3 Cost effectiveness

Section 3 provides detailed guidance on the level of information that should be provided in the evidence submission template about the cost effectiveness of the appraised technology.

When completing the template, also refer to the NICE guide to the methods of technology appraisal and the NICE guide to the processes of technology appraisal.

3.1 Published cost-effectiveness studies

Please provide the following in appendix G:

Identification of studies

Describe the strategies used to retrieve cost-effectiveness studies relevant to decision-making in England from published NICE technology appraisals, the published literature and from unpublished data held by the company. Justify the methods used with reference to the decision problem and the NICE reference case. Provide sufficient detail to enable the methods to be reproduced, and the rationale for any inclusion and exclusion criteria used.

Description of identified studies

Provide a brief overview of each cost-effectiveness study only if it is relevant to decision-making in England. Describe the aims, methods and results for each study. Each study's results should be interpreted with reference to a critical appraisal of its methodology. When studies have been identified and not included, justification for this should be provided. If more than 1 study is identified, please present the information in a table as suggested below.

Quality assessment of the identified studies

Provide a complete quality assessment for each relevant cost-effectiveness study identified. Use an appropriate and validated instrument, such as those of Drummond and Jefferson (1996)[a] or Philips et al. (2004)[b].

This section should be read with the NICE guide to the methods of technology appraisal, section 5.2.

[a] Drummond MF, Jefferson TO (1996) Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. British Medical Journal 313 (7052): 275–83

[b] Philips Z, Ginnelly L, Sculpher M, et al. (2004) Quality assessment in decision-analytic models: a suggested checklist (appendix 3). In: Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technology Assessment 8: 36

In the main submission, summarise the published cost-effectiveness studies using a table similar to the one below:

Table [X] Summary list of published cost-effectiveness studies

Study

Year

Summary of model

Patient population (average age in years)

QALYs (intervention, comparator)

Costs (currency) (intervention, comparator)

ICER (per QALY gained)

Study 1

Study 2

[Add more rows as needed]

Abbreviations: QALYs, quality-adjusted life years; ICER, incremental cost-effectiveness ratio.

3.2 Economic analysis

Summarise how the cost-effectiveness studies identified in appendix G inform the economic analysis.

If a de novo model economic model is included in the submission, please justify why this is necessary.

Patient population

3.2.1 State which patient groups are included in the economic evaluation and how they reflect the population defined in the scope and decision problem for the NICE technology appraisal, marketing authorisation or CE marking, and the population from the trials. If there are differences, please provide the rationale. Explain the implications of this for the relevance of the evidence base to the decision problem. For example, indicate if the population in the economic model is different from that described in the (draft) summary of product characteristics (SmPC) or information for use (IFU) and included in the trials.

Model structure

3.2.2 Describe the model structure and provide a diagram of the model submitted, including the following:

  • Type of analysis (for example, decision tree, Markov model, discrete event simulation model).

  • Justification of the chosen structure in line with the clinical pathway of care described in section 1.3.

  • How the model structure and its health states capture the disease or condition for patients identified in section 1.3.

  • Where appropriate, state the cycle length and whether a half-cycle correction has been applied.

3.2.3 Complete the table below presenting the features of the analysis. If there have been NICE technology appraisals in the same disease area, please summarise the main inputs to the economic models accepted by appraisal committees. If the model in this appraisal uses different inputs, give a rationale.

3.2.4 Compare and justify your chosen values with the methods specified by NICE in the reference case (see the NICE guide to the methods of technology appraisal, section 5, table 5.1).

Table [X] Features of the economic analysis

Previous appraisals

Current appraisal

Factor

TAXXX

TAXXX

Chosen values

Justification

Time horizon

Treatment waning effect?

Source of utilities

Source of costs

Intervention technology and comparators

3.2.5 If the intervention and comparator(s) are not implemented in the model as per their marketing authorisations or CE marking, describe how and why there are differences. Make it clear whether the intervention and comparator(s) included in the model reflect the decision problem. If not, briefly describe how and why, cross referencing to the decision problem section in your submission.

3.2.6 If a treatment continuation rule has been assumed for the intervention and comparator(s), provide the rationale for the continuation rule and where it is referenced (for example, [draft] SmPC, European public assessment report, comparator use, clinical practice, or clinical trial protocols). Please note that this refers to clinical continuation rules and not patient access schemes. If a treatment continuation rule is included in the model that is not stated in the (draft) SmPC or IFU, this should be presented as a separate scenario by considering it as an additional treatment strategy alongside the base-case interventions and comparators. Consideration should be given to the following:

  • the costs and health consequences of implementing the continuation rule (for example, any additional monitoring required)

  • the robustness and plausibility of the end point on which the rule is based

  • whether the 'response' criteria defined in the rule can be reasonably achieved

  • the appropriateness and robustness of the time at which response is measured

  • whether the rule can be incorporated into routine clinical practice

  • whether the rule is likely to predict those people for whom the technology is particularly cost effective

  • issues about withdrawal of treatment for people whose disease does not respond and other equity considerations.

3.3 Clinical parameters and variables

This section should be read with the NICE guide to the methods of technology appraisal, section 5.7.

When relevant, answers to the following questions should be derived from, and be consistent with, the clinical evidence section of the submission (section 2). Cross references to the clinical evidence section should be provided. If alternative sources of evidence have been used, the method of identification, selection and synthesis should be provided as well as justification for the approach. The answers should clearly specify the approach taken in the base-case analysis.

3.3.1 Describe how the clinical data were incorporated into the model, also commenting on the following factors:

  • Whether intermediate outcome measures were linked to final outcomes (for example, if a change in a surrogate outcome was linked to a final clinical outcome). If so, explain how the relationship was estimated, what sources of evidence were used, and what other evidence there is to support it.

  • Whether costs and clinical outcomes are extrapolated beyond the trial follow-up period(s). If so, explain and justify the assumptions that underpin this extrapolation, particularly the assumption that was used about the longer-term difference in effectiveness between the intervention and its comparator. For the extrapolation of clinical outcomes, present graphs of any curve fittings to patient-level data or Kaplan–Meier plots and the methods and results of any internal and external validation exercises. The NICE Decision Support Unit[2] has published technical support document 14, which provides additional information on the implementation of methods and reporting standards for extrapolation with patient level data.

3.3.2 Demonstrate how the transition probabilities were calculated from the clinical data. If appropriate, provide the transition matrix and describe the details of the transformation of clinical outcomes or any other relevant details here.

3.3.3 If there is evidence that transition probabilities may change over time for the treatment effect, condition or disease, confirm whether this has been included in the evaluation. If there is evidence that this is the case, but it has not been included, provide an explanation of why it has been excluded.

3.3.4 If clinical experts have assessed the applicability of the clinical parameters or approximated any of the clinical parameters, provide the following details:

  • 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).

3.4 Measurement and valuation of health effects

This section should be read with the NICE guide to the methods of technology appraisal, section 5.3.

The NICE Decision Support Unit[3] has published several technical support documents that provide additional information on measuring and valuing health benefits in economic evaluation:

  • An introduction to the measurement and valuation of health for NICE submissions (technical support document 8).

  • The identification, review and synthesis of health state utility values from the literature (technical support document 9).

  • The use of mapping methods to estimate health state utility values (technical support document 10).

  • Alternatives to EQ-5D for generating health state utility values (technical support document 11).

  • The use of health state utility values in decision models (technical support document 12).

Health-related quality-of-life data from clinical trials

3.4.1 If health-related quality-of-life data were collected in the clinical trials identified in section 2, comment on whether the data are consistent with the reference case. Consider the following points, but note that this list is not exhaustive:

  • method of elicitation

  • method of valuation

  • point when measurements were made

  • consistency with reference case

  • appropriateness for cost-effectiveness analysis

  • results with confidence intervals.

Mapping

3.4.2 If applicable, describe the mapping methods used to estimate health state utility values from the quality-of-life data collected in clinical trials. Please include the following information:

  • which tool was mapped from and onto which other tool (for example, SF-36 to EQ-5D)

  • details of the methodology used

  • details of validation of the mapping technique

  • if the mapping technique is published or has been used in other NICE technology appraisals for similar diseases or health conditions.

Health-related quality-of-life studies

  • In appendix H describe how systematic searches for relevant health-related quality-of-life data were done. Consider published and unpublished studies, including any original research commissioned for the technology. Provide the rationale for terms used in the search strategy and any inclusion and exclusion criteria used. The search strategy used should be provided in the appendix.

  • Tabulate the details of the studies in which health-related quality of life was measured. Include the following, but note that this list is not exhaustive:

    • population in which health effects were measured

    • information on recruitment (for example, participants of a clinical trial, approximations from clinical experts, utility elicitation exercises including members of the general public or patients)

    • interventions and comparators

    • sample size

    • response rates

    • description of health states

    • adverse reactions

    • appropriateness of health states given the condition and treatment pathway

    • method of elicitation

    • method of valuation

    • mapping

    • uncertainty around values

    • consistency with reference case.

3.4.3 Present the results (including confidence intervals) of the studies identified in the literature review. Highlight any key differences between the values derived from the literature search and those reported in or mapped from the clinical trials. Comment on the appropriateness of the study for the cost-effectiveness analysis.

Adverse reactions

3.4.4 Describe how adverse reactions affect health-related quality of life. The effect of adverse reactions on health-related quality of life should be explored regardless of whether they are included in a cost-effectiveness analysis in the base-case analysis. Any exclusion of the effect of adverse reactions on health-related quality of life in the cost-effectiveness analysis should be fully justified.

Health-related quality-of-life data used in the cost-effectiveness analysis

3.4.5 Define what a patient experiences in the health states in terms of health-related quality of life in the cost-effectiveness analysis. Explain how this relates to the aspects of the disease or condition that most affect patients' quality of life.

3.4.6 Clarify whether health-related quality of life is assumed to be constant over time in the cost-effectiveness analysis. If not, provide details of how it changes over the course of the disease or condition.

3.4.7 If appropriate, describe whether the baseline health-related quality of life assumed in the cost-effectiveness analysis is different from the utility values used for each of the health states. State whether quality-of-life events were taken from this baseline.

3.4.8 If the health state utility values used in the cost-effectiveness analysis have been adjusted, describe how and why they have been adjusted, including the methodologies used.

3.4.9 Identify any health effects found in the literature or clinical trials that were excluded from the cost-effectiveness analysis and explain their exclusion.

3.4.10 In a table, summarise the utility values chosen for the cost-effectiveness analysis, referencing values obtained in sections 3.4.1 to 3.4.4. Justify the choice of utility values, giving consideration to the reference case. For continuous variables, mean values should be presented and used in the analyses. For all variables, measures of precision should be detailed. See below for a suggested table format.

Table [X] Summary of utility values for cost-effectiveness analysis

State

Utility value: mean (standard error)

95% confidence interval

Reference in submission (section and page number)

Justification

Health state 1

HS1

Health state 2

HS2

[Add more rows as needed]

Adverse reaction 1

AR1

Adverse reaction 2

AR2

Abbreviations: HS, health state; AR, adverse reaction.

3.4.11 If clinical experts assessed the applicability of the health state utility values available or approximated any of values, provide the details (see section 3.3.4).

3.5 Cost and healthcare resource use identification, measurement and valuation

This section should be read with the NICE guide to the methods of technology appraisal, section 5.5.

3.5.1 All parameters used to estimate cost effectiveness should be presented clearly in a table with details of data sources. For continuous variables, mean values should be presented and used in the analyses. For all variables, measures of precision should be detailed.

Resource identification, measurement and valuation studies

  • In appendix I describe how relevant cost and healthcare resource use data for England were identified. Include the search strategy and inclusion criteria, and consider published and unpublished studies to demonstrate how relevant cost and healthcare resource use data for England were identified. The search strategy used should also be provided in the appendix. If the systematic search yields limited data for England, the search strategy may be extended to capture data from other countries. Please give the following details of included studies:

    • country of study

    • date of study

    • applicability to clinical practice in England

    • cost valuations used in the study

    • costs for use in the economic analysis

    • technology costs.

3.5.2 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 with reference to section 2.

3.5.3 If clinical experts assessed the applicability of the cost and healthcare resource use values available, or approximated any of the values used in the cost-effectiveness analysis, provide the details (see section 3.3.4).

Intervention and comparators' costs and resource use

3.5.4 In a table, summarise the cost and associated healthcare resource use of each treatment. A suggested format for a table is provided below. Provide a rationale for the choice of values used in the cost-effectiveness model discussed in section 3.1.

Table [X] Unit costs associated with the technology in the economic model

Items

Intervention (confidence interval)

Reference in submission

Comparator 1 (confidence interval)

Reference in submission

[Add more columns as needed]

Technology cost

Mean cost of technology treatment

Administration cost

Monitoring cost

Tests

[Add more rows as needed]

Total

Health-state unit costs and resource use

3.5.5 Summarise and tabulate the costs included in each health state. A suggested format for a table is provided below. Cross refer to other sections of the submission for the resource costs. Provide a rationale for the choice of values used in the cost-effectiveness model. The health states should refer to the states in section 3.2.

Table [X] List of health states and associated costs in the economic model

Health states

Items

Value

Reference in submission

Health state 1

Technology

Staff

Hospital costs

[Add more rows as needed]

Total

Health state 2

[Add more rows as needed]

Adverse reaction unit costs and resource use

3.5.6 Summarise and tabulate the costs for each adverse reaction listed in section 2.10 and included in the cost-effectiveness analysis. A suggested format for a table is provided below. Cross refer to other sections of the submission for the resource costs.

Table [X] List of adverse reactions and summary of costs in the economic model

Adverse reactions

Items

Value

Reference in submission

Adverse reaction 1

Technology

Staff

Hospital costs

[Add more rows as needed]

Total

Adverse reaction 2

Technology

Staff

[Add more rows as needed]

Miscellaneous unit costs and resource use

3.5.7 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.

3.6 Summary of base-case analysis inputs and assumptions

This section should be read with the NICE guide to the methods of technology appraisal, section 5.11.1.

Summary of base-case analysis inputs

3.6.1 Tabulate all variables included in the cost-effectiveness analysis, detailing the values used, range (for example, confidence interval, standard error or distribution) and source. Cross refer to other parts of the submission. Complete the table below that summarises the variables applied in the economic model.

3.6.2 For the base-case analysis the company should ensure that the cost-effectiveness analysis reflects the NICE reference case as closely as possible. Describe the rationale if an input chosen in the base-case analysis:

  • deviates from the NICE reference case or

  • is taken from other sources (such as the published literature) rather than data from clinical trials of the technology (when available).

Table [X] Summary of variables applied in the economic model

Variable

Value (reference to appropriate table or figure in submission)

Measurement of uncertainty and distribution: CI (distribution)

Reference to section in submission

[Age]

[A years]

[x to y (normal)]

[Patient characteristics section X]

[Overall survival]

[B months]

[x to y (Weibull)]

[Trial results section x]

[Add more rows as needed]

Abbreviations: CI, confidence interval.

Assumptions

3.6.3 Provide a list of all assumptions used in the economic model and justify each assumption.

3.7 Base-case results

This section should be read with the NICE guide to the methods of technology appraisal, sections 5.7.4 and 5.11.2 to 5.11.3.

3.7.1 Provide the results of the analysis. In particular, results should include, but are not limited to, the following:

  • the link between clinical- and cost-effectiveness results

  • costs, QALYs and incremental cost per QALY

  • disaggregated results such as life years gained, costs associated with treatment, costs associated with adverse reactions, and costs associated with follow-up or subsequent treatment.

Base-case incremental cost-effectiveness analysis results

3.7.2 When presenting the results of the base-case incremental cost-effectiveness analysis in the table below, list the interventions and comparator(s) from least to most expensive. Present incremental cost-effectiveness ratios (ICERs) compared with baseline (usually standard care) and then incremental analysis, ranking technologies in terms of dominance and extended dominance. If the company has formally agreed a patient access scheme with the Department of Health, present the results of the base-case incremental cost-effectiveness analysis with the patient access scheme.

Table [X] Base-case results

Technologies

Total costs (£)

Total LYG

Total QALYs

Incremental costs (£)

Incremental LYG

Incremental QALYs

ICER versus baseline (£/QALY)

ICER incremental (£/QALY)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Abbreviations: ICER, incremental cost-effectiveness ratio; LYG, life years gained; QALYs, quality-adjusted life years.

In appendix J please provide the following:

Clinical outcomes from the model

For the outcomes highlighted in the decision problem (see section 1) provide the corresponding outcomes from the model and compare them with clinically important outcomes such as those reported in clinical trials, as suggested in the table below. Discuss reasons for any differences between the modelled results in the cost-effectiveness analysis and the observed results in the clinical trials (for example, adjustment for crossover).

Table [X] Summary of model results compared with clinical data

Outcome

Clinical trial result

Model result

Progression-free survival

C1

R1

Post-progression survival

C2

R2

Overall survival

C1+2

R1+2

Adverse reaction 1

C3

R3

[Add more rows as needed]

Provide (if appropriate) the proportion of the cohort in the health state over time (Markov trace) for each state, supplying 1 for each comparator.

Provide details of how the model assumes QALYs accrued over time. For example, Markov traces can be used to demonstrate QALYs accrued in each health state over time.

Disaggregated results of the base-case incremental cost-effectiveness analysis

Provide details of the disaggregated QALYs and costs by health state, and of resource use predicted by the model in the base-case incremental cost-effectiveness analysis by category of cost. The tables that should be completed summarising the disaggregated results (for example, QALY gain by health state, costs by health state, predicted resource use by category of cost) are presented below.

Table [X] Summary of QALY gain by health state

Health state

QALY intervention (X)

QALY comparator (Y)

Increment

Absolute increment

% absolute increment

[Health state 1]

[XHS1]

[YHS1]

[XHS1 – YHS1]

[|XHS1 – YHS1|]

[|XHS1 – YHS1|/(Total absolute increment)]

[Health state 2]

[XHS2]

[YHS2]

[XHS2 – YHS2]

[|XHS2 – YHS2|]

[|XHS2 – YHS2|/(Total absolute increment)]

[Add more rows as needed]

Total

[XTotal]

[YTotal]

[XTotal – YTotal]

Total absolute increment

100%

Abbreviations: QALY, quality-adjusted life year; HS1, health state 1; HS2, health state 2

Adapted from Pharmaceutical Benefits Advisory Committee (2008) Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Canberra: Pharmaceutical Benefits Advisory Committee.

Table [X] Summary of costs by health state

Health state

Cost intervention (X)

Cost comparator (Y)

Increment

Absolute increment

% absolute increment

[Health state 1 (HS1)]

[XHS1]

[YHS1]

[XHS1 – YHS1]

[|XHS1 – YHS1|]

[|XHS1 – YHS1| / (Total absolute increment)]

[Health state 2]

[XHS2]

[YHS2]

[XHS2 – YHS2]

[|XHS2 – YHS2|]

[|XHS2 – YHS2| / (Total absolute increment)]

[Add more rows as needed]

Total

[XTotal]

[YTotal]

[XTotal – YTotal]

Total absolute increment

100%

Abbreviations: HS1, health state 1; HS2, health state 2

Adapted from Pharmaceutical Benefits Advisory Committee (2008) Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Canberra: Pharmaceutical Benefits Advisory Committee.

Table [X] Summary of predicted resource use by category of cost

Item

Cost intervention (X)

Cost comparator (Y)

Increment

Absolute increment

% absolute increment

[Technology cost]

[Xtech]

[Ytech]

[Xtech – Ytech]

[|Xtech – Ytech|]

[|Xtech – Ytech| / (Total absolute increment)]

[Mean total treatment cost]

[Xtreat]

[Ytreat]

[Xtreat – Ytreat]

[|Xtreat – Ytreat|]

[|Xtreat – Ytreat| / (Total absolute increment)]

[Administration cost]

[Xadmin]

[Yadmin]

[Xadmin – Yadmin]

[|Xadmin – Yadmin|]

[|Xadmin – Yadmin| / (Total absolute increment)]

[Monitoring cost]

[Xmon]

[Ymon]

[Xmon – Ymon]

[|Xmon – Ymon|]

[|Xmon – Ymon| / (Total absolute increment)]

[Tests]

[Xtests]

[Ytests]

[Xtests – Ytests]

[|Xtests – Ytests|]

[|Xtests – Ytests| / (Total absolute increment)]

[Add more rows as needed]

Total

[XTotal]

[YTotal]

[XTotal – YTotal]

Total absolute increment

100%

Abbreviations: Tech, technology; treat, treatment; admin, administration; mon, monitoring.

3.8 Sensitivity analysis

This section should be read with the NICE guide to the methods of technology appraisal, sections 5.7 and 5.8.

Probabilistic sensitivity analysis

3.8.1 All inputs used in the analysis will be estimated with a degree of imprecision. As specified in the NICE guide to the methods of technology appraisal, probabilistic sensitivity analysis is preferred for translating the imprecision in all input variables into a measure of decision uncertainty in the cost effectiveness of the options being compared. In non-linear decision models, probabilistic methods provide the best estimates of mean costs and outcomes. The mean value, distribution around the mean, and the source and rationale for the supporting evidence should be clearly described for each parameter included in the model. The distributions for probabilistic sensitivity analysis should not be arbitrarily chosen, but should represent the available evidence on the parameter of interest, and their use should be justified.

Provide the information specified below:

3.8.2 The distributions and their sources for each parameter should be clearly stated if different from those presented in section 3.5, including the derivation and value of 'priors'. If any parameters or variables were omitted from the probabilistic sensitivity analysis, please provide the rationale for the omission(s).

3.8.3 Present the incremental cost-effectiveness results of a probabilistic sensitivity analysis (including 95% confidence intervals). Include scatter plots and cost-effectiveness acceptability curves showing the probability that the treatment is cost effective if the ICER is £20,000 to £30,000 per QALY gained. Describe how the probabilistic ICER(s) were calculated and provide the rationale.

3.8.4 Describe and explain, if any, the variation between the incremental cost-effectiveness analysis results estimated from the base-case analysis (section 3.7) and the probabilistic sensitivity analysis.

Deterministic sensitivity analysis

3.8.5 Identify which variables were subject to deterministic sensitivity analysis, how they were varied, and the rationale behind this. Only report analyses when there is genuine uncertainty about a parameter, giving a rationale for why this is the case.

3.8.6 For example, there may be uncertainty about the extrapolation of outcomes or costs beyond the time horizon of a trial.

  • Do not deviate from the reference case. For example, there should not be sensitivity analysis around the discount rate for costs and outcomes.

  • Ensure that values are clinically plausible and not extreme. For example, do not present analyses assuming no treatment effect for comparators.

3.8.7 Present the results of deterministic sensitivity analysis, focusing on the key drivers of the model. Consider the use of tornado diagrams.

3.8.8 For technologies whose final price or acquisition cost has not been confirmed, sensitivity analysis should be done over a plausible range of prices. This may also include the price of a comparator that includes a confidential patient access scheme.

Scenario analysis

3.8.9 Sensitivity analysis should be used to explore uncertainty around the structural assumptions used in the analysis. Analysis of a representative range of plausible scenarios should be presented and each alternative analysis should present separate results.

3.8.10 Present the results of scenario analysis. Include details of structural sensitivity analysis.

Summary of sensitivity analyses results

3.8.11 Describe the main findings of the sensitivity analyses, highlighting the key drivers of the cost-effectiveness results.

3.9 Subgroup analysis

This section should be read with the NICE guide to the methods of technology appraisal, section 5.10.

When subgroups have been considered in the cost-effectiveness analysis, provide the information specified in sections 3.9.1 to 3.9.6.

3.9.1 Types of subgroups that are not considered relevant are those based solely on the following factors:

  • Individual utilities for health states and patient preference.

  • Different treatment costs for individuals according to their social characteristics.

  • Subgroups specified according to the costs of providing treatment in different locations in England (for example, when the costs of facilities available for providing the technology vary according to location).

3.9.2 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 2.6.

3.9.3 Clearly define the characteristics of patients in the subgroup.

3.9.4 Describe how the statistical analysis was carried out.

3.9.5 If subgroup analyses were done, please present the results in tables similar to those used in section 2.7.

3.9.6 Identify any obvious subgroups that were not considered and explain why. Please refer to the subgroups identified in the decision problem in section 1.

3.10 Validation

Validation of cost-effectiveness analysis

3.10.1 When describing the methods used to validate and quality assure the model, provide:

  • the rationale for using the chosen methods

  • references to the results produced and cross references to the evidence identified in the clinical evidence, measurement and valuation of health effects, and cost and healthcare resource sections.

3.11 Interpretation and conclusions of economic evidence

3.11.1 When interpreting and concluding your economic evidence, consider the following:

  • Are the results from this economic evaluation consistent with the published economic literature? If not, why do the results from this evaluation differ, and why should the results in the submission be given more credence than those in the published literature?

  • 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?



[2] Although the Decision Support Unit is funded by NICE, technical support documents are not formal NICE guidance or policy.

[3] Although the Decision Support Unit is funded by NICE, technical support documents are not formal NICE guidance or policy.