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 document
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) 
Affiliation of authors
Pharmaceuticals Pricing Board (in co-operation with the Social Insurance Institution (Kela) and the Pharma Industry Finland)  
Purpose of the document
To 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 included
No 
Disclosure
Not stated 
Target audience of funding/ author's interests
Pharmaceutical companies and contracted health economists preparing economic analyses for the Pharmaceuticals Pricing Board 
Perspective
Primarily payer's perspective (see Costs to be included).  
Indication
The approved indication for which reimbursement status is applied for.    
Target population
According to the indication for which reimbursement status is applied for.  
Subgroup analysis
Not stated  
Choice of comparator
Therapeutically the most appropriate alternative(s). Reasons must be given and the choice must be based on Finnish clinical practice.  
Time horizon
Long enough to enable taking into account all essential costs and health effects.   
Assumptions required
Clearly recorded and justified 
Preferred analytical technique
In most cases CUA gives the best support to decision making. Other possible methods: CMA, CEA and CBA. Reasons must be given.  
Costs to be included
Irrespective 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 costs
Evaluation must be based on as up-to-date information on the costs in Finland as possible.  
Modeling
A 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 evidences
Systematic 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 efficacy
No. If reliable information is available, also the results according to the routine clinical practice should be presented. 
Preferred outcome measure
Effectiveness must be measured primarily in QALYs. Reasons must be given for the choices made. 
Preferred method to derive utility
Primarily a validated generic quality of life measure. Reasons must be given for the choices made.  
Equity issues stated
Not stated 
Discounting costs
3% and 0%  
Discounting outcomes
3% and 0%  
Sensitivity analysis-parameters and range
Reasons 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-methods
Both deterministic and probabilistic sensitivity analyses are possible, as well as scenario analyses evaluating any uncertainty associated with the assumptions and choices made.  
Presenting results
The 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 analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
No 
Portability of results (Generalizability)
Reflect Finnish context.  
Financial impact analysis
Possible but not required.  
Mandatory or recommended or voluntary
Mandatory  

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

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