Presentation (CTI)

OBJECTIVES: Historically, global launch sequencing for new therapies focused on “priority markets” with high commercial potential, established regulatory pathways, and predictable health technology assessment (HTA) processes. However, several “priority markets” are included in the reference basket for Most Favored Nation pricing models, posing a risk that lower prices in reference markets could impact US price potential. This study aims to evaluate how manufacturers should rethink launch sequencing by placing greater strategic emphasis on high-potential markets with limited risk of impacting US revenue.
METHODS: A structured market prioritization framework was developed to assess markets excluded from the MFN model reference baskets (e.g. GENEROUS, GLOBE, GUARD) which may become more strategically important. Markets were assessed based on purchasing power parity, regulatory approval processes, international reference pricing risk and local implementation requirements. Secondary research was supplemented by select ex-payers, government officials and industry expert interviews to validate findings on strategic launch markets beyond the typical “priority markets” for global launch sequencing, including commercial potential and local implementation considerations.
RESULTS: The analysis identified a set of non-reference markets that may become more strategically important for global launch sequencing under the new MFN pricing policies introduced in 2025. Markets with relatively strong purchasing power, favourable price potential, lower international reference pricing risk, and feasible regulatory or access pathways may warrant earlier launch consideration despite historically being deprioritized versus traditional “priority markets.” Earlier investment in select non-reference markets could help manufacturers reduce the risk that lower prices in reference markets impact US price potential; however, this strategy introduces several trade-offs, including delayed access in traditional priority markets and more complex execution
CONCLUSIONS: The introduction of MFN policy will introduce a shift from conventional launch sequencing toward more diversified global launch strategies. Manufacturers should reassess market prioritization and consider new local access investment to balance global price protection and patient access.