PMG39 Early value assessment interim statement:
appendix 1
15 December 2022
Abbreviations
AAC
AHSN
CECQC
CSO
DAC
DAP
DDD
DHSC
DTAC
H&SC
HTW
IAPTICS
IDAP
MTAC
MTEP
NCDs
NHS
NHS SBSNHSE
NHSE/I TD
NICE
NIHRIO
OCSC
RWD
SCM
SHTG
TI
UKCA
XR

Accelerated Access Collaborative
Academic Health Science Network
European conformity assessment markCare Quality Commission
Central Statistics OfficeDiagnostic advisory committee
Diagnostics Assessment Programme
Devices, Diagnostics and Digital
Department of Health and Social Care
Digital Technology Assessment Criteria
Health and Social Care
Health Technology Wales
Improving Access to PsychologicalTherapies
Integrated Care System
Innovative Devices Access Pathway
Medical technology advisory committee
Medical Technology Evaluation Programme
National Clinical Directors
National Health Service
National Health Service Shared BusinessServices
National Health Service England
National Health Service England andImprovement Transformation Directorate
National Institute for Health and Care
Excellence
National Institute for Health and Care
Research Innovation Observatory
Office of the Chief Scientific Officer
Real-world data
Specialist committee members
Scottish Health Technologies Group
Topic intelligence
UK Conformity Assessment
X-ray

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Figure A: Main functions of topic intelligence

Table 1 Examples of Engagement groups for intelligence
Function
PolicyClinical need

Source/engagement
DHSC, NHSE
NICE Strategy Team,H&SC
AAC
NHSE TD Digital Policyand Digital Investment
Teams
Office of the Chief Scientific
Officer (OCSO)
Health Charities e.g.,King’s Fund
Local Government
AssociationNHS SBSAACNHSE/I TD
NCDs
AHSNs
ICS innovation teams
Royal Colleges
Voluntary and community
sector organisations

PMG39 Early value assessment interim statement: appendix 1Output
Signal of current policy
drivers and priorities
for NHS and social
care systems

CommentEnsures alignment of
NICE to national policy
drivers

Signal of unmet clinicalneed, described as
diagnostic, therapeutic,access, ANDamenable to support
by DDD solution

Ensures NICE isworking with thesystem to support
patients and staff

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Function
Technology

Reimbursement

Source/engagement
Academia
NICE internal
NICE Information Searches
AHSN network
NHSE programmes, e.g.,
IAPT, XR, Cancer, etc
NHSE Innovation Service
NHSE/I TD
Royal Colleges
Voluntary and community
sector organisations
Professional Societies
HTW and SHTG
Trade associations
Industry leaders
AcademiaConferences
DDD news outlets
NIHRIO DDDOffice of the CSO
NHSE/I TD Commercial
Unit
DHSC
NHS SBS

OutputCommentTechnology products
which are suitable forreview by NICE, to be
documented in the TI
database and triaged
accordingly

Multiple feeds availablefor technology, different
quality of outputs,
information governanceconstraints must be
considered for topics
shared with NICE.

--Table 2 Filtering criteria for topic areas and technologies
Criteria
Topic Priority
Platform
Regulation
Funding
Current usage

Evidence
OtherDescription
Technology falls in a priority area for the health andcare system
Lists the platform(s) that the technology operateson, e.g., mobile, desktop, cloud-based
CE/UKCA mark, DTAC, CQC registration
Product linked to a currently funded work
programme
Technology is currently in use within the health andcare system, aligns to NICE or national guidelines,
fits a clinical pathway, and articulates a positive
impact on the pathway
Benefits to patients, and/or the system, and is in a
published format.
Environmental sustainability, workforce impact,inequalities, RWD and data collection issues
captured.

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Table 3 Test and learn approaches to the early value assessment pilot technologies (1/2)
Topic
KardiaMobile
6-Lead(singletechnology)

ScopingStandard
16 week
DAP scope
process

Assessment
20 week
assessment
including
16 weekclinical gap
analysis
4 week cost
reportCYP guided
8 weeks
4 weeks
self-help
consultation Clinical gap
CBTfollowed by analysis andscoping
attempting(multiplevalue oftechnologies) workshop
information
modelling
CaRi-Heart
8 weeks
8 weeks(singleScoping
Clinical gap
technology)
workshop
analysis withwithout
basic
consultation economic
Digital
8 weeks
8 weekstherapies for workshop
Clinical gap
adult
followed by analysis
depression
consultation Basic(multipleeconomictechnologies)
analysis(potential forconceptualmodelling)

Committee/panel Consultation
DAC and SCMs
2 weeks

GEYes

Resolution
2 weeks(factualinaccuraciesonly)

Panel with SCMs

2 weeks

To beNodecidedDAC and SCMs

2 weeks

Yes

No

MTAC or panel(and SCMS)

2 weeks

LikelyNo

Table 4 Test and learn approaches to the early value assessment pilot technologies (2/2)
TopicDigital
therapies for
adult anxiety(multipletechnologies)

Scoping
8 weeks
workshopfollowed byconsultation

Assessment Committee/panel Consultation GE
8 weeks
MTAC or panel
2 weeks
Likely(and SCMs)
Clinical gap
analysisBasiceconomicanalysis(potential forconceptualmodelling)

PMG39 Early value assessment interim statement: appendix 1

Page 4 of 6ResolutionNoTopicGenedrive
MT-RNR1 ID(singletechnology)

ScopingStandard 16week DAP
scopeprocess

ProKnow

8 weeks
consultation
followed byscoping
workshop(singletechnology)

Assessment Committee/panel Consultation
8 weeks
DAC and SCMs
2 weeks
Systematic
review ofclinical andcost
effectivenessevidenceanddevelopment
of an
economicmodel
8 weeks
MTAC and SCMs 2 weeks
Clinical gap
analysisBasiceconomicanalysis(potential forconceptualmodelling)

GETo bedecided

Resolution
NoTo bedecided

To bedecidedFigure B: Flow chart illustrating decision making considerations

Table 5 Principle to guide approach to evidence generation for medical technologies
Principle Description
1
Early engagement with NICE, produces greater opportunities forstakeholders and health system partners to understand and support
further evidence generation for promising new technologies.

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Principle Description
2
Evidence generation plans will be informed or guided by NICE’s realworld evidence framework, the evidence standards framework fordigital health technologies, expertise, and experience from the
managed access approach for medicines, and the Commissioning
through Evaluation programme for medical technologies.
3
The early value assessment evidence generation approach is anassessment of research done to date, gaps in the evidence and factorsthat have contributed to these, resulting in a proposal for proportionate
options to guide further data collection and analysis.
4Technology developers will take a leading position to pursue
opportunities for evidence generation with the support of NICE.
5NICE will provide support and guidance about evidence generation andbroker relationships with stakeholders and partners who can support
adoption, use, data collection and analysis.
6
Multistakeholder collaboration will be key to developing evidence
generation plans.
7
Evidence generation plans will identify what further data needs to becollected, how it could be collected and analysed and how this datacollection will support a future NICE guidance.
8Real-world data collections should build on existing clinical information
flows.
9
Evidence generation should be for the shortest time necessary tocollect the data needed to sufficiently resolve uncertainties in theevidence.
10
The additional burden of any new real-world data collection must be
proportionate to the evidence gap it will address.
11
The technology developer/data or study lead is responsible for making
the evidence generated through early value assessment available toNICE in a form that can be used for decision making as part of aguidance update.

ISBN: 978-1-4731-4818-5

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