During the recent meeting of the German Federal Joint Committee (G-BA) held on October 5, 2023, several decisions were made regarding the early benefit assessments of various pharmaceuticals. These assessments aim to determine the additional benefits these drugs offer compared to existing treatment options. Here are the key decisions made during the meeting:
Imfinzi (durvalumab) received a new indication for biliary tumors in the first line, in combination with gemcitabine and cisplatin. In this case, a minor additional benefit was identified.
Imfinzi (durvalumab) also gained a new indication for non-small cell lung carcinoma (NSCLC) in patients who are EGFR/ALK-negative, first-line, in combination with tremelimumab and platinum-based chemotherapy. However, in both subgroups, no additional benefit was proven.
Another new indication for Imfinzi (durvalumab) in hepatocellular carcinoma (HCC) in the first line, in combination with tremelimumab, did not demonstrate any additional benefit in both subgroups.
Imjudo (tremelimumab), when used for NSCLC in patients who are EGFR/ALK-negative, first-line, in combination with durvalumab and platinum-based chemotherapy, also failed to show any additional benefit in both subgroups.
Similarly, Imjudo (tremelimumab) in hepatocellular carcinoma in the first line, in combination with durvalumab, did not prove any additional benefit in both subgroups.
Dupixent (dupilumab), indicated for the treatment of moderate to severe prurigo nodularis, showed a hint of not-quantifiable additional benefit.
Rayvow (lasmiditan), intended for the acute treatment of migraine, did not demonstrate any additional benefit.
Sotyktu (deucravacitinib), used for plaque psoriasis, also did not show any additional benefit.
Ebvallo (tabelecleucel), designed for Epstein-Barr virus-positive post-transplant lymphoproliferative disease, was designated as an orphan drug, but only a hint of not-quantifiable additional benefit was identified.
Blenrep (belantamab-mafodotin), indicated for multiple myeloma in patients who have undergone at least four previous therapies as a monotherapy, received a re-assessment after the expiry of the previous resolution. It was considered an orphan drug with a not-quantifiable additional benefit, solely based on its orphan drug status.
Lastly, Fidanacogen elaparvovec, intended for the treatment of hemophilia B, prompted a request for real-world data collection.
These decisions reflect the rigorous evaluation process undertaken by the G-BA to assess the benefits and effectiveness of these pharmaceuticals in various medical conditions. It’s important to note that additional benefits were not proven for many of these drugs, highlighting the stringent criteria for assessing their value in the German healthcare system. Manufacturers and healthcare providers will need to consider these assessments when making treatment decisions in these specific indications.
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