Patient-centered Decision Making with a Focus on Improved Quality of Life -

A Medical Device Example

Daniel Jackson PhD.Vice President Market Access

April 11, 2016

Disclosures

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

This presentation is not an offer for sale. Not all products may be currently licensed for sale in Canada. The manufacturer may only sell the device after a licence for that device has been

issued by Health Canada.

Affiliation/Financial Relationship Company

• Employee of Edwards Lifesciences

• Consulting Fees/Honoraria None

• Major Stock Shareholder/Equity Edwards Lifesciences

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Agenda

1. What makes devices different?2. Why is quality of life measurement so important?3. How does industry play a role to ensure patients are best served?

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Medical devices are not pharmaceuticals…

Issues ExamplesRCT data is not always immediately available

• Randomised clinical trials are not always deemed necessary for a successful launch in Europe

• Medical devices are often technologies which improve efficiency or reduce waste for health care providers (e.g. lower administration costs, lower overheads) but lack the “standard” dataset

• No ‘pharma style’ patent protection in many cases, and the pace of innovation is greater

HTA assessment methods are still relatively new and developing

• How do we as an industry approach HTA agencies with a limited data set? • How do we allow for the learning curve?• “Effectiveness of a medical technology is the extent to which it improves

health outcomes” – measured how?

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Valve Technology

SAPIEN2007-2010

SAPIEN XT2010-2014

SAPIEN 3*Current generation

Sheath Compatibility

Available Valve Sizes

23 mm 26 mm 20 mm 23 mm 26 mm 29 mm

SAPIEN Platform evolution over timeDevice Evolution

22-24F

16-20F

14-16F

23 mm

26 mm

29 mm

*This product is not currently licensed for sale in Canada.

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Health-related quality-of-life (HRQoL)

Patients' perceptions of impact of disease and treatment on physical, psychological and social function

“a concept encompassing a broad range of physical and psychological characteristics and limitations, which describe an individual's ability to function and to derive satisfaction from doing so”– Walker and Rosser (1987)

Important in determining effectiveness of an intervention

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Conceptual Framework (Wilson and Cleary 1995)

Biological and

Physiological Variables

Symptom Status

Functional Status

General Health

Perceptions

Overall Quality of

Life

Characteristics of the Individual

Characteristics of the Environment

Personality Motivation

Social and Economic Supports

Symptom Amplification Values Preferences

Physiological Supports

Social and Physiological

Supports

Nonmedical Factors

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What industry needs to do – better define early benefits

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FEELBETTER

BASELINE 30-DAYS

Transient QOL Benefit

FEELWORSE

6-MONTHS 1-YEAR 2-YEAR 3-YEAR

But who is doing the valuing?

Are these patient Values or Population values?

EQ-5D weights are taken from a general population, not patients with a condition

Is this valid? Are these values truly reflecting the patient experience?

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Adaptation to the state

Someone in ill health adapts over time, physically and emotionally

Acquisition of new skills to help cope / change in behaviour to limit impact– E.g., walking with a stick / taking up lower-impact sports in response to damaged knees

Shift in weight placed on health and quality of life

People tend to under-predict ability to adapt– Kahneman (2000)

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Why use general population values?

‘Veil of ignorance’– Rational public decides what is the best course of action when blind to its own self-interest

(Gold et al, 1996)

Patients may behave strategically

Patients may be unable or unwilling to provide values

Adaptation may work against a patient’s best interests

Public funding is public insurance– Public preferences should be used to value health states

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Why use patient values?

Patients know their own health state better than anyone trying to imagine it

It is the well-being of the patient we are interested in

Members of general population have little or no first-hand experience of the health state being valued

Members of the public do not necessarily want to be involved in valuing health states

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Patient Focus Drives Value Creation

Patients are our ultimate customer Significant opportunities in addressing unmet needs Globally, demand and desire growing for superior therapies Although under-represented, the patients’ voice is intensifying Aligns our strategy with clinicians, payors and providers Patient relevant outcomes are the ultimate outcome

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Thank you

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

1. This presentation is not an offer for sale.

2. Not all products may be currently licensed for sale in Canada.

3. The manufacturer may only sell the device after a licence for that device has been issued by Health Canada.

Edwards, Edwards Lifesciences and the stylized E logo are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

© 2016 Edwards Lifesciences Corporation. All rights reserved. CAN-MAPA-002