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Pharmacoeconomic Guidelines Around The World

Country/Region: England & Wales

Submission Guidelines
Guide to the Methods of Technology Appraisals (April 2013)

Submission Guidelines Source:
National Institute for Health and Clinical Excellence (NICE)

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 documentGuide to the Methods of Technology Appraisals (April 2013)  
Affiliation of authorsNational Insititue for Health and Clinical Excellence (NICE) 
Purpose of the documentTo 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 includedNo, however developed a reference case for cost-effectiveness analysis. 
Target audience of funding/ author's interestsAll organizations considering submitting evidence to the Technology Appraisal Program of the Institute.  
PerspectiveFor the reference case, the perspective on outcomes should be all direct health effects, whether for patients or, when relevant, other people (principally carers). 
IndicationClearly define the spectrum of diseases  
Target populationYes, includes age and sex distribution and co-morbidities 
Subgroup analysisYes 
Choice of comparatorRelevant 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 horizonThe 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 requiredYes 
Preferred analytical techniqueFor the reference case, cost-effectiveness (specifically cost–utility) analysis is the preferred form of economic evaluation. 
Costs to be includedPotential direct and indirect resource costs for the NHS and PSS that would be expected. 
Source of costsCurrent official listing published by the Department of Health and/or the Welsh Assembly Government 
ModelingYes. Cost–utility analysis with fully incremental analysis 
Systematic review of evidencesYes 
Preference for effectiveness over efficacyYes 
Preferred outcome measureGiven 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 utilityPatient derived EQ-5D values with UK societal tarrifs applied; alternatively TTO valuation using a representative sample of the public 
Equity issues statedYes. An additional QALY has the same weight regardless of the other characteristics of the individuals receiving the health benefit.  
Discounting costsBase: 3.5%; SA: 0~6% 
Discounting outcomesBase: 3.5%; SA: 0~6% 
Sensitivity analysis-parameters and rangeAll 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-methodsDistributions should be assigned to characterise the uncertainty associated with the (precision of) mean parameter values. Probabilistic sensitivity analysis is preferred.  
Presenting resultsAll data used to estimate clinical and cost effectiveness should be presented clearly in tabular form and include details of data sources. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)In NHS context 
Financial impact analysisYes, 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 voluntaryRecommended 

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

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