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Country/Region: Germany

PE Guidelines
General Methods for the Assessment of the Relation of Benefits to Costs (Version 1.0 dated 19/11/2009)
PDF in English; PDF in German

PE Guidelines Source:
German national institute for quality and efficiency in health care (IQWiG)
http://www.iqwig.de/index.736.en.html

Additional Information:
Working Paper on Modelling in health economic evaluations (Version 1.0 19/11/2009)
PDF in English
Working Paper on Cost Estimation in health economic evaluations (Version 1.0 19/11/2009)
PDF in English

AMNOG law ( German version); ( English version)

Last Webpage Update: Tuesday, October 1, 2013

PE Guidelines Key Features:

Key Features:  
Title and year of the documentGeneral Methods for the Assessment of the Relation of Benefits to Costs (Version 1.0 dated 19/11/2009) 
Affiliation of authorsGerman national institute for quality and efficiency in health care (IQWiG) 
Purpose of the documentIQWiG is commissioned by Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss), the decision making body for the services to be reimbursed within statutory health insurance. Upon commission IQWiG evaluates benefits, harms, and econmic implications of interventions to assist FJC in decision making  
Standard reporting format includedNo 
DisclosureYes, but not applicable, as IQWiG is Germany's independent national institute for quality and efficiency in health care  
Target audience of funding/ author's interestsIQWiG can be commissioned by Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss) or by the Department of Health who are the main addressees of IQWiG's reports.  
PerspectiveAs of Jan 1st, 2011 according to AMNOG law, FJC can define the perspective in its commission of IQWIG. The primary perspective will be the health care sector's, optional perspectives can be social security (including long term nursing care and other branches of social security) or societal perspectives 
IndicationIndication-specific based on the commission by FJC  
Target populationSpecified in the preliminary protocol to be published before IQWiG starts to work on health economic evaluation  
Subgroup analysisYes 
Choice of comparatorAs of Jan 1st, 2011 according to AMNOG law, FJC can define the comparators in its commission of IQWiG. FJC will consider relevant comparators in a given indication for the commission.  
Time horizonAs of Jan 1st, 2011 according to AMNOG law, FJC can set the time horizon for the health economic analysis. It might consider the following specifications of time horizons: Primary time horizon: Duration of RCTs. Secondary time horizon: should be longer than the duration of the RCT(s), but length of time horion depends on the relevance for the decision maker, eg chronic diseases.  
Assumptions requiredIQWiG tries to avoid assumptions specifically on the benefit side in order to prevent an artificial increase in effect size. 
Preferred analytical techniqueEfficiency frontier method based on a CEA, but CUA also possible  
Costs to be includedResource use and costs are to be reported separately. Data should come from German statutory health insurance.  
Source of costsResource use and costs are to be reported separately. Data should come from German statutory health insurance.  
ModelingYes 
Systematic review of evidencesYes, for any health economic analysis is based on prior benefit reports by IQWiG  
Preference for effectiveness over efficacySee the general methods of IQWiG on efficacy vs. effectiveness. RCTs should be focusing on realistic scenarios while high level of evidence for the benefit assessment is warranted  
Preferred outcome measurePatient relevant outcomes (mortality, morbidity, quality of life) as indicated in social code book V relevant for statutory health insurance in Germany  
Preferred method to derive utilityPatient preferences about the hierarchy of endpoints are to be elicited with methods (discrete choice, analytic hierarchy process). At present, IQWiG is testing these methods with regard to validity in the context of the German statutory health insurance system. If uitilities are included in the analysis they are derived from patients and not the general public.  
Equity issues statedEquity issues will be taken into account by the decision maker FJC.  
Discounting costsBase case 3%, sensitivity analyses at 0,5,7, and 10%. 
Discounting outcomesBase case 3%, sensitivity analyses at 0,5,7, and 10%. 
Sensitivity analysis-parameters and rangeSensitivity analyses are performed and respective ranges are chosen to check for robustness of results.  
Sensitivity analysis-methodsBoth univariate and multivariate sensitivity analyses are performed. Mutlivariate sensitivty analyses can be performed as probabilistic sensitivity analyses.  
Presenting resultsResults are presented as numeric figures and also plotted as a basis for the efficiency frontiers. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Efficiency frontier will be presented as a plot. Maximum reimbursable price to be recommended for decision maker will be calculated on the basis of efficiency frontier (ICERs).  
Portability of results (Generalizability)Yes; applies to the insurees of the statutory health insurance  
Financial impact analysisYes; budget impact analysis is mandatory  
Mandatory or recommended or voluntaryMandatory 

Acknowledgement: Andreas Gerber MD, PhD, MA, MSc, Institute for Quality and Efficiency in Health Care (IQWiG), contributed to the PE Guideline Key Features

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