Country/Region: England & Wales
Submission Guidelines

Guide to the Methods of Technology Appraisals (April 2013)
https://www.nice.org.uk/process/pmg9/chapter/foreword

Submission Guidelines Source:

National Institute for Health and Clinical Excellence (NICE)
http://www.nice.org.uk/

Additional Information:

Guide to the Single Technology Appraisal Process (October 2009)
PDF in English

Last Webpage Update: Thursday, February 8, 2018

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Guide to the Methods of Technology Appraisals (April 2013)  
Affiliation of authors
National Insititue for Health and Clinical Excellence (NICE) 
Purpose of the document
To provide an overview of the principles and methods of health technology assessment and appraisal within the context of the NICE appraisal process. It describes key principles of appraisal methodology and is a guide for all organisations considering submitting evidence to the technology appraisal programme of the Institute. 
Standard reporting format included
No, however developed a reference case for cost-effectiveness analysis. 
Disclosure
No 
Target audience of funding/ author's interests
All organizations considering submitting evidence to the Technology Appraisal Program of the Institute.  
Perspective
For the reference case, the perspective on outcomes should be all direct health effects, whether for patients or, when relevant, other people (principally carers). 
Indication
Clearly define the spectrum of diseases  
Target population
Yes, includes age and sex distribution and co-morbidities 
Subgroup analysis
Yes 
Choice of comparator
Relevant comparators for the technology being appraised are those routinely used in the NHS, and therapies regarded as best practice when this differs from routine practice.  Defined in scoping process.  
Time horizon
The time horizon for estimating clinical and cost effectiveness should be sufficiently long to reflect all important differences in costs or outcomes between the technologies being compared. 
Assumptions required
Yes 
Preferred analytical technique
For the reference case, cost-effectiveness (specifically cost–utility) analysis is the preferred form of economic evaluation. 
Costs to be included
Potential direct and indirect resource costs for the NHS and PSS that would be expected. 
Source of costs
Current official listing published by the Department of Health and/or the Welsh Assembly Government 
Modeling
Yes. Cost–utility analysis with fully incremental analysis 
Systematic review of evidences
Yes 
Preference for effectiveness over efficacy
Yes 
Preferred outcome measure
Given its widespread use, the QALY is considered to be the most appropriate generic measure of health benefit that reflects both mortality and HRQL effects.  All direct health effects, whether for patients or, when relevant, carers  
Preferred method to derive utility
Patient derived EQ-5D values with UK societal tarrifs applied; alternatively TTO valuation using a representative sample of the public 
Equity issues stated
Yes. An additional QALY has the same weight regardless of the other characteristics of the individuals receiving the health benefit.  
Discounting costs
Base: 3.5%; SA: 0~6% 
Discounting outcomes
Base: 3.5%; SA: 0~6% 
Sensitivity analysis-parameters and range
All inputs used in the analysis will be estimated with a degree of imprecision. Appropriate ways of presenting uncertainty in cost-effectiveness data parameter uncertainty include confidence ellipses and scatter-plots on the cost-effectiveness plane (when the comparison is restricted to two alternatives) and cost-effectiveness acceptability curves. The presentation of cost-effectiveness acceptability curves should include a representation and explanation of the cost-effectiveness acceptability frontier. 
Sensitivity analysis-methods
Distributions should be assigned to characterise the uncertainty associated with the (precision of) mean parameter values. Probabilistic sensitivity analysis is preferred.  
Presenting results
All data used to estimate clinical and cost effectiveness should be presented clearly in tabular form and include details of data sources. 
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
Yes 
Portability of results (Generalizability)
In NHS context 
Financial impact analysis
Yes, the cost should be disaggregated by appropriate generic organization (NHS, PSS, hospital, primary care) and budgetary categories (drugs, staffing, consumables, capital). 
Mandatory or recommended or voluntary
Recommended 

Acknowledgement: Scott Doyle contributed to the key-feature form. Scott Doyle, Director, Value Evidence & Outcomes, GlaxoSmithKline, Middlesex, UK.

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