Develop P&R strategies supporting OD launch in ex-US markets

Client Challenge

1st launch for a biotech client outside of the US.

12 months from EMA approval, the client wished to understand the revenue optimal ex-US list and net price guidance for Product X, targeting a rare CNS disease with an established SoC.

The goal was to shorten the time to access and revenue generation throughout Europe while achieving a sustainable price.

P4A Solution

P4A assessed the product and then implemented these stages:

  • Analogue analysis
  • Pricing research with payers and KOLs
  • Payer research to validate hypotheses
  • Launch P&R guidance development
We identified broad label P&R challenges, gaps in payer knowledge of the disease and clinical relevance of endpoints

The Successful Outcome

  • Educated organisation and helped re-define ex-US regulatory and access goals to focus only on 2nd line high unmet need patients vs. all-comers
  • Defined list and net price corridors to ensure a sustainable return on investment
  • Developed an EU5 KOL advocacy plan to optimise launch HTA and P&R outcomes
P4A helped our organization understand and adapt our P&R strategy to fit with the ex-US environment.
VP& Head of Region Europe