Supporting reimbursement at launch into a genericized market

The treatment of patients with overactive bladder (OAB) was greatly improved with the emergence of the class of anti-muscarinic drugs in the 90s. Betmiga (mirabegron) was approved by European Medicines Agency (EMA) in 2012 as the first in class at the time where the market was on the wedge of becoming genericized. Astellas Pharma faced the challenge of achieving reimbursement in the Nordic markets and engaged us to develop reimbursement dossiers including relevant economic evaluation. 

To achieve this a cost-effectiveness model was needed. The economic models that were available was developed to meet the requirement across all markets and competitive situations. As a result the analyses were fairly complex. Astellas Nordic and the Astellas’ international Market Access wanted to investigate whether a simpler approach for use in the Nordic and potentially other markets could be established.

Thorough analysis of the market situation and the clinical data revealed that an alternative to the existing economic model was feasible. This analysis was based on a post hoc analysis of utility data collected in the pivotal trial. The analyses for Sweden, Norway, and Finland concluded that Betmiga was cost-effective compared to tolterodine and would be cost-effective even at the likely price differential to be expected after introduction of generic tolterodine.

The project was conducted in an excellent partnership between us, and dedicated staff in Astellas’ Nordic and international commercial functions as well as in the clinical development organisation.

Astellas Nordic was able to launch Betmiga with reimbursement in all of the Nordic markets with a minimal number of questions from authorities on the economic evaluation. Sometimes simpler is better.