Transcript Robotics 2012 Using Automation to improve patient safety

Assessing the value proposition
and promoting the adoption of new
and novel medical technologies
Mark Campbell
Associate Director
Medical Technologies Evaluation Programme (MTEP)
CE 2012: EU Medical Device Regulatory
Revision Conference
Birmingham, 20 September 2012
Content
• General update on NICE
• Development and operation of the NICE medtech
programmes
• Assessing value
• Published and in-development guidance
http://review2011-2012.nice.org.uk/
A short history of NICE
Diagnostics
Publications
Medical
devices
NHS Evidence
accreditation
decisions
Interventional
Procedures
QOF
Clinical
guidelines
Public health
Quality
standards
NHS Chief Executive Report on
Innovation - December 2011
Innovation, health and wealth:
promoting uptake of NICE guidance
•
•
•
•
•
Support for adoption of NICE guidance
Compliance regime and uptake metrics
End to local duplication of NICE evaluation
Support for the NICE scientific advice programme
Targeted effort to implement dementia and
oesophageal Doppler monitoring guidance
• Immediate transfer of DH Innovative
Technology Adoption and Procurement
Programme
(iTAPP) to NICE
“...Through its medtech
progammes, which use
world-leading
methodologies, NICE is at
the forefront of helping
decision-makers derive
maximum value for the
NHS;and we look forward
to continuing to develop
these with clinicians,
policy-makers and
industry..”
Professor Sir Michael
Rawlins
Chairman, NICE
http://jrsm.rsmjournals.com/content/105/suppl_1.toc
Regulation or evaluation ?
Regulation
Evaluation, leading to NICE
guidance
Required in order to place product
on market
Not required to promote and sell
product but guidance is sought by,
and credible with, NHS clinicians
and managers
Location-specific (UK, EU)
Audience for guidance is NHS in
England but very active international
interest
Fundamental quality, safety and
efficacy are evaluated
MTEP evaluates the value
proposition (often using data from
studies of safety/efficacy) including
claimed benefits compared with
standard care
(unless device is part of new or
novel Interventional Procedure)
No assessment of resource impact
Focussed on system benefits using
appropriate economic methods
Medical Technologies Evaluation Programme (MTEP)
bespoke design (1)
Characteristic
Programme design and operational features
Different regulatory environment
Can accept technologies early in life cycle
The relatively sparse evidence base for medical
technologies by comparison with, for example,
pharmaceuticals
All forms of evidence (published and
unpublished
and with no design or quality threshold)
are considered.
Further evidence generation facilitated by NICE
for promising technologies with guidance
recommendations for further research
Medical technologies evolve at a rapid pace
Short timelines. 10 weeks from notification to
selection, 38 weeks from selection to guidance
development
Medical technology products are usually
promoted to the NHS with specific claimed
benefits when used in place of or addition to
standard care
The sponsor’s case for adoption drives the initial
assessment and, if selected, evaluation of the
product to simulate NHS decision-making. Clear
and explicit value propositions are required from
the sponsor before a decision is taken to
evaluate
Medtech products are often claimed to be
resource-releasing and more convenient.
System benefits are given equal prominence to
patient benefits and sustainability benefits are
identified and actively considered.
Appl Health Econ Health Policy 2012; 10 (5): 295-297
Medical Technologies Evaluation Programme (MTEP)
bespoke design (2)
Characteristic
Programme design and operational features
The medical technology industry is large and
diverse with a high rate of output of innovative
products
Innovators (usually a commercial sponsor, i.e.
Manufacturer or distributor) notify their products
directly to NICE so that as wide a range of
productss as possible can be considered.
Improving the efficiency of health services is a
top policy priority
Medical Technologies Guidance specifically
examine products which are plausibly resource
releasing and the primary economic
methodology used is cost-consequences
analysis which gives an estimate of the saving
per patient if the case for adoption is supported
by the evidence
Innovative products may be slowly and/or
unevenly adopted
Products which are novel but not new can
be notified and may be evaluated if there is
evidence that they have plausible claimed
benefits
and are not being routinely adopted.
Technical considerations (safety, compatibility,
procurement, maintenance, calibration, training,
upgrades) can significant influence clinical utility
Access to world-leading technical expertise to
commission bespoke studies to answer specific
questions which are relevant to the assessment
NICE medtech programmes (MTEP,
DAP) at-a-glance
Selection
and routing
Evaluation
(MTG, DG
or other)
Research
facilitation
Scope – products to be evaluated
• Medical devices as defined in EU directives:
– 93/42/EEC (concerning medical devices)
– 98/79/EC (concerning in vitro diagnostic medical devices)
– 90/385/EEC (concerning active implantable medical devices),
as amended
• …..including medical devices used for the purpose of
diagnosis…and medical software
• Genetic tests within the scope of 98/79/EC provided
they have a medical purpose
• Other products (eg tissue engineered products), on
advice from DH
The case for adoption
(compared with standard care)
• Replace ongoing therapy costs with one-off intervention
or device
• Deliver treatment decision or care nearer to home
• Reduce unnecessary surgical interventions
• Enable self-care
• Reduce length of stay
• Enable treatment by a lower grade or less scarce type
of staff
• Improve patient dignity and treatment compliance
• Reduce future hospitalisation
• Speed up recovery
• Etc
Eligibility and selection criteria
Eligibility
Selection
Timing
Patient benefit
New or novel
System benefit
Suitable for evaluation
Disease impact
Cost considerations
Sustainability
Ineligible or not-selected topics are returned to the sponsor with a summary of the
Committee’s considerations
Routing selected topics:
what’s the value proposition ?
Clinical performance
Better
At least equivalent
Cost
Higher
Less overall
Patient benefits (inc
preference)
Evidenced and used
to adjust value
Evidenced and anecdotal
– but not used to adjust
value
Appropriate
evaluation method
Cost effectiveness
Cost consequences
Example
Drug-eluting stents
(TA152)
Oesophageal doppler
monitoring (MTG3)
Which programme at NICE?
Cost modelling – cost consequences
analysis
Cost model - examples
Acquisition costs
System savings (eg
change in setting)
Running costs eg
disposables or concomitant
treatment
Reduced costs of improved
health outcomes
Staffing costs
Improved ease of use or
patient acceptability
MTG recommendations
Usually:
• Case supported (wholly, partly or not)
• Consider using in <case for adoption> <research>
• Resource consequences
NICE medical technology guidance addresses specific technologies
notified to NICE by manufacturers. The ‘case for adoption’ is based on
the claimed advantages of introducing the specific technology
compared with current management of the condition. This ‘case’ is
reviewed against the evidence submitted and expert advice. If the
case for adopting the technology is supported, then the technology
has been found to offer advantages to patients and the NHS. The
specific recommendations on individual technologies are not intended
to limit use of other relevant technologies which may offer similar
advantages.
Development of further evidence
• MTEP has a research workstream as an integral part of
programme
• Designed to facilitate research to address gaps in
evidence which led to research recommendations in
MTG or DG
• Flexible approach to research products but must be
able to be completed within ~ two years
• Subject to findings and evaluation – updated guidance
Assessing value
What do decision makers need to
know about new technologies?
Product
value
What you need to do – constructing
claims and driving value
A point-of-care diagnostic test which allows 'test and treat'
A test which confirms or excludes serious illness more
quickly and/or more accurately allowing faster targeted
treatment/faster discharge
A device which enables people to be more independent
A device which allows more accurate and/or more
convenient monitoring (and therefore shorter or no time
in hospital or fewer hospital visits)
An imaging technology which allows a reduced radiation
dose and/or more accurate imaging and/or better
treatment planning or monitoring
Common pitfalls and....some solutions
Common problem
Solution
Evidence doesn’t match
the claim
Be clear about best possible
application of product before
commissioning study
Lack of clarity about the
product’s position in care
pathway
Talk to UK-based clinicians about how
they might use the product and how it
would change treatment
Unrealistic view of
potential savings
Understand current treatment and
availability – don’t assume a more
expensive comparator is widely used
Not enough evidence to
support the case for
adoption
Share all possible sources of data with
NICE – post-market, audit, unpublished
Getting help
Evidence
generation NIHR NOCRI
www.nocri.nihr.ac.uk
General support for innovation Technology Strategy Board/
Knowledge Transfer Networks
Relevant
evidence for
health
technology
assessment
NICE
Scientific
Advice
www.innovateuk.org
www.nice.org.uk
December 2011
Published and in-development
guidance
11 MTG published, 9 in development
5 DG published, 7 in development
Patient and system benefits of published guidance
Topic
Patient benefits
System
benefits
Cost saving
(per patient*)
MTG 1 Sequent
Please balloon
catheter for
restenosis.
Lower rate of
restenosis and
reduced need for retreatment and major
cardiac adverse
events.
Fewer repeat
procedures.
450
MTG 2
moorLDI imager
for medium-severe
burns.
Better treatment
planning (and less
prodding !)
Avoidance of
unnecessary surgery.
Fewer skin
grafts.
1248
MTG 3
Cardio Q ODM for
intraoperative fluid
management.
Fewer post-op
complications
Earlier mobilisation
(No increase in repeat
surgery or readmission).
Reduced
1100
length of stay.
BBC News at 10: 29 March 2011
Topic
Committee
recommendation
Current status
MTG 4
Promise of excluding
Copeptin assay for acute MI earlier than 2nd
rule out of acute MI troponin (but further
research required)
Recommendations for
further research being
scoped
MTG 5
The MIST Therapy
System for chronic
hard-to-heal
wounds
Promise of more ulcers
healed more quickly (but
further research required)
Evidence generation
underway
MTG 6
Ambulight PDT for
non-melanoma skin
cancer
Early promise but
insufficient evidence to
support case for routine
adoption. NHS should
take into account when
considering investment.
Final guidance published
Latest news on MTG5 - August 2012
Topic
Patient benefits
System
benefits
Annual cost
saving (£ per
patient unless
stated)
MTG 7
Inditherm patient
warming mattress
for prevention of
inadvertent
perioperative
hypothermia
Fewer perioperative
complications
(compared with no
warming)
Less energy
consumption
11,000 per theatre
MTG 8
Veri Q for
assessing graft
flow during CABG
Reduction in perioperative
morbidity/mortality
Reduction in
115
graft occlusion
and
subsequent
graft revision
MTG9
PleurX peritoneal
drainage system
Early and frequent
treatment of
symptoms,
compared with inpatient treatment
Avoidance of
in-patient
treatment
Easier to use
Warms only
the patient
679
Thanks for listening
www.nice.org.uk/mt
Notify a technology:
[email protected]