Singer Yubin, formerly of Wonder Girls, revealed her family's battle with breast cancer and appealed for support in a petition urging the health insurance coverage for the anticancer drug Tukysa (ingredient name: Tucatinib).
On 1st, Yubin stated on her social media (SNS), "My older sister has been struggling with treatment since being diagnosed with breast cancer in 2020, and after the cancer metastasized to her brain last year, she is enduring a painful fight each day," adding, "We found an effective treatment, but due to enormous drug costs and other practical limitations, appropriate treatment has been difficult."
The anticancer drug mentioned by Yubin, Tukysa, is an oral medication developed by Seegene for breast cancer patients who are positive for human epidermal growth factor receptor 2 (HER2). HER2 positive means that there are excessively high amounts of receptors called HER2 on the surface of breast cancer cells. This receptor sends signals for cancer cells to grow.
Existing antibody treatments bind to the HER2 protein and inhibit its function. Herceptin (trastuzumab) and Perjeta (pertuzumab) do just that. However, these antibody treatments cannot cross the blood-brain barrier, which protects the brain, making it impossible to treat breast cancer that has metastasized to the brain.
Tukysa can cross the blood-brain barrier and is effective even in metastatic areas of the brain. Clinical trials have confirmed that when used in combination with existing therapies, it significantly increases overall survival and progression-free survival rates.
This is not the first time Tukysa has come up in a national petition. Previously, after a petition urging domestic approval, the Ministry of Food and Drug Safety granted approval in 2023. However, health insurance coverage has yet to be applied, meaning patients must bear the full cost of the drug. According to the petition shared by Yubin, the cost of Tukysa amounts to 30 million won every two months.
For a new drug to gain health insurance coverage, negotiations on drug prices and economic evaluations are essential. When the pharmaceutical company applies to the Health Insurance Review & Assessment Service (HIRA) for benefit approval, it evaluates the cost-effectiveness by comparing the effectiveness and expenses against existing treatments. Afterward, the National Health Insurance Service and the pharmaceutical company complete the price negotiation, and coverage is determined.
In cases like Tukysa, which is a high-cost drug with a small number of target patients, it is challenging to receive a good score in the economic evaluation. Consequently, the process for insurance coverage often faces delays. Global pharmaceutical companies even refer to the cancer disease review committee (Cancer Committee) and the drug benefit assessment committee (Drug Assessment Committee) of HIRA as the 'Wall of Tears'. This has led to many patients and caregivers directly launching petitions to urge for the coverage of anticancer drugs.
The petition regarding Tukysa noted, "Due to the circumstances of the pharmaceutical company, the domestic sale has been indefinitely delayed, leaving patients in a desperate situation where they must import the drug personally," adding, "Patients in urgent need of treatment can only secure the drug by submitting various documents every three cycles (9 weeks) through a center and waiting 8 weeks, but the costs are exorbitant."
Cost is not the only issue with Tukysa. The petitioner stated, "Tukysa needs to be combined with other anticancer drugs, but since it is a non-covered item, even the other drugs, which were originally covered by health insurance, have been converted to non-covered, leading to an astonishing treatment cost of 200 million won per year."
This is the reality of the current anticancer drug coverage system. According to Kim In-ho, a professor in the Department of Oncology at Seoul St. Mary's Hospital, medication A, which costs 2 million won per month and is covered by health insurance, allows patients to pay only 100,000 won after applying a 5% patient burden rate. However, when a combination therapy is applied using medication B, which costs 2 million won, medication A is also treated as non-covered, forcing patients to bear the full cost of 4 million won.
As a result, patients and experts are increasingly calling for improvements to the anticancer drug coverage system. Ra Sun-young, president of the Korean Cancer Society, pointed out, "Over 70% of the anticancer drugs currently under development are combination therapies, and while new drugs are being developed and overcoming the limitations of cancer treatment, the domestic system fails to keep up with this drug development environment and trend. No matter how good a drug is, if it is not covered, it becomes a pie in the sky for doctors, patients, and caregivers."
However, health authorities cannot simply comply with patients' demands. If high-cost anticancer drugs receive benefit coverage every time they are released, it will inevitably worsen the finances of the health insurance system. According to HIRA, the anticancer drug expenses increased by 26% compared to the previous year as of 2023. Thus, there is also a proposal to establish a separate system concerning high-cost anticancer new drugs outside of the health insurance system.