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Personalized Medicine
- 1. Personalized Medicine Patient-Centred Healthcare April 15, 2015 Julia Novik, VP Business Development
- 2. The White House Office of the Press Secretary: “Most medical treatments have been designed for the “average patient.” As a result of this “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others” Jan 30, 2015http://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative Promises & Pitfalls of Precision Medicine
- 3. Personalized Medicine is Here!
- 4. Every person is different, so why should your medication be the same? Personalized Medicine Making sense of clinical & health economic evidence
- 5. Genetic factors can account for up to 95% of Drug Response variability • These 5 genes are responsible for metabolizing ~ 80% of all drugs Pharmacogenetics (PGx) Genes involved in drug metabolism CYP3A4/5 44% CYP2D6 25% Other CYPs 16%% CYP2C9 10%% CYP2C19 5%%
- 6. Tylenol 3 = acetaminophen (500 mg) + codeine (30mg) CYP2D6 also metabolizes: •Oxycodon (Percocet) Vuilleumier et al. Pharmacogenomics and Personalized Medicine 2012:5; 73- Why are some medications not effective? Codeine Normal CYP2D 6 Defectiv e CYP2D 6 Excessiv e CYP2D6 Morphin e Morphin e Morphin e Morphin e Morphin e Morphin e
- 7. Clinical evidence shows that drug response varies from person to person A genetic test predicts a person’s response to a medication Current: trial & error Future: Evidence-based prescribing Poor Metabolizer Intermediat e Metabolizer Extensive Metabolizer Ultrarapid Metabolizer
- 8. • Oncology (>80) • Antidepressants (25) • Cardiovascular (12) • Opioids • Antivirals • CTP codes in USA: CYP2D6, CYP2C19 • Specific medications reimbursed by Medicare etc… http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm The FDA has genetic biomarkers on 150 drug labels
- 10. “Medicine acts as both remedy and poison” Socrates 200,000 Adverse drug reactions reported annually in Canada 33% Of drug spending is wasted 20% Non-adherence cases attributed to side effects May Cause Side Effects
- 11. Non-adherence is costly • Non-adherence accounts for 30%-50% of treatment failures • Non-adherence leads to a $4Bn increase in healthcare costs* Benefits Canada *http://www.benefitscanada.com/benefits/health-benefits/non-adherence- costs-employers-58070 Figure adapted from: http://www.nature.com/tpj/journal/v13/n6/full/tpj201333a.html Limited Patient Engagement Cost Low Perceived need/efficacy Concern about side effects Complex drug regimens Low health literacy Unclear/misunderstood instructions Impaired Cognition Lack of social support Forgetfulness Non- adherence PGx testing can improve adherence by 50% (Based on clinical studies)
- 12. Is drug utilization effective? Current trial & error prescribing… results in inefficient care… 200,000 reported adverse drug reactions annually up to 22,000 fatalities and causes: Express Scripts Canada $1 out $3 wasted
- 13. “~75% of GWL drug spending is for traditional chronic medications, yet higher costs specialty medications are getting all the attention.” Benefits Canada http://www.benefitscanada.com/benefits/health -benefits/drug-plan-trends-in-canada-62988 Drug plan costs beyond specialty drugs
- 14. Better Health Outcomes Pharmacogenetics enables evidence-based prescribing to help… Predict patient response Prevent adverse reactions & Improve health outcomes Provide patient- centric treatment
- 15. Had a heart attack •Rx: Plavix (Clopidogrel) •Up to 25% of patients Non- Responsive to Plavix due to genetic variant in CYP2C19 •FDA issued Black Box warning on Plavix label * Goeree at al., 2005 Ann today High risk of stroke 8-20% Disability Loss of productivity High cost of disease burden
- 16. Had a heart attack •Gene guided prescribing •No adverse drug reaction •Reduced cost of treatment •Quicker return to work Pharmacogenetics driven treatment optimization can save •up to 20% of disability costs •2-3% of drug costs $500,000 annually per 1000 employees *Proprietary model from RL Analytics Ann tomorrow
- 17. Mental health Only 33% of patients respond to 1st line of treatment for depression Data adapted from Dunnes DL. Primary Psychiatry Vol 14. No 3. 2007 33% 67% Symptoms resolved after initial SSRI treatment Symptoms persisted after initial SSRI treatment
- 18. Week 4 Week 6 Week 10 Improvement from Baseline Without PGx testing With PGx testing PGx guided treatment enables: -Quicker remission -Improvement in depression scores -Earlier return to work Figure adapted from “A Prospective, Randomized, Double-Blind Study Assessing the Clinical Impact of Integrated Pharmacogenomic Testing for Major Depressive Disorder” Winner JG at al., Discovery Medicine, 2013 Mental health Impact of treatment optimization with pharmacogenetics
- 19. Disease Burden Cost Baseline Risk Preclinical Progression Clinical Disease and Progression With PGx optimization PGx Manages Disease & Cost Without PGx optimization
- 20. • BC pharmacies – PGx of warfarin dosing • AssureX & CAMH PGx of depression & psychiatry • TGH & Mayo clinic – clopidogrel PGx • Montreal Heart Institute • SickKids Where is PGx in Canada?
- 21. Benefits of Pharmacogenetics for the right patient.at the right dose,The right medication, Better health outcomes for patients, More effective healthcare spending for payers.
- 22. Pay for effective utilization Reduce drug spend waste Prevent fear of side effects Change behavior (Empower patients) Predict treatment outcome Minimize disability claims “87% of plan sponsors said insurers should play a larger role in managing employee health outcomes” 2013 Sanofi Survey Proactive Workplace Wellness Patient-centred Healthcare 200,000 Reported Adverse drug reactions annually in Canada 33% Of drug spending is ineffective 20% Non-adherence cases attributed to side effects
- 23. FDA CPIC DNA Data Provide personalized drug dosage recommendations Prevent: •Non-adherence •Adverse Side Effects •Drug spend waste •Potential disability costs Predict drug response outcome Better Health Outcomes: Predictive PersonalizedPreventive PGx Solution Patient-centric guide to drug therapy
- 24. Contact information: Julia Novik, MBA, CA julia@geneyouin.ca 416.618.2981 Thank you for your time!
- 25. Am I normal? Confused My Social Life Will prescriptionswork? Embarrassed “No way I’m taking Cipralex (citalopram)! I looked it up online and one of the common side effects is erectile dysfunction. I don’t want that to happen to me!” Jerome, 19 Why PGx testing? Removing fear of side effects
- 26. 10% Educational Knowledge Gap Figure adapted from Stanek EJ, Sanders CL, Taber KA et al. Clinical Pharmacology & Therapeutics. 2012; 91(3): 450-8. # of Respondents Believe genetics affects drug response PGx training in med school or post-grad Feel adequately informed about genetic testing Ordered a PGx test in the last 6 months Anticipate ordering PGx test in next 6 months Test not ordered due to not enough info 98% 29% 13% 26% 57% Medco/AMA Nationwide Physician Survey
- 27. • 17.4% of health care spending, $29.8B is drug costs • 18 prescriptions filled per year by Canadian patient with chronic disease • 6 of top 10 drug classes used for chronic conditions Percentage of adult diagnoses Age 45 to 64 Canada Canadian Survey of Experiences With Primary Health Care, 2008, Statistics Canada; CIHI Impact of Chronic Diseases Adults (45-64) High Blood Pressure 55% Arthritis 58% Heart Disease 38% Diabetes 53% Cancer 52% Chronic Pain 59% Asthma 43% Depression 51% Emphysema or COPD 54%
Editor's Notes
- - Her story brought up the awareness about the importance of disease risk assessment How genetics provides insight into your health and can be used as a preventative measure to manage your health and lifestyle Your diagnosis can prevent catastrophic outcomes
- The purpose of Disease risk: to identify what is the likelihood of developing a certain inherited disease This is expensive testing – few thousands dollars, more complex analysis of your family gene pool Insurability concerns Drug Response Test: what we will focus on today Very different type of genetic testing called Pharmacogenetics It’s based on how
- Raise your hand How many of you had unwanted side effects to a medication you’ve taken? I guess you guys are still very young We as humans share 99% of our DNA, it’s only that 1% that makes each of us unique
- There are many factors that impact how we respond to the medication and whether it’s working for us. Environmental (diet/tobacco use), physiological (age, sex, weight, disease status). Genetic factors play a big role as the scientific literature points out that 95% of a……… CYP are the main family of genes responsible for drug metabolism There is a lot of variability in drug efficacy rates and that has a big impact It has been documented that genetic factors are responsible of up to 95% of drug response. Drug efficacy rates for most major drugs range from 25% to 60% Mariya: Get reference for this slide
- For slow metabolizers, don’t get any improvement. May need to take an alternative medication that your body can metabolize. Morphine on its own If you ultra-fast metabolize of codeine: short-term pain relief, increase in developing addiction you will get Up to 50% are not getting a full impact from Codeine as they cannot metabolize it into Morphine, not getting therapeutic effect, potentially side effects by continuing to take the wrong dose. Toxicated…. Only 48% can metabolize it normally 2% ultra-fast metabolizers, get only temporary relief for a couple of hours
- Using a standard dose for all patients: A lot of times they see one size does not fit all
- FDA has started updating drug labels to include pharmacogenetic recommendation where there is clinical evidence that drug dosage should be optimized with genetic test. It’s not enforceable but it’s recommended It’s an active role that FDA has taken to try and improve the health outcomes and patient safety. In the past year, FDA has increased drug labelling from 100 to 150.
- CPIC follow FDA labels and follow clinical evidence to publish clinical dosing guidelines Purpose of CPIC: Make it easier for clinicians by providing clear guidelines on dosing optmiziation
- Only 200K reported ADR’s causing 10K – 22K fatalities, costs the healthcare system $13.7-$17 Bil/yr The number #1 reason for discontinuation of medication: Adverse side effects One of our SEO analytics shows that GYI websites gets the most hits for Adverse side effects searches People are using Dr. Google to understand what side effects they may anticipate from taking medication 50% of prescriptions don’t get filled potentially due to the fear to side effects Medications are designed to treat specific symptoms, and they work most of the time. This is a pill for your cholesterol, This one is for your heart.. And this one is for your hypertension or diabetes... However frequently people do not experience expected clinical benefits or even worse suffer from adverse side effects. Why this happens?
- Adherence requires patient to believe there is a benefit to the prescribing medicine and that they will not experience side effects
- A lot of focus on managing Specialty drug spends. Most of drug spending is for chronic conditions With the aging population, the drug spend on chronic conditions will only going to get worse.
- As a way to mitigate concerns around: Non-adherence and unwanted side effects Poor health outcomes Wasted drug spending PGx offers: In order to better manage patient health outcomes and reduce wasted healthcare spending, PGx offers
- My aunt: Put on Brilinta – would’ve saved her insurance company and avoid poor health outcomes with a medication that just did not work for her Eliminate trial and error prescribing, would provided a physician with a guided tool to predict health outcome of my aunt on plavix
- Where are the cost savings for employers? Better health outcomes More effective drug utilization Healthier, happier, more productive employees
- Slide 53 the longer it takes for a person to find a correct medication, the more it costs the healthcare system, and employers, if you don’t identify the high risk people, it costs you!!
- Wide adoption difficult without education of physicians and clarity in reimbursement structure
- Simple message to reinforce benefits, at end “better health outcomes for people!”
- Provide patients confidence in that their medication will work for them, they are more likely to take it This is what PGx is helping to do by predicting what medication would work best for the patient
- This is a real example Ruslan consulted
- Despite the known clinical benefits of PGx, physicians are not well informed or educated on the benefits of PGx. Many don’t even know that the companies exist that can provide this service. We have been going to see a number of Family health teams. Physicians seem to be fascinated and some are starting to order some tests. However, without clarity around reimbursement for patients And without making the ordering of the test integrated into physician clinical workflow, the adoption is slow.