Will Verzenio secure expansion for early breast cancer?

Whether Verzenio would be presented to the Cancer Disease Review Committee garners attention

After the initial attempt in May last year, Verzenio's reapplication was submitted in October.

Lily Korea

‘Verzenio’, which faced difficulties in expanding its reimbursement standards last year, is now drawing attention to see if it will pass the review this time.

 

According to industry sources, Lily Korea’s CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st.

 

Their second attempt to expand the reimbursement is for Verzenio’s indication in early-stage breast cancer.

 

Verzenio faced challenges in initial attempt to expand its indication for early-stage breast cancer when it was presented to the Cancer Disease Review Committee.

 

Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May of the previous year, but the result was ‘reimbursement standards non-established.’ After five months, Verzenio re-submitted its reimbursement application to the HIRA in October.

 

After Verzenio was resubmitted, a national petition was posted on the Cheong Wa Dae public petition website in the same month, advocating for ‘the reimbursement of Verzenio as a targeted treatment for early-stage breast cancer’.

 

In the most recent application, clinical evidence was added, including the five-year outcomes from the monarchE study, presented at the 2023 European Society for Medical Oncology (ESMO) Congress.

 

The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology.

 

The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data.

 

In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference.

 

Verzenio appears to have a potential carry-over effect through the fifth year even after the completion of the two-year treatment period.

 

Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer.

 

On November 18, 2022, Verzenio received expanded approval for its use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence.

 

The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients.