Cost Effectiveness of Pharmacogenetic Testing for Drugs with Clinical Pharmacogenetics Implementation Consortium (<scp>CPIC</scp>) Guidelines: A Systematic Review

Morris, Sarah A.; Alsaidi, Ashraf T; Verbyla, Allison; Cruz, Adilen; Macfarlane, Casey; Bauer, Joseph E.; Patel, Jai N.

doi:10.1002/cpt.2754

Cited by 73 publications

(44 citation statements)

References 125 publications

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“…Costs have previously been highlighted as an important barrier to implementation 8,22,29,51 . However, a recent systematic review by Morris et al reported that most studies (71%) evaluating the costs of pharmacogenetic testing for drugs with CPIC guidelines favoured pharmacogenetic testing over standard of care, 52 which argues for increased utilization of pharmacogenetics for personalized treatment. To enhance the clinical utility and cost savings, pharmacogenetic competence in healthcare and decision support in terms of clear recommendations on specific actions are required.…”

Section: Discussionmentioning

confidence: 99%

Implementation of pharmacogenetic testing in medication reviews in a hospital setting

Hjemås¹,

Bøvre²,

Bjerknes

et al. 2023

Brit J Clinical Pharma

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AimTo investigate whether it is feasible to perform pharmacogenetic testing and implement the test results as part of medication reviews during hospitalization of multimorbid patients.MethodsPatients with ≥2 chronic conditions and ≥5 regular drugs with at least one potential gene‐drug interaction (GDI) were included from one geriatric and one cardiology ward for pharmacogenetic testing. After inclusion by the study pharmacist, blood samples were collected and shipped to the laboratory for analysis. For patients still hospitalized at the time when the pharmacogenetic test results were available, the information was used in medication reviews. Recommendations from the pharmacist on actionable GDIs were communicated to the hospital physicians, who subsequently decided on potential immediate changes or forwarded suggestions in referrals to general practitioners.ResultsThe pharmacogenetic test results were available for medication review in 18 of the 46 patients (39.1%), where median length of hospital stay was 4.7 days (1.6‐18.3). The pharmacist recommended medication changes for 21 of 49 detected GDIs (42.9%). The hospital physicians accepted 19 (90.5%) of the recommendations. The most commonly detected GDIs involved metoprolol (CYP2D6 genotype), clopidogrel (CYP2C19 genotype) and atorvastatin (CYP3A4/5 and SLCOB1B1 genotype).ConclusionsThe study shows that implementation of pharmacogenetic testing for medication review of hospitalized patients has the potential to improve drug treatment before being transferred to primary care. However, the logistics workflow needs to be further optimized, as test results were available during hospitalization for less than half of the patients included in the study.

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Section: Discussionmentioning

confidence: 99%

Implementation of pharmacogenetic testing in medication reviews in a hospital setting

Hjemås¹,

Bøvre²,

Bjerknes

et al. 2023

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…As of August 2022, an analysis of policies and guidance documents from the top commercial payers and laboratory benefit managers found that 6 out of 12 policies considered DPYD testing medically necessary, and therefore reimbursable (unpublished data). Pharmacoeconomic analyses that consider the costs of DPYD testing and the subsequent savings have found that DPYD screening is cost‐reducing or at worst cost‐effective 9,11,51,52 . A formal Health Technology Assessment from Ontario Health estimated that DPYD testing saves ~ $150 per patient if testing costs $100, 53 yielding a break‐even price of ~ $250, which approximates testing cost in the United States.…”

Section: Assessment Of Dpyd‐fp Association Using the Fda Pharmacogene...mentioning

confidence: 99%

Response to the FDA Decision Regarding DPYD Testing Prior to Fluoropyrimidine Chemotherapy

Hertz

Smith

Scott

et al. 2023

Clin Pharma and Therapeutics

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Fluoropyrimidine (FP) chemotherapy is associated with severe, life‐threatening toxicities, particularly among patients who carry deleterious germline variants in the DPYD gene. Pretreatment DPYD testing is standard of care throughout most of Europe; however, it has not been recommended in clinical practice guidelines in the United States. Due to increased risk of severe toxicity, a Citizen's Petition asked the US Food and Drug Administration (FDA) to update language in FP drug labels to recommend DPYD testing as part of a boxed warning and recommend FP dose reduction in patients carrying deleterious germline variants. In response, the FDA updated the capecitabine package insert to inform patients about the toxicity risk and test availability and consider DPYD testing. However, the FDA did not include a testing recommendation or requirement, or a boxed warning. Additionally, the FDA did not recommend FP dose adjustment in DPYD variant carriers. This review provides a critical assessment of the DPYD‐FP pharmacogenetic association using the FDA's previously published Pharmacogenetic Pyramid, demonstrating that the evidence is compelling for recommending DPYD testing prior to FP treatment. Additionally, the FDA's stated concerns about recommending DPYD testing and DPYD‐guided FP dose adjustment are addressed and discussed in the context of the FDA's other genetic testing and dose adjustment recommendations. We call on the FDA to follow our European counterparts in recommending DPYD testing and genotype‐based dose adjustment to ensure patients with cancer receive safe and effective FP chemotherapy.

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“…For each gene-drug pair, CPIC has reviewed the available evidence linking genotype to phenotype, and assigned a level of evidence (A, A/B, B, B/C, C, C/D, or D). Pharmacogenetics-guided treatments for antidepressants assigned with CPIC evidence levels A and B have been reported to be either cost-effective or cost-saving ( Morris et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

The pharmacogenetics of CYP2D6 and CYP2C19 in a case series of antidepressant responses

et al. 2023

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Pharmacogenetics has potential for optimizing use of psychotropics. CYP2D6 and CYP2C19 are two clinically relevant pharmacogenes in the prescribing of antidepressants. Using cases recruited from the Understanding Drug Reactions Using Genomic Sequencing (UDRUGS) study, we aimed to evaluate the clinical utility of genotyping CYP2D6 and CYP2C19 in antidepressant response. Genomic and clinical data for patients who were prescribed antidepressants for mental health disorders, and experienced adverse reactions (ADRs) or ineffectiveness, were extracted for analysis. Genotype-inferred phenotyping of CYP2D6 and CYP2C19 was carried out as per Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. A total of 52 patients, predominantly New Zealand Europeans (85%) with a median age (range) of 36 years (15–73), were eligible for analysis. Thirty-one (60%) reported ADRs, 11 (21%) ineffectiveness, and 10 (19%) reported both. There were 19 CYP2C19 NMs, 15 IMs, 16 RMs, one PM and one UM. For CYP2D6, there were 22 NMs, 22 IMs, four PMs, three UMs, and one indeterminate. CPIC assigned a level to each gene-drug pair based on curated genotype-to-phenotype evidence. We analyzed a subgroup of 45 cases, inclusive of response type (ADRs/ineffectiveness). Seventy-nine (N = 37 for CYP2D6, N = 42 for CYP2C19) gene-drug/antidepressant-response pairs with CPIC evidence levels of A, A/B, or B were identified. Pairs were assigned as ‘actionable’ if the CYP phenotypes potentially contributed to the observed response. We observed actionability in 41% (15/37) of CYP2D6-antidepressant-response pairs and 36% (15/42) of CYP2C19-antidepressant-response pairs. In this cohort, CYP2D6 and CYP2C19 genotypes were actionable for a total of 38% pairs, consisting of 48% in relation to ADRs and 21% in relation to drug ineffectiveness.

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Cost Effectiveness of Pharmacogenetic Testing for Drugs with Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines: A Systematic Review

Cited by 73 publications

References 125 publications

Implementation of pharmacogenetic testing in medication reviews in a hospital setting

Implementation of pharmacogenetic testing in medication reviews in a hospital setting

Response to the FDA Decision Regarding DPYD Testing Prior to Fluoropyrimidine Chemotherapy

The pharmacogenetics of CYP2D6 and CYP2C19 in a case series of antidepressant responses

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