Rezdiffra's arrival changed MASH from a market-in-waiting into a live access question. For market access teams, 2026 is less about whether payers will cover MASH therapy and more about how tightly they will manage it — and that is where the commercial risk now sits.
How payers are framing MASH
MASH presents payers with a large potential population, a diagnosis pathway that still leans on non-invasive testing, and a therapy priced as a specialty product. The predictable response is aggressive utilisation management: prior authorisation tied to fibrosis staging, documented diagnostic criteria, and re-authorisation gates.
The diagnosis gate is the access gate
Because coverage criteria hinge on staging, the diagnostic pathway becomes the real determinant of who gets treated. Access strategy that ignores the diagnostic funnel will over-forecast eligible patients.
What a payer & HTA brief should cover
- Coverage criteria and step-edit logic across major US payers.
- Fibrosis-staging requirements and their effect on the eligible population.
- HTA signals from NICE and ICER that will shape ex-US access.
AXLRx delivers this as a custom Payer & HTA brief — primary-sourced from live policy documents and delivered in 72 hours.