NICE process and methods

7 Evidence synthesis and cost-consequence analysis

7 Evidence synthesis and cost-consequence analysis

This section describes the methods used in preparing the sponsor's submission and in guidance development. In addition, sponsors may wish to ask the programme team for guidance and/or seek specialist advice.

The sponsor, as part of the submission, is responsible for evidence synthesis and developing economic models. After receiving the sponsor's submission, NICE may request further data collection and analysis from the sponsor, the external assessment centre or another organisation commissioned by NICE.

7.1 Evidence synthesis

Depending on the size and quality of the evidence base, evidence synthesis or meta-analysis may be used both to summarise evidence from different studies and to measure uncertainty and undertake sensitivity analyses. Quantitative evidence synthesis or meta-analysis approaches and techniques, including indirect and mixed treatment comparisons (network meta-analysis), may be used if appropriate to provide evidential inputs to models.

7.2 Analysis of indirect and intermediate outcomes

The available evidence may not always provide information on all clinical and system outcomes, particularly those in the future or that are not linked to immediate use of the technology. If this is the case, the sponsor's submission should include appropriate modelling of outcomes and these should be reflected in the cost analysis.

7.3 Analysis of costs and consequences

7.3.1 Rationale and context for cost-consequence analysis

As part of the sponsor's submission, analysis may be needed to quantify the resources and expected outcomes associated with the technology under consideration compared with current comparators and healthcare pathways defined in the scope. Such analysis may not be needed if relevant high-quality economic evaluations are already available. Given the remit of the programme, the approach expected to be appropriate for most technologies is cost-consequence analysis.

Cost-consequence analysis considers the costs and resource consequences resulting from, or associated with, the use of the technology under evaluation and comparator technologies, as well as considering relevant clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

The range of costs and resource consequences to be included in the analysis depends on the clinical characteristics of individual medical technologies and their comparators. Generally, the following apply:

  • Typically, cost-consequence analyses include calculating and presenting estimates of resource use and of clinical benefits as separate domains of the evaluation.

  • Estimates of resource use should include comparative costs of technology (and infrastructure) acquisition, use and maintenance. Focusing on these costs may be particularly applicable when the clinical effects of the technology can be assumed to be almost the same as those of comparator technologies.

  • Estimates of resource use may also include the comparative value of healthcare service use outcomes (such as length of hospital stay, or number of hospitalisations, outpatient or primary care consultations) associated with the use of the technology or its comparators.

7.3.2 General principles of cost-consequence models

The decision problem, as defined in the scope, determines the construction and assumption of any models. Models should quantify the effect of introducing a new technology into current healthcare pathways and routine health and social care system use.

Discounting principles are consistent with those used in cost-effectiveness analysis in other NICE guidance programmes. A discount rate of 3.5%, as recommended by the Treasury, is used to reflect the time value of costs and benefits.

The time horizon for accrual of benefits and costs should be determined for the medical technology under evaluation, and may be specified in the scope.

Costs resulting from or associated with the use of the technology should be estimated using prices relevant to the health and social care system and personal social services, and should include acquisition (including infrastructure) and maintenance costs.

Methods that capture the lifetime costs should be used when estimating investments in infrastructure associated with the use of the technology.

If a technology notified to the programme for a particular indication is found to affect more than 1 disease area or patient group, the sponsor should clearly present the assumptions and calculations used to calculate acquisition and infrastructure costs for different indications and uses of the technology in its submission.

Uncertainty analysis techniques (relating to chance, evidential and model uncertainty) should be done. The level of complexity should be appropriate for the specific technology and its comparator healthcare pathway. Various analyses of different complexity may be used, such as scenario-based deterministic sensitivity analyses, threshold analyses or probabilistic sensitivity analyses.

Some technologies may have only a healthcare system benefit. Examples include imaging technologies with nearly equivalent diagnostic performance and laboratory equipment with nearly equivalent diagnostic analytical and clinical validity. If there is evidence of equivalence with existing approaches, the evaluation may concentrate on the health and social care system outcomes.