Verzenio fails to pass third CDDC review for reimb in KOR

Its reimbursement as a early-stage breast cancer treatment remains unclear

Reimbursement criteria still not set since their rejection in March last year

Absence of OS data remains a hurdle... Review criteria that consider the drug’s characteristics required

Unfortunately, the third time was not the charm.

 

The breast cancer treatment Verzenio is facing difficulties in expanding insurance reimbursement for early breast cancer in Korea.

 

On the 23rd, Lilly Korea’s CDK4/6 inhibitor Verzenio (abemaciclib), which sought to secure reimbursement for its early breast cancer indications, failed to pass the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDRC).

 

This is already the company’s third failed attempt..

 

The reason for the committee not establishing Verzenio's reimbursement criteria is believed to be the lack of overall survival (OS) data.

 

However, OS data is difficult to obtain for drugs with early-stage cancer indications such as Verzenio.

 

In fact, overall survival (OS) has been the main reason many drugs fail to pass the CDRC review.

 

This has become one of the biggest points of contention among pharmaceutical companies with oncology portfolios regarding the committee’s evaluation criteria.

 

Verzenio faced difficulties in being reviewed by the CDRC in its first attempt for early breast cancer.

 

After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDRC 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 last year, it was submitted to CDRC for review, facing the same results.

 

The reimbursement of Verzenio for early breast cancer has been a long-standing hope among patients.

 

In fact, a national petition calling for the expansion of reimbursement for Verzenio has garnered more than 50,000 signatures.

 

The 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress reaffirmed the drug’s clinical efficacy for early breast cancer.

 

This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium 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 data suggested that even for those who received treatment with Verzenio for the limited period of 2 years after surgery, the treatment benefit persisted on 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 at high-risk of relapse: ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes and a tumor size of 5 cm or larger, or ▲histological grade 3 disease.

 

Professor Keun Seok Lee from the Breast Cancer Center of 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.”