As more immunotherapy products enter the market, the reliance on biomarkers as a basis for prescribing treatment has been increasingly challenged. Dr. Su Po-Jung of Linkou Chang Gung Memorial Hospital noted that the NHI currently uses the biomarker PD-L1 expression level as the reimbursement criterion for immunotherapy. However, variations in staining agents and testing methods for tissue samples can lead to significant discrepancies in test results, which may, in turn, impact treatment decisions.
Dr. Su highlighted the discrepancies in the results of PD-L1 testing methods, noting that, on average, only about 30% of patients show consistent test results. Furthermore, medical lab scientists often face enormous pressure when interpreting the data, as the test positivity threshold is quite low, and there are significant gray areas in interpretation.
The process of accessing NHI-reimbursed immunotherapy takes approximately five weeks. It involves sending a specimen for testing, confirming a diagnosis, conducting biomarker tests for qualification, and finally applying for treatment. Patients’ conditions may worsen during this waiting period. Dr. Su pointed out that increasing evidence suggests the expression level of a biomarker is often irrelevant to treatment outcomes. The NHI provides immunotherapy for certain cancers, particularly for patients who respond well to chemotherapy. In such cases, where immunotherapy has already been proven effective, the requirement for biomarkers may be redundant.
Dr. Su said that a slightly difference in biopsy location may greatly affect the financial burden on cancer patients.
Mr. Eric Liu, Vice President of the Taiwan Young Patient Association, pointed out that immunotherapy has been used to treat cancer for a decade. The accumulated experience and real-world evidence should be sufficient to support NHI reimbursement decisions.
The current NHI reimbursement criteria vary depending on the type of cancer, which has caused significant anxiety among patients. According to international treatment guidelines, the use of immunotherapy for cancer treatment generally does not require confirmation through PD-L1 testing. In fact, using PD-L1 testing as a universal criterion for NHI-reimbursed immunotherapy deprives many patients of the opportunity to access treatment.
Legislator Liu Chien-Kuo (DPP) noted that the NHIA has accelerated the reimbursement of new drugs; however, patients still face many barriers to accessing treatments, such as unnecessary tests. The government should listen to patient groups and engage in discussions about removing unreasonable regulations to align Taiwan's treatment criteria with international standards.
【2024-12-10 / United Daily 】
