Coverage of pharmacogenetic tests by private health insurance companies

Park, Sharon K.; Thigpen, Jonathan; Lee, Insong James

doi:10.1016/j.japh.2019.10.003

Cited by 20 publications

(24 citation statements)

References 20 publications

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“…Moreover, a study assessing PGx testing among private insurers found that test coverage policies were not readily accessible on company websites and that reimbursement largely varied according to the listed gene-drug pair, with only about 40% of known pairs covered in the policies. 64 Recently, however, the Centers for Medicare and Medicaid Services (CMS) have posted a Local Coverage Determination (LCD) to cover PGx testing, including panel testing, to be effective in the summer of 2020. 65 Uncertainty in health insurer coverage can cause providers to wholly refrain from ordering PGx tests to prevent delays in patient care.…”

Section: Current Limitations To Testingmentioning

confidence: 99%

“…Although PGx testing is a once‐in‐a‐lifetime test and genotype‐guided dosing strategies have shown to be less of an overall economic burden when compared with drug‐related adverse event management costs, payors are still resistant to reimburse testing. Moreover, a study assessing PGx testing among private insurers found that test coverage policies were not readily accessible on company websites and that reimbursement largely varied according to the listed gene‐drug pair, with only about 40% of known pairs covered in the policies 64 . Recently, however, the Centers for Medicare and Medicaid Services (CMS) have posted a Local Coverage Determination (LCD) to cover PGx testing, including panel testing, to be effective in the summer of 2020 65…”

Section: Future Directionsmentioning

confidence: 99%

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DPYD and UGT1A1 Pharmacogenetic Testing in Patients with Gastrointestinal Malignancies: An Overview of the Evidence and Considerations for Clinical Implementation

et al. 2020

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Gastrointestinal (GI) malignancies are among the most commonly diagnosed cancers worldwide. Despite the introduction of targeted and immunotherapy agents in the treatment landscape, cytotoxic agents, such as fluoropyrimidines and irinotecan, remain as the cornerstone of chemotherapy for many of these tumors. Pharmacogenetics (PGx) is a rapidly evolving field that accounts for interpatient variability in drug metabolism to predict therapeutic response and toxicity. Given the significant incidence of severe treatment-related adverse events associated with cytotoxic agents, utilizing PGx can allow clinicians to better anticipate drug tolerability while minimizing treatment interruptions or delays. In this review, the PGx profiles of drug-gene pairs with potential impact in GI malignancy therapy-DPYD-5-fluorouracil/capecitabine and UGT1A1-irinotecanand the available clinical evidence of their roles in reducing severe adverse events are discussed. Considerations for clinical implementation, such as optimal laboratory workflows, electronic health record integration, and stakeholder engagement, as well as provider education, are addressed. Last, exploratory PGx markers in GI malignancy treatment are described. As the PGx knowledge base rapidly evolves, pharmacists will be vital in leveraging their pharmacology knowledge and clinical skills to implement PGx testing in the clinic.

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Section: Current Limitations To Testingmentioning

confidence: 99%

Section: Future Directionsmentioning

confidence: 99%

DPYD and UGT1A1 Pharmacogenetic Testing in Patients with Gastrointestinal Malignancies: An Overview of the Evidence and Considerations for Clinical Implementation

et al. 2020

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“…Despite many potential benefits, the implementation of PGx testing in clinical practice remains a slow process, particularly outside academic institutions. Challenges include limited and sometimes controversial evidence with regard to improved clinical outcomes for many drug–gene pairs [ 9 ], discrepancies between guidelines from PGx expert groups vs. different medical specialty associations [ 7 , 10 , 11 ], reaction time of regulatory authorities regarding the implementation of new PGx evidence, and limited reimbursement of the costs for PGx testing [ 12 , 13 ]. Furthermore, even if a valid PGx test is performed, it may be challenging to find an expert who can interpret its findings and manage pharmacotherapy within a patient’s individual clinical context [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients

Niedrig

Rahmany²,

Heib³

et al. 2021

JCM

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There is a growing number of evidence-based indications for pharmacogenetic (PGx) testing. We aimed to evaluate clinical relevance of a 16-gene panel test for PGx-guided pharmacotherapy. In an observational cohort study, we included subjects tested with a PGx panel for variants of ABCB1, COMT, CYP1A2, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6, CYP4F2, DPYD, OPRM1, POR, SLCO1B1, TPMT and VKORC1. PGx-guided pharmacotherapy management was supported by the PGx expert system SONOGEN XP. The primary study outcome was PGx-based changes and recommendations regarding current and potential future medication. PGx-testing was triggered by specific drug–gene pairs in 102 subjects, and by screening in 33. Based on PharmGKB expert guidelines we identified at least one “actionable” variant in all 135 (100%) tested patients. Drugs that triggered PGx-testing were clopidogrel in 60, tamoxifen in 15, polypsychopharmacotherapy in 9, opioids in 7, and other in 11 patients. Among those, PGx variants resulted in clinical recommendations to change PGx-triggering drugs in 33 (32.4%), and other current pharmacotherapy in 23 (22.5%). Additional costs of panel vs. single gene tests are moderate, and the efficiency of PGx panel testing challenges traditional cost-benefit calculations for single drug–gene pairs. However, PGx-guided pharmacotherapy requires specialized expert consultations with interdisciplinary collaborations.

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“…[11][12][13][14][15] The who, what, and when of pharmacogenetic testing are largely determined by insurance coverage of the tests, which is low and varies across tests and health plans. [16][17][18] Coverage determination is informed by the availability of evidence supporting clinical utility. 13,16,17 Data from 2012 indicate that coverage of pharmacogenetic tests across a handful of commercial plans was only 30% of the tests reviewed, and coverage was inconsistent from insurer to insurer.…”

Section: Introductionmentioning

confidence: 99%