On December 13, 2023, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)" (referred to as the "new edition catalog"). Eli Lilly and Company's CDK4 & 6 inhibitor Verzenio (abemaciclib tablets) in the oncology field, used in combination with endocrine therapy (tamoxifen or aromatase inhibitors) for the adjuvant treatment of adult patients with early breast cancer who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node-positive, at high risk of recurrence, and with Ki-67 ≥ 20%, has been included in the national medical insurance for the first time. Additionally, two indications for HR+, HER2- advanced endocrine-sensitive and advanced endocrine-resistant breast cancer have successfully been renewed. Thus, Verzenio (abemaciclib tablets) has not only become the first CDK4 & 6 inhibitor to be included in the national medical insurance catalog but is also currently the only CDK4 & 6 inhibitor covered by national medical insurance for both early and advanced breast cancer populations. The newly adjusted national medical insurance catalog is expected to be implemented starting January 1, 2024, and the reimbursement process and timing in various regions will be subject to local government announcements.
Breast cancer is the most commonly diagnosed cancer among women globally. According to statistics from the International Agency for Research on Cancer (IARC), in 2020, China reported approximately 416,000 new cases of breast cancer and about 117,000 deaths, accounting for approximately 17.1% of global breast cancer-related deaths. Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common subtype, making up roughly 70% of all breast cancer patients. As the only CDK4 & 6 inhibitor approved globally and in China for three major indications—adjuvant treatment of high-risk early-stage HR+, HER2- breast cancer, late-stage endocrine-sensitive, and late-stage endocrine-resistant breast cancer—abemaciclib can reduce the long-term risk of recurrence over five years by 32% in high-risk early-stage breast cancer patients while extending overall survival in HR+, HER2- advanced breast cancer patients.,, all of its indications have been unanimously recommended by authoritative guidelines both in China and internationally (including CSCO, CACA, NCCN, etc.).
It is reported that Verzenio (abemaciclib tablets) was approved in China in December 2020 for two indications in advanced breast cancer – for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: (1) in combination with an aromatase inhibitor as the initial endocrine therapy for postmenopausal female patients; (2) in combination with fulvestrant for patients who experienced disease progression after prior endocrine therapy. In 2021, it was included in the National Reimbursement Drug List (NRDL), becoming the first CDK4 & 6 inhibitor to enter the NRDL.
In December 2021, Verzenio (abemaciclib tablets) was approved in China for adjuvant treatment of early breast cancer, specifically in combination with endocrine therapy (tamoxifen or aromatase inhibitors) for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, high-risk of recurrence, and Ki-67 ≥20% early breast cancer. It is the first and only CDK4 & 6 inhibitor approved in China for patients with early breast cancer. Previous studies have shown that approximately 30% of high-risk patients still experience recurrence after endocrine therapy alone, progressing to incurable metastatic disease, with a five-year recurrence risk three times higher than other non-high-risk patients. In August 2023, abemaciclib successfully expanded its indications to include the high-risk population enrolled in the monarchE study, characterized by clinical pathological features such as ≥4 positive lymph nodes, or 1-3 positive lymph nodes along with at least one of the following: tumor size ≥5cm, histological grade 3, or Ki-67 ≥20%. Abemaciclib represents the first major breakthrough in the global field of adjuvant treatment for HR+, HER2-negative high-risk early breast cancer in 16 years.
Since its launch, Verzenio (abemaciclib tablets) has benefited more than 60,000 Chinese breast cancer patients. This time, the addition of Verzenio (abemaciclib tablets) to the National Reimbursement Drug List (NRDL) for adjuvant treatment of HR+, HER2-, lymph node-positive, high-risk recurrence, and Ki-67≥20% early breast cancer will fill the gap in the current NRDL where there are no targeted drugs available in this therapeutic area. It will further promote early breast cancer treatment, reduce patients' treatment costs and financial burden, and maximize patient accessibility and affordability. At the same time, the successful renewal of indications for late-stage endocrine-sensitive and late-stage endocrine-resistant treatments will help patients continue to access the innovative CDK4 & 6 inhibitor at a preferential NRDL price, achieving multiple benefits in terms of drug clinical value and patient outcomes, and further advancing breast cancer treatment in China.
