R194: ISPOR International Initiatives on the Assessment of ...€¦ · technology along the lifecycle by improved experience (Learning curve), short cycle technological enhancements

R194: ISPOR International

Initiatives on the Assessment of

the Value of Medical Technologies

ISPOR Health Technology Assessment Council

Working Group

Thursday, 11 May 2017

ISPOR was founded in 1995 with 300 members,

and now has over 20,000 members worldwide

Mission:

To promote health economics and outcomes

research excellence to improve decision making for

health globally.

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International Society for Pharmacoeconomics and

Outcomes Research

ISPOR is a nonprofit, international, educational and scientific organization that promotes health economics and outcomes research excellence to improve decision making for health globally

Medical Technologies

Contribute significantly to modern health services supporting the management of care from prevention to detection, treatment, alleviation, and follow-up

Cover a range of diverse modalities categorized into national and international classification systems

More than 500,000 medical device products registered worldwide

Life cycle of medical technologies may contain continuous evolvements in performance – rapid refinements in response to experiences derived from clinical practice

(device iteration)

Methodologies to evaluate health technologies are evolving in order to evaluate their safety, cost-effectiveness and consequences for health systems and society

Initiatives to reform healthcare towards a value based health care and measure the benefits that matter to patients

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Speakers

Øyvind Melien, MD, PhD, MSc, Norwegian Directorate of

Health, Norway

Mirella Marlow, MBA, MA, The National Institute for Health

and Care Excellence (NICE), United Kingdom

Katharina Hawlik, MD, MSc, Ludwig Boltzmann Institute for

Health Technology Assessment (LBI-HTA), Austria

Yves Verboven, MedTech Europe, Belgium

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Question 1

What are the major methodological challenges your

institute experienced when assessing medical

technologies?

• What should we do with promising technologies that

appear likely to have important patient benefits but which

don’t have enough evidence to prove these benefits at

the time of licensing?

Q1 What are the major methodological challenges your

institute experienced when assessing medical

technologies?

In Europe: gap between approval and reimbursement requirements

HTA is given the role of critical assessor: safety and efficacy assessment

Assessments very early, with very low evidence, low quality of evidence

lacking suitable comparators, comparative trials

lacking (patient)-relevant outcomes

Q1 What to do with promising technologies that appear likely to have

important patient benefits, but do not have enough evidence to

prove these benefits at the time of licensing?

• This is a common situation

• Ideally regulators and HTA agencies should be involved in advising

companies on the evidence that could feasibly be developed to

demonstrate value, over a plausible timescale

• Device and diagnostic developers should understand in depth, how their

product affects the treatment pathway

• Developers should be offered access to evidence design and HTA

expertise and build this into their product development plans

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Question 2

What are some of the main differences in carrying out HTA

for medical technologies and diagnostics, as opposed to

HTA for pharmaceuticals?

• Evidence is mainly regulatory rather than focusing on clinical and

cost effectiveness (eg accuracy data only for diagnostic tests)

• Cost per QALY is often irrelevant because devices often change

the setting or experience of treatment without improving outcomes

• Commentary from professionals needs to inform the HTA, because

sometimes claims made for devices or diagnostic tests are

implausible

• Longer term data on device performance may be required

• Modelling may have to take a linked evidence approach to explore

impact on outcomes

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Q2 Main differences in carrying out HTA for medical

technologies and diagnostics as opposed to pharmaceuticals?

• Wide spectrum of medical technologies:

diagnostic, procedures, devices, screening

• Life-cycle: Incremental innovation & iteration

• Learning curve of the device user

• Organizational implications

Q2 Main differences in carrying out HTA for medical

technologies and diagnostics as opposed to pharmaceuticals?

Industry view : HTA methodologies should be specific in term of disease condition, type of medical technology and

• Consider all scientifically valid evidence including real world evidence and develop methodologies to improve utilization of all available evidence

• Account for the continuous improvement in the value offered by medical technology along the lifecycle by improved experience (Learning curve), short cycle technological enhancements and new innovation, improved organization and patient identification.

• Address the fragmented and repetitive conduct of HTA by many different parties especially in the US but also in Europe.

• Ensure the choice of the health outcomes, the value assessed need to be more comprehensive as there are multiple stakeholders’ perspectives to be covered.

• A future vision of role of HTA should be defined considering the total product lifecycle and access model of medical technologies.

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Q2 Main differences in carrying out HTA for medical

technologies and diagnostics as opposed to pharmaceuticals?

What Is Your View On Future Role HTA In MedTech?

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Question 3

Q3 What Is Your View On Future Role HTA In MedTech?

Within a value-based system, where the value of Medtech is appreciated in

new ways, our view on how HTA could fit a value based access model is :

“A modern HTA facilitating transformative innovation:

supporting developers to determine the (economic) value along the lifecycle

informing decision makers on the value of the transformative technologies.

supporting the use/adoption for the benefit of patients, carers, healthcare,

health systems and society”

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Demand driven by decision maker’s based on local high, unmet patients/health system needs, high risk diseases, burden of illness requiring structural, organizational health system changes and/or investment

Clear and predictable criteria for the choice of technologies, driven by value and economic gains for the health system

Focus on Transformative Medical Technologies and solutions

At appropriate timing in lifecycle, agreed with and based upon stakeholders and decision makers using real world evidence.

Implementation

Focus on Transformative technologies :

Medical technologies or solutions that have the potential to address high unmet patient

and/or healthcare needs, high risk disease, burden of illness and are accompanied with

significant structural and/or organizational change needed.

Transformative technologies represent transformative innovation in medical

technologies, introducing positive modifications to clinical pathways, including significant

improvements in patient outcomes, in the organization of healthcare delivery, healthcare

systems and/or in the society of countries, regions, states.

Q3 What Is Your View On Future Role HTA In MedTech?

Collaboration at international level: EUnetHTA

• to reduce overlap and duplication of effort

• to promote more effective use of HTA-resources: increase

efficiency

• to facilitate good practice in HTA methods and processes

o collaboration becomes easier over years due to

harmonization of format, language, methods

o EUnetHTA HTA Core Model® as facilitator to build on each

other´s assessments

o Methodological guidelines for the assessment of medical

technologies

Q3 What Is Your View On Future Role HTA In MedTech?

A New International Initiative Is Needed!

Recommendation

There is a need to explore more closely how to utilize and adapt HTA as a supportive tool in the life cycle of medical technologies to benefit patients, health systems and society, and consider the value of other tools and initiatives on novel value frameworks to inform decisions and reach policy objectives.

Objective

Identify current and future roles of Health Technology Assessments (HTA) compared to other tools and initiatives used to assess the value of medical technologies throughout their life cycles to inform decisions and reach healthcare policies.

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Several international organizations will cooperate to approach

these challenges with the following focal points:

Perform a gap analysis

Collect perspectives from stakeholders

Analyze the role of evidence generation

Study future roles of HTA for medical technologies

Give inputs to capacity building and international collaboration

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Method

International Organizations:

WHO, ISPOR, OECD

HTA Bodies:

EUnetHTA JA3, NICE, LBI-HTA

Research/Academia:

Unites States National Institute of Health/National Institute of Cancer

University of Berlin, Germany; University of Bocconi, Italy

Regulators:

US Food and Drug Administration (FDA)

Public/Private Partnership:

Medical Device Innovation Consortium (MDIC)

Industry:

MedTech Europe, AdvaMed, DITTA

(additional partners expected) 18

Participating Organizations

Thank You

Interested to learn more about the ISPOR

International Initiatives on the Assessment of the

Value of Medical Technologies

Go to https://www.ispor.org/councils/HTAC-Intl-

Initiatives-on-Medical-Devices.asp

Or email [email protected]