Full Title: Lifecycle Management: Accessing New Patient Populations - Maximizing Return on Investment of Indication Management
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Introduction Successfully managing the lifecycle of molecules within marketed portfolios is an essential capability for the pharma industry. With R&D productivity stalling, and profit margins increasingly eroded by cost containment initiatives, maximizing the return on investment of in-line brands, by extending their use to new patient populations, is a key objective for pharmaceutical companies. Scope - Quantitative analysis of Datamonitor’s Indication Expansion Database of 81 supplemental indications in the US
- Detailed case studies of 32 molecules, analyzing sales and prescription data to highlight outcomes across a range of indication management strategies
- Case study analysis combined with future focused environmental assessment, to identify best practice strategies for accessing new patient populations
- Examination of the role of new indication in growing sales, expanding franchises, countering generics and seizing untapped market opportunities
Highlights Indication expansion is an almost universally employed LCM technique. Of the 50 top selling brands in 2004, 84% have had additional indications approved since their initial launch in the US, and a further 6% are known to have subsequent indications in development.
A number of high-profile drug safety issues (including the withdrawal of Vioxx in late-2004, and investigation of the links between SSRI’s and suicide) are changing the environment for pharmaceuticals, and pharmaceutical marketing in particular, and may reduce the potential for companies to profit from off-label use of their products.
Although there can be exclusivity benefits to line extensions, US and EU regulatory reform has reduced effectiveness of indication expansion as a standalone generic protection strategy. Indication expansion must be paired with a method to differentiate the product in the new use, preventing off-label uptake of generics in the new indication.
Reasons to Purchase - Identify the optimal indication management strategy for your brand
- Understand the impact of regulatory reform and raised drug safety awareness on off-label drug use
- Gain insight into how launch timing, competitive positioning, pricing, and market characteristics influence success of indication expansion strategies
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