Here are the latest G-BA decisions from the G-BA meeting held on 19 Sep 2024 on the early benefit assessments of Skyclaris, Vyvgart, Abecma, Imfinzi, Evrysdi and Elucirem.
A complete database of all previous G-BA resolutions is available upon request.
This time, the G-BA decisions include the assessment of the diagnostic agent Elucirem, which unsurprisingly concluded with “no additional benefit proven”, since there were no RCT data available.
- Skyclaris (omaveloxolone); Friedreich’s ataxia, Patients aged ≥ 16 years – Orphan drug, Hint of not-quantifiable additional benefit
- Vyvgart (efgartigimod alfa); myasthenia gravis, AChR antibodies+; reassessment of an orphan drug after exceeding €30 million threshold – Additional benefit not proven
- Abecma (idecabtagene vicleucel); 2 indications: multiple myeloma, after at least a) 3 previous therapies, b) 2 previous therapies; reassessment of an orphan drug after exceeding the €30 million threshold – Additional benefit not proven
- Imfinzi (durvalumab); new indication: hepatocellular carcinoma, first line, monotherapy) – Time restriction of previous resolution was removed
- Evrysdi (risdiplam); spinal muscular atrophy) – start of RWE data collection on 30 Oct 2024, reassessment starting 1 April 2028
- Elucirem (gadopiclenol); contrast-enhanced magnetic resonance imaging, patients aged ≥ 2 years – Additional benefit not proven
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