Reimb for Verzenio in early breast cancer undergoes review

is being reviewed by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee

Second attempt since failing to set reimbursement standards the past year

Confirmed additional benefit through 5-year monarchE data

Verzenio, the first CDK4/6 inhibitor to apply for insurance reimbursement in early breast cancer, is taking the second step to extend its reimbursement coverage.

 

According to a report, the agenda of reimbursing Lilly Korea’s Verzenio (abemaciclib) will be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee today (March 6).

 

Therefore, the industry’s attention is on whether Verzenio will succeed in its second reimbursement attempt.

 

The company had difficulty reaching the CDDC stage during its first attempt for reimbursement in early breast cancer.

 

After a long 6-month wait after submitting the application, the case reached the CDDC deliberation stage in May last year, but no standards were set.

 

The company resubmitted the reimbursement application 5 months later to HIRA in October.

 

The same month, a petition was posted on the Cheong Wa Dae National Petition Board, “Petition requesting reimbursement for the targeted therapy Verzenio in early breast cancer.” Also, the application was backed by additional clinical evidence.: 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress.

 

This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium Annual and Lancet Oncology in December 2022.

 

Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4.

 

At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms.

 

This suggests that even after completing treatment with Verzenio for a limited period of time, 2 years after the surgery, the treatment benefit continued to year 5.

 

Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer.

 

The drug’s indication was expanded on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy.

 

More specifically, the drug is indicated for a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease.

 

Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio and 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.”