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81. Lonoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Lonoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V 1 Translation of addendum A16-66 Elotuzumab (multiples Myelom) – Addendum zum Auftrag A16-32 (Version 1.0; Status: 9 November 2016). 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. Addendum 9 November 2016 1.0 Commission: A16-66 Version: Status: IQWiG Reports – Commission (...) Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) ISS International Staging System MID minimally important difference MMRM mixed-effects model repeated measures PFS progression-free survival SAE serious adverse event SD standard deviation SGB Sozialgesetzbuch (Social Code Book) Addendum A16-66 Version 1.0 Elotuzumab – Addendum to Commission A16-32 9 November 2016 Institute

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

82. Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V

Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Saxagliptin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 September 2016). 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. A16-43 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-43 Version 1.0 Saxagliptin/metformin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

83. Ibrutinib (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Ibrutinib (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ibrutinib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 September 2016). 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. A16-39 Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-39 Version 1.0 Ibrutinib (chronic lymphocytic leukaemia) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

84. Sitagliptin - Benefit assessment according to §35a Social Code Book V

Sitagliptin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 30 September 2016). 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. A16-44 (...) Sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-44 Version 1.0 Sitagliptin (type 2 diabetes mellitus) 30 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

85. Sitagliptin/metformin - Benefit assessment according to §35a Social Code Book V

Sitagliptin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sitagliptin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 30 September 2016). 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. A16-45 Sitagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-45 Version 1.0 Sitagliptin/metformin (type 2 diabetes mellitus) 30 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

86. Saxagliptin - Benefit assessment according to §35a Social Code Book V

Saxagliptin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Saxagliptin (Diabetes mellitus Typ 2 – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 September 2016). 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. A16-42 (...) Saxagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-42 Version 1.0 Saxagliptin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Saxagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

87. Rilpivirine (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

assessment A15-55 Version 1.0 Rilpivirine (new TI) – Benefit assessment acc. to §35a Social Code Book V 30 March 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - Conclusions on the added benefit based on one-arm study designs are only possible in the presence of very large effects (so-called dramatic effects) regarding patient-relevant outcomes. To derive such an effect, the C213 study first would have to be generally suitable to provide information on rilpivirine for the research (...) Rilpivirine (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Rilpivirin (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2016). 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. A15

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

88. Ticagrelor (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

disorders 267 (5.0) 268 (5.0) General disorders and administration site conditions 695 (13.1) 775 (14.5) Non-cardiac chest pain 268 (5.0) 302 (5.7) Investigations 328 (6.2) 322 (6.0) Injury, poisoning and procedural complications 428 (8.0) 399 (7.5) a: MedDRA version 17.0. AE: adverse event; ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial (...) and urinary disorders 53 (1.0) 50 (0.9) General disorders and administration site conditions 118 (2.2) 135 (2.5) Non-cardiac chest pain 71 (1.3) 79 (1.5) Injury, poisoning and procedural complications 91 (1.7) 71 (1.3) a: MedDRA version 17.0. ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial; SAE: serious adverse event; SOC: System Organ Class

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

89. Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.6, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Insulin degludec (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 May 2015). 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. A15-10 Insulin degludec (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-09 Version 1.0 Insulin degludec (new TI) – Benefit assessment acc. to §35a SGB V 28 May 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

90. Emtricitabine/tenofovir alafenamide - Benefit assessment according to §35a Social Code Book V

Emtricitabine/tenofovir alafenamide - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Emtricitabin/Tenofoviralafenamid (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 29 September 2016). 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. A16-30 Emtricitabine/ tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-30 Version 1.1 Emtricitabine/tenofovir alafenamide (HIV infection) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Emtricitabine/tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

91. Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 September 2016). 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. A16-35 Nivolumab (...) (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-35 Version 1.0 Nivolumab (melanoma) 12 September 2016 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: 8 June 2016 Internal Commission No.: A16-35

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

92. Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events EQ-5D European Quality of Life-5 Dimensions ER oestrogen receptor FACT-B Functional Assessment of Cancer Therapy-Breast Cancer FACT-G Functional Assessment of Cancer Therapy-General G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HER2 human epidermal growth factor receptor 2 HR hormone receptor IQWiG Institut für Qualität und (...) Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 23 February 2017). 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. A16-74 Palbociclib

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

93. Ibrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

Ibrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ibrutinib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 December 2016). 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. A16-60 Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-60 Version 1.0 Ibrutinib (chronic lymphocytic leukaemia) 28 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

94. Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V

Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Macitentan (pulmonal arterielle Hypertonie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 January 2017). 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. A16-67 Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-67 Version 1.0 Macitentan (pulmonary arterial hypertension) 9 January 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

95. Crizotinib (lung cancer) - Benefit assessment according to §35a Social Code Book V

Crizotinib (lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Crizotinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-59 (...) Crizotinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-59 Version 1.0 Crizotinib (non-small cell lung cancer) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Crizotinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

96. Ceritinib (lung cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Ceritinib (lung cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ceritinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-62 Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-62 Version 1.0 Ceritinib (non-small cell lung cancer) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

97. Opicapone (Parkinson disease) - Benefit assessment according to §35a Social Code Book V

Opicapone (Parkinson disease) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Opicapon (Parkinsonkrankheit) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-61 Opicapone (...) (Parkinson disease) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-61 Version 1.0 Opicapone (Parkinson disease) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Opicapone (Parkinson disease) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 September 2016

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

98. Idelalisib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

Idelalisib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Idelalisib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 5 January 2017). 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. A16-64 Idelalisib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-64 Version 1.1 Idelalisib (chronic lymphocytic leukaemia) 5 January 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Idelalisib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

99. Lenvatinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MSKCC Memorial Sloan Kettering Cancer Center PFS progression-free survival PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMQ Standardized Medical Dictionary for Regulatory Activities Query SOC System Organ Class SPC Summary of Product Characteristics VEGF vascular endothelial growth factor Extract of dossier assessment A16-63 Version (...) the last dose of the study medication. Table 12 shows the risk of bias at study level. Table 12: Risk of bias at study level – RCT, direct comparison: lenvatinib + everolimus vs. everolimus Study Adequate random sequence generation Allocation concealment Blinding Reporting independent of the results No additional aspects Risk of bias at study level Patient Treating staff Study 205 Yes Yes No No Yes Yes Low RCT: randomized controlled trial; vs.: versus The risk of bias at study level for study 205

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

100. Trifluridine/tipiracil (colorectal cancer) - Benefit assessment according to §35a Social Code Book V

Trifluridine/tipiracil (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Trifluridin/Tipiracil (Kolorektalkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 November 2016). 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. A16-54 Trifluridine/tipiracil (colorectal cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-54 Version 1.0 Trifluridine/tipiracil (colorectal cancer) 11 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Trifluridine/tipiracil (colorectal cancer) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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