Rx to OTC Switch Assessment for Rx Company
An Rx client was anticipating a serious competitive threat for one of its category-leading brands and wanted to understand whether OTC switch of one or more dosage strengths, before patent expiration, could help defend the brand by generating incremental sales and profit growth.
- Can we switch our lowest dose OTC and keep the rest of the brand Rx?
- If so, would this strategy drive sufficient incremental sales and profit to justify the effort?
Our Approach and Output
- Trained the client team on switch requirements and key considerations, switch process, and relevant case precedent
- Led the team in scenario planning
- Developed strategic analysis for key variables, including:
- Primary obstacles to approval and strategies to overcome them, based on a review of the clinical data, expert interviews, and understanding of switch precedent
- Market scenarios for volumetric testing and financial modeling, based on competitive insight and review of technology pipeline
- Alternate positioning platforms vs. competition, for market research
- OTC partner selection criteria, evaluation and prioritization
- Provided guidance on specific decision inputs and assumptions, based on NCI analysis and proprietary case files, including:
- OTC pricing options, taking into account trade, managed care, and competitive insights
- Revenue potential, including OTC sales curves, Rx-to-OTC usage patterns and user values, potential impact of restricted distribution, and impact of order of entry
- Expense estimates, including spending for marketing/promotion, pre-approval investment, sales infrastructure and staffing requirements, royalty rates and deal terms for OTC partnering
- Infrastructure requirements (resources, staffing) for stand-alone commercialization, without an OTC partner
- Validated switch as a viable growth strategy for the client's brand, based on overall strategic assessment, volumetric research and long-term modeling
- Decision was made to continue to pursue switch as a lifecycle strategy
- Supported team in making a compelling case for switch in FDA submissions
"Looking back, it's a little scary...we didn't know how much we didn't know. I shudder to think how our analysis might have turned out had we not had the benefit of NCI's experience."