KPS Applies for Insurance Pricing of First Breast Cancer Drug Preventing 'Recurrence and Brain Metastasis'

[Asia Economy Reporter Jang Hyowon] KPS's bio-subsidiary BigThink Therapeutics announced on the 20th that it has submitted the first application to the Health Insurance Review and Assessment Service for health insurance coverage of Nerlynx tablets (nerlynx), an extended adjuvant treatment for early breast cancer.

According to KPS, BigThink held an online press conference the day before to commemorate the domestic approval of Nerlynx tablets and to promote the clinical usefulness of the new breast cancer drug, announcing this progress.

Kim Hayong, CEO of KPS, stated, "As the first and only anticancer drug that prevents not only recurrence but also the risk of brain metastasis in early breast cancer patients, we hope it will be supplied to patients at an appropriate price as soon as possible," adding, "After insurance reimbursement, significant sales growth will also be possible."

The application of domestic health insurance pricing and drug price calculation for Nerlynx tablets (active ingredient neratinib maleate) is targeted as early as the end of this year, or at the latest within next year. Nerlynx tablets are administered once daily, with a supply price of 6.99 million KRW per bottle containing 180 tablets.

BigThink Therapeutics has been in discussions with the Ministry of Food and Drug Safety for insurance coverage since the domestic approval of Nerlynx tablets in October last year. Currently, the first application has been submitted to the Health Insurance Review and Assessment Service, and the results are awaited.

Nerlynx tablets are the first and only extended adjuvant treatment proven to prevent brain metastasis in HER2-positive early breast cancer, having received approval from the US FDA in 2017 and the European EMA in 2018.

In particular, Nerlynx tablets were recommended as a treatment for early and metastatic breast cancer in last year’s clinical guidelines by the Korean Breast Cancer Society and the US National Comprehensive Cancer Network (NCCN).

At the press conference, Professor Park Kyunghwa of the Department of Hematology and Oncology at Korea University Anam Hospital explained the "Latest Treatments for HER2-Positive Early Breast Cancer and the Clinical Usefulness of Nerlynx Tablets."

According to the 5-year long-term follow-up results of the Phase 3 clinical trial ‘ExteNET,’ Nerlynx tablets reduced the recurrence risk by more than 42% in patients with hormone receptor-positive and HER2-positive early breast cancer. Professor Park emphasized that the risk of brain metastasis occurrence or death was reduced by more than 59%.

While antibody therapies such as trastuzumab after surgery are effective in preventing recurrence, they have not been able to reduce the risk of brain metastasis. This is because large-molecule antibody therapies cannot cross the blood-brain barrier (BBB), making it difficult to overcome the risk of brain metastasis. In contrast, Nerlynx tablets, as a small-molecule oral therapy, are advantageous in crossing the blood-brain barrier.

Nerlynx tablets are an irreversible pan-HER small-molecule tyrosine kinase inhibitor (TKI) that inhibits intracellular tyrosine kinases. It irreversibly binds to the intracellular tyrosine kinases of epidermal growth factor receptor (EGFR), HER2, and HER4 proteins, suppressing the cancer cell signaling pathways and thereby blocking tumor cell growth and proliferation.

This content was produced with the assistance of AI translation services.