The application instructions for a new medicinal product issued by the Pharmaceuticals Pricing Board have been updated. The changes concern the national price and reimbursement application process for a product that has undergone a joint clinical assessment (JCA) under the HTA regulation ((EU) 2021/2282). The instructions will enter into force immediately and the new instructions will be applied when the first products that have undergone a joint clinical assessment are assessed.
The Pharmaceuticals Pricing Board will make maximum use of joint clinical assessment in national processes. The applicant should not resubmit the documents available on the joint assessment IT platform in the national process. However, references to sources must be made appropriately. The list of sources must contain all documents referred to and the documents found on the joint assessment IT platform must be specified. To make use of the joint assessment referred to the HTA regulation of the European Union, the applicant must in its national application documents provide a reasoned opinion on the suitability of the joint clinical assessment (JCA) (relevance of the assessment framework (PICO) at the time of the application) as a basis for the national clinical assessment.
Non-clinical assessment (incl. economic assessment) will still be carried out nationally. Similarly, valuation of the joint clinical assessment analyses, estimate of the suitability of the analysis as a basis for national decision-making, and the conclusions fall within the scope of national decision-making.
If necessary, the application instructions will be specified and updated when sufficient experience of the national processes following the joint clinical assessments has accumulated. The Pharmaceuticals Pricing Board welcomes comments and views concerning the new JCA process and the national process following it. Comments and questions sent to the Pharmaceuticals Pricing Board should be addressed primarily to Senior Specialist Tua Lusa, +358 295 163 140 or tua.lusa@gov.fi.