Testing HLA-B*15:02: Is it worth it?

Persons carrying the HLA-B*15:02 allele (predominantly those of Asian descent) are at high risk of hypersensitivity reactions to carbamazepine, including Stevens-Johnson syndrome and toxic epidermal necrolysis.1 Having considered the data on risk, regulatory authorities, including the Food and Drug Administration and European Medicines Agency, recommend HLA-B*15:02 testing before starting treatment.2 When making a recommendation about testing, regulators will not usually consider health economic (cost-effectiveness) or wider effects on patient care, nor will they consider how such recommendations should be implemented in complex heath systems. Not surprisingly therefore, there is potential for such recommendations to have consequences on services and use of health care resources, which may not be in the best interest of patients or the wider society.