Presentation (CTI)

OBJECTIVES: To assess the policy implications and potential mitigation solutions to US MFN Pricing policy
METHODS: Leveraging MFN policy rules for OECD IRP we calculated the range of consequences for a basket of 10 leading Oncology drugs through benchmarking. High-cost oncology biologics are potentially a MFN target and the pricing gap is stark with OECD oncology injectables being priced 35-74% lower than U.S. counterparts. Strategies to protect the US WAC price were modelled across scenarios including withdrawals, delayed launches, no launch, price transparency rules across markets, availability of MEAs to protect confidentiality on price, longer term product development strategies to decouple US and Ex-US pricing.
RESULTS: The stark price differences mean that should MFN be activated as presently written mitigation strategies must be evaluated. Simply withdrawing products may cause reputational damage as seen by Aspen Pharma and Sanofi in the past. Patient access to oncology drugs was seen to need to be constrained in many leading OECD countries. Leveraging our internal MEA revenue simulation tool, we were able to demonstrate that protecting net price was the solution to keep USA prices stable in many but not all OECD markets.
CONCLUSIONS: Biopharma clients can deploy a range of targeted strategies to mitigate MFN-linked revenue erosion across key markets - the elegance of one global list price with confidential discounts via MEAs was considered the best if not most challenging to execute. The combination of low list prices and lack of effective confidential net price mechanism has the potential to hold back patient access as seen presently in UMIC / LMIC markets. Proactive scenario planning and mitigation planning is needed to evaluation implications for existing Launch Strategies in the USA and across OECD markets. A mindset shift will be necessary to protect patient access to innovation across OECD markets.