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New guidelines for preparing a health economic
evaluation
The guidelines for preparing the health economic evaluation attached to the application for reimbursement status and reasonable wholesale price for a medicinal product have been updated. The health economic evaluation must be prepared according to the guidelines appended to the Decree of the Ministry of Social Affairs and Health on applications and price notifications made to the Pharmaceuticals Pricing Board. The amended annex entered into force on 1 May 2011. In addition to the guidelines the Pharmaceuticals Pricing Board provides application instructions for a health economic evaluation. The aim of these application instructions is to help the applicant in applying the guidelines for preparing a health economic evaluation. The instructions include recommended practices and procedures as well as examples and sources of information. The guidelines are a collaboration between the Pharmaceuticals Pricing Board, the Social Insurance Institution of Finland (Kela) and the Pharmaceutical industry.
The applicant is requested to submit the health economic evaluation with appendices to the Pharmaceuticals Pricing Board in two paper copies and in two separate electronic documents.
Application forms and instructions:
Application for reimbursement
status and wholesale price for a medicinal product subject to
marketing authorization
(pdf, 681 kB)
Application
instructions (pdf, 66 kB)
Application
instructions for a health economic evaluation (pdf, 48
kB)
Application for reimbursement
status and wholesale price in the reference price
system for a medicinal product subject to marketing
authorization (pdf, 670 kB)
Application
instructions (pdf, 65 kB)
Application for
reimbursement status and wholesale price for a medicinal
product subject to special licence, an application for the
manufacturer, wholesaler or importer (pdf, 661 kB)
Application
instructions (pdf, 54 kB)
Application for reimbursement status and
wholesale price for basic ointment (pdf, 572
kB)
Application
instructions (pdf, 39 kB)
Application for
reimbursement status and wholesale price for clinical
nutritional preparation (pdf, 608 kB)
Application
instructions (pdf, 42 kB)
Appendices:
Estimate of the
sales (xls, 38 kB)
Prices and reimbursement in
EEA- countries (xls, 49 kB)
Other instructions: