Presentation on the evaluation on promising innovative technologies made at an internal meeting with Merck

1. Catalysing
knowledge
generation in
real-world
setting-
Current work at
INESSS
Reiner Banken, M.D. M. Sc. - Advisor to the CEO- Alliances and networks
Geneviève Plamondon, M.Sc. - Scientific professional- Innovation
Dima Samaha, Pharm D MAS - Advisor Innovation and external affairs
November 19th 2014

2. 2
Outline of the presentation
1. Quick presentation of INESSS
2. Advisory committee on HTA and innovative
technologies
3. Current work on knowledge generation in real-world
settings
4. The new approach proposed
5. Questions and discussion

3. 3
INESSS – 40 years of science
advice for decision-making
1972
1996
Conseil d’évaluation des
technologies de la santé
(1988)
Réseau de revue
d’utilisation des
médicaments
January, 19,
Agences d’évaluation
des technologies et
des modes d’intervention
en santé
Comité de revue
de l’utilisation des
médicaments
2000
Conseil consultatif
de pharmacologie
Conseil du
médicament
2003
2003
Institut national
d’excellence
en santé et en
services sociaux
Social Services
Clinical Practice
Guidelines
2009
2011
1988
1991
Medical Biology
Lab tests

4. 4
INESSS’ Mission
• The mission of the Institute is to promote clinical
excellence and the efficient use of resources in the
health and social services sector
Informing decisions at the macro, meso and
micro level in health care and social
services.
An Act respecting the Institut national d'excellence en santé et en
services sociaux http://bit.ly/m6QZqT

5. 5
INESSS assesses technologies and
health and social care interventions
 HTA of drugs for listing purposes (new active substances, generics,
new formulations …)
 HTA of laboratory tests for listing purposes
 Full HTAs (health and social care interventions)
 Optimal use guides
 Clinical practice guidelines
 Rapid HTAs
 Collective prescriptions (in collaboration with MSSS)
 Methodological tools
 Community of Practice of Hospital-Based HTA

6. 6
HTA for drug listing purposes
Act respecting the INESSS article 7
If the Institute considers that the therapeutic value of a medication
has been established, it sends its recommendation to the
Minister after assessing:
1. the reasonableness of the price charged
2. the cost-effectiveness ratio of the medication
3. the impact that entering the medication on the list will have on
the health of the general public and on the other components of
the health and social services system
4. the advisability of entering the medication on the list, given the
purpose of the basic prescription drug insurance plan
http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/I_13_03/I13_03_A.html

7. 7
Advisory committee on HTA and
innovative technologies (CÉTI)
• Created in December 2012
• Advisory to the CEO
Objective: To promote a common understanding of the
challenges of introducing innovative technologies into the health
system, and to identify possible solutions to ensure consistency in
doing so, for the benefit of users
Composition: Representatives from patient and user groups, from the
health technologies industry, from the research and HTA communities,
from the economic development community, and managers of the
health and social services network (local, regional and national levels)
For more information: http://www.inesss.qc.ca/en/networks-andpartnerships/bridging-mechanisms/
advisory-committee-on-hta-and-innovative-technologies.html

8. 8
• The Committee’s work led to the first HTA and Innovative Technologies
Forum on December 3 2013
 Focus on implementing a
more dynamic
assessment process
better suited to the
particularities of
innovative technologies
For more information: eti.inesss.qc.ca/2013+About

9. 9
CÉTI: current work and next steps
 To optimise the generation of knowledge in real-world settings for
innovative technologies with the greatest potential for positive impacts on
patients and the health system
Objectives:
• To define the concepts related to the production of knowledge in real world
settings;
• To develop a method for generation of knowledge in real-world settings for
innovative technologies, including a method to identify and prioritise the most
promising technologies;
• To identify and discuss the operational and implementation challenges of the
proposed approach;
• To propose a framework for the production of knowledge in real-world settings;
• To promote and facilitate the use of this framework by different groups of
stakeholders

10. 10
Knowledge generation in real-world
settings
• The living lab approach has been explored based on the suggestions
of CÉTI members
“A living lab is a user-centric innovation environment, built on realistic
activities and research where all relevant partners are involved in open
processes, with objective to generate sustainable values for living lab
partners and stakeholders”1
• Among the key characteristics of living labs:
– Value is created through the collaboration of different stakeholders in
public-private-people-partnerships
– Users are involved as co-creators
– Activities take place in real-world environments
– The innovation process is open and iterative
1- Bergvall-Kåreborn, B., IhlströmEriksson, C., Ståhlbröst, A., et Svensson, J., A Milieu for Innovation - Defining Living
Lab, presented at the 2nd ISPIM Innovation Symposium, New York, december 6-9 2009, available at
https://pure.ltu.se/portal/files/3517934/19706123_Paper.pdf

11. 11
Progressive field evaluation
Premises:
 Applies to technologies with a high potential for positive impacts on
patients and the health system and for which the added value could
be best verified in real-world settings
– Implies a clear definition of what qualifies as a promising
innovative technology, as well as a way to judge the plausibility of
the value proposition
 Current work aim to develop an approach, but not its
implementation
 The concept of progressive field evaluation in its actual form is NOT
linked to the reimbursement processes. However it bares some
similarities with what has been suggested for coverage with evidence
development.

12. Objectives:
• Align the value proposal of an
• Integrate the knowledge and the
• Identify optimal conditions and
• Collect information about the
12
Progessive field evaluation
innovative technology with the
needs of the users
experience of the partners involved
adapt the use of a technology
accordingly
effectiveness of a technology, as
well as contextual and
organizational elements relevant to
decision makers
Image adapted from the Living Lab Methodology Handbook, Ståhlbröst et Holst, 2012, available at
http://www.ltu.se/cms_fs/1.101555!/file/LivingLabsMethodologyBook_web.pdf

13. 13
A starting point for the progressive
field evaluation
Research protocol → methods
 Projects are part of public
research (protocols are peer-reviewed
and results are
published)
 Participative research designs
(user centered)
 Research designs allow for
adjustments during the project
• Data generated is open by
default (with confidential
elements to be defined)
Innovation protocol → social contract
 Project governance framework
 Definition of the roles of each
partner
 Agreement on the level of
interaction between the partners
 Start and end of the project
 Funding of the project

14. 14
How is the progessive field evaluation
different from other approaches?
• Evolving nature: the process fosters the adaptation of the use
of the technology according to the users’ “real” needs
• Co-responsibility: activities are influenced by all partners and
the decision making (within the project) is shared
• Co-production: knowledge is generated through the
participation and the commitment of all partners
• Transparency: the information is public (open data), the rules
are clear and known (innovation protocol) and the processes
are open

15. 15
Towards a learning health system
Health system

16. 16
Challenges for pharmaceuticals
• Defining the role and place of progressive field
evaluations in relation to the life cycle of drug
development and use
• Cohabitation between an open collaborative
approach with the rules and practice of regulation
and market access
• Trust between the health system, industry and
patients
• Links to other innovative initiatives such as adaptive
licensing and IMI Get Real

17. 17
Proposal for discussions
• What could be the contribution of progressive field
evaluations in the post-market space?
• Which would be the possible triggers for progressive field
evaluations in the post-market space ?
• What would be the contribution of progressive field
evaluations for improving the patient care and health system
performance?