Systematic review of the evidence on the cost-effectiveness of pharmacogenomics-guided treatment for cardiovascular diseases

Abstract

Purpose: To examine the evidence on the cost-effectiveness of implementing pharmacogenomics (PGx) in cardiovascular disease (CVD) care. Methods: We conducted a systematic review using multiple databases from inception to 2018. The titles and abstracts of costeffectiveness studies on PGx-guided treatment in CVD care were screened, and full texts were extracted. Results: We screened 909 studies and included 46 to synthesize. Acute coronary syndrome and atrial fibrillation were the predominantly studied conditions (59%). Most studies (78%) examined warfarin-CYP2C9/VKORC1 or clopidogrel-CYP2C19. A payer's perspective was commonly used (39%) for cost calculations, and most studies (46%) were US-based. The majority (67%) of the studies found PGx testing to be cost-effective in CVD care, but costeffectiveness varied across drugs and conditions. Two studies examined PGx panel testing, of which one examined pre-emptive testing strategies. Conclusion: We found mixed evidence on the cost-effectiveness of PGx in CVD care. Supportive evidence exists for clopidogrel-CYP2C19 and warfarin-CYP2C9/VKORC1, but evidence is limited in other drug-gene combinations. Gaps persist, including unclear explanation of perspective and cost inputs, underreporting of study design elements critical to economic evaluations, and limited examination of PGx panel and pre-emptive testing for their costeffectiveness. This review identifies the need for further research on economic evaluations of PGx implementation.

A model-based cost-effectiveness analysis of pharmacogenomic panel testing in cardiovascular disease management: preemptive, reactive, or none?

“…[23][24][25] The model tracks individuals in the cohort through each health state and estimates costs and quality-adjusted life years (QALYs) over 50 years. The specific CVD-related conditions and/or outcomes considered are identified in the systematic review 14 as well as from a comprehensive review of guidelines from the American Heart Association, American College of Cardiology, and other cardiology-related societies or organizations (eTable 1) are as follows: myocardial infarction (MI), coronary heart disease (CHD), atrial fibrillation (AF), valvular heart disease (VHD), hyperlipidemia (HLP), peripheral artery disease (PAD), and ischemic stroke (stroke).…”

“…Evidence on the costeffectiveness of implementing PGx panel testing, either preemptively or reactively, compared with usual care for any of the gene-drug combinations is scarce. 14 The aim of this study was to compare cost-effectiveness of preemptive and reactive PGx panel testing strategies with usual care (no PGx testing) to guide treatment choices for a population with average CVD risk. The secondary aim of the study was to assess cost-effectiveness of the three strategies in different patient subgroups varied by age, gender, race, CVD risk level, and timeframe for whom experimental studies are either very costly, infeasible, or require significantly longer time to complete.…”

Genotype‐guided warfarin therapy: Still of only questionable value two decades on

“…Furthermore, given that approximately 60% of the variability in dose/response to warfarin is due to factors other than CYP2C9/VKORC1 genotypes and that other genetic markers of risk continue to be reported, it may be over‐optimistic to expect current genotyping strategies alone to significantly enhance the safety and effectiveness of warfarin therapy in the majority of patients in routine clinical settings. Not unexpectedly, therefore, cost‐effectiveness of genotype‐guided warfarin dosing remains controversial, especially since this varies with geography depending on local health economics or patient population studied …”

Farmacogenômica e Doença Cardiovascular: Onde Estamos e Para Onde Vamos

“…46 Por outro lado, e considerando o custo-benefício relacionado ao uso da varfarina e do clopidogrel, uma revisão sistemática recente que incluiu 31 ECRs mostrou que, comparado à terapia padrão, o teste FGx foi superior em 81% das vezes. 13 Paralelamente aos estudos de medicamentos isolados, o conceito de teste preventivo vem crescendo e apresentando algumas evidências de benefício. Em 2012, Schildcrout et al 47 mostraram, em uma coorte de 52.942 pacientes em cuidado domiciliar, uma exposição de 64,8% a pelo menos um medicamento de mecanismo influenciado por variantes genéticas.…”

“…Com o auxílio da FGx, o médico poderá ter mais segurança e assertividade ao prescrever o medicamento adequado e a dose correta, já que possuirá informações importantes sobre o perfil genético do paciente, sem deixar de levar em conta outros fatores importantes relacionados ao indivíduo que está sendo tratado. 13 Assim, a DCV está na vanguarda da terapia guiada por FGx, sendo interessante que os cardiologistas estejam atentos para as informações relativas a essa área do conhecimento.…”