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

An update on pharmacogenomics

Webinar February 21, 2019

Welcome

Patrick Charbonneau

Director of Product Management, TELUS Health

Michel Hébert

Medical Director, 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

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.

Pharmacogenomics vs pharmacogenetics

5

The genomic world

Source: Grand View Research https://seekingalpha.com/article/4006027-fulgent-genetics-ipo-shows- promise?page=2

https://twitter.com/erictopol/status/987723700760993793 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

Pharmacogenetic Testing

$1,000 $750 $500 $250 $175 $1,000,000 $100,000 $1,000 $350 $0 $200,000 $400,000 $600,000 $800,000 $1,000,000 $0 $200 $400 $600 $800 $1,000

Lower costs

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

https://cjasn.asnjournals.org/content/13/10/1561

Testing

Availability of testing Cost of testing Slow turnaround time for results Data management Testing reimbursement

Informatics

Lack of standardization

• f terminology

Poor interoperability of clinical informatics systems Inadequate decision support and point-of- care tools Few clinical genetic data storage solutions Few patient centered tools (e.g. apps)

Clinical

Few drug or dose selection algorithms Lack of real-world or randomized controlled data on outcomes (clinical utility) and economic value Lack of medication use data Few patient return of results systems

Education

Poor training of current and future health professionals in pharmacogenomics and pharmacogenomics communication No common point-of- care education resources Few patient education materials

ELSI

Ethics (privacy, equity, incidental findings, decision making) Privacy issues (informed consent) Legal issues (discrimination, patents) Incomplete coverage of the Genetics Nondiscrimination Act (GINA)

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

Canadian population Clinicians

MDs – Pharmacists – Other

Public payers Private insurers Tests Analyses Interpretations

EMR

Pharmacy software

Payers Test providers

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 Community Pharmacy) Study

• Two community pharmacies in Toronto offered pharmacogenomic

screening as part of their professional services program.

• Eligible patients received a GeneYouIn’s Pillcheck test (via a simple

buccal swab)

• Pharmacists cited the most common reasons for testing as ineffective

therapy (44.6%), to address an adverse reaction (35.5%), and to guide initiation of therapy (11.8%).

• An average of 1.3 drug therapy problems were identified per patient.
• Pharmacist recommendations included change in therapy (57.1%),

dose adjustment (14.3%), discontinuation of a drug (7.1%), and increased monitoring (19.6%).

• Generally, physician feedback was positive, but did reveal an
• pportunity for a broader understanding of the technology.

57.1% 14.3% 7.1% 19.6%

10 20 30 40 50 60

Change in therapy Dose adjustment Discontinuation

• f drug

Increased monitoring

15

Insurer – adoption status

Sun Life

Sun Life Financial was the first insurer to launch a pilot, in August 2017

• Joined the IMPACT study that has been underway at

Toronto’s CAMH since 2011

• PGx provider : Assurex Health
• Pilot results not disclosed at this time

IMPACT study facts & outcomes

• 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

Great West Life

• Pilot launched in early 2018
• Patients concerned with genetic and health data safety
• Addressed by vendor achieving SOC 2 type II

certification

• Best results achieved with patients having « simple »

PGx profiles

• Larger portion of participants with complex PGx profiles

are associated to long term disability claims

16

Early clinical pilot projects

Total number of patient in pharmacy data base: 6840 patients

High risk:

267 patients (4%)

Small risk:

1312 patients (19%)

Minimal risk:

4570 patients (67%)

Average risk:

691 patients (10%)

17

Payor perspective – focus on anxiety/depression

https://www.cdc.gov/workplacehealthpromotion/health-strategies/depression/evaluation-measures/index.html

Using pharmacogenetics on new claimants, there is an opportunity to reduce switching productivity losses well beyond the cost of a test.

“In a 3-month period, patients with depression miss an average of 4.8 workdays and suffer 11.5 days of reduced productivity”

Source : CDC article

Nearly 30% of new claimants would benefit from faster identification of the optimal drug.

2018 Depression drug claims

Claimants Totals paid All claimants 1 075 399 $189M New claimants 409 543 $82.6M Drug switches (avg 72 days) 120 958 $19M

18

Payor perspective – focus on cholesterol control

Insurers cannot require pharmacogenetic testing to grant access to a drug but may reimburse the tests to facilitate access.

In some cases, physicians may use pharmacogenetic tests to identify if a significantly more expensive drug is the best

• ption for the patient.

The physician will consider what is in the best

• verall interest of the patient and medication

adherence, which is in part impacted by drug cost and part of the bigger picture.

2018 Cardiovascular drug claims

Claimants Totals paid Avg cost All claimants 970 655 $116M 119$ New claimants 237 150 $35M Repatha (all) 2 253 $9M 4 014$ Repatha (new) 1 110 $6M

19

TELUS Health Strategy in Pharmacogenomics

Facts Unknown Strategy

Technology whose benefits have been demonstrated in accelerating the selection of the most effective monotherapy medication Particularly effective in mental health Inconclusive data in managing cases with combination therapy or multiple health problems Increase in the number of tests prescribed by physicians Time required to integrate the electronic and simplified test results with the EMR What are the points of sale or points of access to tests that the market will favour? Implement a technology that makes it easier for physicians to adopt Observe market trends with regard to points of access/points of purchase for pharmacogenomic tests Plan out the implementation of claim solutions suited to the market (SSC, eClaims, CPHA)

20

Questions ?

21

22