Country/Region: Norway
PE Guidelines

Guidelines on how to conduct pharmacoeconomic analyses (March, 2012)
PDF in English

PE Guidelines Source:

The Norwegian Medicines Agency
http://www.legemiddelverket.no/

Additional Information:
Last Webpage Update: Wednesday, August 15, 2012

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Guidelines on how to conduct pharmacoeconomic analyses (March, 2012) 
Affiliation of authors
NOMA, the Norwegian Medicines Agency 
Purpose of the document
To improve the basis for decision making as regards granting of reimbursement for drug expenses in the National Insurance Scheme. Specially as to whether the cost of a medicine is in reasonable proportion to the therapeutic value and the costs associated with alternative treatment(s). 
Standard reporting format included
Yes, a reference case is stated 
Disclosure
Yes 
Target audience of funding/ author's interests
NOMA staff, pharmaceutical companies and contracted health economists preparing economic analyses for use in applications to NOMA  
Perspective
Societal point of view, but with some limitations (see the section about costs) 
Indication
Approved indication 
Target population
The patient population to be treated with the pharmaceutical under study. Age, gender, health status, relevant comorbidity and prognosis (both untreated and treated with the most relevant of current treatments) should be stated.  
Subgroup analysis
Separate calculations must be performed for the different sub-populations if the intervention is expected to differ significantly in cost and / or efficacy for different patient groups. 
Choice of comparator
The comparator(s) should be the one (those) most likely to be partially or wholly replaced, typically established practice and/or the most widespread. If it is not clear whether this (these) is (are) cost-effective compared with other relevant comparators or with no treatment, then all these options should be included. If neither of the aforementioned comparators are the one(s) recommended by the national clinical guidelines, then this (these) should be used as well. 
Time horizon
Long enough such that all relevant important differences in future costs and health effects between treatment alternatives are captured.  
Assumptions required
All assumptions must be clearly stated and accounted for. 
Preferred analytical technique
Cost-Utility Analysis (CUA) 
Costs to be included
All resource usage related to the provision of each of the included treatments in Norway. Special considerations: Inclusion of productivity gains and costs due to the treatment effect is not compulsory; costs related to added/extra life years and deadweight loss due to tax funding should not be included.  
Source of costs
Norwegian Directorate of Health, Norwegian Medical Association, HELFO, Statistics Norway (non-exhaustive list) 
Modeling
Yes. But the internal and external validity of the model(s) should be carefully evaluated.  
Systematic review of evidences
Yes. Compulsory to make use of relevant databases (Medline, Embase, Cochrane, etc). State search, inclusion and exclusion criteria. Data from randomized controlled trials (RCTs) with adequate internal and external validity are preferred as the main basis for documenting health effects.  
Preference for effectiveness over efficacy
Yes. Any available data on effectiveness should be incorporated in the analysis in order to correct/support the efficacy data. 
Preferred outcome measure
Quality-Adjusted Life-Years (QALY) and Life-Years Gained (LYG) 
Preferred method to derive utility
Generic MAU instruments preferred. And it is compulsory to perform a systematic literature review in order to document that the Quality of Life (QoL)-data used in the analysis is of the highest possible quality (in relation to practicality, reliability and validity).  
Equity issues stated
Yes, the distributional profile of the reimbursement decision must be reported. 
Discounting costs
A real discount rate of 4%. 
Discounting outcomes
A real discount rate of 4%. 
Sensitivity analysis-parameters and range
Parameters with the greatest potential influence on model outcomes (e.g. key clinical variables and costs), identified in a Tornado-diagram and if necessary by experts. 
Sensitivity analysis-methods
Deterministic and/or probabilistic methods, depending on the source of uncertainty under study (methodological, parameter, structural or generalization uncertainty) 
Presenting results
Results of the analyses must be presented both at an aggregated level and broken down into categories for both costs and health effects 
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
Yes 
Portability of results (Generalizability)
Yes, Norwegian context 
Financial impact analysis
Yes, with a five-years perspective 
Mandatory or recommended or voluntary
Mandatory 

Acknowledgement: The key features form was contributed to by Enrique Jiménez, Researcher, Norwegian Medicines Agency

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