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