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61. Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - 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 2 Jahre, mit Gating-Mutationen) – 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. A19-67 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-67 Version 1.0 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) 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

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

62. Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

was generally prohibited in the studies DRI12544 and QUEST. According to the study protocol, mepolizumab and benralizumab were explicitly excluded as pre- and concomitant medications and were not available to patients as an option for treatment escalation in the VENTURE study. Nevertheless, it is assumed that the studies presented included a relevant number of patients for whom mepolizumab, reslizumab or benralizumab were suitable options for treatment escalation. In the subpopulations considered (...) Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (Asthma) – 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. 19-74 Dupilumab (asthma) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

63. 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)

64. 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)

65. 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)

66. 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)

67. 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)

68. 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)

69. Mepolizumab (asthma) - Benefit assessment according to §35a Social Code Book V

Mepolizumab (asthma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Mepolizumab (Asthma bei Jugendlichen und Kindern ab 6 Jahren) – 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. A18-58 Mepolizumab (asthma in adolescents and children aged 6 years and older) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-58 Version 1.0 Mepolizumab (asthma in adolescents and children aged 6 years and older) 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: Mepolizumab (asthma

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

70. Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (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. A18-63 Palbociclib (breast cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-63 Version 1.0 Palbociclib (breast cancer) 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: Palbociclib (breast cancer) – Benefit assessment according to §35a Social

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

71. Ocriplasmin (vitreomacular traction, including when associated with macular hole) - Benefit assessment according to §35a Social Code Book V (reassessment after expiry of the decision)

vitrectomy a: Presentation of the respective ACT specified by the G-BA. ACT: appropriate comparator therapy; G-BA: Federal Joint Committee The G-BA further stated that the approval of ocriplasmin did not exclude use in asymptomatic VMT. According to the generally acknowledged state of medical science, however, a therapeutic intervention was argued to not be medically indicated in the asymptomatic VMT scenario. Therefore, the group of patients with asymptomatic VMT was to be excluded from this benefit (...) Ocriplasmin (vitreomacular traction, including when associated with macular hole) - Benefit assessment according to §35a Social Code Book V (reassessment after expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Ocriplasmin (vitreomakuläre Traktion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 March 2019). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Encorafenib (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Encorafenib (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 21 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. A18-61 Encorafenib (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-61 Version 1.0 Encorafenib (melanoma) 21 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Encorafenib (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Binimetinib (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Binimetinib (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 21 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. A18-62 Binimetinib (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-62 Version 1.0 Binimetinib (melanoma) 21 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Binimetinib (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Durvalumab (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 Durvalumab (lokal fortgeschrittenes, inoperables NSCLC) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 January 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. A18-69 Durvalumab (locally advanced, unresectable NSCLC) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-69 Version 1.0 Durvalumab (locally advanced, unresectable NSCLC) 10 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Durvalumab (locally advanced, unresectable NSCLC) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

75. Erenumab (prophylaxis of migraine) - Benefit assessment according to §35a Social Code Book V

Erenumab (prophylaxis of migraine) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Erenumab (Migräne) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 January 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. A18-71 Erenumab (migraine) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-71 Version 1.0 Erenumab (migraine) 30 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Erenumab (migraine) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 October 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

76. Pembrolizumab (head and neck squamous cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (head and neck squamous cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Pembrolizumab (Plattenepithelkarzinom des Kopf-Hals-Bereichs) – Nutzenbewertung gemäß § 35a SGB V (Version 1,0; Status: 11 January 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. A18-67 Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-67 Version 1.0 Pembrolizumab (head and neck squamous cell carcinoma) 11 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pembrolizumab (head and neck squamous

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

77. Abemaciclib in combination with an aromatase inhibitor (breast cancer) - Benefit assessment according to §35a Social Code Book V

Abemaciclib in combination with an aromatase inhibitor (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Abemaciclib (Mammakarzinom; Kombination mit einem Aromatasehemmer) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 January 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. A18-72 Abemaciclib (breast cancer; combination with an aromatase inhibitor) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-72 Version 1.0 Abemaciclib (breast cancer; combination with an aromatase inhibitor) 30 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

78. Tildrakizumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V

Tildrakizumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tildrakizumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; 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. A18-78 Tildrakizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-78 Version 1.0 Tildrakizumab (plaque psoriasis) 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: Tildrakizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

79. Alirocumab (primary hypercholesterolaemia or mixed dyslipidaemia) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Alirocumab (primary hypercholesterolaemia or mixed dyslipidaemia) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of the executive summary of the dossier assessment Alirocumab (primäre Hypercholesterinämie und gemischte Dyslipidämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 January 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. A18-74 Alirocumab (primary hypercholesterolaemia and mixed dyslipidaemia) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A18-74 Version 1.0 Alirocumab (primary hypercholesterolaemia and mixed dyslipidaemia) 30 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

80. Semaglutide (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Semaglutide (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Semaglutid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 January 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. A18-75 Semaglutide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-75 Version 1.0 Semaglutide (type 2 diabetes mellitus) 30 January 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Semaglutide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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