MFN and IRP analysis for a new therapy for an orphan developmental disorder ​

• The client was considering the ex-US commercial opportunity for a new orphan therapy for the treatment of an orphan paediatric developmental disorder​
• There was high uncertainty regarding the commercial viability of an ex-US launch (considering the predicted high list and net price differentials between the US and ex-US MFN reference markets). To address this the senior management team required an understanding of the likely impact of MFN on US pricing/revenue to inform potential refinements to the planned global launch order sequence  ​

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• Define the predicted list and net pricing potential for the new therapy across key MFN reference markets ​
• Evaluate predicted implications of the proposed ex-US pricing corridor (and planned launch sequence) on the US price and global revenue under the GLOBE model​
• Analysis of potential variation in the MFN impact according to the application of Method I or II for the MFN pricing calculation, and for a scenario where MFN is extended beyond 2031 ​
• Inform strategic recommendations on optimisation of the global launch sequence to support the commercial viability of the ex-US opportunity ​

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• We completed a primary research programme to inform the predicted pricing corridor for the new therapy across key MFN reference markets (and predicted uptake in clinical practice)​
• The SyMAP framework was used to analyse the implications of the ex-US list/net pricing corridor and launch sequence for the US price benchmark and US/global revenue over the proposed period for GLOBE (and the implications of a potential extension of GLOBE before 2031) ​

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• The client received a clear understanding of the predicted impact on MFN on the US and global revenue potential for the new asset, and the commercial implications for global launch planning​
• Analysis addressed the potential risks of providing net pricing information across reference markets (under Method II), and the optimal referencing approach to mitigate the commercial impact of MFN​
• Scenario analysis provided details on the potential implications of future policy developments (e.g., an extension of MFN beyond 2031) and potential implications/risk mitigation required for global launch planning ​

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