Olaparib's New Indication Included in China's 2023 National Reimbursement Drug List, Expanding Access for Ovarian Cancer Patients

ShanghaiDecember 13, 2023PR Newswire -- The National Healthcare Security Administration announced the 2023 adjustment results of the national medical insurance drug list today. Multiple oncology drugs from AstraZeneca have been included in the medical insurance list, including LYNPARZA (olaparib), a PARP inhibitor jointly developed and commercialized by AstraZeneca and MSD.^®(General name: Olaparib Tablets) in combination with Bevacizumab for the first-line maintenance treatment of advanced ovarian cancer positive for homologous recombination repair deficiency (HRD). This is the fourth indication for Olaparib to be included in the medical insurance directory, which also means that the population covered by medical insurance will be further expanded, benefiting more patients with ovarian cancer.。

To date, all four indications of Olaparib approved in China have been included in the medical insurance directory. These include the newly added indication "in combination with bevacizumab for the maintenance treatment of adult patients with HRD-positive advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy combined with bevacizumab," as well as "as monotherapy for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have achieved complete or partial response after first-line platinum-based chemotherapy; for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after platinum-based chemotherapy; and for the treatment of adult patients with metastatic castration-resistant prostate cancer carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have failed prior treatments (including a novel endocrine therapy drug)." This ongoing effort continues to help reduce the medication burden for cancer patients.

The unmet needs of ovarian cancer patients are significant,HRD-Positive Patients Face Greater Challenges

Ovarian cancer is one of the common malignant tumors in gynecology, characterized by difficulty in early screening, high recurrence, and high mortality. Data shows that the number of new cases of ovarian cancer in China is 52,100 per year, with deaths reaching 22,500 per year, ranking third in the incidence of gynecological tumors.^[1], with the highest mortality rate among gynecological tumors^[2]Since the ovaries are deep in the pelvic cavity, symptoms of ovarian lesions are hidden in the early stages, resulting in about 70% of ovarian cancer patients being diagnosed at an advanced stage.^[2]Although surgery and chemotherapy are the main methods for treating ovarian malignant tumors^[1], but 70% of patients still relapse within three years after initial surgery + chemotherapy, and even with further chemotherapy, patients will repeatedly experience relapses or progression.^[2]The 5-year survival rate is only about 40%.^[2]。

Particularly in ovarian cancer patients, about 50% are HRD-positive ovarian cancer patients.^[2]`, facing greater survival challenges, the progression-free survival period after conventional surgery + chemotherapy is only about 1 year.` ^[3]The advent of PARP inhibitors has brought significant changes to the treatment of ovarian cancer, forming a new model of "surgery + platinum-based chemotherapy + maintenance therapy".^[4], significantly delaying the recurrence of ovarian cancer, improving prognosis, and bringing more survival hope to patients.。Studies show that the combination therapy of Olaparib and Bevacizumab achieves a progression-free survival (PFS) of 46.8 months and an overall survival (OS) of 75.2 months in HRD-positive ovarian cancer patients, with a 5-year OS rate benefit of 65%.^[5]。

Currently, the authoritative foreign guidelines "2023 NCCN Clinical Practice Guidelines in Oncology for Ovarian Cancer," "2021 ESMO Clinical Practice Guidelines for Ovarian Cancer," and the authoritative domestic guidelines "CGCS Guidelines for the Maintenance Treatment of Epithelial Ovarian Cancer in China (2022 Edition)" and "CSGO Clinical Application Guidelines for PARP Inhibitors in Ovarian Cancer (2022 Edition)" all provide the highest level of recommendation for the use of olaparib combined with bevacizumab as first-line maintenance therapy in HRD-positive ovarian cancer patients.

Medical insurance continues to promote the accessibility of innovative therapies, supporting ovarian cancer5-Year Survival Rate Increase

Although there are currently approved precise targeted monotherapy and combination therapies for first-line maintenance treatment in HRD-positive ovarian cancer patients, there are no explicitly defined precise targeted drugs within the existing medical insurance catalog that can provide OS benefits to patients. Moreover, as ovarian cancer progresses, the more recurrence episodes a patient experiences, the shorter their progression-free period becomes, while also increasing the financial burden of treatment costs on the patient.

As the only PARP inhibitor to date that has shown overall survival (OS) benefits in HRD-positive ovarian cancer, the inclusion of olaparib's new indication in the National Reimbursement Drug List (NRDL) expands its beneficiary population from patients with BRCA mutations to a broader group of HRD-positive patients. This extension provides more patients with the opportunity for prolonged survival and helps improve the five-year survival rate for the ovarian cancer population. Additionally, it is important to emphasize that precise genetic testing is a prerequisite for benefiting from PARP inhibitors. HRD testing (including BRCA1/2 mutations) holds significant clinical value for newly diagnosed advanced ovarian cancer patients, offering a basis for selecting subsequent treatment plans and predicting prognosis. Moreover, accurately identifying the benefiting population can also help enhance the efficiency of the medical insurance fund usage.

Starting from January 1, 2024, the new version of the National Medical Insurance Drug Catalog will be officially implemented. Olaparib is a PARP inhibitor in the catalog that combines clinical value and price accessibility. Mr. Chen Kangwei, General Manager of AstraZeneca China Oncology Business Unit, stated: "There has been a significant unmet need for ovarian cancer patients, with an urgent need for more effective and affordable treatment options. AstraZeneca has always started from the needs of patients, continuously providing high-quality innovative drugs, and actively responding to the call of national medical insurance policies, helping to improve the accessibility and affordability of innovative drugs. This time, the inclusion of Olaparib HRD-positive ovarian cancer maintenance treatment indication into the medical insurance catalog is another fulfillment of our long-term commitment to improving the quality of life for ovarian cancer patients. In the future, we will continue to adhere to 'patient-centeredness', promote scientific innovation, with the aim of providing higher quality and affordable treatment options for more cancer patients, contributing to Healthy China 2030!"

*As of December 13, 2023

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-led global biopharmaceutical company focused on the research, development, manufacturing, and marketing of prescription medicines. The company prioritizes key areas such as oncology, rare diseases, and biopharmaceuticals including cardiovascular, renal, metabolic, respiratory, and immunology. AstraZeneca's global headquarters is located in Cambridge, UK, with operations spanning over 100 countries worldwide, delivering innovative medicines to millions of patients globally. For more information, please visitwww.astrazeneca.com。

About AstraZeneca China

Since entering China in 1993, AstraZeneca has focused on the treatment areas with the most urgent needs for Chinese patients, including oncology, cardiovascular, renal, metabolism, respiratory, digestive, rare diseases, vaccines and antibodies, as well as autoimmune diseases, and has brought nearly 40 innovative drugs to China. The headquarters of AstraZeneca China and the global R&D China Center are located in Shanghai, with global production and supply bases established in Wuxi, Taizhou, and Qingdao, delivering high-quality medicines to nearly 70 global markets. In recent years, the company has set up regional headquarters in Beijing, Guangzhou, Hangzhou, Chengdu, and Qingdao. AstraZeneca has also joined hands with partners to create an innovative "troika" comprising the China Smart Health Innovation Center (CCiC), the International Life Science Innovation Park (iCampus), and the AstraZeneca Zhongjin Healthcare Industry Fund, building a diversified international innovation health ecosystem to jointly promote the long-term development of regional economies and the healthcare industry. Today, China has become AstraZeneca's second-largest market globally.

Disclaimer: This material is for reference only and not intended for any promotional purposes. The information provided should not be considered as treatment or usage advice. If you have any questions, please consult a healthcare professional.

^[1] Chinese Guidelines for Maintenance Therapy of Epithelial Ovarian Cancer (2022 Edition) Gynecologic Oncology Professional Committee of China Anti-Cancer Association

^[2] NCCN Guidelines Version 1.2023

^[3] Isabelle L. Ray-Coquard.  Presented at ESMO 2022. Abs No. LBA29

^[4] NCCN Guidelines Version 1.2023

^[5]Li Yi, Cui Heng. Chinese Journal of Clinical Obstetrics and Gynecology. 2019;20(5)385-387.