Will Verzenio’s reimbursement be extended to early breast cancer?

Reimbursement application resubmitted by the Korean Society of Medical Oncology’s Breast Cancer Division

Company secures OS data, which had been a key hurdle… expected to be reviewed with Kisqali at the CDDC meeting held in May

Hope has been rekindled once again for expanded reimbursement of Verzenio in early breast cancer after three failed attempts.

According to industry sources, the Breast Cancer Division of the Korean Society of Medical Oncology submitted an application to expand insurance reimbursement for Verzenio (abemaciclib), Eli Lilly Korea’s CDK4/6 inhibitor, in February. This marks the first time a medical society, rather than a pharmaceutical company, has taken the initiative to seek reimbursement coverage of a drug for early-stage breast cancer.

Additionally, the society recently submitted a petition urging the Health Insurance Review and Assessment Service (HIRA) to expedite the review schedule for Verzenio’s listing, including the results of a signature campaign organized by the Union of Breast Cancer Patients.

Accordingly, there is growing speculation that Verzenio could be brought before the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service in May, alongside Kisqali (ribociclib), another breast cancer treatment with the same mechanism that is currently undergoing the reimbursement process.

Furthermore, Verzenio has secured data demonstrating an improvement in overall survival (OS), which was the biggest obstacle in the coverage expansion process last October.

According to results from the monarchE study presented at the ESMO 2025 Annual Congress, at a median follow-up of 6.3 years, Verzenio combination therapy reduced the risk of death by 15.8% compared with endocrine therapy alone. The 7-year survival rates were 86.8% for Verzenio combination therapy and 85.0% for endocrine monotherapy, with an absolute difference of 1.8%.

Verzenio faced difficulties in being reviewed by CDDC from its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDDC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March and July last year, it was submitted to CDDC for review, to face the same results.

Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”

Meanwhile, a considerable number of drugs in the breast cancer field are still struggling to obtain expanded reimbursement. Perjeta (pertuzumab), which has become a standard of care in the postoperative adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, has been approved in Korea for eight years but has yet to clear the hurdle for coverage.

Unlike neoadjuvant chemotherapy (preoperative adjuvant therapy), which is covered under selective reimbursement at 30%, the postoperative adjuvant indication failed to obtain during the 2019 review because the drug lacked high-level recommendations in global guidelines and long-term follow-up data.

However, the 10-year follow-up results from the global Phase III APHINITY study, released last year, are expected to fill this gap. According to the study, adjuvant therapy with Perjeta plus Herceptin (trastuzumab) demonstrated clear improvement, including a 21% reduction in the risk of death compared with trastuzumab alone in lymph node-positive patients at high risk of recurrence.