[비즈한국] A national petition to the National Assembly demanding the expansion of health insurance coverage for the breast cancer treatment 'Enhertu (generic name: trastuzumab deruxtecan)' has once again surpassed 50,000 signatures after about a year. A petition with the same intent was posted last August, garnering over 60,000 signatures. In April, the Korean Breast Cancer Society released the revised 'Korean Breast Cancer Treatment Guidelines' for the first time in two years, explicitly recommending Enhertu treatment for 'HER2-low' patients based on the latest clinical studies.
Petitioner: "Low-expression patients bear a burden of 5 to 7 million won per injection"
There is growing demand to expand health insurance coverage for the HER2 (human epidermal growth factor receptor 2)-positive breast cancer treatment 'Enhertu (generic name: trastuzumab deruxtecan)' to include 'HER2-low metastatic breast cancer.' According to the National Assembly's national petition website, as of 3 PM that day, 50,341 people had signed the 'Petition for health insurance coverage of Enhertu for HER2-low patients.'
With this, the petition, which was published on the 8th of last month, surpassed the 50,000-signature threshold with just one day left before the closing date. A petition that receives over 50,000 signatures is referred to the relevant standing committee of the National Assembly. This petition currently holds the third-highest number of signatures among active petitions. Previously, a petition with the same purpose received approximately 60,000 signatures in August last year and was referred to the National Assembly's Health and Welfare Committee.
The petitioner, identified as Song, wrote, "Currently, insurance coverage for Enhertu is limited to HER2-positive patients, so low-expression patients who could expect therapeutic benefits from the same drug are giving up treatment because they cannot afford the high costs. Considering domestic and international clinical results and the medical necessity, HER2-low patients must also be included in the coverage."
Song stated, "Because health insurance does not apply, patients must fully cover 5 to 7 million won for a single injection (every 4 weeks). No matter how much I added the savings and salary my sister and I collected, I had to put down the calculator while trying to figure out how many times we could afford it." She added, "If the expansion of coverage is discussed again and the pharmaceutical company and the government join hands, not only my mother but countless other patients in the same situation can be given a chance for treatment."
Korean Breast Cancer Society explicitly recommends 'Enhertu treatment' for low-expression patients
Currently, Enhertu is covered by health insurance for HER2-positive metastatic breast cancer and gastric cancer. Having garnered attention even before its domestic approval due to its superior clinical efficacy, Enhertu became the first drug to receive over 50,000 signatures in a national petition demanding its approval and insurance coverage. After price negotiations, it received health insurance coverage on April 1 of last year, just one year and three months after its approval, in accordance with a Ministry of Health and Welfare notification.
Since then, there have been consistent demands to expand the health insurance scope to include metastatic breast cancer patients with 'HER2-low' status, whose HER2 expression levels are low. HER2-low patients account for about half of all metastatic breast cancer patients. Amid this, attention was focused on the 'Korean Breast Cancer Treatment Guidelines' revised by the Korean Breast Cancer Society in April, which explicitly recommended Enhertu treatment for cases of HER2-low expression.
However, the hopes of patients were inevitably dampened when treatment for 'HER2-low' failed to achieve coverage status at the subsequent deliberative committee meeting. The Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) reviewed the expansion of Enhertu's coverage criteria on April 30. Although the treatment of 'HER2-mutated non-small cell lung cancer' and 'HER2-low breast cancer' were included in the deliberation, HIRA decided on 'no setting of coverage criteria.' At that meeting, only Janssen Korea's bladder cancer treatment 'Balversa (generic name: erdafitinib)' and Servier Korea's bile duct cancer treatment 'Tibsovo (generic name: ivosidenib)' succeeded in setting coverage criteria.