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Country/Region: Switzerland

PE Guidelines
Operationalisation of the Terms Effectiveness, Expediency and Profitability of Pharmaceuticals (2011)

PE Guidelines Source:
Swiss Federal Office of Public Health (BAG)

Additional Information:

Last Webpage Update: Wednesday, November 30, 2016

PE Guidelines Key Features:

Key Features:  
Title and year of the document1. Document Operationalisierung der Begriffe Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit; Arbeitspapier vom 21. Juli 2011 (currently under revision)
2. Set of forms for filing submissions (with instructions), 2008 - 2013 (currently under revision), see  
Affiliation of authorsSwiss Federal Office of Public Health (BAG)  
Purpose of the documentGuidance on how to apply the criteria "Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit in the appraisal of submissions for reimbursement of medical services  
Standard reporting format includedYes. Key facts (currently under revision)  
Target audience of funding/ author's interestsFederal Commission of Pharmaceuticals  
PerspectiveHealth services  
Target populationYes, usually determined by a precise indication for the medical technology application, and defined by inclusion and exclusion criteria   
Subgroup analysisNo. According to Swissmedic (national licensing authority) authorization.  
Choice of comparatorClosest therapeutic equivalent. Current state-of-the-art treatment. First choice treatment.  
Time horizonDesicion 60 days after market authorization.  
Assumptions requiredEconomic assumptions required.  
Preferred analytical technique 
Costs to be includedComparison of prices with therapeutic equivalent pharmaceutical and external price referencing with 9 reference countries.  
Source of costs1. Reimbursement rates established by health insurers, tariffs and other administratively fixed rates; 2. market prices if 1 is not available  
Systematic review of evidencesYes 
Preference for effectiveness over efficacyYes 
Preferred outcome measureNot specified.  
Preferred method to derive utilityNot specified.  
Equity issues statedNot specified.  
Discounting costsNot specified.  
Discounting outcomesNot specified.  
Sensitivity analysis-parameters and rangeNot specified.  
Sensitivity analysis-methodsNot specified.  
Presenting resultsAs defined in forms  
Incremental analysisNot specified.  
Total costs vs effectiveness (cost/effectiveness ratio)Not specified.  
Portability of results (Generalizability)Not specified.  
Financial impact analysisRequired.  
Mandatory or recommended or voluntary 

Acknowledgement: Felix Gurtner, MD, MSc, Christoph Kuenzli, Jörg Indermitte, PhD, Matthias Menig, MD, Stefan Otto, MD, Thomas Fankhauser, Swiss Federal Office of Public Health (BAG), Bern, Switzerland

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