Brenda Dooley _IMSTA 2015 Annual Meeting
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Transcript of Brenda Dooley _IMSTA 2015 Annual Meeting
Does Economic Evaluation lead to
increased uptake of new medical
technologies?
Brenda Dooley March 25th 2015
For consideration today
• What is Economic Evaluation?
• Methodological approaches in current use?
• Impact of evaluation decisions made in one jurisdiction
• Relevance for Ireland
What is an Economic Evaluation?
• Formal assessment of the major health effects a
new technology will have on the patient and the
health care system.
• Purpose is to inform decision making & meet the
needs of the decision maker.
• Assessment methods and practices need to fit
the technologies to be assessed, specific to the
decision to inform.
• Positive outcome should lead to funding and
uptake of new technology.
Differences between health innovations?
• Process of innovation for medical
devices and pharmaceuticals
differs greatly
• Dissimilar mechanism of action
• Product lifecycle
• Provision of robust clinical
evidence – v challenging for
medical devices
• Ready established pathways for
evaluation of pharmaceuticals not
entirely suitable for medical
technologies.
HTA in Practice
Medical Technologies Evaluation Programme (MTEP)
• MTEP provides a single entry point for manufacturers to submit
products for evaluation – then routed to appropriate evaluation
programme
• Overall objectives threefold – to simplify access to, speed up and
increase evaluation capacity for medical devices
• Products must have a CE mark, be new or represent a significant
modification and have clear benefits for patients of NHS
• 1st MTEP guidance published in 2010
• Recommended technologies not subject to mandatory funding
Methodological Approach by MTEP
• Cost Consequence Analysis – no attempt to summarise the benefits into
a single outcome measure.
• Subjective decision making - relative value of each outcome
considered.
• Limitations of the CCA - a medical device is only more beneficial than
current practice if it is resource releasing.
• Approach to evidence synthesis.
• “it (NICE) may discriminate against technologies that would ultimately
provide a net benefit to the NHS” 1
1. Greene W and Hutton J . Health technology assessments in England: an analysis of
the NICE Medical Technologies Evaluation Programme. Eur J Health Econ. 2014 .
Has MTEP been successful to date ?
• Medical Technology Guidance ( MTG ) published for 15 technologies in
initial 3 years of MTEP.
• Target for year 1 = 15 50 in future years
• 4 MTG published in 1st year
Overall
Evaluations
( 2010-2013 )
Recommended ,
some with
specific
circumstances
Further
research
required
Not
Recommended
15 12 2 1
Has MTEP been successful ?
2. Chapman, A.M., Taylor, C.A., & Girling, A.J., 2014. Are the UK Systems of Innovation and
Evaluation of Medical Devices Compatible? The Role of NICE's Medical Technologies Evaluation
Programme (MTEP). Appl Health Econ Health Policy, 12(4), pp.347-357.
Has MTEP been successful to date ?
2.Chapman, A.M., Taylor, C.A., & Girling, A.J., 2014. Are the UK Systems of Innovation and
Evaluation of Medical Devices Compatible? The Role of NICE's Medical Technologies
Evaluation Programme (MTEP). Appl Health Econ Health Policy, 12(4), pp.347-357.
By mid 2014,
nearly 2/3
exceeded
target with avg
of 16.7 mo’s 2
Has MTEP been successful to date ?
• While MTEP provides an accessible entry point for companies wishing to
submit a product for evaluation, barriers exist
• The current process at NICE attracts a small subset of mainly large
device manufacturers.
• Due to current evaluation timelines, high risk of guidance being
outdated prior to uptake.
• No Mandatory uptake of MTEP guidance in England.
NICE efforts to support uptake of new technologies
• Health Technologies Adoption Program (HTAP)
• Develops resources to aid the adoption of NICE guidance
• Topics selected are those identified as having potential adoption
barriers in England
• HTAP teams works with the NHS with a) demonstrator projects or
b) adoption projects
An Example
• Ambu aScope2 system; sterile, single-
patient use endoscope and reusable
monitor for complex intubations.
• During development of NICE guidance -
Ambu aScope3 launched
• HTAP developed a site demonstrator
pack to aid implementation & uptake
of usage : including info on new design
• One major limitation : no metrics on
impact of HTAP
Copyright Ambu Ltd
2013
Copyright Ambu Ltd 2013
Relevance for Ireland
• AdvaMed report recommends “use of value based criteria should be
routine in medical device procurement vs simplistic recourse to
procurement based on lowest price” 3
• IMSTA has called for a multi disciplinary Professional Evaluation Group
to be established to standardise medical technology Evaluation in
Ireland
• Also conducting a piece of work examining the issues associated with
how clinical investigations are currently conducted here
• Objective is a list of recommendations to help standardise how
evidence is collected in clinical investigations
3. IMSTA publication “New Approaches for procuring effective healthcare solutions”
published with permission of AdvaMed 2014
Conclusions
• The MTEP experience would suggest that evaluation of medical
technologies to date has not led to increased uptake
• Partly due to design of the MTEP
• Recent developments indicate willingness to address gaps in uptake
• Key learnings for Ireland if economic evaluation is to be introduced
• Appropriate timelines central coupled with appropriate methodologies
that are fit for purpose of evaluating medical technologies
• NB. A link should be established between guidance and uptake
THANK YOU