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Key
Features: |
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| Title and year of the Document | NICE Technology Appraisals No. 5, 2001 Guidance for manufacturers and sponsors |
| Affiliation of authors | National Institute for Clinical Excellence (NICE) |
| Main policy objective | Assist manufacturers and sponsors to frame their submissions and help the NICE discharge its duty to the Secretary of State in identifying clinically effective and cost-effective technologies for the NHS, to remove unfairness in the availability of technologies in different localities and to minimize the possibility of inequity being introduced. |
| Standard reporting format included | Yes |
| Disclosure | Not stated |
| Target audience of funding/ author’s interests | Manufacturers and sponsors |
| Perspective | NHS & Personal Social Service decision-makers |
| Indication | Approved one(s) |
| Target population | Yes, age and sex distribution and co-morbidities. |
| Subgroup analysis | Yes, especially high risk patients |
| Choice of comparator | Main comparator is the most frequently used intervention. |
| Time horizon | Should cover the period over which the main health effects and health care resource use are expected to be experienced. |
| Assumptions required | Yes |
| Preferred analytical technique | CEA or CUA |
| Costs to be included | All relevant direct costs and social services costs from NHS and PPS. Resources used by patients should be recorded separately. |
| Source of costs | Use standard unit cost reflecting average cost to the NHS and PPS. Clearly state the source. |
| Modeling | Yes, requires details |
| Systematic review of evidences | Yes, Preferred prospective RCT with a naturalistic design |
| Preference for effectiveness over efficacy | Yes, especially long-term clinical effectiveness with self-assessment of health status by patients at each stage of disease progression |
| Preferred outcome measure | Default: Quality of life, final outcomes. Health improvement should be expressed in “standard measures for combining life years and quality of life” |
| Preferred method to derive utility | Provide a reasonable basis and derived based on the general population of England and Wales |
| Equity issues stated | Yes |
| Discounting costs | Base and SA: at 6%; |
| Discounting outcomes | Base: benefit at 1.5%; SA: 6%, 0% |
| Sensitivity analysis-parameters and range | All the data sources must be justified and point estimate, ranges and distribution of values identified to test best case and worst case scenario. |
| Sensitivity analysis-methods | Probabilistic SA, Baysian approaches. |
| Presenting results | In disaggregated form so that the nature and extent of differences between comparators are easily seen. Quantities of resources used and unit costs for each type of resource should be presented separately. |
| Incremental analysis | Yes |
| Total C/E | Yes |
| Portability of results (Generalizability) | Yes, settings, populations and methods |
| Financial impact analysis | Yes, on the NHS system. Estimates over a 3 to 5 year period. |
| Mandatory or recommended or voluntary | |
