Table 1.

Data extracted

Category of data	Specific items recorded
Appraisal characteristics	Date of publication
	Appraisal process (STA or MTA)
	Type of document (ACD or FAD)
	Was the guidance an update to a previous appraisal?
	Has the guidance been subsequently reviewed?
Technology and condition	Prevalence and incidence of the condition
	Total population size
	Type of technology (pharmaceutical, device, diagnostic, other)
Guidance	Type of recommendation (OIR or AWR)
	Type of research recommended (experimental or observational)
	Recommendations for subgroups and subgroup definitions
	Was the guidance conditional on a PAS?
Cost effectiveness	Sponsor and independent Assessment Group estimates:
	the ICERs for the whole population and the OIR/AWR subgroup
	the probability of the technology being cost effective at a £20,000 and a £30,000 per QALY gained threshold
	The ICER (mean and/or range) reportedly judged by the NICE Appraisal Committee to be the most plausible
Stated rationale for the OIR/AWR recommendation
Clinical effectiveness	Insufficient evidence of:
	relative clinical effectiveness (whole population)
	relative clinical effectiveness (OIR/AWR subgroup)
	natural history/progression of disease
	long-term data
	potential adverse effects
	mechanism of treatment action
Cost effectiveness	High uncertainty in cost-effectiveness estimates
	The need for cost-effectiveness data with appropriate comparator
	The need for more information on quality of life
	The need for more information on costs
	Other uncertainties
Other considerations	Concern about potential budget impact
	Concern about potential investment and irreversible costs
	Concern about potential impact on ongoing research

ACD Appraisal Consultation Document, AWR approval with research, FAD Final Appraisal Determination, ICER incremental cost-effectiveness ratio, MTA multiple technology appraisal, NICE National Institute for Health and Clinical Excellence, OIR only in research, PAS patient access scheme, STA single technology appraisal