Infectious diseases

The xx medicinal products assessed in the field of infectious diseases include products for the treatment of hepatitis (types A, B and C), HIV infections and other bacterial, viral and fungal diseases. To date, the G-BA has passed xx resolutions, with the result that a major additional benefit or a considerable additional benefit has been identified for xx% and XX% of the respective subpopulations, weighted according to patient share in the resolution. A minor additional benefit has been identified in XX% of the subpopulations, and a non-quantifiable additional benefit has been identified for XX% of the subpopulations.

The remaining XX% of subpopulations weighted by patient share include a total of xx% of the potential total of xx million patients using the medicinal product assessed in the therapeutic area. The G-BA did find no additional benefit for these patients in relation to the appropriate comparative therapy.

All G-BA resolutions concerning infectious diseases

Nirsevimab (3) Beyfortus® Sanofi-Aventis Deutschland GmbH Infectious diseases Prevention of RSV infections, children during their 1st RSV season, which are not addressed in the therapeutic indication for RSV antibodies 541,000–555,000 100% Indication of considerable additional benefit
Cabotegravir (2) Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, treatment-experienced adolescents, combination with rilpivirine, 12 to 17 years of age 65 100% no additional benefit
Sipavibart Kavigale® AstraZeneca GmbH Infectious diseases COVID-19, pre-exposure prophylaxis, ≥ 12 years 0 100% no additional benefit
Ceftazidim / Avibactam (2) Zavicefta® Pfizer Pharma GmbH Infectious diseases Bacterial infections, several therapeutic indications, from birth to < 3 years 10–27 100% additional benefit considered proven
Artesunat Artesunate Amivas® Amivas Ireland Ltd Infectious diseases Severe malaria, from birth 87 100% non-quantifiable additional benefit Orphan
Meropenem / Vaborbactam Vaborem® Berlin-Chemie AG Infectious diseases Acterial infections, several therapeutic indications 1,294–1,405 100% additional benefit considered proven
Isavuconazol (2) Cresemba® Pfizer Pharma GmbH Infectious diseases Mucormycosis, ≥ 1 to ≤ 17 years 8 100% Hint for non-quantifiable additional benefit Orphan
Isavuconazol (3) Cresemba® Pfizer Pharma GmbH Infectious diseases Aspergillosis, ≥ 1 to ≤ 17 years 40–215 100% Hint for non-quantifiable additional benefit Orphan
Aztreonam / Avibactam Emblaveo® Pfizer Pharma GmbH Infectious diseases Bacterial infections, several therapeutic indications 2,600–6,600 100% additional benefit considered proven
Nirsevimab (2) Beyfortus® Sanofi-Aventis Deutschland GmbH Infectious diseases Secondary prophylaxis of RSV infections, children during their 2nd RSV season, ≥ 24 months of life 9,535 100% no additional benefit
Cefepim / Enmetazobactam Exblifep® Advanz Pharma Germany GmbH Infectious diseases Bacterial infections, several areas of application 1,000–2,600 100% additional benefit considered proven
Nirsevimab Beyfortus® Sanofi-Aventis Deutschland GmbH Infectious diseases Secondary prophylaxis of RSV infections, children during their 1st RSV season 52,450–66,450 100% no additional benefit
Rezafungin Rezzayo® Mundipharma Infectious diseases Invasive candida infections 31,800–34,600 100% Hint for non-quantifiable additional benefit Orphan
Letermovir (3, reassessment >€30m) Prevymis® MSD Sharp & Dohme GmbH Infectious diseases CMV reactivation/disease, prophylaxis after stem cell transplantation 1,400–1,800 100% Hint for non-quantifiable additional benefit Orphan (turnover limit)
Letermovir (2) Prevymis® MSD Sharp & Dohme GmbH Infectious diseases CMV disease, prophylaxis after kidney transplantation 320 100% no additional benefit Orphan (turnover limit)
Bedaquilin (4, reassessment) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis 70–100 100% Hint for considerable additional benefit Orphan
Dalbavancin (2) Xydalba® Advanz Pharma Germany GmbH Infectious diseases Acute bacterial skin and soft tissue infections (ABSSSI), ≥ 3 months 190–9,800 100% additional benefit considered proven
Tixagevimab / Cilgavimab (2) Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, Preexposition prophylaxis, ≥ 12 years 0 100% no additional benefit
Dolutegravir / Abacavir / Lamivudin (2) Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 14 kg to < 12 years 86 100% no additional benefit
Bictegravir / Emtricitabin / Tenofoviralafenamid (2) Biktarvy® Gilead Sciences GmbH Infectious diseases HIV-Infection, 2 until < 18 years 184 100% no additional benefit
Maribavir Livtencity® Takeda GmbH Infectious diseases Cytomegalovirus infection (CMI), refractory to therapy 90–130 100% Hint for minor additional benefit Orphan
Dalbavancin Xydalba® Advanz Pharma Germany GmbH Infectious diseases Acute bacterial skin and skin structure infections (ABSSSI) 0 resolution w/o assessement
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 2 to < 6 years 16 100% no additional benefit
Tixagevimab / Cilgavimab Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre 0 100% Hint for minor additional benefit
Remdesivir (4) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg) 2,600–14,200 100% no additional benefit
Remdesivir (3) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years 350–1,060 100% no additional benefit
Ceftolozan / Tazobactam (7) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications, < 18 years of age 40 100% additional benefit considered proven
Eravacyclin Xerava® PAION Deutschland GmbH Infectious diseases Reserve antibiotics: Complicated intra-abdominal infections (cIAI) 2,600–6,600 100% additional benefit considered proven
Nirmatrelvir / Ritonavir Paxlovid® Pfizer Pharma GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression 218,000–1,307,000 100% Hint for considerable additional benefit
Sotrovimab Xevudy® GlaxoSmithKline GmbH & Co. KG Infectious diseases COVID-19, ≥ 12 years 0 100% Hint for considerable additional benefit
Imipenem / Cilastatin / Relebactam (2) Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 2,598–6,600 100% additional benefit considered proven
Ceftolozan / Tazobactam (6) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 2,600–6,600 100% additional benefit considered proven
Ceftazidim / Avibactam Zavicefta® Pfizer Pharma GmbH Infectious diseases Bacterial infections, multiple indications 2,600–6,600 100% additional benefit considered proven
Doravirin / Lamivudin / Tenofovirdisoproxil (2) Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 10–20 100% no additional benefit
Doravirin (2) Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 130–140 100% no additional benefit
Casirivimab / Imdevimab (2) Ronapreve® Roche Pharma AG Infectious diseases Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years 0 100% Hint for minor additional benefit
Casirivimab / Imdevimab Ronapreve® Roche Pharma AG Infectious diseases COVID-19-Infection, ≥ 12 years 0 100% Hint for considerable additional benefit
Dolutegravir (4, reassessment) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, age 6 to < 18 years 0 resolution w/o assessement
Sofosbuvir / Velpatasvir (3) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 3 to < 6 years of age 1–12 100% no additional benefit
Remdesivir (2) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression 218,000–1,307,000 100% Hint for minor additional benefit
Cefiderocol (2) Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens 2,600–6,600 100% additional benefit considered proven
Delamanid Deltyba® Otsuka Novel Products Infectious diseases Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg 80–114 100% Hint for non-quantifiable additional benefit Orphan
Elbasvir / Grazoprevir (2) Zepatier® MSD Sharp & Dohme B.V. Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 0 100% no additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir (2) Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 24–39 100% no additional benefit
Imipenem / Cilastatin / Relebactam Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Pneumonia, Bacteriemia 0 resolution w/o assessement
Ceftolozan / Tazobactam (5) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) 0 resolution w/o assessement
Glecaprevir / Pibrentasvir (3) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 3 to < 12 years 146–238 100% no additional benefit
Cabotegravir Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with rilpivirin 59,900 100% no additional benefit
Rilpivirin (3, Rekambys®) Rekambys® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with cabotegravir 59,900 100% no additional benefit
Cefiderocol Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens 0 resolution w/o assessement
Remdesivir Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, ≥ 12 years, additional oxygen supply 45,000–79,000 34% Hint for minor additional benefit
Fostemsavir Rukobia® ViiV Healthcare GmbH Infectious diseases Multidrug-resistant HIV infection 80–240 100% no additional benefit
Bedaquilin (3) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis, 5 to 11 years 1 100% Hint for non-quantifiable additional benefit Orphan
Baloxavir marboxil (2) Xofluza® Roche Pharma AG Infectious diseases Influenza prophylaxis, ≥ 12 years 1,909,000–3,965,000 58% Indication of considerable additional benefit
Baloxavir marboxil Xofluza® Roche Pharma AG Infectious diseases Influenza, ≥ 12 years 1,871,000–3,303,000 100% no additional benefit
Dolutegravir (3) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV-Infection, children ≥ 4 weeks to < 6 years 29 100% no additional benefit
Amikacin (liposomal) Arikayce® liposomal Insmed Germany GmbH Infectious diseases Mycobacterium avium complex (MAC) lung infections 350–760 100% Hint for non-quantifiable additional benefit Orphan
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 6 to < 18 years 120 100% no additional benefit
Bulevirtid Hepcludex® MYR GmbH Infectious diseases Chronic hepatitis Delta 300–4,800 100% Hint for non-quantifiable additional benefit Orphan
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases Multidrug-resistant HIV infection 50–110 100% no additional benefit
Sofosbuvir (3) Sovaldi® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 30–50 100% Hint for non-quantifiable additional benefit
Ledipasvir / Sofosbuvir (3) Harvoni® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 100–170 50% Hint for non-quantifiable additional benefit
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases HIV infection, combination with atazanavir or darunavir, 12 to < 18 years 130 100% no additional benefit
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases Clostridioides difficile infection, children and adolescents 350 54% Hint for considerable additional benefit
Bedaquilin (2) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years 9–13 100% Hint for non-quantifiable additional benefit Orphan
Dolutegravir / Lamivudin Dovato® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 52,060–61,380 100% no additional benefit
Glecaprevir / Pibrentasvir (2) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 12 to < 18 years 540 100% no additional benefit
Doravirin Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 57,800–73,700 100% no additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 48,800–68,000 100% no additional benefit
Bedaquilin Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis 0
70–100
100% considerable additional benefit Orphan
Tenofoviralafenamid (2, reassessment) Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 12,400–38,100 100% no additional benefit
Bictegravir / Emtricitabin / Tenofoviralafenamid Biktarvy® Gilead Sciences GmbH Infectious diseases HIV infection 66,800 100% no additional benefit
Dolutegravir / Rilpivirin Juluca® ViiV Healthcare GmbH Infectious diseases HIV infection 53,000 100% no additional benefit
Bezlotoxumab Zinplava® MSD Sharp & Dohme GmbH Infectious diseases Prevention of recurrent Clostridium difficile infection 6,800–37,600 100% Indication of minor additional benefit
Letermovir Prevymis® MSD Sharp & Dohme GmbH Infectious diseases Cytomegalovirus infection 0
1,000–1,800
100% non-quantifiable additional benefit Orphan
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 6 to < 12 years 100 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) Stribild® Gilead Sciences GmbH Infectious diseases HIV infection, 12 to < 18 years 100 100% no additional benefit
Sofosbuvir (2) Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, 12 to < 18 years 1,025 100% Hint for non-quantifiable additional benefit
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid Symtuza® Janssen-Cilag GmbH Infectious diseases HIV infection 62,050 100% no additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 104,600 100% no additional benefit
Ledipasvir / Sofosbuvir (2) Harvoni® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, 12 to < 18 years 5,300 50% Hint for non-quantifiable additional benefit
Glecaprevir / Pibrentasvir Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 104,600 100% no additional benefit
Tenofoviralafenamid Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 0
12,400–38,100
100% no additional benefit
Dolutegravir (2) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, 6 to < 12 years 110 100% no additional benefit
Elbasvir / Grazoprevir Zepatier® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 64,800 100% no additional benefit
Emtricitabin / Rilpivirin / Tenofoviralafenamid Odefsey® Gilead Sciences GmbH Infectious diseases HIV infection 56,800–59,300 100% no additional benefit
Sofosbuvir / Velpatasvir Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 100,000 28% Hint for considerable additional benefit
Emtricitabin / Tenofoviralafenamid Descovy® Gilead Sciences GmbH Infectious diseases HIV infection 63,000 100% no additional benefit
Rilpivirin (2) Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection, 12 to < 18 years 10 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection 56,800 100% no additional benefit
Isavuconazol Cresemba® Basilea Pharmaceutica International Ltd. Infectious diseases Aspergillosis, mucormycosis 1,293–5,342 100% non-quantifiable additional benefit Orphan
Ombitasvir / Paritaprevir / Ritonavir Viekirax® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 54,800 9% Indication of considerable additional benefit
Dasabuvir Exviera® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 61,700 24% Indication of considerable additional benefit
Ledipasvir / Sofosbuvir Harvoni® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 74,100 79% Hint for considerable additional benefit
Dolutegravir / Abacavir / Lamivudin Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 54,398 9% Indication of considerable additional benefit
Daclatasvir Daklinza® Bristol-Myers Squibb GmbH & Co. KGaA Infectious diseases Chronic hepatitis C 70,500 1.4% Hint for considerable additional benefit
Simeprevir Olysio® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 64,800 91% Indication of considerable additional benefit
Cobicistat Tybost® Gilead Sciences GmbH Infectious diseases HIV infection 57,400 100% no additional benefit
Dolutegravir Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 57,399 11% Proof of considerable additional benefit
Sofosbuvir Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 99,841 4% Indication of considerable additional benefit
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2) Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection 46,000 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil Stribild® Gilead Sciences GmbH Infectious diseases HIV infection 49,800 100% no additional benefit
Fidaxomicin Dificlir® Astellas Pharma GmbH Infectious diseases Clostridium difficile infections 33,300 41% Proof of considerable additional benefit
Emtricitabin / Rilpivirin / Tenofovirdisoproxil Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection, non-pretreated patients 1,260 100% Proof of minor additional benefit
Rilpivirin Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection 1,260 100% Proof of minor additional benefit
Telaprevir Incivo® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 46,000 100% Indication of non-quantifiable additional benefit
Boceprevir Victrelis® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 46,000 100% Indication of non-quantifiable additional benefit