Pharmacoeconomic Guidelines Around The World

Country: Finland, Region: Northern Europe

PE guidelines
Guidelines for Preparing A Health Economic Evaluation (March, 2009)

PE guidelines Source:
Decree of the Ministry of Social Affairs and Health on applications and price notifications made to the Pharmaceuticals Pricing Board
PDF Version in English
Finnish VersionSwedish Version

References:


PE guidelines Key Features:
Key Features:  
Title and year of the DocumentGuidelines for Preparing A Health Economic Evaluation (March, 2009) 
Affiliation of authorsMinistry of Social Affairs and Health 
Main policy objectiveAssist submission to the Pharmaceuticals Pricing Board. A health economic evaluation is obligatory in applications for the reimbursement status and a reasonable wholesale price for medicinal products containing a new active substance 
Standard reporting format includedNo 
DisclosureNot stated 
Target audience of funding/ author’s interestsPharmaceutical companies and contracted health economists preparing economic analyses for the Pharmaceuticals Pricing Board 
PerspectiveSocietal 
IndicationIndication approved for the medicinal product for which reimbursement status is applied or, if there are several indications, the most important one or ones 
Target populationClearly specified 
Subgroup analysisYes 
Choice of comparatorTo be replaced product, most commonly used treatment, the best or minimum therapy. Need justification 
Time horizonSufficiently long to permit an evaluation of all the essential costs and health effects 
Assumptions requiredClearly recorded and justified 
Preferred analytical techniqueAny one of CMA, CEA, CUA, CBA 
Costs to be includedAll direct health care costs and comparable social welfare costs. Indirect costs shall be presented separately 
Source of costsReflect Finnish conditions 
ModelingYes 
Systematic review of evidencesNot stated 
Preference for effectiveness over efficacyYes 
Preferred outcome measureNot stated 
Preferred method to derive utilityNot stated 
Equity issues statedNot stated 
Discounting costs3% and 0% 
Discounting outcomes3% and 0% 
Sensitivity analysis-parameters and rangeOn uncertain parameters at credible range 
Sensitivity analysis-methodsNot stated 
Presenting resultsTotal and incremental costs and benefits. The various phases and results of the analysis shall be presented in such a way as to enable the reader to verify the essential effects on health and the costs related to the therapies at issue 
Incremental analysisYes 
Total C/EYes 
Portability of results (Generalizability)Not stated 
Financial impact analysisNo 
Mandatory or recommended or voluntaryThe evaluation shall be prepared in accordance with the guidelines 

Acknowledgement: Mareena Paldán highly contributed to the key feature form. Mareena Paldán, Chief Pharmaceutical Officer, Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health, Finland

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