Process and methods
4 Cost-comparison analysis
When completing the template, also refer to the NICE process and methods addenda.
This purpose of this section is to present a descriptive summary; quantification of resource use and the associated costs should be presented in section 4.2. Include cross references to other sections where relevant.
4.1.1 Describe the location or setting of care (that is, primary and/or secondary care, commissioned by NHS England specialised services and/or clinical commissioning groups). If this differs from the location or setting of care for the comparators listed in the final scope from NICE, describe these differences.
4.1.2 Identify the main resource use to the NHS associated with the technology being appraised.
4.1.3 Describe any differences in resource use between the technology and the comparators listed in the final scope from NICE. For example, differences in frequency of administration, monitoring and follow-up. Provide details of additional tests or investigations needed, and any additional infrastructure requirements.
4.2.1 State the time horizon used in the cost-comparison analysis, and the rationale for the chosen time horizon. The time horizon should be long enough to reflect materially important differences between the technologies being compared:
As a minimum, this must include acquisition costs of the technologies. If other relevant differences in costs or resource use are identified, these may also be included (for example, drug administration, time on treatment, monitoring and healthcare appointments).
If there are relevant differences in health outcomes that affect resource use (for example, managing adverse events), the time horizon must be long enough to capture these. Substantial differences between technologies in costs directly relating to health outcomes (such as adverse events) indicate that the intervention and comparator(s) may not provide similar overall health benefits, so any such cost differences must be clearly justified.
4.2.2 State whether costs were discounted. Discounting of costs is not normally required in a cost-comparison analysis, but can be applied if relevant. If a discount rate is applied, include the rationale.
4.2.3 In a table, present the acquisition costs of the intervention and comparator technologies included in the cost-comparison analysis. A suggested format for the table is provided in the submission template. Indicate whether the acquisition costs represent list prices or include a patient access scheme or other nationally available price reduction (for example, through contracts negotiated by the NHS Commercial Medicines Unit).
4.2.4 When an intervention has a patient access scheme that has been agreed with the Department of Health, or when there is another form of nationally available reduction to the list price, these should be included in the base-case analysis to best reflect the prices relevant to the NHS.
4.2.5 If a comparator technology has a patient access scheme or nationally available price reduction that is confidential, the list prices should be presented here.
4.2.6 In a table, present the healthcare resource costs associated with the intervention and comparator technologies included in the cost-comparison analysis, and the methods used to estimate them. This should include, where relevant, the costs associated with drug administration, patient monitoring and patient follow-up. A suggested format for the table is provided in the submission template. Costs should be based on use in line with the summary of product characteristics for the new technology (if available) and the comparator(s), and relevant costs included in the published appraisal(s) of the comparator(s). Whenever possible and appropriate, cost data and data sources should be consistent with any corresponding data and sources that were considered appropriate in the published NICE guidance for the comparator(s) for the same indication, but should reflect the most up-to-date information available from these sources. Refer to section 5.5 of the NICE guide to the methods of technology appraisal for guidance on resource costs that are relevant to the NICE reference case.
4.2.7 Identify the unit cost for each resource (for example, cost per GP or hospital appointment £XX, cost per blood test £XX and cost per MRI scan £XX). Justify why that cost was chosen, together with a supporting reference and the price year.
4.2.8 Estimate the value of each resource for each technology (that is, the quantity of resources affected multiplied by their unit cost). Justify the quantity of resources estimated.
In appendix G describe how relevant cost and healthcare resource data for England were identified. Explain any assumptions made and the rationale for these. It may be appropriate to use a systematic approach to identify resource use and cost data, for example, if service provision or disease management has changed since the technology appraisal for the comparator(s), or if there are differences in resource use between the technology and the comparators which warrant the identification of new data sources. Search strategies and inclusion criteria should be provided in the appendix. Published and unpublished studies may be considered. If there are limited data for England, the search strategy may be extended to capture data from other countries. Please give the following details of included studies:
4.2.9 When describing how relevant unit costs were identified, comment on whether NHS reference costs or payment-by-results (PbR) tariffs are appropriate for costing the intervention being appraised. Describe how the clinical management of the condition is currently costed in the NHS in terms of reference costs and the PbR tariff. Provide the relevant Healthcare Resource Groups and PbR codes and justify their selection.
4.2.10 Describe and tabulate the unit costs and resource use associated with the adverse reactions included in the cost-comparison analysis. For each adverse reaction, provide a breakdown of the costs associated with managing it (including technologies used to treat it, staff costs and hospital costs), with source references for each value. Calculate the total cost of adverse reactions per course of treatment for the intervention and each comparator, and calculate the total cost of adverse events over the full time horizon.
4.2.11 Substantial differences between technologies in costs directly relating to health outcomes such as adverse events may indicate that the intervention and comparator(s) may not provide similar overall health benefits, so any such cost differences must be clearly justified.
4.2.12 Describe and tabulate any additional costs and healthcare resource use that have not been covered elsewhere (for example, costs relating to subsequent lines of therapy received after disease progression, personal and social services costs). If none, please state.
the criteria for selecting the experts
the number of experts approached
the number of experts who participated
declaration of potential conflict(s) of interest from each expert whose opinion was sought
the background information provided and its consistency with all the evidence provided in the submission
the method used to collect the opinions
the medium used to collect opinions (for example, was information gathered by direct interview, telephone interview or self-administered questionnaire?)
the questions asked
whether iteration was used in the collation of opinions and if so, how it was used (for example, the Delphi technique).
4.4.1 Describe the impact of varying inputs in the cost-comparison analysis that are subject to uncertainty, as identified in section 4.2. Tabulate the results.
This section should be read with the NICE guide to the methods of technology appraisal, section 5.10. Only provide results of subgroup analyses if the technology does not provide similar or greater health benefits at a similar or lower cost to the comparator in the full population for whom the comparator has been recommended by NICE.
4.5.1 Please specify whether analysis of subgroups was carried out and how these subgroups were identified, referring to the scope and decision problem specified for the NICE technology appraisal. When specifying how subgroups were identified, confirm whether they were identified based on a prior expectation of different clinical or cost effectiveness because of known, biologically plausible mechanisms, social characteristics or other clearly justified factors. Cross refer to the clinical effectiveness section 3.7.
4.5.2 Clearly define the characteristics of patients in the subgroup.
4.5.3 If subgroup analyses were done, please present the results in tables similar to those in section 4.3.
4.6.1 When interpreting and concluding your economic evidence, consider the following:
Is the economic evaluation relevant to all groups of patients who could potentially use the technology as identified in the decision problem?
How relevant (generalisable) is the analysis to clinical practice in England?
What are the main strengths and weaknesses of the evaluation? How might these affect the interpretation of the results?
What further analyses could be carried out to enhance the robustness or completeness of the results?