Three Rare and Underserved Cancer Treatments to Receive Expanded Health Insurance Coverage from October
Reimbursement Extended to Retebmo, Biroijoo, and Padcepju plus Keytrudaju
Improved Access to Rare and Severe Cancer Treatments
Lowering the Financial Burden for Patients
With health insurance now covering treatments for rare gene mutation lung cancer, advanced or metastatic gastric cancer, and combination therapy for urothelial carcinoma, the financial burden on patients with rare and neglected cancers will be reduced.
The Ministry of Health and Welfare announced on September 30 that, starting October 1, health insurance coverage will be expanded to include 'Retemvo Capsules,' a rare gene mutation lung cancer medication; 'Biloyu,' a treatment for unresectable advanced or metastatic gastric cancer; and the first-line combination therapy of 'Padcep Injection + Keytruda Injection' for urothelial carcinoma.
First, Retemvo Capsules are used to treat RET fusion-positive non-small cell lung cancer and medullary thyroid cancer. RET fusion-positive non-small cell lung cancer is a rare cancer, accounting for about 1–2% of all lung cancer cases, with fewer than 300 patients estimated in Korea.
Unlike conventional cytotoxic chemotherapy drugs, Retemvo Capsules specifically target and attack certain cancer cells. As an oral medication rather than an injection, it is expected to reduce the inconvenience for patients caused by repeated hospital visits, according to the Ministry.
'Biloyu' will also become eligible for health insurance coverage. Unresectable advanced or metastatic gastric cancer has a significantly worse prognosis compared to all gastric cancer. According to statistics from 2019 to 2023, the five-year relative survival rate for all gastric cancer is 78.6%; however, the median survival period for unresectable advanced or metastatic gastric cancer is only 6–10 months, with the five-year relative survival rate remaining at just around 10%.
According to the Ministry of Health and Welfare, Biloyu has demonstrated a 41% reduction in the risk of drug resistance compared to conventional treatments and has proven to nearly double overall survival. Through this inclusion in the insurance coverage, patients’ financial burden from expensive new pharmaceuticals is also expected to be alleviated.
For urothelial carcinoma, the first-line combination therapy of Padcep Injection and Keytruda Injection will now be newly covered by health insurance. Urothelial carcinoma is a neglected cancer, accounting for about 2.5% of all cancer occurrences, and, due to its rapid progression, early treatment is crucial.
Previously, there were restrictions on using Keytruda Injection as a first-line treatment, with health insurance benefits only available from the second-line stage after failure of the initial treatment. This new measure enables patients to receive a combination of Keytruda Injection and Padcep Injection from the very first stage of treatment. The two drugs attack cancer cells through different mechanisms, and major clinical results have shown that this combination nearly doubles the median overall survival compared to previous therapies.
This is especially notable as it effectively marks the first case in which health insurance has covered the combined use of new drugs patented by different pharmaceutical companies. Under current regulations, each company must negotiate individually with the health authorities, which can lead to conflicting interests. However, negotiations were successfully concluded with the shared goal of minimizing the treatment gap for patients with rare and severe diseases. Based on this case, the Ministry plans further regulatory revisions to expand health insurance coverage for other combination therapies involving new drugs developed by different companies.
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Lee Hyung-hoon, the Second Vice Minister of Health and Welfare, stated, "I hope that the expanded coverage under the health insurance system will ease the burden on patients and families who have delayed or given up on treatment due to the high cost of medications," adding, "We will continue to strengthen the coverage of health insurance for treatments for rare and severe diseases."
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