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The topics will be selected in collaboration with DHSC. The technologies considered for LSA include those that have:
high annual cost to the NHS (based on the technologies being procured at high cost and low volume or low cost and high volume)
existing procurement framework for the category in the NHS
price variation between technologies in the market
incremental innovation and performance claims that have led to incremental price increases.
Technologies selected for LSA will be scoped in line with sections on medical technologies and diagnostic technologies in section 2 of NICE's health technology evaluation manual. Changes to the scoping process for LSA can include:
Consultation of the scope may take place in addition, or as an alternative, to the scoping workshop. Reasons for consulting on the scope could relate to the complexity of the care pathway and decision problem, the clinical and economic evidence base, or the number of stakeholders.
The scope can include details of the innovative aspects of the technologies and their evaluation (see section 4.23). It can also present information on current commissioning and procurement in the NHS and related issues.
It can state non-clinical outcomes and user preferences.
Determining user preferences for the multi-criteria decision analysis may form part of the discussion at the scoping workshop (see section 4.23).
The quality and quantity of evidence is expected to vary by LSA topic. To understand the level of available evidence before the formal EAG review, NICE will do pragmatic literature searches during scoping.
Analysis of the pragmatic searches and company information will determine whether there is an existing economic model (the principal model) that can inform or be an appropriate base for the economic evaluation. NICE prefers the principal model to have been developed for the NHS using data from a UK setting. If there are no existing or relevant economic evaluations, the search will then aim to scope the available clinical evidence. This will guide what methods can be used for the protocol and the assessment (see sections 5.7 and 5.8).
The pragmatic searches, along with stakeholder advice, can also identify relevant UK-based registries that may be able to provide data to inform the assessment.
LSA will follow the standard approach to assessing the evidence for a NICE evaluation as outlined in section 3 of NICE's health technology evaluationmanual.
The EAG will develop an assessment protocol from the final scope of the evaluation. The assessment protocol outlines what the EAG will do during the evaluation and the information it will provide in the external assessment report. Examples of information in the protocol include:
the approach to evidence review
search strategies and data requests
inclusion and exclusion criteria
quality assessment and critical appraisal strategies
methods of analysis or synthesis
the approach to economic modelling, including whether a cost-comparison approach is appropriate.
The evidence base could include real-world evidence collected in registries, existing economic models, systematic reviews and meta-analyses, and randomised controlled trials. This evidence will be used to adapt an existing economic model or develop a new model relevant to the decision problem defined in the scope. The aim of the evidence review is to identify the most relevant data and evidence relating to the decision problem, to improve the robustness of the evaluation.
When there is a large amount of relevant evidence to present during the assessment stage, the EAG can prioritise those studies or data it considers most relevant to the decision problem. Along with relevance to the decision problem, the relevance of earlier versions of the technologies should be considered.
In addition to reviewing the published literature on the technologies, reviews may be needed to look for other data sources. These could include studies and registries that report relevant information for updating or developing a relevant economic evaluation. Such data could include evidence on comparative interventions, subgroups, and the relationship between surrogate and final clinical outcomes.
Technical evidence, post-market surveillance data and technical assessments may be used when LSA topics have little or no evidence, or to complement published clinical evidence.
The evidence reviews may be done using pragmatic approaches when appropriate. Rapid review methods could include, but are not limited to:
single screening and data extraction
searching a limited selection of databases
umbrella reviews, that collate evidence from other existing reviews.
Updating existing systematic reviews and meta-analyses may be appropriate. As part of the assessment a judgement will be made on which elements of the previous systematic review can be reused, and which need to be redone. This will be based on the level of similarity between the original and new scope, protocols and methods. Examples of elements that can be considered for reuse include:
literature searches and literature search results
evidence tables for included studies
critical appraisal of included studies
data extraction and meta-analysis
previously identified information on equalities and health inequalities.
Critical appraisal of key studies will be done in accordance with section 3 of NICE's health technology evaluationsmanual. The quality and reliability of the studies in the evidence base will be summarised and reported. This will focus on studies that report key outcomes relevant to the decision problem. Quality assessment using validated checklists will be done for pivotal clinical studies, systematic review or meta-analysis, and economic studies. Real-world evidence should be critically appraised as described in NICE's real-world evidence framework. The report should explicitly detail the potential main sources of bias. Comments on the generalisability of the results to clinical practice in the NHS should also be made.
A quantitative meta-analysis (including network meta-analysis) may be done if relevant and appropriate. Published meta-analyses may be described and used if available and appropriate.
The evidence assessment processes that will be explored include:
an EAG producing an assessment report for the LSA pilot projects
stakeholder and specialist committee members being invited to comment on the assessment report, focusing on factual accuracy, before the committee discussion
stakeholders being informed of the dates of any comment period at least 1 week before documents are released
a streamlined approach to internal approval of final documents within NICE and the need for a resolution period.
LSA will aim to include an economic evaluation to assess the economic case for the technologies. The approach to economic evaluation may vary by topic depending on the available data and previous technology evaluations. Proposed work will be discussed and agreed between the NICE team and the EAG from an early stage to inform development of the protocol for the assessment (see section 4.8). More detail on approaches can be found in section 4 of NICE's health technology evaluation manual.
The objectives of the economic evaluation are to:
when feasible and appropriate, develop an economic evaluation that represents current practice, based on national guidance and policy, real-world experience and recent data
assess the potential benefits of individual technologies or relevant features, or both, to determine whether the incremental differences represent value for money, based on the incremental costs and effects
identify the key cost drivers and uncertainties of the economic evaluation and the additional value attributed to the differences between technologies.
When technologies are comparable, a cost-comparison approach may be used. In some circumstances when there is limited data on health outcomes, a cost-comparison approach may be used with limitations and assumptions stated. Further information can be found in section 4.2 of NICE's health technology evaluation manual.
When limited clinical data suitable for decision making is available, a summary of costs and expert opinion or expert elicitation on the clinical effectiveness and resource impact of technology features or a technical assessment can be produced. A full economic evaluation may not be possible.
The reference case will be the same as described in section 4.2 of NICE's health technology evaluation manual. In some circumstances deviation from the reference case will be considered, to better inform decision making in the NHS.
Guidance for presenting data and results of models is described in section 4.10 of NICE's health technology evaluation manual. Outputs of models should be presented to easily allow clinicians to validate model results. The extent of work done to validate model outcomes should be described.
When appropriate and feasible, user preferences and additional outcomes may be considered through an additive Multi-Criteria Decision Analysis (MCDA) model. This process will capture factors that influence decision making when selecting a technology, and create a weighted scoring matrix. These criteria could be features of the technology or potential benefits of the technology not captured quantitatively in the economic evaluation. This scoring matrix will allow the technologies to be quantitatively evaluated against these criteria. Only including criteria that are not captured in the economic evaluation will avoid double counting aspects of a technology. If it is clear that all the relevant criteria are captured in the economic evaluation, then the MCDA may not be continued. In this case, the criteria that make up user preferences and additional outcomes will be reported narratively to help inform committee decision making.
When applicable, the output from the MCDA will be presented to the committee along with the output from the economic evaluation. The individual MCDA score of each technology will be compared with the scores of the other technologies to give an indication of stakeholder preference. This score may be used by the committee to inform its considerations. Guidance on how the committee should use stakeholder views for appraisal and decision making can be found in sections 6.2.7, 6.2.8 and 6.3.1 of NICE's health technology evaluation manual.
Criteria that stakeholders feel are relevant to their decision making, but are removed from the MCDA because of the risk of double counting with the economic evaluation, will be reported narratively but will not contribute to the final MCDA score.
The scoring matrix from the MCDA can be published to support future procurement decisions, when appropriate, and allow companies to collect evidence on how their technologies address stakeholder preferences. The MCDA output is not a substitute for existing standard criteria already used in the procurement framework for the category. Instead, it is to complement these criteria. Procurement teams have flexibility to use any available MCDA output according to their standard procurement process.
LSA guidance will recommend technologies or features of technologies that are considered value for money based on whether they are within the price range that represents the best options for patients and value for money for the NHS. Technologies or features of technologies that are in a higher price range will be recommended if this is justified by improved clinical or non-clinical outcomes and user preferences. Potential net budget impact of the higher price range can be considered in the recommendations.
LSA guidance will also identify features or outcomes of technologies that justify price variation by improving clinical outcomes and patient benefit, user preferences and non-clinical outcomes not captured in the economic evaluation.
The NICE committee will:
acknowledge the predetermined price range that represents the best options for patients and value for money for the NHS (this may include acknowledgement of limitations and uncertainty)
decide on the most relevant clinical outcomes and whether differences in results will justify a price difference
decide on the most relevant non-clinical outcomes and user preferences and value added, and whether these features will justify a price difference.
When appropriate, the committee can:
confirm the named technologies that are below the predetermined price range that represents the best options for patients and value for money for the NHS (assuming the technologies have sufficient evidence of clinical efficacy)
confirm the named technologies or technology features that deliver additional benefit, so that the named technologies or technology features can be priced above the stated price range that represents the best options for patients and value for money for the NHS
confirm the named technologies or technology features that are at high risk of not having value for money
identify features of technologies that can deliver patient benefits and justify price variation by improving clinical or non-clinical outcomes.
The committee considerations include:
assessing clinical, non-clinical outcomes, user preferences and technical requirements
pricing and the comparison with the predetermined price range
user preference
equality issues
uncertainty in the evidence.
Further detail on how committee should reach its decisions can be found in section 6 of NICE's health technology evaluation manual.
The recommendations and rationale may include:
the price range that represents the best options for patients and value for money for the NHS
a list of the key economic and clinical outcomes
a list of the key non-clinical outcomes, user preferences and technical requirements that can justify a variation in price.
The recommendations and rationale may:
state whether technologies are priced below the price range that represents the best options for patients and value for money for the NHS
state whether technologies represent the best options for patients and value for money for the NHS when the price difference is justified based on assessment of clinical or non-clinical outcomes and user preferences
state whether technologies are priced above the price range that represents the best options for patients and value for money for the NHS, and do not offer sufficient value through clinical or non-clinical outcomes to justify the higher price
state whether technologies with evidential issues should be priced accordingly to mitigate the risk of uncertainty
highlight uncertainties in the evidence that could be addressed by further data collection to improve future decision making.
NICE will consult on draft guidance as outlined in sections 5.8.44 to 5.8.63 of NICE's health technology evaluation manual, except stakeholders have 14 days from the date of sending to submit comments on the draft guidance.
Based on the consultation comments received, the chair can decide whether another committee meeting is needed.
The guidance will then be finalised as outlined in sections 5.8.64 to 5.8.69 of NICE's health technology evaluation manual.
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