been confirmed through large-scale clinical trials. They should be considered as a new standard of care for high-risk patients with early-stage breast cancer.”

The problem is that these treatments are not being fully utilized in actual clinical practice.

Although CDK4/6 inhibitors have been approved in Korea, reimbursement is not applied in adjuvant therapy for early breast cancer, forcing patients to bear the full cost of these expensive drugs.

In contrast, Verzenio is already covered by national health insurance in major countries such as the United Kingdom, Australia, Canada, France, Germany, Italy, China, and Singapore, ensuring access to treatment.

Professor Ji-hyun Kim added, “From the perspective of an individual patient, one would want to try every possible treatment, but in terms of national finances, there is the difficulty of balancing resources across various diseases. There needs to be a social discussion on how to rate the value of therapies that prevent recurrence in advance.”

“Financial resources and equity are variables”… attention on government’s judgment over reimbursement criteria

In the panel discussion that followed, policy issues surrounding access to new drugs for early breast cancer were intensively discussed.

Professor Seong-bae Kim of Asan Medical Center in Seoul, who moderated the discussion, emphasized, “While triple-negative breast cancer is generally known to be more aggressive, some hormone receptor-positive breast cancers also present a higher risk of recurrence. It is important to identify high-risk groups and apply appropriate treatments.”

He added, “The efficacy of CDK4/6 inhibitors has already been clinically proven. The issue lies in reaching a social consensus on how to apply this in actual clinical practice and which patient groups should be prioritized within limited financial resources.”

Professor In-Hae Park of Korea University Guro Hospital said, “Even in high-risk patients, there are cases in which it is difficult to actively explain or recommend treatment because of the economic burden. The reality itself, in which treatment strategy must be adjusted in consideration of the patient’s financial situation, places a burden on medical staff as well.”

The panelists also pointed out that the threshold for reimbursement has risen as the weight of financial impact assessments has increased in recent Cancer Disease Deliberation Committee meetings.

A view of the panel discussion

Yoon-ho Eo, a reporter for Daily Pharm, stated, “Currently, the results of reimbursement reviews are structured such that only the decision to approve or deny coverage is disclosed, lacking transparency regarding the basis for the judgment. There is a need to strengthen the transparency and flexibility of the evaluation process.”

The government maintains a cautious stance but intends to continue related discussions.

Min-jung Kim, an official at the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare, stated, “Reimbursement applications for Verzenio and Kisqali have been submitted, and discussions are expected to proceed in the Cancer Disease Deliberation Committee within the first half of the year. We plan to conduct a fair review by comprehensively considering clinical utility, patient access, and the impact on National Health Insurance finances.”

She continued, “In line with the recent trend toward strengthening coverage for anticancer drugs, the scope of reimbursement has been continuously expanding. Since equity must be maintained within limited financial resources, careful review of the patient group setting and the scope of application is necessary.”

The Health Insurance Review and Assessment Service presented a similar position.

Ae-ran Park, Director of the Pharmaceutical Benefits Standards Division at HIRA, explained, “We are fully aware of the clinical necessity and field demands for preventing early recurrence of breast cancer. The demand to apply follow-up treatments at an early stage is a trend common not only in breast cancer but across various cancer types.”

Park added, “While expanding treatment accessibility based on clinical utility is important, we must also consider the balance with the sustainability of the National Health Insurance finances. Setting the criteria for which patient groups should be prioritized is the key task.”