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MaxiMed PGx Test Sales Training


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PGx, PGx Testing, Pharmacogentic Test, Pharmacogentics, DNA test, DNA testing

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MaxiMed PGx Test Sales Training

  1. 1. PGx Test Training P: (800) 848-7240 F: (888) 865-8954
  2. 2. Understanding Pharmacogenomics • Pharmacogenomics is the study of how an individual's genetic inheritance affects the body's response to drugs. • The goal of these test results could be used to optimize drug choice and/or dose earlier for more effective therapy, avoid serious adverse effects, and decrease medical costs. • CYP450 tests provide information on how quickly or slowly the patient will metabolize a certain drug (ex: warfarin or clopidogrel). This allows one to assess the likely risk of adverse drug reactions, drug toxicity, decreased effectiveness or drug failure when using a specific drug in one particular individual.
  3. 3. Understanding Cytochrome P450 • Cytochrome P450 (CYP450) is a large enzyme family mostly found in the liver that is involved in the metabolism and processing of many drugs and chemicals in our body. • Since the CYP450 enzymes have more than 50 variations, their activity may vary from person to person. Individual differences of cytochrome P450 activity can mean that certain drugs aren’t metabolized at all, are metabolized slowly, or are metabolized very quickly. • These results can lead to adverse drug reactions or a lack of therapeutic effect under standard therapy conditions.
  4. 4. CYP450 • Essential for production of cholesterol, steroids, prostacyclins, and thromboxane A2 • Necessary for detoxification of foreign chemicals and metabolism of drugs • CYP450 – cell (cyto)+heme pigment (chrome and P)+ absorbs light at wavelength of 450 when exposed to CO • Over 50 CYP450 enzymes • CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5 metabolize 90% of drugs
  5. 5. Pharmacogenomics • For each drug test requested, The Pgx Lab provides an analysis of the patient’s genetic response to that specific drug, classifying them as: • Normal Metabolizers (NM) • Poor Metabolizers (PM) • Intermediate Metabolizers (IM) • Rapid Metabolizers (RM) • Ultra Rapid Metabolizers (URM) • Key Point to Remember: Each person responds to drug treatments differently
  6. 6. Genetic Enzymes Tested • Enzymes Associated with Cytochrome P450: • CYP2D6 – responsible for the metabolism or elimination of approx. 25% of clinically used drugs. • CYP2C19 – primary enzyme for the metabolism of Plavix • CYP3A4 & 3A5 – primarily functions in metabolism of pain drugs. Active in nearly 50% of all pain drugs used today. • CYP2C9 – Nearly 100 therapeutic drugs are metabolized by this enzyme.
  7. 7. Breaking Down Pain Management CYP450 2C19, 2C9, 2D6, 3A4, 3A5: Key Factors in Effective Pain Management
  8. 8. Breaking Down Pain Management • Drugs are the “first line” of treatment for most forms of pain. • Goal of successful pain management is to effectively control patient pain without causing excess side effects from the medication prescribed. • However, only 58% of those who took prescription medication received any form of pain relief. • Less than 41% of patients taking over-the-counter pain medication reported relief.
  9. 9. Overdose Prevention • The incidence of unintentional (and preventable) overdose- related deaths is growing exponentially. • Of all drug-related deaths in the U.S., 43% are due to pain relief medication. • 80% of all pain management drugs are prescribed by the general practitioner or the internist
  10. 10. Codeine and FDA Guidance 2007 • Evidence suggests that individuals who are ultrarapid metabolizers (those with a specific CYP2D6 genotype) may convert codeine to its active metabolite, morphine, more rapidly and completely than other people. • In nursing mothers, this metabolism can result in higher than expected serum and breast milk morphine levels. • In a nursing mother known to be or suspected to be an ultra-rapid metabolizer of codeine, consider other options for relieving pain or persistent cough.
  11. 11. Cardiac Pharmacogenomic Testing
  12. 12. Cardiac Molecular Testing CYP2C19 and its Relationship to the Cardiac Response • CYP450 includes a gene (CYP2C19) that codes for numerous liver enzymes involved in the metabolism of toxins, metabolic intermediates, lipids, sterols and xenobiotic substances such as drugs. • These enzymes account for 75% of the metabolic processes involved in the metabolism and bioactivation of all drugs. • Detecting these genetic variations helps clinicians predict how a patient will respond to these types of drugs, such as Plavix. • Patients with reduced function alleles have ~3.5x greater risk for major adverse cardiovascular events – with the greatest risk for poor metabolizers of CYP2C19.1 • People of African and Asian ancestry have a greatly increased prevalence of Poor Metabolizer status of CYP2C19.2
  13. 13. Plavix Black Box Warning
  14. 14. Adverse Drug Reactions • “appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.” • 100,000 Americans die due to medication-related problems every year • 10.7% of hospital admissions in older adults are associated with adverse drug reactions • Four medications accounted for more than two thirds of these emergency hospitalizations: warfarin (33%) Insulins (14%) oral antiplatelet agents (13%) oral hypoglycemic agents (11%)
  15. 15. Cardiac Molecular Testing Factor II and its Relationship to Cardiac Events • The increased risk of venous thrombosis in patients who are heterozygous for the prothrombin gene polymorphosis is 3X greater than normal. • Patients with a previous or current thrombotic event that have the prothrombin gene polymorphism are at increased risk for a re-occurrence.
  16. 16. Factor II Mutation • Prothrombin 20212 mutation • Having a heterozygous prothrombin mutation increases the risk of developing a first DVT by about 2 to 3 times the background • May increase risk of heart attacks in young women, particularly those who smoke
  17. 17. MTHFR • MTHFR is an abbreviation for the gene that codes for an enzyme called methyltetrahydrofolate reductase. The MTHFR enzyme helps the body to manufacture proteins. Two mutations are the most studied: 677 and 1298, although there are more than 50 known MTHFR variants. • Mutations in the 677T variant is associated with thromboembolic and cardiovascular disease, which can lead to blood clots, strokes, embolisms, and heart attacks. • Mutations in the 1298C variant are associated with a number of chronic diseases, including fibromyalgia, irritable bowel syndrome, migraines, and other conditions. • Studies have found that 98% of autistic children have an MTHFR abnormality.
  18. 18. MTHFR Elevated homocysteine levels increase risk of: • Atherosclerosis • DVT • Dementia • Having a child with a neural tube defect (i.e. spina bifida) • Increased risk of pregnancy complications (preeclampsia, placental abruption, pregnancy loss)
  19. 19. MTHFR We consider the MTHFR genetic test one of the most important to your health. MTHFR is involved in processing folic acid. Small changes in this chemical process can be associated with any of the following conditions:  Depression  Anxiety  Chronic pain  Chronic fatigue  Nerve pain  Migraines  Elevated homocysteine levels  Bipolar disorder  Schizophrenia  Parkinson’s  Stroke  Heart Disease  Multiple miscarriages  Stillbirths, as well as other birth defects  Down syndrome  Autism  Fibromyalgia  Irritable Bowel Syndrome  Alzheimer’s
  20. 20. Simple Testing Process Complete Test Requisition form Collect the buccal swab sample Ship Lab processes sample • Requisition form completion and non-invasive buccal swab collection under 5 minutes • INCLUDE patient’s current medications list, demographic face sheet, copy of front and back of insurance card. • Ship to lab overnight • Results back to provider typically within 10 business days from receipt
  21. 21. Test Requisition Form Provider’s Information Patient’s Information-current medications list, demographic face sheet, copy of front and back of insurance card. Panel Choice ICD-10 Codes Healthcare professional must sign in order for test to be run Barcode stickers for sample envelope
  22. 22. Sample Report Our comprehensive panel includes: CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, F2, F5, MTHFR, VKORC1, APOE, COMT, CYP1A2, SLCO1B1
  23. 23. SAMPLE Billing • If PGx Lab is an out of network lab. • Total cost of comprehensive test charged to insurance: $7195. • Noridian LCD limits PGX payment to CV and Psych. • Growing utilization of PGX in Pain and Geriatrics. • Cash Price program to continue supplying the need within markets other than CV and Psych: • List Price example of $600 • Option 1- One time payoff by Check or Credit-$600 – 25%=$450.00 • Option 2- 3 installments (1 every 2 months) of $175.00 over 6 months. 3 X $175= $525 or a 12.5% discount. • Option 3- 12 month installments of $50.00. 12 X $50=$600 • Medicare covers: • Cardiovascular panel • Psychiatric panel • Thrombosis/Anti-Clotting panel
  24. 24. How To Start 1. Complete New Client paperwork for each new account/physician office and fax to (888) 865-8954. 2. Once New Client paperwork is received, start up materials are then sent out to physician office including test kits, return shipping labels, personalized test request forms, etc. a. Test request forms will be prepopulated with provider information and then printed for ordering and signature.
  25. 25. Questions? 800-848-7240