The Danish Medicines Agency deemed a drug class “irrational” based on Real-World Data. Our client challenged this and sought to clarify the data behind the decision.
A case study by NHTA
Market Access
Leverage Real-World Data to nuance public reimbursement discussions
The Challenge
The Danish Medicines Agency reassessed the reimbursement status of a class of medications claiming the use as “irrational”, based on Real-World Data analyses, conducted by the Danish Health Authority.
Our client did not fully agree with the conclusions and wished to provide a more nuanced presentation of the underlying data for the authorities’ recommendations.
Solution
NHTA replicated the real-world data (RWD) analyses conducted by the authorities, enriching them with additional clinical context, such as comorbidities, relevant endpoints, and prior treatment histories, to better justify or explain treatment initiation decisions.
The more nuanced analyses were used effectively in public hearing responses and direct communications with authorities, helping to address data gaps and support a more informed dialogue.
Impact
Our support helped the client to successfully address the data gaps and nuance the public reimbursement discussion while engaging with the authorities.
