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41. Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, ab 18 Jahre mit R117H-Mutation) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A19-68 Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-68 Version 1.0 Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ivacaftor (cystic fibrosis, 18

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

42. Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V

Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Olaparib (Ovarialkarzinom; Erstlinie Erhaltung) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 October 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-56 (...) Olaparib (ovarian cancer: first-line maintenance) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-56 Version 1.0 Olaparib (ovarian cancer: first-line maintenance) 11 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Olaparib (ovarian cancer: first-line maintenance) – Benefit assessment according to §35a Social Code Book V Commissioning

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

43. Ravalizumab - Benefit assessment according to §35a Social Code Book V

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LDH lactate dehydrogenase MAVE major adverse vascular event MedDRA Medical Dictionary for Regulatory Activities PNH paroxysmal nocturnal haemoglobinuria pRBC packed red blood cells PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics ULN upper limit of normal Extract of dossier (...) Ravalizumab - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ravulizumab (paroxysmale nächtliche Hämoglobinurie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 October 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-59

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

44. Dupilumab (atopic dermatitis in adolescents) - Benefit assessment according to §35a Social Code Book V

Dupilumab (atopic dermatitis in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (atopische Dermatitis bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A19-75 Dupilumab (atopic dermatitis in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-75 Version 1.0 Dupilumab (atopic dermatitis in adolescents) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dupilumab (atopic dermatitis in adolescents) – Benefit assessment according to §35a Social Code Book V Commissioning

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

45. Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, ab 6 Jahre, mit G551D-Mutation) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A19-65 Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-65 Version 1.0 Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ivacaftor (cystic fibrosis, 6

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

46. Osimertinib (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

Osimertinib (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Osimertinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 October 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. IQWiG Reports – Commission No. A18-45 Osimertinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-45 Version 1.0 Osimertinib (non-small cell lung cancer) 11 October 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Osimertinib (non-small cell lung cancer) – Benefit assessment according

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

47. Brivaracetam (epilepsy) - Benefit assessment in accordance with §35a Social Code Book V

questions for the benefit assessment of brivaracetam Research question Indication ACT a 1 Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in children and adolescents age = 4 to < 16 years with epilepsy Individualized adjunctive epilepsy treatment to the extent medically indicated and in the absence of known drug resistance/intolerance or contraindications, using one of the following drugs: Eslicarbazepine b , gabapentin b , lacosamide, lamotrigine (...) -onset seizures with or without secondary generalization in children and adolescents age = 4 to < 16 years with epilepsy Individualized adjunctive epilepsy treatment to the extent medically indicated and in the absence of known drug resistance/intolerance or contraindications, using one of the following drugs: Eslicarbazepine b , gabapentin b , lacosamide, lamotrigine, levetiracetam, oxcarbazepine b , topiramate, valproic acid, zonisamide b Treatment specified by the physician under consideration

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

48. Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Ipilimumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 September 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-44 Ipilimumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-44 Version 1.0 Ipilimumab (melanoma) 27 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 June 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

49. Tofacitinib (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V

/download/General- Methods_Version-5-0.pdf. 2. Skipka G, Wieseler B, Kaiser T, Thomas S, Bender R, Windeler J et al. Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs. Biom J 2015; 58(1): 43-58 The full report (German version) is published under https://www.iqwig.de/en/projects- results/projects/drug-assessment/a18-51-tofacitinib-psoriatic-arthritis-benefit-assessment- according-to-35a-social-code-book-v.10484.html. (...) Tofacitinib (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tofacitinib (Psoriasis Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

50. Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bictegravir/Emtricitabin/Tenofoviralafenamid (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 September 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English- language readers. However, solely the German (...) original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-43 Bictegravir/emtricitabine/ tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-43 Version 1.0 Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) 27 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

51. Bosutinib (pretreated chronic myelogenous leukaemia) - Benefit assessment according to §35a Social Code Book V

Bosutinib (pretreated chronic myelogenous leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bosutinib (vorbehandelte chronische myeloische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2018). Please note: This document was translated by external translators and is provided as a service by IQWiG to English- language readers. However, solely the German original text (...) is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-54 Bosutinib (pretreated chronic myelogenous leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-54 Version 1.0 Bosutinib (pretreated chronic myelogenous leukaemia) 28 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Bosutinib (pretreated chronic

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

52. Tofacitinib (Colitis) - Benefit assessment according to §35a Social Code Book V

Tofacitinib (Colitis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tofacitinib (Colitis ulcerosa) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-52 Tofacitinib (ulcerative colitis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-52 Version 1.0 Tofacitinib (ulcerative colitis) 28 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tofacitinib (ulcerative colitis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

53. Ingenol mebutate (actinic keratosis) - Benefit assessment according to §35a Social Code Book V

Ingenol mebutate (actinic keratosis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Ingenolmebutat (aktinische Keratose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 November 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally (...) binding. IQWiG Reports – Commission No. A18-55 Ingenol mebutate (actinic keratosis) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A18-55 Version 1.0 Ingenol mebutate (actinic keratosis) 29 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ingenol mebutate (actinic keratosis) – Benefit assessment according to §35a

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

54. Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 November 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-53 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-53 Version 1.0 Nivolumab (melanoma) 29 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27 August 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

55. Dabrafenib (melanoma) - Benefit assessment according to §35a Social Code Book V

Dabrafenib (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Dabrafenib (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-59 Dabrafenib (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-59 Version 1.0 Dabrafenib (melanoma) 20 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dabrafenib (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 24 September

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

56. Sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to § 35a Social Code Book V (expiry of the decision)

for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Günther Egidi, practice for general medicine, Bremen IQWiG thanks the medical and scientific advisor for his/her contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. The responsibility for the contents of the dossier assessment lies solely with IQWiG. IQWiG employees involved in the dossier assessment: ? Virginia Seiffart ? Ulrich Grouven (...) Sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to § 35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 19 December 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

57. Trametinib (melanoma) - Benefit assessment according to §35a Social Code Book V

Trametinib (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Trametinib (Melanom)– Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-60 Trametinib (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-60 Version 1.0 Trametinib (melanoma) 20 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Trametinib (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 24 September

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

58. Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Lenvatinib (hepatozelluläres Karzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 13 February 2019). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A18-57 Lenvatinib (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-57 Version 1.1 Lenvatinib (hepatocellular carcinoma) 13 February 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lenvatinib (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

59. Tenofovir alafenamide (chronic hepatits B) - Benefit assessment according to §35a Social Code Book V

Tenofovir alafenamide (chronic hepatits B) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tenofoviralafenamid (chronische Hepatitis B) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A18-64 Tenofovir alafenamide (chronic hepatitis B) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-64 Version 1.0 Tenofovir alafenamide (chronic hepatitis B) 20 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tenofovir alafenamide (chronic hepatitis B) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

60. Daratumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V

Daratumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Daratumumab (multiples Myelom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG (...) Reports – Commission No. A18-66 Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-66 Version 1.0 Daratumumab (multiple myeloma) 20 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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