Early awareness and alert (EAA) of innovation, appropriate ... › contenidos... · Early awareness...
Transcript of Early awareness and alert (EAA) of innovation, appropriate ... › contenidos... · Early awareness...
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Early awareness and alert (EAA) of innovation, appropriate use of technologies and disinvestment
Dr. Hans Peter Dauben1, Dr. Iñaki Gutiérrez-Ibarluzea2, 1 DAHTA-DIMDI, German Agency for HTA, 2 Osteba. Basque Office for HTA. Ministry for Health. Basque Government. Basque Country.
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23/11/2007
Aims
• The workshop is aimed at delegates who want to find out about the life cycle concept and the implementation of EAA of innovation and disinvestment systems.
• They may be completely new to EAA and disinvestment activities, in the early stages of developing an EAA or disinvestment system or be working in an EAA or disinvestment system in Low and Middle Income countries (LMIc).
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Panelists
• Hans-Peter Dauben, DAHTA-DIMDI, Germany
• Iñaki Gutiérrez-Ibarluzea, Osteba, Basque Country
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Outline of first session
• Classical HTA
• Properties and impacts to be assessed
• From regulation to coverage…
• Decisions and overlaps, levels of decision
• Gaps in the continuous of decision making processes
• The life cycle concept
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HTA is mainly a retrospective assessment approach
Use o
f t
echnolo
gy in
healt
h c
are
Time line of research -innovation - technology
Experi-mental
Investiga-tional
Nearly established
Established Technology
Basic research
Applied research
Technologies of low added
value. Obsolete?
HTA
Healt
h
Need
s
Assessm
ent
?
Proactive HTA? EAA
Disinvestment
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Time
Use
Access
Innovative Technology
Obsolescence/ Replacement
General Use Research and development
Experimental Technology
HTA HTA
Where we go?
HTA?
HTA
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7
Properties and Impacts of health technologies to be Assessed
Main categories:
• Technical properties
• Safety
• Efficacy and effectiveness
• Cost and other economic attributes
• Social/cultural, legal, ethical, organizational or political impacts
7
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From regulation to coverage R
egu
lati
on
Safety and efficacy
Evid
en
ce B
ased
he
alth
car
e
Effectiveness
Co
mp
arat
ive
effe
ctiv
enes
s
Comparison of effectiveness among different technologies
HTA
Organizational, economic, legal social/cultural, political, ethical
+ + +
Can it work? Does it work? Does it work proper than
others? Is it worth it?
Market authorization
Prescription Provision Coverage
reimbursement decisions
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Decisions and overlaps
• Decisions could be taken on the basis of existing information in each step
• Decisions better informed and more efficient when all the properties and impacts are considered.
• Overlaps exist in reality.
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Decisions and levels
• Prescription relates to micro decisions
• Provision relates to meso decisions
• Coverage and reimbursement relates to macro decisions.
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Gaps in the decission making process
Phase I / II Phase III Phase IV
Help and consultancy on innovation. Horizon Scanning
Health Technology Assessment
Regulation
Reimbursement Delisting
Desinvestment
Provision
Post-introduction
Innovation
Technology Prospection
11
Gap
Regulatory bodies
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12
It is not only technology
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Value and technology
100
80 70
40
20 10
0
20
40
60
80
100
%
Original value
Value related to an incorrect purchaseprocess
Value related to oversophistication
Value related to irrational use
Value related to the inexistence ofreplacement pieces
Value related to lack of mainteinance orrepairment
Before use After use
Fuente: Swiss Center for International Health, Basel, 2005
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14
What is HTA?
• Health technology assessment (HTA) is a multidisciplinary activity that systematically examines the safety, clinical efficacy and effectiveness, cost, cost-effectiveness, organisational implications, social consequences, legal and ethical considerations of the application of a health technology – usually a drug, medical device or clinical/surgical procedure or health program
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HTA and LMIc
• Mostly centered on reimbursement processes and HTM
• Lack of resources
• Different priorities
• Most of the HTA reports in HIc do not fit with LMIc needs – Vaccines
– Communicable diseases
• Not much experience on analysis of variability in practice and disinvestment
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Gaps in the decission making process (I) • Before regulation
– Technology Prospection (what could be applicable to the health care system?)
– Requirements of the systems – Health Needs Assessment – Horizon Scanning – Early dialogue with manufacturers
• From regulation to reimbursement – Early dialogue among regulators and HTA
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Gaps in the decission making process (II) • Reimbursement and Investment
– Health Technology Assessment – Health Technology Management – Post-introduction observation – Analysis of variability in practice
• Disinvestment and Innovation – Health Impact Assessment – Efficiency
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Clinical research
Health Services Related
Assessment
Appropriate use
Innovation
Preclinical research
RD+i
EBHC + HTA
Regulation Market authorisation
Investment Health provision
Disinvestment Exclusion from provision
Technology Early dialogue
HTA reports Including ELSOI and economic
analysis
Clinical Practice Guidelines
and
Post-introduction HTA
reassessments
Clinical trials and other
epidemiological designs
Proofs of concept
Technology
feasibility reports
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Clinical research
Health Services Related
Assessment
Appropriate use
Innovation
Preclinical Research
RD+i
Regulation Market authorisation
Investment Health provision
Disinvestment Exclusion from provision
Research & development Early dialogue
HTA reports Including ELSOI and economic
analysis
Clinical Practice Guidelines
and
Post-introduction HTA
reassessments
Clinical trials and other
epidemiological designs
Proofs of concept
Technology
feasibility reports
Evidence based life
cycle information
Health Impact
Assessment
Health Technology Assessment
Health Technolog
y Managem
ent
Health Needs
Aassessment
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Who is the customer?
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Who is the customer?
• Public or private?
• Provider or purchaser?
• Professionals or managers?
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Factors to consider:
1. When does your customer want or need to know about technologies?
2. When is the technology likely to enter your healthcare system?
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Buxton’s law “It’s always too early until, unfortunately, it’s suddenly too late!”
Martin Buxton, 1987
• Too early and there may not be enough information for decision makers
• Too late and the decision may have already been made
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Buxton’s law
“It’s always too early until, unfortunately, it’s suddenly too late!”
Martin Buxton, 1987
• Too early and there may not be enough information for decision makers
• Too late and the decision may have already been made
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When does your customer want to know? It depends:
– when (before?) health authorities, hospitals, doctors, or patients start demanding a new technology (near horizon)
– when (before?) doctors ask to purchase a new type of diagnostic or surgical equipment, or when companies start marketing it (near horizon)
– when (after?) a new treatment appears promising in early research & development (distant horizon)
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Typical time horizons
• Many EAA system use a 0 to 3 year time horizon (near horizon)
• Some look ahead up to 5 years (distant horizon) – particularly for larger trends (e.g., 3D printing, precision medicine….)
• May mean looking for technologies several years before they are commercially available
• Most technologies of interest will likely be on the near horizon (i.e., within a year of being marketed, or newly licensed & in early stage of diffusion)
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When is the technology likely to enter the healthcare system? • Different types of technologies take more or less time
to reach the market
• For drug technologies, the stages of development & timelines to marketing are easier to track (e.g., phase I, II, or III trials, & sometimes post-market trials)
• Devices & other non-drug technologies don’t necessarily follow this process
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…When is the technology likely to enter the healthcare system?
• In new areas (e.g., companion diagnostics, stem cell therapies) technologies may follow a more complex & longer development timeline
• Some technologies (e.g., public health interventions or surgical procedures) may enter healthcare without requiring regulatory approval
• Regulatory approval times vary worldwide - what is new or emerging in one country or region may have been available for several years elsewhere
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Technology lifecycle
• Tongue in cheek, but true! • Most technologies follow something of this S diffusion
curve over their lifecycle
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Technology lifecycle
• Information may be needed at various points over the technology’s lifecycle, from early alerts and awareness to obsolescence (for possible disinvestment)
• Many technologies that appear promising never make it to the market
• The further from marketing or widespread use the less “good” evidence may be available
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Current Trends
• To be closer to provision:
– HTA in hospitals
• CEDIT
• Gemelli
• Miguel Servet (Zaragoza)
• Clinic (Barcelona)
• Txagorritxu hospital
• INESS
– Created by the Health provider
• NICE..
– Or insurance and providers
• Kaiser Permanente
• BlueCross BlueShield
• EUnetHTA – Macro decisions – Sharing information,
actions and methods – Low impact on
provision • France:
– Centralised and regulatory
– Low impact on provision
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Trends
Macro
Meso
Micro
• Closer to decision • Sustainability • Impact on provision • Increase stakeholders
involvement • Not just recommendations but
involment in the implementation and the evaluation
• Assessment-Re-assessment – Life cycle of technologies
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HEALTH TECHNOLOGY ASSESSMENT
Health care system sustainable and closer to the needs of the population
Provision
Clinical Practice
Society
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What we could share… • Macro level
– Core elements – Implementation low – Low impact on provision and
prescription • Meso level
– Evidence – Benchmarking – Impact on provision – Low impact on prescription
• Micro level
– Benchmarking – High internal validity – External validity low – High impact on prescription
METHODS AND
EVIDENCE
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Existing HTA units… so similar… so different • How they are related to the customer
• How they produce information
• How far they involve stakeholders
• Dimensions that they include in the analysis
• Relations with other HTA units or agencies
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Some ideas….
• Health technologies should be considered as a whole
• Life cycle of technologies is a more appropriate concept
• Different processes are comprised – Identification of health needs
– Innovation
– Effective implementation of technologies
– Delisting or disinvestement of technologies of low-added or no added value
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Initiatives currently in practice • Horizon scanning / Early Awareness and Alert Systems
– EuroScan, HTAi ISG on DEA • Early Dialogue.
– JA2 EUnetHTA and Tender DG SanCo; – Concept papers and guidances
• Incorporation – Innovative purchasing process
• Coverage with evidence • Risk sharing agreements
– Post-introduction observation • Disinvestment
– HTAi ISG on DEA – EuroScan – Brazil Guideline on Disinvestment – Argentinean process on Disinvestment – Bahamas analysis of drugs to be reimbursed
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CONCLUSIONS
• Context is important
• Same evidence could lead to different recommendations
• HTA is needed at the three levels
• HTA initiatives that have been focused at the macro level are not successfull
• Identify the customer and feed its needs
• Importance of the combination of methods (qualitative and quantitative)