Gatineau, April 7 2014

CADTH Symposium

Concurrent Session A5

HTA for Non-Drug

Technologies:

Current Initiatives

Across Canada

HTA for Non-Drug

Technologies:

Perspectives

from Québec

Reiner Banken M.D. M.Sc.

reiner.banken@inesss.qc.ca

2

Outline

• The birth of HTA: non-Drug Technologies

• Differences between drug and non-drug technologies

• Convergence of drug and non-drug technologies: Work on HTA and Innovation in Québec

• Conclusions

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Once upon a time .....

Request of the US Congress Senate Committee on

Human Resources to OTA in 1974:

« whether a reasonable amount of justification should

be provided before costly new medical technologies

and procedures are put into general use»

•Knowledge Pull from Decision-makers

•Non mandatory HTA for complex decisions

•Paradigm of Evidence-informed decision-making

•HTA Institutions as Boundary Organisations

4

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

médicaments Conseil 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

1972 1991

Medical Biology

Lab tests

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Drugs and non-drug

technologies: similar yet different

• Purpose: Relief and intervention, but non-drugs include diagnostics

• Method of use: Drugs are mostly used directly by patients, non-drugs often by an operator

• Length of use: For non-drugs, several years for non-drugs, ex prosthetic hip

• Research and development: RCTs for drugs, randomization often impossible for non-drugs

• Regulatory requirements: Certification and assessment are mandatory for drugs, for non-drugs only certification

Participant guide. 2013 Forum Better Innovation through Assessment,

see http://www.inesss.qc.ca/en/networks-andpartnerships/bridging-

mechanisms.html

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Sponsor

Health Canada

INESSS

Professional associations,

patient groups , users

Minister of health and social

services

RAMQ

Basic prescription drug

insurance plan List of Medications

List of Medications

PMPRB

Patented Medicine Prices

Review Board

Decision Recommendation

Notice of compliance

2a

2b

1

Drugs

CSEMI

Adapted from CIRS, 2012

Institutions

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Health Canada

INESSS

Professional associations,

patient groups , users

Ministre de la santé et

services sociaux

Decision Recommendation

Market authorization

Scientific Committees

Health and Social Services Medical Biology

Procedures

MSSS Regional agencies

RAMQ Hospitals

Sponsor

2

1

Medical devices, including Medical Biology

Procedures

Adapted from CIRS, 2012

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HTA and Innovation

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Definition of Innovation

A definition inspired by the Global Forum for Health Research

Innovation encompasses the entire process from the generation of new ideas, to their transformation into useful services, products, methods, management practices and policies in health and social services.

Innovation is characterized by the added value it offers compared to what is currently used

Invention becomes an innovation when adopted by the health system

Mobilizing a range of stakeholders

Transforms the context

Global Forum for Health Research (GFHR) (2010). Innovating for the health of all. Genève, Suisse. Available at :

bit.ly/1gFuWxJ

CV

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Time

Use

Licensing

Innovative Technology

Obsolescence/ Replacement

General Use Research and development

Experimental Technology

HTA

HTA

HTA and Innovation

Early Advice Classic HTA HTA for disinvestment

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HTA and Innovation

• Innovation is about added values…for the patient, for the health system, for families..

• Uncertainties are a fundamental characteristic of innovative technologies

• HTA adds value by defining the uncertainties, risks and conditions of introducing the innovative technologies

• Under conditions of high uncertainties of desired innovative technologies HTA should be followed by field evaluations, by prospective focussed evidence development under real world conditions

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HTA and innovative technologies

Time

Use

HTA

HTA

Pre-market

assessment

Assessment

Assessment Field evaluation

Continuity and consistency

Innovative Technology

Obsolescence/ Replacement

General Use Research and development

Experimental Technology

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Challenges for HTA

• HTA needs to adapt to:

- the unavailability of evidence

- the pace and the dynamics of innovation

- values and expectations of clinicians, patients and citizens

- the challenges of innovation for network managers

Need for new policy tools and HTA

methods that favour evidence-based

decision making without hindering

innovation

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Work on HTA and Innovation

in Québec

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Québec HTA and Innovative

Technologies Advisory Committee:

Stakeholder Representation

• Patient Groups

• Physicians and Pharmacists

• Health Care Managers (local, regional, ministry of health)

• Industry (pharmaceuticals, devices, …)

• Research (FRQ-S, ministry, Génome Québec)

• HTA producers (INESSS and hospital-based HTA)

• Ministry of Finance and Economic Development

• Agree an a common language on innovation

• Foster a shared understanding of the challenges

• Identify potential solutions

• Support a dialogue in a public event

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Better Innovation Through Assessment

Event December, 3, 2013

Health and social services network:

31%

Pharmaceutical Industry: 29%

Other sectors: 12%

Medical technology industry: 9%

Government sector: 8%

Universities: 8%

Patients and user's groups: 3%

Breakdown of participants, by sector

250 participants

http://www.inesss.qc.ca/en/networks

-andpartnerships/bridging-

mechanisms.html

• Present 12 month of work of the advisory committee on HTA and innovative technologies

• Enhanced dialogue on challenges and solutions

• Comitments of Stakeholders

• Suggest workplan for the committee

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Time

Use

Innovative Technology

Obsolescence/ Replacement

General Use Research and development

Experimental Technology

Mapping of proposed solutions at

Better Innovation Through Assessment

Event

Knowledge of clinical and health

systems needs

Focus on the patient

Change in culture and pratice

Management of obsolence

Improve Health IT

Adapt Knowledge produced elswhere

Risk sharing agreements

Consensus on dimensions of value

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Centralising Procurement for the

Québec Health System – the role of

HTA

• 2011 Objective of cost savings by centralizing procurement

• 2012 Centralization of procurement from 11 to 4 agencies

• 2013 Pilot project of mandatory procurement for medical devices for 4 areas:

– cardiology

– opthalmology

– orthopedics

– dialysis

• 2013-02-27 MoH Bulletin on obligation to conform to pilot projet and link to HTA

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20

Bulletin February, 27, 2013

• Procurement processes have to integrate HTA knowledge

• INESSS is a member of the Coordinating and Follow-up committee for the pilot project

• This committee determines which procurement processes should be informed by a formal HTA and the necessary financing needed

• The committee determines if the HTA should be performed by INESSS, by the hospital-based units or by outside providers

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Developments in 2013

• The Québec treasury has accepted new rules for procurement to take into account the need for innovation and health systems realities. Example for cardiology: – 70% procurement for pacemakers (60% lowest bidder, 40% second

lowest, to diminish recall problems)

– 30% open purchase at the lowest price of procurement

• Transparency in kickbacks (up to 12 %), to be used by the purchasing hospitals

• Consensus of medical specialists, no need for HTA

• Need for HTA to be defined for the multi year procurement plan (rapid HTA and classic HTA)

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Lessons from HTA in centralised

procurement

• Negotiations between silos in the MoH are needed to integrate HTA into procurement (MoH champion: biomedical engineer trained in HTA-Ulysses program)

• The Federation of Medical Specialists has insisted to include INESSS (social credibility built over a 25 year period)

• Need for HTA products to be adapted to the timeline of decision-making (rapid HTA)

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Conclusions

• The paradigm of HTA started with non-drug technologies.

• Drugs and non-drug technologies have characteristics that are different and the role of the assessment and the process are different.

• In some areas of technological innovation, drug and non-drug technologies need to be assessed together: personalized medicine.

• Innovation in HTA methods and processes, including stakeholder involvement, are necessary for HTA creating value in the innovation process.

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Overview of challenges presented to

Quebec Network for Personalized

Healthcare (19-3-2014)

• Need to demonstrate the added value of desirable innovations

– Balance the uncertainties of added value with the opportunity of improving patients’ health and health systems

– Define the organisational conditions necessary for creating the added value

– Manage the risks of introduction under uncertainty

• Collaboration and trust between stakeholders

– Development of knowledge depends on partnerships between industry, health system and academia

• Culture change for access to innovative technologies

– Innovative access programs in pilot projects

– Development of learning health systems and agile health systems (rapid feedback loops between knowledge production

and health system organisation)