Rx to OTC Switch Analysis

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Project ThumbRx to OTC Switch Analysis
Clients:
Contract API Manufacturer
Description:

An active pharmaceutical ingredient manufacturer supplying several members of a particular drug category needed to explore implications of a possible Rx-to-OTC switch of one or more members of the class. Because no drugs from the category had previously been approved for OTC sale, we first established probabilities of FDA approval through detailed evaluation of clinical data in the context of agency Rx-to-OTC switch criteria, recommendations from major physician organizations, and other stakeholders.

After establishing odds of FDA approval both at an overall and individual formulation level, VOI analyzed payer OTC policies, customer purchase habits, shelf space, and other volume-drivers. These factors were incorporated in a multiple scenario, ten-year forecast that also allows the client to make changes based on regulatory and market developments.

Results:

The client is now fully informed about the implications of various scenarios and is positioned to adjust capacity and earnings projections using our flexible, event-driven forecasts.

Categories:

Rx-to-OTC switch, regulatory consulting, FDA regulations

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