Evaluating the implementation of a pharmacogenetic passport in Italy: an health impact assessment

Abstract Background Adverse drug reactions (ADRs) are a major cause of morbidity and healthcare expenditure and are partly driven by inter-individual genetic variation in drug-metabolising enzymes. The pharmacogenetic (PGx) passport is a preemptive test panel covering multiple pharmacogenes enabling personalised treatment decisions and potentially safer prescribing. This study evaluates the potential impact of the implementation of the PGx passport in the Italian context. Methods A Health Impact Assessment was conducted, analyzing potential impacts of the PGx passport implementation on health outcomes, organizational feasibility, patient acceptability, and economic sustainability. Evidence collected through literature reviews and expert consultations was discussed with a multidisciplinary steering committee including clinicians, lab professionals, pharmacologists, and PGx specialists. Results Evidence from a multicentric RCT showed a 30% reduction in clinically relevant ADRs through genotype-guided prescribing with a 12-gene PGx passport and high feasibility across diverse organizational settings. Studies on patients’ acceptability reveal high willingness to undergo testing, rising to > 90 % when recommended by clinicians, yet highlights the need for targeted education to close residual knowledge gaps. Economic evaluations consistently find both single gene-drug tests and multigene panels to be cost-effective, supporting sustainable adoption. Several implementation barriers have been identified, including limited clinician expertise in interpreting results, uneven laboratory capacity, substantial upfront investment, and concerns over equitable access and data governance. Conclusions These findings position the PGx Passport as a clinically beneficial, patient-acceptable, and economically viable innovation, whose successful implementation will hinge on strategic investments that overcome organizational barriers and build sufficient workforce and infrastructure capacity. Key messages • Implementing a PGx passport in Italy may reduce ADRs and improve prescribing safety. • Organizational readiness, provider education, and policy development are crucial for national adoption.