Pharmacoeconomic Guidelines: England & Wales
Country/Region: England & Wales
Submission Guidelines
NICE health technology evaluations: the manual (January 2022) https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation
Health technology evaluations: interim methods and process guide for the proportionate approach to technology appraisals https://www.nice.org.uk/process/pmg40/chapter/developing-guidance
Submission Guidelines Source:
National Institute for Health and Care Excellence (NICE)
http://www.nice.org.uk/
http://www.nice.org.uk/
Additional Information:
NICE health technology evaluation topic selection: the manual (January 2022) https://www.nice.org.uk/process/pmg37/chapter/about-this-guide
Information current as of Friday, November 17, 2023
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | NICE health technology evaluations: the manual (January 2022) |
| Affiliation of authors | National Insititue for Health and Care Excellence (NICE) |
| Purpose of the document | This manual explains how NICE does health technology evaluations. It includes both the processes we use – that is, what steps happen, when, and who is involved – and the methods – that is, how different types of evidence are collected and considered, and the principles and considerations that go into making recommendations. The processes and methods are presented throughout the manual, to show what happens and how throughout the evaluation process. |
| Standard reporting format included | Yes, templates available here: https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance |
| Disclosure | No |
| Target audience of funding/ author's interests | All organizations considering submitting evidence to the Technology Appraisal Program of the Institute. |
| Perspective | For the reference case, the perspective on outcomes should be all direct health effects, whether for patients or, when relevant, carers. The perspective on costs is National Health Service (NHS) and Personal Social Services (PSS). |
| Indication | Licensed indication |
| Target population | Must be clearly described |
| Subgroup analysis | Subgroup analysis should be clearly justified. |
| Choice of comparator | Relevant comparators for the technology being appraised are those routinely used in the NHS, and therapies regarded as best practice when this differs from routine practice. Defined in the scope developed by NICE. |
| Time horizon | The time horizon for estimating clinical effectiveness and value for money should be long enough to reflect all important differences in costs or outcomes between the technologies being compared. |
| Assumptions required | Must be clearly described and justified |
| Preferred analytical technique | Two forms of economic evaluation are available for guidance-producing programmes in the Centre for Health Technology Evaluation: Cost-utility (with fully incremental analysis) and cost-comparison analysis. |
| Costs to be included | Costs should relate to NHS and PSS resources. |
| Source of costs | Costs should relate to NHS and PSS resources and should be valued using the prices relevant to the NHS and PSS. |
| Modeling | Yes. |
| Systematic review of evidences | Yes. |
| Preference for effectiveness over efficacy | Yes. |
| Preferred outcome measure | Health effects should be expressed in quality adjusted life years (QALYs). |
| Preferred method to derive utility | The measurement of changes in health-related quality of life should be reported directly from patients and the utility of these changes should be based on public preferences using a choice-based method. Given the need for consistency across evaluations, the EQ-5D measurement method is preferred to measure health-related quality of life in adults. |
| Equity issues stated | Yes. |
| Discounting costs | For the reference case, costs should be discounted at the same rate of 3.5% per year. Alternative analyses using rates of 1.5% for costs may be presented alongside the reference-case analysis, in specific circumstances. |
| Discounting outcomes | For the reference case, health effects should be discounted at the same rate of 3.5% per year. Alternative analyses using rates of 1.5% for health effects may be presented alongside the reference-case analysis, in specific circumstances. |
| Sensitivity analysis-parameters and range | All inputs used in the analysis will be estimated with a degree of imprecision. Appropriate ways of presenting uncertainty in cost-effectiveness data parameter uncertainty include confidence ellipses and scatter-plots on the cost-effectiveness plane (when the comparison is restricted to two alternatives) and cost-effectiveness acceptability curves (a graph that plots a range of possible maximum acceptable ICERs on the horizontal axis against the probability (chance) that the intervention will be cost effective at that ICER on the vertical axis). The presentation of cost-effectiveness acceptability curves should include a representation and explanation of the cost-effectiveness acceptability frontier (a region on a plot that shows the probability that the technology with the highest expected net benefit is cost effective). Present results exploring uncertainty in a table, identifying parameters that have a substantial effect on the modelling results. |
| Sensitivity analysis-methods | Probabilistic and deterministic sensitivity analyses |
| Presenting results | The result presentation templates provided by NICE in the submission documents and appendices should be followed. All data used to estimate clinical and cost effectiveness should be presented clearly in tabular form and include details of data sources. |
| Incremental analysis | Yes. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes. |
| Portability of results (Generalizability) | In NHS context |
| Financial impact analysis | Yes, estimates of net NHS (and PSS, when appropriate) costs of the expected resource impact should be provided to allow effective national and local financial planning. The cost should be disaggregated by appropriate generic organization (NHS, PSS, hospital, primary care) and budgetary categories (for example, drugs, staffing, consumables or capital). |
| Mandatory or recommended or voluntary | Recommended |
Acknowledgement:
Anuja Chatterjee - Health Technology Assessment Analyst, Technology Appraisals
Zoe Garrett - Senior Technical Advisers, Science Policy and Research Programme