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81. Abemaciclib in combination with fulvestrant (breast cancer) - Benefit assessment according to §35a Social Code Book V

Abemaciclib in combination with fulvestrant (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 Fulvestrant) – 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. A18-73 Abemaciclib (breast cancer; combination with fulvestrant) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-73 Version 1.0 Abemaciclib (breast cancer; combination with fulvestrant) 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: Abemaciclib

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

82. 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)

83. 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)

84. Enzalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

Enzalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Enzalutamid (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 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. A18-80 Enzalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-80 Version 1.0 Enzalutamide (prostate cancer) 26 February 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Enzalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

85. 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)

86. 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)

87. 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)

88. 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)

89. 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)

90. 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)

91. 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)

92. 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)

93. 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)

94. 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)

95. 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)

96. 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)

97. 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)

98. 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)

99. 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)

100. 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)

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