Digestive system diseases

Medicinal products that are intended to improve digestion and metabolism, for example in Crohn’s disease, ulcerative colitis, short bowel syndrome or irritable bowel syndrome (IBS), are grouped by the G-BA into the category of diseases of the digestive system. Up until this time, xx products have been assessed in xx procedures. In the xx subpopulations assessed by the G-BA, xx% have displayed a major, XX% a considerable and XX% a minor additional benefit in relation to the comparative therapy. A non-quantifiable additional benefit has been proved for a weighted XX% of the subpopulations. At the same time, no additional benefit was seen in XX% of the subpopulations, corresponding to xx% of the xx million of the patients suitable for treatment with the assessed medicinal products.

All G-BA resolutions concerning digestive system diseases

Seladelpar Lyvdelzi® Gilead Sciences GmbH Digestive system diseases Primary biliary cholangitis (combination with ursodeoxycholic acid) 6,000–13,000 100% Indication of minor additional benefit Orphan
Mirikizumab (2) Omvoh® Lilly Deutschland GmbH Digestive system diseases Crohn's disease, pre-treated 12,600–78,300 100% no additional benefit
Dupilumab (11) Dupixent® Sanofi-Aventis Deutschland GmbH Digestive system diseases Eosinophilic oesophagitis, ≥ 1 year to < 12 years 530–590 100% no additional benefit
Elafibranor Iqirvo® Ipsen Pharma GmbH Digestive system diseases Primary biliary cholangitis (combination with ursodeoxycholic acid) 6,000–13,000 100% Hint for minor additional benefit Orphan
Risankizumab (4) Skyrizi® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis, pre-treated 29,100 100% no additional benefit
Maralixibat (2) Livmarli® Mirum Pharmaceuticals International B.V. Digestive system diseases Progressive familial intrahepatic cholestasis (PFIC), ≥ 3 months 80–180 100% Hint for non-quantifiable additional benefit Orphan
Etrasimod Velsipity® Pfizer Pharma GmbH Digestive system diseases Ulcerative colitis, ≥ 16 years 29,100 100% no additional benefit
Mirikizumab Omvoh® Lilly Deutschland GmbH Digestive system diseases Ulcerative colitis, pre-treated 5,300–25,000 100% no additional benefit
Upadacitinib (7) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Morbus Crohn, pretreated 18,900–35,350 100% no additional benefit
Dupilumab (8) Dupixent® Sanofi-Aventis Deutschland GmbH Digestive system diseases Eosinophilic oesophagitis, ≥ 12 years, min. 40 kg 3,900–4,400 100% no additional benefit
Maralixibat Livmarli® Mirum Pharmaceuticals Germany GmbH Digestive system diseases Alagille-Syndrome, ≥ 2 months 139–377 100% Hint for non-quantifiable additional benefit Orphan
Risankizumab (3) Skyrizi® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Morbus Crohn, pre-treated 18,800–35,250 40% Hint for minor additional benefit
Upadacitinib (6) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis (UC), pre-treated 5,300–25,000 100% no additional benefit
Vedolizumab (2) Entyvio® Takeda GmbH Digestive system diseases Antibiotic-refractory pouchitis, pre-treated patients 20–40 100% no additional benefit
Ozanimod (2) Zeposia® Bristol-Myers Squibb GmbH & Co. KGaA Digestive system diseases Ulcerative colitis (UC), pre-treated patients 5,300–25,000 100% no additional benefit
Filgotinib (2) Jyseleca® Galapagos Biopharma Germany GmbH Digestive system diseases Ulcerative colitis (UC), pretreated patients 5,300–25,000 100% no additional benefit
Odevixibat Bylvay® Albireo Pharma AB Digestive system diseases Cholestasis, ≥ 6 months 40–110 100% Hint for minor additional benefit Orphan
Naldemedin Rizmoic® Hexal AG Digestive system diseases Opioid-induced constipation 65,000 100% no additional benefit
Tofacitinib (3) Xeljanz® Pfizer Pharma GmbH Digestive system diseases Ulcerative colitis 5,300–25,000 100% no additional benefit
Darvadstrocel Alofisel® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases Anal fistulas in Crohn's disease 90–230 100% non-quantifiable additional benefit Orphan
Obeticholsäure Ocaliva® Intercept Pharma Deutschland GmbH Digestive system diseases Biliary cirrhosis 0
1,050–7,350
100% non-quantifiable additional benefit Orphan
Teduglutid (2) Revestive® Shire Deutschland GmbH Digestive system diseases Short bowel syndrome, 1 to < 18 years 230–500 100% non-quantifiable additional benefit Orphan
Teduglutid Revestive® NPS Pharma Germany GmbH Digestive system diseases Short bowel syndrome 1,100–2,400 100% minor additional benefit Orphan
Vedolizumab Entyvio® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases Ulcerative colitis, Crohn's disease 16,100 100% no additional benefit
Linaclotid Constella® Almirall Hermal GmbH Digestive system diseases Irritable bowel syndrome (IBS) 394,000–838,000 100% no additional benefit