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Authorised medicinal product – extension

These instructions apply when the marketing authorisation holder is applying for an extension of the reimbursement status for an original product. The instructions also apply when an extension of the reimbursement status for another product is applied if no reimbursement status has been approved to the same extent for other products containing the same active substance.

The Pharmaceuticals Pricing Board approves the reimbursement status of a medicinal product to the extent referred to in the summary of product characteristics that is valid at the date of issuing the decision on reimbursement status, unless otherwise mentioned in the decision. If the marketing authorisation authority later approves an extended therapeutic indication for the medicinal product, the product is not reimbursable within its new indication unless extension of the reimbursement status is applied from the Pharmaceuticals Pricing Board. It is also question of extension of the reimbursement status if the application concerns the abolishment of a valid restriction for a medicinal product.

The application for the extension is processed in an extensive process if a health economic evaluation has been attached to the application. Otherwise the processing is, as a rule, on a limited basis. Provide the application type specifier, considering the extent of the processing.

If you are applying for different reimbursement statuses for different packages of the same medicinal product and/or their therapeutic indications differ from each other, the indications and the reimbursement status you are applying for must be separately detailed for each package.

See also the general instructions for the application at applying for reimbursement status and reasonable wholesale price.

Application documents

  • Attach the following documents to your application:
    • valid summary of product characteristics
    • valid marketing authorisation decision (if the marketing authorisation was granted in a centralised authorisation procedure, also attach the information published by the European Medicines Agency on the different product packages and their marketing authorisation numbers)
    • clinical assessment by a marketing authorisation authority of the therapeutic indication for which the reimbursement status is applied
    • information on the therapeutic value
    • information on the costs and economic value
    • health economic evaluation or grounds for not attaching the evaluation to the application
    • market forecast
    • sales information and number of patients
    • information on prices and reimbursement statuses in EEA states
    • other information the applicant considers necessary
    • list of sources and sources
  • In the application memorandum, report the following
    • information of the product’s therapeutic value
    • justifications for special reimbursement status when applying for it
    • information on the costs and economic value of medicinal treatment
    • basis for the market forecast and the estimates of sales and patient volumes
  • Name the files as follows:
    • Application memorandum
    • Sales data and number of patients
    • Market forecast
    • Prices in EEA states
    • Summary of product characteristics
    • Clinical assessment
    • Marketing authorisation decision
    • Health economic evaluation
    • List of sources
    • Source_Lastname_Year
    • Source_HEE_Lastname_Year
    • Name other attachments appropriately, for example: Expert Opinion_Lastname

Therapeutic value

  • Describe the therapeutic indications for which reimbursement status is applied.
  • If you are applying for restricted reimbursement status (the medicinal product is particularly expensive), present
    • proposed restriction of the reimbursement status (therapeutic indication specified in detail)
    • grounds for the therapeutic value within the therapeutic indication
    • grounds for the appropriateness of the proposed restriction as regards the implementation of pharmacotherapy
  • Present a summary of clinical studies on the product to the extent of the sought reimbursement status and attach related research publications to the application.
  • Present a statement on the benefits of reimbursement status compared with other medicinal products or treatments used for treating the same disease.
    • Describe the current treatment of the disease and attach treatment recommendations to the application.
    • Present evidence of how patients benefit from the medicinal product and for which patient groups it is intended
  • In addition to the above, an application for special reimbursement status must also
    • Describe the type of the disease
    • Present a specification of the necessity and the remedial or replacement effect of the medicinal product in the treatment of the disease in question
    • Present a specification of the experience of the use of the product Attach the following documents to your application:
      • patient exposure or sales information from Finland and worldwide, as well as how the information has been estimated or counted
      • assessment report by the marketing authorisation authority of the latest periodic safety update report
      • the latest periodic safety update report if a new safety update report has been prepared after the latest assessment report by the marketing authorisation authority
      • information about harmful effects reported after the granting of the marketing authorisation entered into the summary of product characteristics
      • if desired, research information about the use of the product in real-life treatment contexts.

Costs and economic value

  • Present a statement on the average dosage based on the summary of product characteristics as well as the common dosages used in treatment practice and/or studies and the resulting medicinal treatment costs calculated on the basis of the proposed wholesale price and retail price including VAT per a day of treatment and a period of time essential for the treatment.
  • Compare treatment costs to other reimbursed products in the market used for treating the same disease based on the treatment dosages given in the summaries of product characteristics and a common treatment dosage per a day of treatment and a period of time essential for the treatment.

Health economic evaluation

  • Attach a health economic evaluation to the application in case of a substantial extension of reimbursement status and if no reimbursement status has been approved to the same extent for other products containing the same medicinal substance.
  • A health economic evaluation must be presented
    • when the case concerns, in relation to a product’s previously approved, reimbursed therapeutic indication
      • a different disease,
      • a different treatment line for the same disease or
      • a different patient group for the same diseaseand
      • the comparative treatments,
      • the costs of the applied product and/or comparative treatments or
      • the health effects of the applied product and/or comparative treatmentsdiffer from the therapeutic indication previously approved for reimbursement.
    • when applying for a removal of a reimbursement restriction.
  • By default, a health economic evaluation does not need to be attached to applications that concern an extension of the therapeutic indication to the treatment of pediatric patients, for example.
  • If you do not attach a health economic evaluation to your application, you must present grounds for this.
  • Prepare the health economic evaluation in accordance with the instructions appended to the Decree of the Ministry of Social Affairs and Health on applications and price notifications made to the Pharmaceuticals Pricing Board. The Pharmaceuticals Pricing Board has provided more detailed instructions on the preparation of a health economic evaluation on its website.

Market forecast

  • Describe the group of medicinal products with similar therapeutic indications within which the product will be marketed, what similar products there already are within the group, how the use of medicinal products is expected to change within the group, and what changes are anticipated in the market conditions. Is the product expected to replace other available medicinal treatments or will it supplement them?
  • Present an estimate of the total sales of the group of medicinal products in retail prices including VAT in the current year and the three years following it
    • in a situation where the product subject to the application has reimbursement status and
    • in a situation where the product subject to the application does not have reimbursement status.
  • Estimate the share of the product/products of total sales (in euros and %) and present the change that will result from the reimbursement status of the product subject to the application (in euros and %) of the total sales in the group.
  • Submit the market forecast using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.

Sales and number of patients

  • Estimate the sales of the product at the proposed wholesale price and retail price including VAT per package and as total sales. Estimate the number of patients using the product. The sales concerns the sales reimbursed under the Health Insurance Act and must be provided for the current year and the three years following it.
  • Present the share of the extension of the total sales (in euros and %).
  • Include the sales estimates given in the previous application as well as the actual sales during the period of validity of the decision and in the current year per package and as total sales of the product.
  • If the actual sales deviate significantly from the estimate given in the previous application, give explanation on the deviation and refer to the notification of exceeding the sales estimates submitted to the Pharmaceuticals Pricing Board.
  • Report the sales data and patient numbers using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.
  • In addition to the above, the application for special reimbursement status must also contain
    • an estimate of the effect of the special reimbursement status on the sales of the product
    • an estimate of the costs resulting from the extension of the special reimbursement status to health insurance.

Prices and reimbursement statuses in other EEA states

  • List trade names of the medicinal product used in other EEA states.
  • State the existing wholesale prices in euros, using the exchange rates valid at the time of submitting the application. If no wholesale prices are available, give the ex factory prices of the packages. Also provide this information on packages that are not sold in the Finnish market. Report if the product is subject to an agreement (publicly available information).
  • Report whether the medicinal product is included in a reimbursement system to the applied extent and whether the reimbursement is provided on a general or patient-specific basis. Also give information on the restrictions and conditions for reimbursement.
  • Report the prices and reimbursement statuses in EEA states using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.

Other information

  • When an application concerns a product with confirmed conditional reimbursement status and the applicant proposes a continuation of the conditional reimbursement status, the application must include the ordinary application documents and a separate document containing a proposal for conditional reimbursement status. The Pharmaceuticals Pricing Board has issued instructions on the procedure for conditional reimbursement status on its website (Other instructions).
  • Attach any other information you consider necessary to your application, such as
    • an expert opinion that must clearly state the expert’s conflicts of interest (see instructions on the website of the Pharmaceuticals Pricing Board for drawing up an expert opinion and example of declaration of interests)
    • itemised specification of the medicinal product’s research, product development and production costs to the extent that you wish to appeal to them.
  • When reimbursement status and a wholesale price are applied for a product which previous reimbursement status and wholesale price application for equivalent extent has been rejected, present a summary of the changes and updates made to your application.

List of sources and sources

  • Attach to the application a list containing all the sources referred to in the application. The sources must be presented in a logical order, for instance alphabetically. If a source publication is extensive, page number, table number or other similar reference should be given.
  • All sources used should be attached to the application.
    • If there is a supplement or an appendix connected with an article, include also the supplementary material.
    • For sources that are only available on the Internet, the precise source reference and hyperlink shall be given. The Internet source must be freely available.

This page was updated on 25 March 2026.