A drug-antibody conjugate (ADC), known as a 'guided missile' that specifically attacks cancer cells, has become the second in South Korea to pass the health insurance coverage threshold. The cost burden for breast cancer patients, who previously had to pay over 200 million won for one year of treatment, is expected to decrease.
The Health Insurance Review and Assessment Service (HIRA) noted on the 6th that the appropriateness of the drug's coverage was recognized during the Pharmaceutical Benefits Review Committee meeting, confirming that the ADC developed by the American pharmaceutical company Gilead, 'Trodelvy' (active ingredient: sacituzumab govitecan), meets the coverage criteria.
The next-generation ADC technology, which is key to cancer treatment, targets only cancer cells by attaching drugs to antibodies, leading to higher therapeutic effects and preventing damage to normal cells compared to existing cancer drugs. Trodelvy has become the second ADC to pass the review after the breast cancer treatment 'Enhertu' developed by the British company AstraZeneca and the Japanese company Daiichi Sankyo.
Having passed both the Cancer Disease Review Committee and the Pharmaceutical Benefits Review Committee, Trodelvy will undergo negotiations on drug pricing with the National Health Insurance Service. Following approval and announcements from the Ministry of Health and Welfare, it will finally receive coverage.
Trodelvy is the last treatment option for patients with late-stage triple-negative breast cancer, who have no other treatment alternatives. Triple-negative breast cancer is characterized by the absence of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2), which are necessary for targeted cancer therapies. Treatment options are limited compared to other types, and the risk of metastasis and recurrence is high.
Trodelvy, which received domestic approval in May 2023, had been prescribed without insurance coverage until now. Patients had to pay an expense of 15 million won per treatment session (every three weeks). Given that the total expenses exceed 2.5 billion won a year, it was essential for the drug to receive insurance coverage.
Trodelvy, which passed the Cancer Disease Review Committee in November 2023, had failed to secure approval during the first Pharmaceutical Benefits Review Committee held in August last year, leading to a re-challenge in this second review. It submitted a financial burden plan that included further reductions in drug pricing as per HIRA's guidelines.
On the same day, the Pharmaceutical Benefits Review Committee also recognized the appropriateness of coverage for the pulmonary arterial hypertension treatment 'Adempas' (active ingredient: riociguat) developed by the German company Bayer, alongside Trodelvy. The psoriasis treatment from the Belgian pharmaceutical company UCB and the atopic dermatitis treatment from the U.S. company Eli Lilly received a conditional coverage assessment of 'acceptable under evaluation amount.'