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Pharmacoeconomic Guidelines Around The World

Country/Region: Scotland

Submission Guidelines
Guidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (Revised June 2007) Part C: Guidance to Manufacturers for Completion of New Product Assessment Form Economic Sections (Sections 6 and 7)
PDF in English

Submission Guidelines Source:
Scottish Medicines Consortium
http://www.scottishmedicines.org.uk

Additional Information:

Last Webpage Update:

Submission Guidelines Key Features:

Key Features:  
Title and year of the documentGuidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (Revised June 2007) Part C: Guidance to Manufacturers for Completion of New Product Assessment Form Economic Sections (Sections 6 and 7) 
Affiliation of authorsHealth Technology Board for Scotland 
Purpose of the documentAssist submission to Scottish Medicines Consortium 
Standard reporting format includedNo 
DisclosureNot stated 
Target audience of funding/ author's interestsManufacturers. Scottish Medicines Consortium 
PerspectiveScottish healthcare system, patients and their families 
IndicationNot stated 
Target populationNot stated 
Subgroup analysisNot stated 
Choice of comparatorMost likely to be displaced in Scotland 
Time horizonBe sufficient for the main health outcomes and resource use effects to be explored 
Assumptions requiredYes 
Preferred analytical techniqueAny one of CMA, CEA, CCA, CUA, CBA. Need justification 
Costs to be includedDirect healthcare resources, patent resources 
Source of costsReflect Scottish context, or a UK setting 
ModelingYes, requires details 
Systematic review of evidencesYes 
Preference for effectiveness over efficacyYes 
Preferred outcome measureNeed clearly explained 
Preferred method to derive utilityOutlined and qualified 
Equity issues statedYes 
Discounting costsBase: 6 %; SA:0%~full Treasury discount rate 
Discounting outcomesBase:1.5%; SA:0%~full 
Sensitivity analysis-parameters and rangePresent the associated 95%CI. 
Sensitivity analysis-methodsPrefer probabilistic SA (Monte Carlo simulation or Bayesian approach) 
Presenting resultsEach aggregation step required to derive the summary measures should be presented in detail for the reader to be able to disaggregate and verify any derived results. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)Yes, reflect Scottish context 
Financial impact analysisNo 
Mandatory or recommended or voluntary 

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