The Path to Widespread Pharmacogenomics Implementation...Possible protagonists in PGx expansion •...
Transcript of The Path to Widespread Pharmacogenomics Implementation...Possible protagonists in PGx expansion •...
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The Path to Widespread Pharmacogenomics
Implementation
Tyler Gallo, PharmDUniversity of ArizonaCollege of Medicine and College of Pharmacy
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No financial conflicts of interest to disclose
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Overview
• Current state of Pharmacogenomic (PGx) testing
• Challenges in making PGx testing more widespread
• What is needed to expand the use of testing
• Possible models for PGx testing expansion
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Pre-emptive vs. reactive testing
• Reactive testing is done when needed for a specific drug-gene interaction
• Pre-emptive testing is done before results are needed
Drug A ?PGx ResultsCYP2C9 CYP2C19CYP2D6VKORC1 CYP4F2
Drug B
PGx ResultsCYP2C9 CYP2C19CYP2D6VKORC1 CYP4F2
Drug A ? Drug B
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Current state
• Pre-emptive testing is largely for research purposes
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Funding
• Research-funded testing• Federal grants• Foundational funds• Philanthropic donations
• Centers for Medicare and Medicaid Services has very limited coverage for reactive testing• CYP2C19 for clopidogrel• CYP2D6 for amitriptyline/nortriptyline
• Almost no coverage with private insurance
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Why is funding limited?
• Lack of sufficient evidence of improved outcomes
• Lack of pharmacoeconomic demonstration• Those that do exist tend to be for single drug-gene pairs
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The evidence of PGx benefits
• PGx testing benefits for drug-gene pairs have been demonstrated in numerous studies
• These results have led to published guidelines on how to use/interpret test results
• Guidelines do not specify when testing should occur
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Improving the evidence of benefit
• Need additional studies showing benefit and cost effectiveness to help make a case for testing being medically necessary
• Pre-emptive testing needs to show evidence of benefit from a panel of pharmacogenes
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Education
• Relatively new and expanding field that might not have been covered in health sciences education
• Current providers need some level of education to understand when to order and how to interpret results
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Standardization
• Standardization in gene panels could help expansion• What genes are tested• What polymorphisms are tested
• Standards for reporting
• Interoperable systems
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Need for usable results
PDFCYP2C9 poorCYP2D6 ultrarapidVKORC1 sensitiveCYP2C19 normalG6PD normalSLCO1B1 unknownHLAB1502 sensitive
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Need for usable results
Hicks. Implementation of CPIC Guidelines into Clinical Practice: Cleveland Clinic Experience. 2016 http://cpicpgx.org/wp-content/uploads/2016/02/Hicks-presentation.pdf
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Need for usable results
Gammal RS, Crews KR, Haider CE, et al. Pharmacogenetics for Safe Codeine Use in Sickle Cell Disease. Pediatrics. Jul 2016.
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Possible protagonists in PGx expansion
• Organizational funding
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Possible protagonists in PGx expansion
• Federal reimbursement
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Possible protagonists in PGx expansion
• Private health insurance
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Possible protagonists in PGx expansion
• Direct-to-consumer (DTC)/patient push
• 23andMe was the first (and currently only) company to have an FDA approved DTC pharmacogenetic test
• DTC testing should not be used for medical decision making and should be confirmed with clinical testing
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Summary
• Most PGx testing is currently research-funded
• Increased evidence of benefit and pharmacoeconomic studies are needed
• There are challenges in optimizing the usefulness of PGx data
• A possible shift in funding could drive an increase in PGx testing
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Questions?