Pfizer's Lorlatinib Included in China's National Reimbursement Drug List, Ushering in the ALK 3.0 Era of Broad Accessibility

On January 18, 2023, the National Healthcare Security Administration officially released the "National Reimbursement Drug List for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance" (2022), which successfully included lorlatinib (brand name: Boerona), Pfizer’s world-first third-generation ALK inhibitor. Lorlatinib was approved in China in April 2022 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK). The inclusion of lorlatinib in the new edition of the national medical insurance drug list will further reduce the treatment burden for patients, allowing more patients with ALK-positive advanced NSCLC to access innovative drug therapy.

"The adjustment of the National Medical Insurance Drug Catalog is one of the important reform measures in China's pharmaceutical field, which can greatly meet the clinical medication needs in relevant diagnosis and treatment areas and reduce the medical burden on patients. Upholding the concept of 'bringing breakthrough innovations that change patients' lives,' Pfizer actively participates in national pharmaceutical reforms, continuously promoting the comprehensive accessibility of innovative drugs and treatment solutions to meet the urgent needs of Chinese patients," said Mr. Jean-Christophe Pointeau, President of Pfizer's Global Biopharmaceutical Commercial Group in China. "Lorlatinib brings a new treatment landscape for ALK-positive non-small cell lung cancer patients in China. We firmly believe that its inclusion in the medical insurance will further promote the comprehensive accessibility of lorlatinib, benefiting a wide range of patients in China and contributing to the early realization of 'Healthy China 2030.'"

Lung cancer is the cancer type with the highest incidence and mortality rate in China, imposing a heavy burden on patients, families, and society. However, the ALK gene mutation, known as the "diamond mutation," is highly sensitive to targeted drugs. The emergence of ALK inhibitors has extended patients' progression-free survival. Nevertheless, traditional first- and second-generation ALK inhibitors still face serious challenges in clinical treatment, such as brain metastasis and acquired drug resistance.

"As the world's first third-generation ALK inhibitor, lorlatinib’s unique macrocyclic amide structure allows for more stable binding to the target, addressing the challenges of brain metastasis and drug resistance faced by earlier generations," said Professor Wu Yilong, Honorary Director of the Guangdong Lung Cancer Institute. "The inclusion of lorlatinib in medical insurance will help improve patient medication adherence, further extend progression-free survival, and promote standardized treatment for lung cancer. This is of great significance for enhancing overall tumor treatment outcomes and achieving chronic disease management of lung cancer."

Extending the survival period of cancer patients and achieving their standardized treatment has been a key focus in the recent healthcare system reform in China. The continuous exploration and improvement of multi-party co-payment models, such as medical insurance reimbursement, will significantly reduce the medication burden on patients, extend innovative treatments to more patients in grassroots areas, and achieve equitable healthcare. Pfizer continues to explore innovative models to accelerate the approval and market launch of Lorlatinib in China, helping Chinese patients gain earlier access to medications in sync with international standards. The inclusion of this drug in the National Medical Insurance Drug List further enhances the accessibility of innovative drugs.

Professor Lu Shun, Director of the Oncology Department at the Chest Hospital affiliated with Shanghai Jiao Tong University, stated: "The dynamic adjustment of the National Medical Insurance Drug List has effectively promoted the clinical application of innovative drugs in China and significantly improved the accessibility and affordability of these drugs. After Lorlatinib was included in the National Medical Insurance Drug List, patients with ALK-positive lung cancer have achieved longer survival times and better quality of life. We hope to achieve broader hospital availability for this drug as soon as possible, allowing more patients with ALK-positive advanced lung cancer to benefit sooner and promoting comprehensive access to ALK 3.0."