Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

Summary What is known and objectives Many drug labels contain information on pharmacogenomic biomarkers ( PGBM s), but the information is not necessarily actionable. Pharmacogenomics Knowledgebase (Pharm GKB ) aims to clarify the level of action for PGBM s ( PG x levels) implied in each label as issued by the US Food and Drug Administration. We wished to evaluate the association between the PG x level for US and Japanese drug labels and the insurance coverage for PGBM testing or approval for in vitro diagnostics ( IVD s) in each country. Methods We investigated the information on PGBM s in US and Japanese drug labels with PG x levels, insurance coverage of PGBM tests and IVD approval in the US and Japan. We analysed the relationship of PG x levels with insurance coverage. Results A total of 243 labels were listed by Pharm GKB , and 215 (88%) had PG x levels for US labels and 52 (21%) for Japanese labels. Of the 215 US labels, 54 were designated as “Testing Required” in PG x levels. PG x levels in US labels were strongly associated with coverage of PGBM testing. Tests in 52 (96%) of the 54 labels with Testing Required had insurance coverage, 2 (50%) of 4 in “Testing Recommended,” 38 (38%) of 100 in “Actionable PG x,” 11 (19%) of 57 in “Informative PG x” and 3 (11%) of 28 in “No Level.” In Japanese labels, only 14 of 52 were listed as Testing Required, and all were covered by the National Health Insurance in Japan. What is new and conclusion The PG x level given in drug labels provides information on availability of PGBM testing. Higher PG x levels, based on better evidence of usefulness of PGBM testing, provide a route to broader test coverage.