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Dr Brenda Dooley, Managing Director, AXIS Healthcare Consulting Ltd.
1. Does Economic Evaluation lead to
increased uptake of new medical
technologies?
Brenda Dooley
March 25th 2015
2. For consideration today
• What is Economic Evaluation?
• Methodological approaches in current use?
• Impact of evaluation decisions made in one jurisdiction
• Relevance for Ireland
3. 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.
4. 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.
6. 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
7. 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 .
8. 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
9. 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.
10. 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
11. 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.
12. 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
13. 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
14. 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
15. 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