CAC Meeting Agenda, Participant Conflict of Interest (COI) Disclosure Statement, Bibliography, and Tentative Key Questions: Pharmacogenomics
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- Will be available June 20, 2019.
- All meeting participants must complete and submit the COI Disclosure Statement to firstname.lastname@example.org no later than June 19, 2019 and must declare any relevant COI verbally prior to speaking.
- Mancinelli L, Cronin M, Sadée WJAP. Pharmacogenomics: the promise of personalized medicine. 2000;2(1):29-41.
- Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). 2018; https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHFFR2017/NSDUHFFR2017.htm#mde2. Accessed 1/31/2019.
- Valiengo LdCL, Stella F, Forlenza OV. Mood disorders in the elderly: prevalence, functional impact, and management challenges. Neuropsychiatric disease and treatment. 2016;12:2105-2114.
- Gartlehner G, Gaynes BN, Amick HR, et al. Nonpharmacological Versus Pharmacological Treatments for Adult Patients With Major Depressive Disorder. Agency for Healthcare Research and Quality;2015.
- Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40.
- MacQueen G, Santaguida P, Keshavarz H, et al. Systematic Review of Clinical Practice Guidelines for Failed Antidepressant Treatment Response in Major Depressive Disorder, Dysthymia, and Subthreshold Depression in Adults. Can J Psychiatry. 2017;62(1):11-23.
- Altar CA, Hornberger J, Shewade A, Cruz V, Garrison J, Mrazek D. Clinical validity of cytochrome P450 metabolism and serotonin gene variants in psychiatric pharmacotherapy. Int Rev Psychiatry. 2013;25(5):509-533.
- Singh AB. Improved Antidepressant Remission in Major Depression via a Pharmacokinetic Pathway Polygene Pharmacogenetic Report. Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology. 2015;13(2):150-156.
- Brennan FX, Gardner KR, Lombard J, et al. A naturalistic study of the effectiveness of pharmacogenetic testing to guide treatment in psychiatric patients with mood and anxiety disorders. 2015;17(2).
- Pérez V, Salavert A, Espadaler J, et al. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC psychiatry. 2017;17(1):250-250.
- Han C, Wang S-M, Bahk W-M, et al. A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial. Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology. 2018;16(4):469-480.
- Hall-Flavin DK, Winner J, Allen J, et al. Using a pharmacogenomic algorithm to guide the treatment of depression. 2012;2(10):e172.
- Hall-Flavin DK, Winner JG, Allen JD, et al. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. 2013;23(10):535-548.
- Winner J, Allen JD, Altar CA, Spahic-Mihajlovic A. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013;3:e242.
- Winner JG, Carhart JM, Altar A, Allen JD, Dechairo BMJDm. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. 2013;16(89):219-227.
- Macaluso M, Preskorn SHJJoPP. Knowledge of the pharmacology of antidepressants and antipsychotics yields results comparable with pharmacogenetic testing. 2018;24(6):416-419.
All questions are related to psychiatric medications only. Answers will become part of the evidentiary record. While we prefer to use the highest quality evidence in writing coverage policy, we recognize that there may be gaps in the literature, and we are interested in expert opinion addressing these gaps. Please feel free to say that you are not comfortable answering or that you feel that the answer is beyond your area of expertise:
- Please give a general background of how genetics related to the selection of medications or medication dosage?
- Are there particular genes known to physiologically affect drug metabolism in humans?
- Are there particular genes known to affect physiologically drug efficacy in humans via pharmacodynamics pathways?
- Generally speaking, when does knowing the presence or absence of a genetic variant that affects pharmacokinetics or pharmacodynamics provide a physician with clinically actionable information? Is knowledge of lifestyle factors also necessary, or is genetic information sufficient?
- Are there particular genes that are known to provide clinically actionable information in humans and that show reproducible improved clinical outcomes that are sustainable for the selection or dosing of psychiatric medications? Can you give information about the evidence underlying this?
- For each of the genes that are known to provide clinically actionable information, what should be the minimum testing standards in terms of variants identified?
- Is the evidence sufficient to conclude that large combinatorial pharmacogenomics panels (e.g. Geneight, IDGenetix, CNSDose, etc.) add something to medication selection above and beyond single gene testing? If so, in which populations, and with what strength of evidence?
- In which kinds of circumstances would either single gene or combinatorial testing be used?
- Do you have any other thoughts or information that you believe should be part of the evidentiary record in the development of a coverage policy?
Last Updated Aug 19, 2019