OBJECTIVES: Because one size does not fit for all, personalized medicines (PMs) allow health professionals to select the right drug for the right patient. The concept of PMs are promising, however, drugs and their companion diagnostic tests may not be covered by national health insurance programs. This preliminary study aimed to explore reimbursement status of companion diagnostic tests in selected countries. The secondary objectives is to explore factors influencing companion diagnostic tests reimbursement decision.

METHODS: Six pairs of PMs were selected: UGT1A1 with irinotecan, VKORC1/CYP2C9 with warfarin, HLA-B*5801 with allopurinol, HER2/neu with trastuzumab, BCR-ABL with nilotinib, and EGFR mutation with gefitinib. Reimbursement status of companion diagnostic tests were evaluated among Thailand, Malaysia, China, Australia and United Kingdom. Factors possibly influence reimbursement of companion diagnostic tests included recommendation from health authority, practice guidelines, evidence based study and economic evaluation.

RESULTS: Decision to reimburse PMs’ companion diagnostic tests were varied across countries. All countries agreed to reimburse HER2/neu for trastuzumab, but disagreed to cover VKORC1/CYP2C9, HLA-B*5801, and UGT1A1 for adjusting warfarin dose, avoiding allopurinol serious adverse events, and reducing irinotecan side effect, respectively. The coverage decision of BCR-ABL, EGFR and their drugs were in the same direction. It was found that the decision to reimburse companion diagnostic test are congruent with health authority recommendation and clinical practice guidelines. Local economic studies were found only in some countries and not relevant to coverage decision. Evidence of the systematic review of the test efficacy normally support decision to select drug candidates, but not support decision for adjusting appropriate dose, or reducing adverse drug events or lowing possible side effects.

CONCLUSIONS: Benefits of PMs are realized, but access to PMs are still limited. Further clinical and economic evidences is required especially for middle income country to support reimbursement decision.