Will 'Verzenio' be reimb for early breast cancer in 2025?

Non-reimbursed drug for over 2 years

Whether Verzenio will be considered for the Cancer Disease Review Committee (CDRC) review is drawing attention

Failed to be reviewed for the reimbursement list twice

Product photo of Verzenio

The industry eyes whether 'Verzenio,' with expanding reimbursement challenges, will obtain results this year.

 

According to sources, Lilly Korea's CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the upcoming Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) for its indication for early breast cancer.

 

Verzenio faced challenges in the first attempt at the CDRC review for its indication to treat early breast cancer.

 

Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May 2023, but the result was 'reimbursement standards non-established.' After five months, Verzenio re-submitted its reimbursement application to the HIRA in October.

 

Then, the drug was considered for the CDRC, but the result was the same as before.

 

Patients have high hopes for reimbursement approval of Verzenio for early breast cancer.

 

In fact, the public petition yielded over 50,000 votes.

 

The efficacy of the drug was demonstrated again through the five-year outcomes from the monarchE study, which was 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 completing 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 was approved for expanded 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.

 

Professor Keun Seok Lee, Professor at National Cancer Center's Center for Breast Cancer Korea, said, "The use of Verzenio in combination with endocrine therapy is recommended by the Korean and international chief guidelines as a post-surgical adjuvant therapy for relapsed and high-risk patients, based on significant evidence.

 

Since the drug's clinical usefulness has been confirmed through clinical studies and chief academic reviews, we need improvements to patient treatment access through reimbursement to increase the survivability of patients who qualify as relapsed and high-risk conditions."