Other diseases

The G-BA defines the category other as including diagnostic products used as stress triggers for myocardial perfusion imaging, for example, as well as preparations for the prevention of side effects such as chemotherapy-related nausea and those medicinal products that cannot be assigned to any other group. In this therapeutic area, xx medicinal products have so far been evaluated in XX procedures with a total of xx subpopulations. A major additional benefit has been identified for a weighted xx% of these subpopulations, with a considerable additional benefit for XX%. Proof of a minor additional benefit for XX% of the subpopulations and of a non-quantifiable additional benefit for XX% has been seen.

The G-BA has seen no additional benefit proven for XX% of the subpopulations. This corresponds to xx% of the total xx million patients who fall within the indication areas of the assessed medicinal products and for whom the G-BA therefore sees no proof of additional benefit.

All G-BA resolutions concerning other diseases

Remimazolam (2) Byfavo® Paion Pharma GmbH Other diseases Induction and maintenance of general anaesthesia 12,000,000 100% additional benefit not proven
Remimazolam (1) Byfavo® Paion Pharma GmbH Other diseases Procedural sedation 2,620,000–2,730,000 100% additional benefit not proven
Sebetralstat (1) Ekterly® KalVista Pharmaceuticals Germany GmbH Other diseases Hereditary angioedema, acute treatment, ≥ 12 years 1,000–1,100 100% Hint for non-quantifiable additional benefit Orphan
Garadacimab (1) Andembry® CSL Behring GmbH Other diseases Hereditary angioedema, prophylaxis, ≥ 12 years 140–440 100% Hint for considerable additional benefit
Natriumthiosulfat (1) Pedmarqsi® Norgine GmbH Other diseases Prevention of ototoxicity due to cisplatin chemotherapy, solid tumours, 1 month to < 18 years 38–228 16% Indication of non-quantifiable additional benefit
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse) (2) Palforzia® Stallergenes GmbH Other diseases Peanut allergy, ≥ 1 to < 4 years 9,960–22,700 100% Hint for non-quantifiable additional benefit
Gadopiclenol (1) Elucirem® Guerbet GmbH Other diseases Contrast-enhanced magnetic resonance imaging, ≥ 2 years 2,900,000–3,300,000 100% additional benefit not proven
Fezolinetant (1) Veoza® Astellas Pharma GmbH Other diseases Severe vasomotor symptoms (VMS) associated with the menopause 2,589,650–3,015,900 80% Hint for minor additional benefit
Lanadelumab (3) Takhzyro® Takeda GmbH Other diseases Hereditary angioedema, prophylaxis, 2 to < 12 years 1–30 100% additional benefit not proven Orphan (turnover limit)
Cannabidiol (8) Epidyolex® Jazz Pharmaceuticals Germany GmbH Other diseases Seizures associated with tuberous sclerosis, ≥ 2 years 200–2,700 100% additional benefit not proven Orphan (turnover limit)
Vosoritid (3) Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 4 months to < 2 years 35–49 100% Hint for non-quantifiable additional benefit Orphan (turnover limit)
Vosoritid (2) Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 2 years 330–460 100% Indication of non-quantifiable additional benefit Orphan (turnover limit)
Lonafarnib (1) Zokinvy® EigerBio Europe Ltd. Other diseases Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over 5–6 100% Hint for non-quantifiable additional benefit Orphan
Birkenrindenextrakt (1) Filsuvez® Amryt Pharma GmbH Other diseases Wound treatment in epidermolysis bullosa (from 6 months) 270–860 100% Hint for minor additional benefit Orphan
Glycopyrronium (1) Axhidrox® Dr. August Wolff GmbH & Co. KG Arzneimittel Other diseases Severe primary axillary hyperhidrosis 73,000–704,000 100% additional benefit not proven
Glucarpidase (1) Voraxaze® SERB GmbH Other diseases Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults. 90–440 100% Hint for non-quantifiable additional benefit Orphan
Isofluran (1) Sedaconda® Sedana Medical AB Other diseases Sedation of mechanically ventilated patients during intensive care therapy (ICT) 146,000–219,000 100% additional benefit not proven
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse) (1) Palforzia® Aimmune Therapeutics Germany GmbH Other diseases Peanut allergy, ≥ 4 years 43,900–97,200 100% additional benefit not proven
Vosoritid (1) Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 2 years 0
340–480
100% Hint for non-quantifiable additional benefit Orphan repealed
Misoprostol (1) Angusta® Norgine GmbH Other diseases Labor induction 76,500–90,000 100% additional benefit not proven
Berotralstat (1) Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 140–430 100% additional benefit not proven
Lanadelumab (2) Takhzyro® Takeda GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 140–430 100% additional benefit not proven Orphan (turnover limit)
Cannabidiol (5) Epidyolex® GW Pharmaceuticals plc Other diseases Seizures in Tuberous Sclerosis, ≥ 2 years 0
500–2,700
100% Hint for non-quantifiable additional benefit Orphan repealed
Sucroferric Oxyhydroxide (2) Velphoro® Fresenius Medical Care Deutschland GmbH Other diseases Serum phosphate level control in chronic kidney disease, ≥ 2 to 18 years 390–470 100% additional benefit not proven
Apremilast (2) Otezla® Amgen GmbH Other diseases Behçet's disease 750–2,200 100% additional benefit not proven
Regadenoson (2) Rapiscan® GE Healthcare Buchler GmbH & Co. KG Other diseases Stenosis, Fractional Flow Reserve Measurement (FFR) 0
780,000
100% additional benefit not proven repealed
Lanadelumab (1) Takhzyro® Shire Deutschland GmbH, Teil der Takeda Group Other diseases Hereditary angioedema (HAE) 0
140–430
100% considerable additional benefit Orphan repealed
Glycopyrroniumbromid (1) Sialanar® Proveca Limited Other diseases Sialorrhea 2,800–3,100 100% Hint for non-quantifiable additional benefit
Rolapitant (1) Varuby® TESARO Bio Germany GmbH Other diseases Nausea and vomiting due to chemotherapy 157,700–279,700 100% additional benefit not proven
Netupitant / Palonosetron (1) Akynzeo® RIEMSER Pharma GmbH Other diseases Nausea and vomiting due to chemotherapy 157,700–279,700 100% additional benefit not proven
Sucroferric Oxyhydroxide (1) Velphoro® Fresenius Medical Care Deutschland GmbH Other diseases Serum phosphate level control in chronic kidney disease 56,600–71,500 100% additional benefit not proven
Propranolol (1) Hemangiol® Pierre Fabre Dermatologie Other diseases Infantile hemangioma 1,668–6,999 33% Indication of major additional benefit
Lebende Larven von Lucilia sericata (1) BioBag, BioMonde Freie Larven® BioMonde GmbH Other diseases Chronic or hard to heal wounds 500,000–1,000,000 100% additional benefit not proven
Colestilan (1) BindRen® Mitsubishi Pharma Deutschland GmbH Other diseases Hyperphosphatemia 44,500–57,000 100% additional benefit not proven
Regadenoson (1) Rapiscan® Rapidscan Pharma Solutions EU Ltd. Other diseases Myocardial perfusion imaging 41,000 100% additional benefit not proven