According to the Health Insurance Review & Assessment Service on Saturday, the Tyvaso inhalation solution was rejected on Thursday during its ninth pharmaceutical benefit evaluation committee meeting of 2025.
The drug, developed by U.S. based United Therapeutics Corporation and domestic copyrights owned by Korean firm Antrogen, was seeking coverage for pulmonary hypertension associated with interstitial lung disease, a serious and progressive disease.
The denial effectively blocks patients from accessing the only approved treatment for the fatal condition, which gradually hardens lung tissue while dangerously elevating blood pressure in pulmonary arteries. Patients suffer severe breathing difficulties and declining physical capacity before ultimately facing life-threatening heart complications.
The disease carries a grim prognosis, with five-year survival rates hovering around just 30 percent. For most patients, lung transplantation remains the sole hope, though the path is fraught with obstacles and lengthy waiting periods.
Clinical trials demonstrated that Tyvaso reduced the risk of clinical worsening by 55 percent, offering patients precious time to await transplants or extend their lives. The drug had emerged as the only therapeutic option for this devastating condition.
Medical experts argue the medication meets all criteria for essential drugs under current regulations, including lack of alternative treatments and proven clinical benefits for life-threatening conditions affecting small patient populations. About 1,671 patients were on lung transplant waiting lists between 2009 and 2020, with 31 percent dying while awaiting procedures.
The drug was first applied for insurance coverage in June of last year but faced rejection, prompting a second attempt in February targeting severely ill patients with similarly disappointing results.
reporter
Kim Dong-young
davekim0807@ajupress.com
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