Pharmacoeconomic Guidelines: Finland
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 (December 2019)
PDF in English
Submission Guidelines Source:
Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health
http://www.hila.fi
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
PDF in English
Information current as of Thursday, September 8, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| 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 (17.12.2019) |
| 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. |
| Sensitivity analysis-methods | The uncertainty of the model used in the health economic evaluation must be assessed with regard to stochastic, parameter, heterogeneity-related and structural uncertainty. Parametric uncertainty can be assessed with deterministic and probabilistic sensitivity analyses. |
| 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 costs of compared therapies and the health effects achieved with the therapies must be divided into appropriate subcategories. |
| 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: