For the first time, specific criteria have been set for calculating the expense of clinical trial drugs (investigational drugs) used by patients with life-threatening conditions such as terminal cancer to gain a chance at treatment. For certain investigational drugs, including high-priced biologics, providers may bill patients for the "cost," but controversy has persisted due to the lack of clear standards on what exactly constitutes cost.
The Ministery of Food and Drug Safety said on the 26th that it has established the "guidelines on detailed cost items for billing expenses for treatment use of clinical trial drugs." When investigational drugs are used for treatment, this is a guidance document for the public that specifies in detail the expense items that providers may bill to patients.
The "treatment-use program for clinical trial drugs" allows attending physicians, with approval from the Ministery of Food and Drug Safety, to use domestic or overseas investigational drugs for treatment to give patients with life-threatening conditions such as terminal cancer a chance at therapy. Those who have obtained clinical trial plan approval or pharmaceutical companies provide the drugs.
Most investigational drugs are provided free of charge. However, when the manufacturing expense is high, as with biologics such as cell and gene therapies, providers of investigational drugs may bill patients for expenses directly incurred in manufacturing.
The issue was the scope of "directly incurred expenses." While it had only been stipulated that items such as facility maintenance, environmental management, and research and development were excluded, the specific detailed items were not clear. This led to confusion over the appropriateness of expense calculation between patients and providers.
The new guidelines limit billable cost items to patients to ▲ raw material and supplies expenses directly incurred in manufacturing the investigational drug ▲ labor costs ▲ manufacturing overhead. Research and development or facility and environmental management expenses are not included.
The guidelines also present standards for cost calculation to ensure that the expenses charged to patients do not exceed what was actually投入 in manufacturing. The aim is to prevent providers of investigational drugs from setting expenses at their own discretion.
The Ministery of Food and Drug Safety said it "will help guarantee patients' treatment opportunities while increasing transparency in expense calculation."