Market access support for Constella
We supported Almirall Nordic in applying for reimbursement in the Nordic countries for Constella (linaclotide). Constella is indicated for the treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C).
We prepared the reimbursement applications in the Nordic countries in line with the country specific requirements. An additional hurdle in Norway was that no reimbursement code existed for IBS-C or any functional bowel diseases. Hence, to get Constella reimbursed in Norway, we compiled additional documentation needed to establish that IBS-C is a chronic and severe disease. Such documentation is required in the Norwegian system in order to obtain a new reimbursement code.
Furthermore, Almirall Nordic wanted to investigate whether a simplified economic analysis could be established.
Based on our insight into the clinical data and data from an earlier situation analysis we designed a new cost-effectiveness model using a with-in-trial (WITA) approach. This model included utility gains observed in the Constella pivotal trials. This analysis represents a very conservative approach since potential cost offsets, known to exist in this disease area, were excluded. The simplified model was populated with clinical data in close collaboration with the Almirall Global and Nordic Market Access Team and Clinical Study Statistician.
The model was submitted in Norway, Sweden and Finland and was well accepted by the reimbursement authorities and Constella was granted general reimbursement in all three markets.
Working with consultants that at a highly professional level are able to perform for several Nordic countries simultaneously is making the process of the creation of reimbursement applications very effective and fruitful. In the creation of the Constella reimbursement applications for the Nordics the process can be characterized as very smooth – there was a constant focus on strategic important issues, a precise overview of the project process and a high drive in the execution of the project always adhering to agreed timelines. All this ensuring a very high quality of the product delivered.
Mette Lange, Nordic Market Access Manager, Almirall