Pharmacoeconomic Guidelines: Germany
Country/Region: Germany
PE Guidelines
General Methods for the Assessment of the Relation of Benefits to Costs (Version 6.1 published 05/02/2022)
PDF in English; PDF in German
PDF in English; PDF in German
PE Guidelines Source:
German national institute for quality and efficiency in health care (IQWiG)
Additional Information:
Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System 2.0 (Version 2.0 16/03/2009) PDF in German
AMNOG law ( German version); ( English version)
Information current as of Tuesday, July 26, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| Title and year of the document | General Methods for the Assessment of the Relation of Benefits to Costs (Version 6.1 dated 23/08/2021) |
| 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 economic 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: