PharmacoEconomics & Outcomes News 311 - 5 May 2001

population of England and Wales.NICE guidance for economic• Effects on social productivity may be evaluated ifevaluation updated considered sufficiently important for specific

healthcare technologies.The UK National Institute for Clinical Excellence• From the perspective of NICE, the resources that(NICE) has published new guidance documents for its

should be considered are those required for theTechnology Appraisal Programme. The documents arehealth and social care related to the use of theintended to replace the Interim Guidance tohealthcare technology. When modelling long-termManufacturers and Sponsors, first published inoutcomes from short-term clinical trials, only theSeptember 1999 and updated in December 1999.future healthcare resources used in managing theThe Technical Guidance for Manufacturers andlong-term sequelae of the disease in question shouldSponsors provides recommendations to helpbe included. Resources used by patients in receivingmanufacturers and sponsors of healthcare technologiestreatment (e.g. time and travel) should be recordedin the preparation of submissions, thereby assistingseparately.NICE in the identification of clinically effective and cost-

• The resources used during each treatment approacheffective technologies for the National Health Servicemust be presented separately, aggregrated in natural(NHS).units; total costs should be calculated by applying

Best available evidence standard unit values, which should generally reflectThe revised guidance states that the best outcomes the average cost to the NHS and PSS.

data are required, with a preference for final (rather than • Future costs should be discounted at 6% per annum,intermediate) outcomes from controlled, prospective and future outcomes should be discounted at 1.5%studies conducted in routine-care situations. However, per annum, according to current recommendationswhen an appraisal is necessary before the best from the Department of Health and Nationaloutcomes data are available, it is appropriate to use Assembly of Wales. These rates should be used inmodelling to adapt the best available data to the the base-case analysis, but sensitivity analysesproblem being addressed. should be conducted using, amongst others, the

The guidance contains the following combinations 6% per annum for costs and 0% perrecommendations. annum for outcomes, and 6% per annum for both• The evaluation should be conducted from the costs and outcomes.

perspective of the NHS and Personal Social Service • The results of the economic comparisons should be(PSS) decision-maker. subjected to sensitivity analysis testing wherever

• Either a cost-effectiveness or cost-utility analysis possible. When data are drawn from clinical trials,should be conducted, depending on the nature of 95% confidence intervals can be calculated for cost-the clinical disorder being addressed. Incremental effectiveness ratios; when data are drawn from acost-effectiveness ratios and/or cost-utility ratios variety of sources and used in a modellingshould be presented, as well as total costs and framework, probabilistic sensitivity analysis isoutcomes for each comparator. recommended.

• The time horizon of the analysis should span the • An analysis of the likely budget impact on the NHS ofperiod over which the main health effects and using the technology should be provided. For newhealthcare resource use are expected; this may technologies, this should include estimates of therequire extrapolation beyond the period for which changing budget impact over the first 3–5 yearsdata from controlled clinical trials are available. after product introduction and once diffusion has

• The comparator should usually be the most reached ‘steady state’. Any requirements for specificfrequently used intervention for the patient group in healthcare resources should also be explained.question, and will normally be determined by the • Detailed information on the probable clinical andscope of the appraisal by NICE in its request for social status of patients likely to benefit from thesubmissions. new technology should be provided. Any aspects of

• Preferred outcomes data are long-term clinical the technology which might impact on the personaleffectiveness (morbidity and mortality) with patient- costs of patients and their carers and families shouldassessed health status at each disease stage. These also be explained.data can be used in cost-effectiveness analyses and, The next review of the Technical Guidance forwhen combined with data on social preferences Manufacturers and Sponsors is planned for Februarybetween health states, in cost-utility analyses. 2004.Modelling techniques may be used to adjust efficacy

National Institute for Clinical Excellence. Technology appraisal programme: newdata to reflect what is expected in clinical practice. guidance documents. Internet Document : [76 pages], 6 Feb 2001. Available from:

URL: http://www.nice.org.uk/pdf/brdfeb01item6.pdf [Accessed on 20 Apr• The details of the studies from which outcomes and2001] 800817573cost data are drawn should be given, and the

implications of generalising the data to the NHS inEngland and Wales discussed.

• Subgroup analysis is justified when there is a soundbiological a priori rationale, and when evidenceexists that clinical effectiveness or cost effectivenessvaries between subgroups.

• In cost-utility analyses, health gain valuation mustreflect the health state preferences indicated by theanalytical perspectives; given the perspectivespreferred by NICE (the NHS and PSS perspectives),the most relevant values are those of the general

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PharmacoEconomics & Outcomes News 5 May 2001 No. 3111173-5503/10/0311-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved