An update on pharmacogenomics Webinar February 21, 2019 Welcome - PowerPoint PPT Presentation

An update on pharmacogenomics Webinar February 21, 2019

Welcome Patrick Charbonneau Michel Hébert Director of Product Management, Medical Director, TELUS Health TELUS Health 2

The statements and opinions expressed in the presentation represent the views of the author(s) and do not necessarily represent the views of TELUS. The information contained in the presentation is of a general nature. It is neither legal advice nor medical advice. It should not be construed as or in any way considered to be legal advice or medical advice. 3

 What is pharmacogenomics?  Scientific and clinical update  Market adoption  Insurer perspective  TELUS Health strategy 4

Pharmacogenomics vs pharmacogenetics Pharmacogenomics is a broader term, which studies how all of the genes (the genome) can influence responses to drugs. Pharmacogenetics usually refers to how variation in one single gene influences the response to a single drug. 5

The genomic world https://twitter.com/erictopol/status/987723700760993793 Source: Grand View Research https://seekingalpha.com/article/4006027-fulgent-genetics-ipo-shows- promise?page=2 Cell, Volume 157, Issue 1, / Eric J. Topol, Individualized Medicine from Womb to Tomb, Pages 241-253, 2014 6

Scientific and clinical update http://agenabio.com/products/panels/pharmacogenetic-solutions/ 7

Reduction in costs driving affordability Lower costs $1,000 $1,000,000 $800 $800,000 $600 $600,000 $400 $400,000 $200 $200,000 $0 $0 Pharmacogenetic $1,000 $750 $500 $250 $175 Testing $1,000,000 $100,000 $1,000 $350 Whole Genome Sequencing 8

Genome sequencing cost Cambridge-based Veritas Genetics will be lowering its $999 whole genome sequencing and interpretation service to just $199 for two days, or to the first 1000 people who buy spit kits. “We’re sending a clear signal to the medical research community that the $99 genome will be here in three to five years” he says. “People might be thinking it’s still a decade away. We want to wake them up.” MEGAN MOLTENI, SCIENCE 11.19.18 http://agenabio.com/products/panels/pharmacogenetic-solutions/ 9

Vast array of use cases Single report describing the complete genome-drug interaction profile. Patients will «carry» their report managing access through consent and share with those they desire.  Family physicians  Specialists  Psychiatrists, pediatrician, oncologist  Pharmacists  Healthcare professionals  Insurers (?) 10

5 Challenges to overcome Testing Informatics Clinical Education ELSI Availability of testing Lack of standardization Few drug or dose Poor training of current Ethics (privacy, equity, of terminology selection algorithms and future health incidental findings, Cost of testing professionals in decision making) Poor interoperability of Lack of real-world or pharmacogenomics and Slow turnaround time for clinical informatics randomized controlled Privacy issues (informed pharmacogenomics results systems data on outcomes consent) communication (clinical utility) and Data management Inadequate decision Legal issues economic value No common point-of- support and point-of- (discrimination, patents) Testing reimbursement care education care tools Lack of medication use resources Incomplete coverage of data Few clinical genetic data the Genetics Few patient education storage solutions Few patient return of Nondiscrimination Act materials results systems (GINA) Few patient centered tools (e.g. apps) https://cjasn.asnjournals.org/content/13/10/1561 11

Genetic non-discrimination act (GNA) Became law in May 2017 – formerly known as Bill S-201  Requires consent for each and every test. Providers of goods and services , including insurance providers, cannot  Request or require that a person undergo a genetic test  Request or require the disclosure of previous or future genetic test results” Federally regulated employers cannot  Use a person’s genetic test results in decisions about hiring, firing, job assignments, or promotions  Request or require genetic test results of an employee Punishment : Jail (up to 5 years) and or fine (up to 1 000 000$) for conviction on indictment Reminder : Canadian Human Rights Act bans discrimination based on genetic characteristics In Quebec  The Government of Quebec has referred the legislation to the Quebec Court of Appeal, questioning whether it is unconstitutional because insurance is regulated at the provincial, not federal, level.  CLHIA is supporting Quebec’s position that the legislation is unconstitutional. 12

Overview of the pharmacogenomic test ecosystem Users Payers Test providers Canadian population Tests Public payers Analyses Clinicians Interpretations Private insurers MDs – Pharmacists – Other Pharmacy EMR software 13

Canadian vs US standards Canada - Health Canada Highly regulated industry in Canada  The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)  Medical Dictionary for Regulatory Activities MedDRA United States  Mixture of strict regulation and industry practices  FDA regulated in vitro diagnostic devices (IVDs)  Tests covered under the Clinical Laboratory Improvement Amendment « home-brew »  Source of concerns / test inconsistencies 14

Pharmacy – adoption status ICANPIC (Innovative Canadian Pharmacogenomic Screening Initiative in 60 57.1% Community Pharmacy) Study  Two community pharmacies in Toronto offered pharmacogenomic 50 screening as part of their professional services program.  Eligible patients received a GeneYouIn’s Pillcheck test (via a simple 40 buccal swab)  Pharmacists cited the most common reasons for testing as ineffective 30 therapy (44.6%), to address an adverse reaction (35.5%), and to guide initiation of therapy (11.8%). 19.6% 20  An average of 1.3 drug therapy problems were identified per patient. 14.3%  Pharmacist recommendations included change in therapy (57.1%), 10 7.1% dose adjustment (14.3%), discontinuation of a drug (7.1%), and increased monitoring (19.6%). 0  Generally, physician feedback was positive, but did reveal an Change in Dose Discontinuation Increased therapy adjustment of drug monitoring opportunity for a broader understanding of the technology. 15

Insurer – adoption status Sun Life Great West Life  Sun Life Financial was the first insurer to launch a pilot, Pilot launched in early 2018 in August 2017  Patients concerned with genetic and health data safety  Joined the IMPACT study that has been underway at  Addressed by vendor achieving SOC 2 type II Toronto’s CAMH since 2011 certification  PGx provider : Assurex Health  Best results achieved with patients having « simple »  Pilot results not disclosed at this time PGx profiles  Larger portion of participants with complex PGx profiles IMPACT study facts & outcomes are associated to long term disability claims  Over 9 000 patients participated  27% of patients with depression symptoms experienced a significant reduction in symptoms after 8 weeks of treatment.  In previous studies, PGx provider reported 70% improvement of symptoms over usual treatment when PGx guided treatment was used 16

Early clinical pilot projects Total number of patient in pharmacy data base: 6840 patients Minimal risk : 4570 patients (67%) High risk : 267 patients (4%) Average risk: Small risk : 691 patients (10%) 1312 patients (19%) 17

Payor perspective – focus on anxiety/depression 2018 Depression drug claims “In a 3-month period, patients with depression miss an average of 4.8 workdays and suffer 11.5 Claimants Totals paid days of reduced productivity” Source : CDC article All claimants 1 075 399 $189M New claimants 409 543 $82.6M Nearly 30% of new claimants would benefit Drug switches 120 958 $19M (avg 72 days) from faster identification of the optimal drug. Using pharmacogenetics on new claimants, there is an opportunity to reduce switching productivity losses well beyond the cost of a test. https://www.cdc.gov/workplacehealthpromotion/health-strategies/depression/evaluation-measures/index.html 18

Payor perspective – focus on cholesterol control 2018 Cardiovascular drug claims In some cases, physicians may use pharmacogenetic tests to identify if a Claimants Totals paid Avg cost significantly more expensive drug is the best option for the patient. All claimants 970 655 $116M 119$ The physician will consider what is in the best New claimants 237 150 $35M overall interest of the patient and medication Repatha (all) 2 253 $9M 4 014$ adherence, which is in part impacted by drug cost and part of the bigger picture. Repatha (new) 1 110 $6M Insurers cannot require pharmacogenetic testing to grant access to a drug but may reimburse the tests to facilitate access. 19