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Pharmacoeconomic Guidelines Around The World

Country/Region: Finland

Submission Guidelines
Preparing a Health Economic Evaluation to Be Attached to the Application for Reimbursement Status and Wholesale Price for a Medicinal Product. Application Instructions (31.1.2017)
PDF in English

Submission Guidelines Source:
Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health
http://www.hila.fi

Additional Information:
Guidelines for Preparing a Health Economic Evaluation (2011): Annex to the Decree (201/2009) describing the legal basis of the submission guideline.
PDF in English

Last Webpage Update: Monday, January 15, 2018

Submission Guidelines Key Features:

Key Features:  
Title and year of the documentPreparing a Health Economic Evaluation to Be Attached to the Application for Reimbursement Status and Wholesale Price for a Medicinal Product. Application Instructions (31.1.2017) 
Affiliation of authorsPharmaceuticals Pricing Board (in co-operation with the Social Insurance Institution (Kela) and the Pharma Industry Finland)  
Purpose of the documentTo assist applicant in preparing a health economic evaluation according to the Decree of the Ministry of Social Affairs and Health on applications and price notifications made to the Pharmaceuticals Pricing Board. 
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 
PerspectivePrimarily payer's perspective (see Costs to be included).  
IndicationThe approved indication for which reimbursement status is applied for.    
Target populationAccording to the indication for which reimbursement status is applied for.  
Subgroup analysisNot stated  
Choice of comparatorTherapeutically the most appropriate alternative(s). Reasons must be given and the choice must be based on Finnish clinical practice.  
Time horizonLong enough to enable taking into account all essential costs and health effects.   
Assumptions requiredClearly recorded and justified 
Preferred analytical techniqueIn most cases CUA gives the best support to decision making. Other possible methods: CMA, CEA and CBA. Reasons must be given.  
Costs to be includedIrrespective of the payer, all direct health care and comparable social welfare costs related to the therapies that are being compared. If productivity losses are included in the cost calculation, the results must also be presented so that those are excluded. Medicine wastage has to be included in the costs.  
Source of costsEvaluation must be based on as up-to-date information on the costs in Finland as possible.  
ModelingA detailed account of the structure of the model as well as the data and the calculation formulas used in the model must be provided. The model must also be provided in an electronic form.  
Systematic review of evidencesSystematic reviews and meta-analyses are often the best way of combining the results of different studies. Reasons for the chosen studies must be given.  
Preference for effectiveness over efficacyNo. If reliable information is available, also the results according to the routine clinical practice should be presented. 
Preferred outcome measureEffectiveness must be measured primarily in QALYs. Reasons must be given for the choices made. 
Preferred method to derive utilityPrimarily a validated generic quality of life measure. Reasons must be given for the choices made.  
Equity issues statedNot stated 
Discounting costs3% and 0%  
Discounting outcomes3% and 0%  
Sensitivity analysis-parameters and rangeReasons must be given for the sensitivity analyses and the variables chosen for them. Attention should be paid to the most significant uncertainty factors in view of the final results. When selecting the distributions, it should be ensured that the chosen distribution is suitable for the variable concerned. 
Sensitivity analysis-methodsBoth deterministic and probabilistic sensitivity analyses are possible, as well as scenario analyses evaluating any uncertainty associated with the assumptions and choices made.  
Presenting resultsThe health effects and costs shall be presented both as total benefits and total costs and as incremental benefits and incremental costs in the form of a table. The main results should be compiled in a separate table.  
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)No 
Portability of results (Generalizability)Reflect Finnish context.  
Financial impact analysisPossible but not required.  
Mandatory or recommended or voluntaryMandatory  

Acknowledgement: Mareena Paldán, Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health, Finland

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