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)
http://www.bag.admin.ch/index.html?lang=en

Additional Information:
Last Webpage Update: Wednesday, November 30, 2016

PE Guidelines Key Features:

Key Features:  
Title and year of the document
1. 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 http://www.bag.admin.ch/themen/krankenversicherung/00263/00264/04853/index.html?lang=de  
Affiliation of authors
Swiss Federal Office of Public Health (BAG)  
Purpose of the document
Guidance on how to apply the criteria "Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit in the appraisal of submissions for reimbursement of medical services  
Standard reporting format included
Yes. Key facts (currently under revision) http://www.bag.admin.ch/themen/krankenversicherung/06492/07568/index.html?lang=de  
Disclosure
Yes 
Target audience of funding/ author's interests
Federal Commission of Pharmaceuticals  
Perspective
Health services  
Indication
Yes 
Target population
Yes, usually determined by a precise indication for the medical technology application, and defined by inclusion and exclusion criteria   
Subgroup analysis
No. According to Swissmedic (national licensing authority) authorization.  
Choice of comparator
Closest therapeutic equivalent. Current state-of-the-art treatment. First choice treatment.  
Time horizon
Desicion 60 days after market authorization.  
Assumptions required
Economic assumptions required.  
Preferred analytical technique
 
Costs to be included
Comparison of prices with therapeutic equivalent pharmaceutical and external price referencing with 9 reference countries.  
Source of costs
1. Reimbursement rates established by health insurers, tariffs and other administratively fixed rates; 2. market prices if 1 is not available  
Modeling
Yes 
Systematic review of evidences
Yes 
Preference for effectiveness over efficacy
Yes 
Preferred outcome measure
Not specified.  
Preferred method to derive utility
Not specified.  
Equity issues stated
Not specified.  
Discounting costs
Not specified.  
Discounting outcomes
Not specified.  
Sensitivity analysis-parameters and range
Not specified.  
Sensitivity analysis-methods
Not specified.  
Presenting results
As defined in forms  
Incremental analysis
Not specified.  
Total costs vs effectiveness (cost/effectiveness ratio)
Not specified.  
Portability of results (Generalizability)
Not specified.  
Financial impact analysis
Required.  
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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