In general, there is never too much lead time in putting together a launch strategy, and it’s ideal to begin work at least twelve months prior to anticipated FDA-approval. Some key questions that impact effective launch strategies include:
- Is the manufacturer a new company, and what specific actions are required to prepare for access across all payers?
- What is the current payer landscape for the new molecule, and how do payers approach decision-making related to drug coverage, prior authorization, formulary placement, and specialty pharmacy requirements?
- How do Oncology Benefit Managers, clinical pathway organizations, and internal physician pathways impact the availability of new products?
- How are compendia positioning potential competitor products, and what level of data will be required for a new product coming into this disease state?