Decisions / 7594
final resolution2025-12-18active

Arzneimittel-Richtlinie/Anlage XII: Omaveloxolon (Neubewertung eines Orphan Drugs nach Überschreitung der 30 Millionen Euro-Grenze (Friedreich-Ataxie, ≥ 16 Jahre))

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G-BA source · retrieved 2026-08-05

Structured conclusion

Final result by patient group

1 source-verified result

Patient group

Erwachsene und Jugendliche ab 16 Jahren mit Friedreich-Ataxie

Added benefit not proven

Comparator
Best Supportive Care

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Decision orientation

What the G-BA did

4 cited claims

Each claim links to the official G-BA page or an exact PDF page range.

Official metadata

Decision date
2025-12-18
Effective
18.12.2025
Action type
final resolution
Committee
Arzneimittel

Case context

Listed normative targets

directiveArzneimittel-Richtlinie
directive annexAnlage XII: Nutzenbewertung nach § 35a SGB V

A listed target is not treated as a new directive version unless an official version source exists.

Official document package