A flowchart of the assessment process is presented in Figure 1 below.
Companies are invited to look into their portfolios to identify products that are expected to receive a CHMP positive opinion in the following months. The companies are encouraged to be in contact with Fimea, NoMA or TLV at this point to prepare for immediate initiation of the assessment after CHMP positive opinion.
FINOSE also proactively identifies suitable products and contacts developers directly to make them aware of the opportunity of submission to FINOSE.
Selection of assessment topics
The FINOSE collaboration focuses on new products that are coming to market after marketing authorisation. The assessment is initiated in such a manner that its outcomes are available as soon as possible after the marketing authorisation has been granted.
The actual FINOSE assessment process requires the company’s consent for data sharing. For this reason, the selection of potential topics is based on companies’ expression of interest. The decision to launch a FINOSE assessment is made based on common interests of Fimea, NoMA and TLV, taking into account national measures already taken on the topic in question.
All kinds of pharmaceuticals can be submitted to FINOSE. 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.
It is foreseen that not all products are suitable for FINOSE, therefore some basic criteria are set to ensure the most efficient selection of products. Products with the following characteristics will be prioritised:
- New active substances with new mode of actions and innovative drugs
- Applications with development program suitable for CUA:
- Comparative data are preferred over other types of study designs
- Development programs with relevant active comparators with H2H clinical studies
- Developments with existing (at least preliminary) plans for Health economic modelling
The company will be invited to submit a summary of the PICO of the product if a product is identified to be of interest for FINOSE. The summary is used to assess whether the product is suitable for a joint assessment.
A scoping meeting is agreed upon with the company to discuss the scheduling and content of the assessment, and to discuss on process details.
The company makes identical submissions to all the respective agencies to start the joint assessment. Further, the company also submits any country-specific documents which were agreed on at the Scoping meeting. To allow joint work with confidential material, the company signs a waiver of confidentiality.
When all documents have been submitted the submission package, the joint assessment starts. The agencies produce a draft joint report written in English.
Before the joint report becomes public, the company has the possibility to note whether the draft joint report contains confidential data.
The aim is to finalise the FINOSE joint report in 90 days, which is shorter than the current national processes for assessment. The joint report will be complemented with local details and used to inform national decision makers.