Market Access and Reimbursement Risk Assessment.

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Market Access Insights

MARA rated linvoseltamab (Lynozyfic) B+ (Very Weak)

MARA rated linvoseltamab (Lynozyfic) B+ (Very Weak) before the G-BA published Beschluss 7730 on 19 March 2026. The B+ signal was driven by two structurally weak decision-critical domains: no HRQoL data were reported in either the FDA label or EMA SmPC, and no cost-effectiveness analysis had been submitted. The evidence base relied entirely on single-arm studies, with no randomized head-to-head comparison against the standard of care — a comparator limitation MARA flagged as a primary constraint on G-BA benefit assessment. The G-BA concluded No Additional Benefit for both patient subgroups, citing the absence of assessable data across all endpoint categories — the same evidentiary gaps MARA identified as structurally constraining. MARA’s historical G-BA signal placed No Additional Benefit above the dataset baseline (+10%), consistent with the outcome observed.