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 document
General Methods for the Assessment of the Relation of Benefits to Costs (Version 1.0 dated 19/11/2009) 
Affiliation of authors
German national institute for quality and efficiency in health care (IQWiG) 
Purpose of the document
IQWiG 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 included
No 
Disclosure
Yes, but not applicable, as IQWiG is Germany's independent national institute for quality and efficiency in health care  
Target audience of funding/ author's interests
IQWiG 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.  
Perspective
As 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 
Indication
Indication-specific based on the commission by FJC  
Target population
Specified in the preliminary protocol to be published before IQWiG starts to work on health economic evaluation  
Subgroup analysis
Yes 
Choice of comparator
As 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 horizon
As 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 required
IQWiG tries to avoid assumptions specifically on the benefit side in order to prevent an artificial increase in effect size. 
Preferred analytical technique
Efficiency frontier method based on a CEA, but CUA also possible  
Costs to be included
Resource use and costs are to be reported separately. Data should come from German statutory health insurance.  
Source of costs
Resource use and costs are to be reported separately. Data should come from German statutory health insurance.  
Modeling
Yes 
Systematic review of evidences
Yes, for any health economic analysis is based on prior benefit reports by IQWiG  
Preference for effectiveness over efficacy
See 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 measure
Patient 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 utility
Patient 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 stated
Equity issues will be taken into account by the decision maker FJC.  
Discounting costs
Base case 3%, sensitivity analyses at 0,5,7, and 10%. 
Discounting outcomes
Base case 3%, sensitivity analyses at 0,5,7, and 10%. 
Sensitivity analysis-parameters and range
Sensitivity analyses are performed and respective ranges are chosen to check for robustness of results.  
Sensitivity analysis-methods
Both univariate and multivariate sensitivity analyses are performed. Mutlivariate sensitivty analyses can be performed as probabilistic sensitivity analyses.  
Presenting results
Results are presented as numeric figures and also plotted as a basis for the efficiency frontiers. 
Incremental analysis
Yes 
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 analysis
Yes; budget impact analysis is mandatory  
Mandatory or recommended or voluntary
Mandatory 

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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