Here are the G-BA decisions from the G-BA meeting held on 5 October 2023 on the early benefit assessments of Imfinzi, Imjudo, Dupixent, Rayvow, Sotyktu, Ebvallo and Blenrep.
A complete database of all previous G-BA resolutions is available through my membership.
- Imfinzi (durvalumab); new indication: Biliary tumours, first line, in combination with gemcitabine and cisplatin – Indication of minor additional benefit
- Imfinzi (durvalumab); new indication: non-small cell lung carcinoma, EGFR/ALK-negative, first-line, in combination with tremelimumab and platinum-based chemotherapy – In both subgroups, additional benefit not proven
- Imfinzi (durvalumab); new indication: hepatocellular carcinoma, first-line, in combination with tremelimumab – In both subgroups, additional benefit not proven
- Imjudo (tremelimumab); non-small cell lung carcinoma, EGFR/ALK-negative, first-line, in combination with durvalumab and platinum-based chemotherapy – In both subgroups, additional benefit not proven
- Imjudo (tremelimumab); hepatocellular carcinoma, first-line, in combination with durvalumab – In both subgroups, additional benefit not proven
- Dupixent (dupilumab); new indication: treatment of moderate to severe prurigo nodularis – Hint of not-quantifiable additional benefit
- Rayvow (lasmiditan); migraine, acute treatment – Additional benefit not proven
- Sotyktu (deucravacitinib); plaque psoriasis – Additional benefit not proven
- Ebvallo (tabelecleucel); Epstein-Barr virus-positive post-transplant lymphoproliferative disease – Orphan drug, Hint of not-quantifiable additional benefit
- Blenrep (belantamab-mafodotin); multiple myeloma, at least 4 previous therapies, monotherapy; re-assessment after expiry of previous resolution – Orphan drug, not-quantifiable additional benefit solely based on OD status
- Fidanacogen elaparvovec; haemophilia B – Request for real-world data collection
Combination discounts
I had previously posted about the new combination discount that was introduced with the GKV-FinStG in Nov 2022. The law means that an additional discount of 20% on top of the negotiated price will be applied to drugs that have a minor, non-quantifiable or no additional benefit and are used in combination.
The G-BA was tasked with naming these product combinations. This list is meant to be used as a reference for SHI funds to be able to apply the discounts.
Previously, the G-BA published a list of the possible combinations, which was purely based on overlapping indications. This meant, if two products have the same indication and combination treatment is not explicitly excluded, then they were included in the combination list. The medical plausibility of these combinations was not assessed.
Yesterday, the G-BA now redefined its approach towards the evaluation of drug combinations. It will now use a more stringent criterion for designating active substances as combination partners, thus, significantly shortening the list of possible combinations. Now, the combination decisions will be based on the SPC of the drug. The SPC must at least contain details regarding its use in combination therapy with another drug to be considered for listing as a drug combination.
The G-BA will apply this approach prospectively for all future resolutions and retrospectively for all decisions since November 2022.
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