Background
ATC classifications are used extensively by payers for the definition of comparators. In addition, some countries are planning the pricing and reimbursement reviews of product groups based on their ATC codes. Thus, achieving an appropriate alternative ATC classification could have a significant impact on market access and reimbursement.
Our client wanted to understand the impact of each possible ATC code to assess the possible risks and benefits. The client had developed a novel formulation of a product to be the first treatment for treating rare parasitic infections and needed to understand the optimal ATC classification to ensure optimal patient access.
Valid Insight Approach
We conducted an initial assessment to identify all possible ATC classes, requirements for such classifications, and the probability of successful application for each classification. Collaborative workshops were held to present the proposed submission strategy, rationale and implications for market access and pricing. Following the workshops, Valid Insight developed the main application letter and collected all documentation required to support our client with their WHO submission.
Results
We provided our client with clear recommendations and identified the most appropriate ATC class for a novel formulation of the product with the highest benefit potential from a market access and commercial perspective. Furthermore, a clear mitigation strategy ensured we could minimize the risks of classification in an undesired class.