Assessment process
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PICO
The company is invited to submit a PICO (Population, Intervention, Comparator(s), Outcomes) for the product. Based on the PICO, the FINOSE-team determines if the product is suitable for a joint Nordic assessment.
Scoping meeting
If needed, the company is invited to a scoping meeting to discuss timelines and submission. The meeting is also an arena/platform for any questions the company may have (e.g., differences between the national and joint assessment procedure).
Submission
The company makes identical submissions to all four agencies. If there is any country specific information the company does not wish to share with all four agencies this should be submitted directly to the concerning agency. To allow joint work with confidential material, the company submits a signed Waiver of confidentiality to FINOSE.
Waiver of confidentiality FINOSE (pdf)
Assessment
The assessment starts when FINOSE confirms that the submission package is complete. A contact person at one of the agencies will coordinate the communication between the company and the assessment team throughout the assessment process. The agencies write a draft joint FINOSE-report in English.
Finalisation
Before publication, the draft report is shared with the company to check for factual errors and information the company considers confidential.
The joint report will be complemented with national details when required and used for national decisions on pricing and reimbursement and can also be used for price negotiations on national or Nordic level.
Selection of assessment topics
The FINOSE collaboration focuses on new products coming to the market. For products supported by evidence from RCTs the aim is to have an assessment report finalized within 90 days after submission of a complete dossier.
Companies are encouraged to express their interest for an assessment through FINOSE by taking contact with the FINOSE teams in the respective countries. FINOSE also proactively identifies suitable products and contacts developers directly to make them aware of the opportunity of assessment through FINOSE.
The FINOSE assessment process requires the company’s consent for data sharing. The decision to initiate a FINOSE assessment is based on an agreement between the company and the assessing agencies.
All kinds of medicinal products can be submitted to FINOSE for assessment. Nevertheless, it should be noted that in case of an out-patient product in Finland, the FINOSE assessment cannot replace the normal process for pricing and reimbursement. For confirmation of reimbursement and a reasonable wholesale price of an out-patient product in Finland, the company must submit an application to the Pharmaceutical Pricing Board as per usual.