NICE's position
Disease-specific reference case extensions
1. To enable standardised health economic modelling approaches to inform guidance development, NICE will develop reference case extensions in selected disease areas or conditions.
2. Some of the evidence on which the reference case is based will be stronger for some elements than others. Where there is clearly a best approach, the extension will make it clear that a specific element is 'required'. Where there is some uncertainty, an assumption or method will be 'recommended'. Reference case extensions will also evolve as new evidence becomes available (for example, elements may be revised from 'recommended' to 'required').
3. Reference case extensions will only add detail to the NICE reference case and will not contradict it.
4. Deviations from reference case extensions should be explained and justified by companies, EAGs and guideline developers, and agreed through committees and NICE's quality assurance processes. NICE will keep the reference case extensions under review to assess whether updates are needed.
5. The reference case extension development process will include extensive engagement opportunities. Workshops during the design of a reference case extension will allow patient advocates, clinicians, commissioners, industry stakeholders, health economic modellers and data scientists to give feedback and be involved in the process.
6. All stakeholders will be invited to participate in a non-competitive space (that is, a reference case extension is not developed as part of a specific appraisal) to avoid any perceived unfair advantages to any particular stakeholder.
7. When NICE is aware of a model (or models) that meets one of its reference case extensions, it will notify stakeholders.
8. In some circumstances, NICE will consider building its own reference model.
9. NICE acknowledges the operational challenges of developing and using reference models, such as model ownership, resourcing and maintenance, and management of confidential company data, and will continue to explore their use.
10. If NICE decides a reference model would be useful, it will consider doing any of the following:
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adapting a model that is already being developed within NICE processes (for example, for guideline updates or for multiple technology appraisals [MTAs])
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using an existing model that can be adapted for NICE's purposes
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developing a new model.
Topic selection
11. Selection of topics for future disease-specific reference case extensions will focus on NICE's high-priority clinical areas.
12. Prioritisation will also consider which areas can gain significant benefit from a prescribed approach. For example, where:
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committees, EAGs, stakeholders or NICE technical staff have identified significant methodological weaknesses or inconsistencies in modelling approaches in existing models, or
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modelling methods are not yet well established, such as when there are new technologies in the pipeline that will significantly change the management of a disease area or condition, or
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there is a high level of innovation in a disease area and the volume of new products being developed in parallel risks inconsistent approaches to modelling.
13. NICE's intention to develop a reference case extension for a disease area or condition will be signalled to external stakeholders through our usual processes to ensure that any model development can be aligned.