Process and methods
Appendix D: Routing considerations used by the topic oversight group
- Considerations for routing technologies to the medical technologies evaluation programme
- Considerations for routing technologies to the diagnostic assessment programme
- Considerations for routing technologies to the interventional procedures programme
- Considerations for routing technologies to the technology appraisals programme
- Considerations for routing technologies to the NICE guidelines programme
- Considerations for routing to other NICE programmes or national organisations for evaluation
The topic oversight group applies the selection criteria (appendix B) to technologies under consideration. For selected technologies, it then decides to which evaluation programme technologies should be routed; this is usually but not always a NICE programme. The considerations the topic oversight group applies in making these routing decisions are based on the remits of the individual programmes and the characteristics of the technologies being routed.
Following on from the principles for developing medical technologies guidance, the specific considerations for routing a technology to the medical technologies evaluation programme are:
the technology appears likely to achieve a similar clinical benefit at less cost or more benefit at the same cost as current practice evidence on its costs and benefits can be assessed on the basis of a sponsor's future submission
the technology has characteristics that distinguish it from other technologies for the same indication(s) and can, therefore, be evaluated as an individual product or device
there are no major outstanding safety concerns relating to the technology
there is likely to be value in developing guidance for the health and social care system in a relatively short timescale.
When identifying suitable technologies for evaluation through this programme, consideration is given to promoting research, in particular whether the health and social care system can contribute to generating additional evidence by using the technology on a trial basis.
The diagnostics assessment programme evaluates diagnostic technologies that have the potential to improve health outcomes, but the introduction of the technology is likely to result in an overall increase in resource costs to the health and social care system.
This programme is likely to be suitable for evaluating diagnostic tests and technologies for which recommendations could only be made on the basis of clinical utility and cost-utility analysis. There should normally be a 'gold standard' or established comparator to enable an assessment of potential benefit of the technology. This programme can evaluate classes of technologies or individual technologies.
Diagnostic technologies that appear likely to achieve a similar clinical benefit at less cost or more benefit at the same cost as current practice in the health and social care system may be more suitable for evaluation by the medical technologies evaluation programme.
The specific considerations for routing a technology to the interventional procedures programme are:
it is used in an interventional procedure that involves an incision or entry into a body cavity, use of radiation, or acoustic or electromagnetic energy
the procedure in which the technology is used is new (that is, it is being used in the health and social care system for the first time)
there is uncertainty about the efficacy or safety of the procedure in which the technology is used
comparative effectiveness and health economic considerations are not relevant at this point
interventional procedure guidance on the safety and efficacy of the technology will benefit the health and social care system and patients.
For details of the routing considerations for technology appraisals, see the NICE guide to the processes of technology appraisal.
Technologies routed to the technology appraisals programme progress to the pre-scoping stage of the existing topic selection process (decision point 3). Therefore their progress through topic selection is not disadvantaged compared with technologies that go through the standard technology appraisals topic selection process.
Companion diagnostic technologies with the primary purpose of enhancing the clinical or cost effectiveness of pharmaceutical products may be suitable for this programme if the pharmaceutical product that they are intended to enhance is appraised. In other cases, companion diagnostic technologies may be more suitable for evaluation by the diagnostics assessment programme.
NICE guidelines comprise recommendations, based on the best available evidence, on the appropriate management of specific diseases and conditions. A technology is more likely to be routed for consideration to this programme if:
there are a number of equivalent technologies available
the equivalent technologies have been available in clinical practice for some time
the benefits of the technology are likely to be best evaluated in the context of a care pathway in development or already developed by NICE.
Technologies selected for routing to the NICE guidelines programme are not disadvantaged compared with technologies that go through the standard topic selection process. For more details, please refer to developing NICE guidelines: the manual.
A technology may not meet the criteria for evaluation by a NICE guidance programme but may in the view of the topic oversight group benefit from evaluation by another NICE programme or other national organisation. In these circumstances, the topic oversight group identifies the programme appropriate to consider the technology. NICE then either routes directly to a NICE programme or notifies the relevant external organisation. Any routing to an external organisation is with the agreement of the sponsor of the technology.