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HTA for Non-Drug Technologies: Current Initiatives Across Canada
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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.
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
3
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
5
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
6
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
7
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
8
HTA and Innovation
9
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
10
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
11
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
12
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
13
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
14
Work on HTA and Innovation
in Québec
15
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
16
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
17
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
18
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
19
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
21
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)
22
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)
23
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.
24
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)