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Closing the Gaps in Pre-Approval Information Exchange to Accelerate Product Success and Patient Access

Pharmaceutical Executive, Lorie Mody

As more innovative pharmaceutical products enter the pipeline, payers (defined by FDA as healthcare decision-makers in the 2018 guidance) seek more detailed information about products earlier in the approval process to inform their budget planning and formulary decisions. Given the heightened demand for pre-approval information exchange (PIE), it is increasingly important for biopharma companies to proactively develop and share information, such as anticipated indication, clinical trial results, target patient demographics and epidemiology, and product pricing insights, up to 12 months prior to the projected approval date. While pre-approval communication has increased over the last five years, there remains a gap in the information payers receive versus what they need to make informed decisions for their beneficiaries, according to a survey AmerisourceBergen’s Consulting team conducted among payers participating in its proprietary Managed Care Network.

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