2014 11-19 rb progressive fieldevaluationmerck

Catalysing

knowledge

generation in

real-world

setting-

Current work at

INESSS

Reiner Banken, M.D. M. Sc. - Advisor to the CEO- Alliances and networksGeneviève Plamondon, M.Sc. - Scientific professional- InnovationDima Samaha, Pharm D MAS - Advisor Innovation and external affairs

November 19th 2014

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Outline of the presentation

1. Quick presentation of INESSS

2. Advisory committee on HTA and innovativetechnologies

3. Current work on knowledge generation in real-world settings

4. The new approach proposed

5. Questions and discussion

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INESSS – 40 years of science

advice for decision-making

Conseil d’évaluation des

technologies de la santé

(1988)

Agences d’évaluation

des technologies et

des modes d’intervention

en santé

Comité de revue

de l’utilisation des

médicaments

2000

Réseau de revue

d’utilisation des

médicamentsConseil consultatif

de pharmacologie

Conseil du

médicament

2003

2003

Social Services

Clinical Practice

Guidelines

Institut national

d’excellence

en santé et en

services sociaux

2009

January, 19,

2011

1988

1996

19721991

Medical Biology

Lab tests

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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

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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

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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

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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

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• 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

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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

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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 realisticactivities 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., Ihlström Eriksson, 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

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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 itsimplementation

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.

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Progessive field evaluation

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

Objectives:

• Align the value proposal of an innovative technology with the needs of the users

• Integrate the knowledge and the experience of the partners involved

• Identify optimal conditions and adapt the use of a technology accordingly

• Collect information about the effectiveness of a technology, as well as contextual and organizational elements relevant to decision makers

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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

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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

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Towards a learning health system

Health system

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Challenges for pharmaceuticals

• Defining the role and place of progressive fieldevaluations in relation to the life cycle of drugdevelopment and use

• Cohabitation between an open collaborative approach with the rules and practice of regulationand market access

• Trust between the health system, industry and patients

• Links to other innovative initiatives such as adaptive licensing and IMI Get Real

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Proposal for discussions

• What could be the contribution of progressive fieldevaluations in the post-market space?

• Which would be the possible triggers for progressive fieldevaluations in the post-market space ?

• What would be the contribution of progressive fieldevaluations for improving the patient care and health system performance?