Process and methods

2 Developing the scope

2.1 Introduction

2.1.1 The 'scoping' process examines the appropriateness of the proposed remit and defines what the appraisal will and will not examine. Scoping determines the nature and content of the evidence to be included in the assessment phase of the appraisal. However, the Appraisal Committee may consider issues that are not defined in the scope if necessary in the light of the evidence provided. Further details of the scoping process, including the identification of interested parties and consultation on documents, can be found in documents relating to the technology appraisal process (see section 7) and on our website for the topic selection process.

2.1.2 The scope provides a framework for the appraisal. It defines the issues of interest (for example, population, comparators, and health outcome measures) and sets the boundaries for the work undertaken by the independent academic groups and the manufacturer(s) or sponsor(s) of the technology who produce reports for the Appraisal Committee.

2.1.3 The issues for consideration in the appraisal that are described in the scope include:

  • the disease or health condition and the population(s) for whom treatment with the technology is being appraised

  • the technology (and the setting for its use; for example, hospital [inpatient and outpatient] or community if relevant)

  • the relevant potential comparator technologies (and the setting for their use if relevant)

  • the principal health outcome measures appropriate for the analysis

  • the costs, including when the Department of Health asks NICE to consider costs (savings) to the public sector outside the NHS and personal social services

  • the time horizon over which health effects and costs will be assessed

  • consideration of patient subgroups for whom the technology might be particularly clinically and cost effective

  • issues relating to advancing equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and society as a whole

  • other special considerations and issues that are likely to affect the appraisal, for example, existing relevant NICE guidance and the innovative nature of the technology.

2.2 Components of the scope

Background information on the disease or health condition

2.2.1 The scope briefly describes the disease or health condition relevant to the technology under appraisal together with appropriate information on its prognosis, epidemiology and alternative treatments currently used in the NHS.

The technology

2.2.2 The scope includes information about the marketing authorisation (or CE mark for medical devices) of the technology, and the stage of regulatory approval for technologies not yet licensed. It may include a brief description of the clinical trials on which the licensed indication is based. The scope specifies the mode of administration and the circumstances of use, particularly if different from that of alternative treatments for the same patient group, or when there are several other circumstances in which the technology may be used.

The population

2.2.3 The scope defines the population for whom the technology is being appraised as precisely as possible. When the technology is a medicine, the marketing authorisation will generally specify the therapeutic indications. The scope may highlight potential subgroups of the population for whom the clinical or cost effectiveness of the technology might be expected to differ from the overall population, or who require special consideration.

The comparator technologies

2.2.4 The scope identifies all potentially relevant comparators, taking into account issues likely to be considered by the Appraisal Committee when selecting the most appropriate comparator (see sections 6.2.1–4). At this stage of the appraisal, identification of comparators should be inclusive.

2.2.5 Comparator technologies may include branded and non-proprietary (generic) drugs and biosimilar products.

2.2.6 Sometimes both the technology and comparator form part of a treatment sequence in the pathway of care. In these cases the appraisal may compare alternative treatment sequences.

The evidence base

2.2.7 The scoping process should highlight issues about the available evidence base, for example, emerging key trials, important clinical databases, availability of relevant health-related quality of life data, and the evidence around comparator technologies.

The measures of health outcome

2.2.8 As far as possible, the scope identifies principal measures of health outcome(s) that will be relevant for the estimation of clinical effectiveness. That is, they measure health benefits and adverse effects that are important to patients and/or their carers. The clinical outcome measures usually quantify an impact on survival or health-related quality of life that translates into quality-adjusted life years (QALYs) for the evaluation of cost effectiveness.

The measures of costs

2.2.9 The potential impact on resource costs and savings that would be expected from the introduction of the technology should be considered from the perspective of the NHS and personal social services. In exceptional circumstances, when requested by the Department of Health in the remit for the appraisal, the scope will list requirements for adopting a broader perspective on costs.

Other issues likely to impact upon the appraisal

2.2.10 The scope includes details of:

  • related NICE guidance, such as other technology appraisals and clinical guidelines

  • related policy developments

  • details of service settings related to the technology under appraisal that are either of particular interest or are to be excluded from consideration

  • the potential innovative nature of the technology, in particular its potential to make a significant and substantial impact on health-related benefits that are unlikely to be included in the QALY calculation during assessment

  • issues relating to advancing equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and society as a whole.