Trastuzumab Emtansine (Kadcyla®), China's First HER2-Positive Breast Cancer ADC, Included in National Reimbursement Drug List for Both Early and Advanced Indications

HeavyweightADCDrug"Trastuzumab Emtansine"(Product name: Kadcyla^®) Both early and late indications included in medical insurance

BeijingJanuary 18, 2023/PR Newswire/ --2023On January 18, the National Healthcare Security Administration released the latest announcement regarding Roche's breast cancer anti-HER2 biologic agent, Kadcyla.^®(General name: Trastuzumab Emtansine) has officially been included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022 Edition)" and the national medical insurance payment standard has been simultaneously determined. As the first ADC drug for breast cancer in China to be covered by medical insurance, patients' affordability has significantly improved, greatly enhancing the overall benefits for HER2-positive breast cancer patients in China throughout their diagnosis and treatment process, and truly ushering breast cancer treatment in China into the ADC era.

Kadcyla^®(Trastuzumab Emtansine) is the world's first Antibody-Drug Conjugate (ADC). In 2020, it was granted Breakthrough Therapy Designation by the U.S. FDA and was also given priority review by the Center for Drug Evaluation (CDE) for the treatment of HER2-positive breast cancer. ADC drugs are known in the industry as "magic missiles," with a mechanism of action that achieves a synergistic effect of "1+1>2" by combining targeted therapy with chemotherapy. Unlike previous chemotherapy and targeted drugs, ADCs effectively balance the precision of targeted drugs with the potent cytotoxic effects of chemotherapeutic agents, offering patients greater safety benefits. As the preferred option for second-line treatment of advanced disease both domestically and internationally, the successful negotiation to include Trastuzumab Emtansine in the National Reimbursement Drug List (NRDL) not only fills a gap in second-line treatments within the NRDL but also allows more early-stage HER2-positive non-pCR (patients with residual lesions after neoadjuvant therapy) to achieve precise cures. This update to the NRDL is undoubtedly the biggest positive news for China’s vast population of breast cancer patients at the start of 2023.

Breast Cancer InnovationADCDrug"From morning to night"Universal Health Insurance Coverage

According to the latest data from the World Health Organization, breast cancer has replaced lung cancer as the most common cancer globally. The onset age of breast cancer in China is earlier than in Western countries, with a peak incidence between 45-55 years old, while in Western countries, it mostly occurs after the age of 65. In 2020, there were over 416,000 new cases of breast cancer among women in China, with an incidence rate of 39.1 per 100,000, and approximately 117,000 deaths annually due to breast cancer.^[1]Breast cancer has become the most common cancer among women in China. HER2-positive breast cancer accounts for about 20%-30% of all breast cancer cases. HER2-positive breast cancer is highly aggressive and has a poor prognosis, especially for patients with advanced breast cancer.

With the advancement of technology and continuous improvement in diagnostic and treatment models, the landscape of HER2-positive breast cancer diagnosis and treatment in China has undergone tremendous changes. Two decades ago, the emergence of trastuzumab, the world's first targeted drug for breast cancer, completely transformed the outcomes for patients with HER2-positive breast cancer. In 2018, pertuzumab was successfully approved, marking a giant leap forward in China’s breast cancer treatment into the "dual-targeted therapy" era, making it possible for early-stage HER2-positive breast cancer to be fully cured. Thanks to a series of new drug expedited approval policies introduced in China, in 2020, ado-trastuzumab emtansine was officially approved for marketing in China. The successive launches of these three treatment drugs have ushered in an era of comprehensive anti-HER2 treatment across all stages in China, making HER2-positive breast cancer the subtype with the highest cure rate, the most comprehensive range of targeted therapies, and the most advanced diagnostic and treatment methods within the field of breast cancer treatment.

Medical Insurance Escort,HER2Breast cancer patients no longer give up easily

For patients with HER2-positive advanced breast cancer, anti-HER2 targeted therapy remains the cornerstone of treatment. Currently, the goal of treatment for patients with advanced breast cancer is to prolong survival and improve quality of life. Moreover, the standardization of treatment is even more crucial for advanced patients compared to early-stage patients. The inclusion of trastuzumab emtansine in the National Medical Insurance Catalogue will provide strong support for HER2-positive advanced breast cancer patients in China and better leverage the true efficacy and value of this special drug. Now, patients with advanced breast cancer in China can manage their disease like chronic conditions such as hypertension and diabetes, allowing their life expectancy to approach that of healthy individuals. They will not only live longer but also enjoy a better quality of life.

The treatment goal for early breast cancer is cure, and neoadjuvant anti-HER2 therapy is a key step in achieving a cure for early breast cancer. Neoadjuvant therapy can significantly increase the pathological complete response (pCR) rate in breast cancer patients, but approximately 30%-60% of patients still have residual lesions (non-pCR). Compared to patients who achieve pCR, HER2-positive patients with non-pCR face higher risks of recurrence and mortality. In major guidelines both in and outside China, trastuzumab emtansine has become the first-line recommended regimen for intensified adjuvant therapy in patients with residual lesions after neoadjuvant anti-HER2 therapy. After treatment with trastuzumab emtansine, the risk can be further reduced by 50%.^[2]The risk of disease recurrence and mortality, trastuzumab emtansine has paved a new path to cure for patients with poor response to neoadjuvant anti-HER2 targeted therapy.

According to the requirements of national documents, the new version of the medical insurance directory will be officially implemented on March 1, 2023. It is hoped that after trastuzumab emtansine (Kadcyla) is included in the medical insurance and officially implemented, it will benefit more HER2-positive breast cancer patients.

^[1] Swain SM et al.Lancet Oncol. 2020;21(4):519-530
^[2] von Minckwitz G, Huang C S, Mano M S, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer[J]. New England Journal of Medicine, 2019, 380(7): 617-628.