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61. 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)

62. 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)

63. 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)

64. 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)

65. 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)

66. 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)

67. 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)

68. 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)

69. 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)

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

Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Dapagliflozin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (neue wissenschaftliche Erkenntnisse) (Version 1.0; Status: 27 September 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. A19-53 Dapagliflozin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A19-53 Version 1.0 Dapagliflozin (type 2 diabetes mellitus) 27 September 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin (type 2 diabetes mellitus) – Benefit assessment

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Pembrolizumab (non-squamous non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Pembrolizumab (nicht plattenepitheliales NSCLC, Kombinationschemotherapie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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. A19-30 Pembrolizumab (non-squamous NSCLC, combination chemotherapy) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-30 Version 1.0 Pembrolizumab (non-squamous NSCLC, combination chemotherapy) 27 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pembrolizumab (non-squamous NSCLC, combination

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

72. Fluticasone furoate/umeclidinium/vilanterol (COPD) - Benefit assessment according to §35a Social Code Book V

Fluticasone furoate/umeclidinium/vilanterol (COPD) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Fluticasonfuroat/Umeclidinium/Vilanterol (mit LABA + LAMA vorbehandelte COPD) – 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. A18-79 Fluticasone furoate/ umeclidinium/vilanterol (COPD pretreated with LABA + LAMA) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-79 Version 1.0 Fluticasone furoate/umeclidinium/vilanterol (COPD pretreated with LABA + LAMA) 13 February 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

73. Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin (Diabetes mellitus Typ 1) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 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. A19-37 Dapagliflozin (type 1 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-37 Version 1.0 Dapagliflozin (type 1 diabetes mellitus) 30 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin (type 1 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

74. Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (neue wissenschaftliche Erkenntnisse) (Version 1.0; Status: 27 September 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. A19-52 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A19-52 Version 1.0 Dapagliflozin/metformin (type 2 diabetes mellitus) 27 September 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin/metformin (type

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

75. Turoctocog alfa pegol - Benefit assessment according to §35a Social Code Book V

of Transfusion Medicine, Cell Therapeutics and Haemostaseology, Clinic for Anaesthesiology, University Hospital Munich (LMU), Munich, Germany IQWiG thanks the medical and scientific advisor for his 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: ? Michael Köhler ? Katharina Biester ? Ulrich (...) Turoctocog alfa pegol - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Turoctocog alfa pegol (Hämophilie A) – 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. A19-58 Turoctocog

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

transmembrane conductance regulator CI confidence interval EMA European Medicines Agency FEV1 forced expiratory volume in 1 second G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MMRM mixed-effects model repeated measures RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMD standardized mean difference SPC Summary of Product (...) weeks, the VX12-770-111 study (Part 1) included by the company is unsuitable for a benefit assessment in the therapeutic indication of CF. CF is a chronic disease requiring lifelong treatment. The European Medicines Agency (EMA) guideline recommends a minimum study duration of 6 months for the investigation of a clinical outcome [9]. IQWiG’s General Methods also consider long-term studies to be necessary for the benefit assessment in chronic diseases [1]. Short-term studies are inadequate

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

77. Cemiplimab - Benefit assessment according to §35a Social Code Book V

Cemiplimab - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Cemiplimab (kutanes Plattenepithelkarzinom) – 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. A19-60 Cemiplimab (...) (cutaneous squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-60 Version 1.0 Cemiplimab (cutaneous squamous cell carcinoma) 30 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cemiplimab (cutaneous squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

to decision by the physician or the patient. Treatment in the intervention arm was generally restricted by the maximum number of allowed cycles of pembrolizumab (35 cycles); none of the patients in the study achieved this maximum number. After discontinuation of the study medication (e.g. due to disease progression), the patients in both treatment arms could be treated with subsequent therapies. There were no restrictions regarding the type of subsequent therapy. Moreover, suitable patients with disease (...) Pembrolizumab (squamous non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Pembrolizumab (plattenepitheliales NSCLC, Kombinationschemotherapie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

79. 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)

80. 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)

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