China's First Subcutaneous Therapy for HER2-Positive Breast Cancer Included in National Reimbursement Drug List

Benchmarking against chronic disease management like diabetes, cancer patients can also "spend less time being a patient and more time being themselves."

ShanghaiDecember 13, 2023PR Newswire -- December 13, 2023, the National Healthcare Security Administration released the latest announcement regarding Roche's breast cancer anti-HER2 subcutaneous biologic, Herceptin.^®(General Name: Trastuzumab Injection (Subcutaneous Injection)) has officially been included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)" and the national medical insurance payment standard has been determined simultaneously. On the path from "seeking treatment" to "seeking recovery," this allows breast cancer patients in China to have the opportunity to choose a more convenient, comfortable, and worry-free personalized treatment model. The inclusion of this product in the medical insurance catalog will greatly reduce the financial burden on patients and further improve drug accessibility.

As the world's first innovative targeted drug for HER2-positive breast cancer, trastuzumab is the cornerstone of treatment for HER2-positive breast cancer. The new subcutaneous injection formulation of trastuzumab has revolutionized the treatment model for HER2-positive breast cancer, allowing administration to be completed in just 2-5 minutes, greatly improving the treatment experience for patients. This makes it possible for cancer treatment not to interrupt patients' normal work and life, helping China’s HER2-positive breast cancer management truly enter a new era of "chronic disease" management.

Dosage Form Innovation: Herceptin Blows the "Pioneer" Horn Again, Ushering in a New Era2-5 Minutes "Cure" New Era

According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 2.26 million new cases of breast cancer globally in 2020, surpassing lung cancer (2.21 million cases) for the first time to become the most prevalent cancer worldwide. China is a country with a high incidence of breast cancer, with over 416,000 new cases of breast cancer among Chinese women in 2020.^[1]The incidence rate is 39.1 per 100,000, with approximately 117,000 deaths from breast cancer annually.^[2]。

The "Healthy China 2030" Planning Outline proposes: By 2030, achieve chronic disease health management for the entire population and throughout the whole life cycle, with an overall 15% increase in the five-year cancer survival rate. Over the past 20 years, with the development of technology, innovative anti-HER2 drugs and treatment models have continuously emerged and upgraded. In recent years, the approval and market launch of innovative drugs such as Perjeta and Kadcyla in China have made HER2-positive breast cancer a subtype of breast cancer with an increasing cure rate, targeted drugs covering nearly the entire course of the disease, and a more mature diagnosis and treatment model. Currently, the five-year survival rate for early HER2-positive breast cancer patients in China has exceeded 90%, far ahead of other tumors, entering the era of clinical cure.

In today's increasingly rich landscape of breast cancer treatments, trastuzumab remains the "gold standard" and "cornerstone" for the comprehensive treatment of HER2-positive breast cancer. Combined with surgery, targeted therapy, chemotherapy, and radiotherapy, it has significantly improved long-term outcomes for patients with HER2-positive breast cancer ranging from early to advanced stages. Early-stage breast cancer can now move towards a cure, while the diagnosis and treatment of mid- to late-stage breast cancer are gradually aligning with chronic disease management. In the *CSCO Breast Cancer Diagnosis and Treatment Guidelines (2023 Edition)*, combination therapies based on trastuzumab are listed as a first-level recommendation, whether in neoadjuvant or maintenance therapy for early-stage breast cancer, or in salvage therapy for advanced/metastatic breast cancer.

As early-stage breast cancer patients move towards a cure, Herceptin^®The subcutaneous injectable formulation elevates the "cure" dimension once again. While ensuring efficacy and without increasing safety concerns, it reduces the treatment process, which previously took several hours each time, to 2-5 minutes, greatly enhancing the treatment experience for patients. Its simple, convenient, and minimally invasive method of administration liberates breast cancer patients from the constraints of traditional treatments, allowing more patients to truly free their minds and bodies, return to their families, their lives, and society. This achieves chronic disease management for breast cancer patients, helping more of them regain themselves and take back control of their lives. It is hoped that more patients can use their precious time to live and work, spend less time being patients, and more time being themselves!

With Medical Insurance Support: Fulfilling the New Year's Wish of "Less Time Being a Patient, More Time Being Yourself"

In recent years, "value-based healthcare" has been closely aligned with Healthy China. On the path toward Healthy China 2030, the Party and the state have consistently adhered to a people-centered development philosophy, upheld reform and innovation, and actively promoted the transformation of medical service models from "disease-centered" to "people's health-centered," emphasizing "enhancing patient experience." Subcutaneous formulations have broken the limitations of existing intravenous therapies, significantly reducing the time patients and their families spend in hospitals through rapid and convenient drug administration. Moreover, subcutaneous formulations cause minimal trauma, improving patient comfort while eliminating risks such as venous thrombosis, helping patients and their families save on hospitalization and intravenous access costs. This advancement has driven the anti-HER2 treatment model towards outpatient, community-based, and home-based care, enabling patients to "freely, flexibly, comfortably, and conveniently" access medical services, return to normal life, and embrace a better quality of life!

Technological innovation should be people-oriented. Subcutaneous formulations help patients return to their normal lives more quickly with a convenient treatment model. The purpose of innovative drug development is not only to extend survival time but also to help patients improve their overall quality of life. Herceptin^®Subcutaneous formulations allow us to see that drug development is no longer limited to the level of innovative drug treatment, but truly reaches and fulfills the inner needs of patients, achieving a perfect progression for patients from physical, to psychological, and then to social function, from "treatment" to "healing." This helps patients shed the label of disease and return to life and society with dignity. This time, Herceptin^®The inclusion of subcutaneous formulations in medical insurance has greatly improved drug accessibility, helping breast cancer patients in China enter a more comfortable, relaxed, and convenient era of "chronic disease" management, similar to diabetes patients.

Epilogue:"Heal" Her, Embrace the Future

China is a country with a high incidence of cancer, making the establishment of a comprehensive cancer prevention and treatment system particularly important. With the support of new drugs and therapies, an increasing number of cancer treatments are moving towards chronic disease management. How can we meet the growing demand of cancer patients for quality of life treatment? How can we free up busy oncologists and surgeons from repetitive tasks so they can focus on more valuable diagnosis, treatment, and research? The new model of subcutaneous drug administration is the trend and future of anti-cancer treatment. By leveraging standardized subcutaneous formulations as a starting point, we can create experimental ground for reforming cancer chronic disease management, enhance patient experience and satisfaction, and help patients move from physical recovery to psychological and social functional recovery—a shared goal for society as a whole.

[1] "Global Cancer Burden in 2020, IARC"

[2] https://www.iarc.fr/faq/latest-global-cancer-data-2020-qa/ All data in the article are from: International Agency for Research on Cancer, World Health Organization