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61. 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)

62. 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)

63. 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)

64. 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)

65. 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)

66. 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)

67. 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)

68. 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)

69. 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)

70. 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)

71. 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)

72. 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)

73. 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)

74. 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)

75. Reslizumab (severe eosinophilic asthma) ? Benefit assessment according to § 35a Social Code Book V

Reslizumab (severe eosinophilic asthma) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Reslizumab (Asthma) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 April 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. A17-02 Reslizumab (...) (asthma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-02 Version 1.0 Reslizumab (asthma) 11 April 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Reslizumab (asthma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 16 January 2017 Internal Commission No.: A17-02

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

therapy from several options, the respective choice of the company is printed in bold. b: It is assumed for the present therapeutic indication that the NSCLC patients have stage IIIB to IV disease (staging according to IASLC, UICC), without a medical indication for curative resection, radiotherapy or radiochemotherapy. c: This applies especially to patients for whom nivolumab or cytotoxic chemotherapy is not an option due to their reduced general condition – in particular, these can be patients (...) Trametinib (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 Trametinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 July 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

77. Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V

Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Etelcalcetid (sekundärer Hyperparathyreoidis- mus) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 August 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. A17-25 Etelcalcetide (secondary hyperparathyroidism) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-25 Version 1.0 Etelcalcetide (secondary hyperparathyroidism) 30 August 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Etelcalcetide (secondary hyperparathyroidism) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Saxagliptin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 25 October 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. A17-33 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-33 Version 1.0 Saxagliptin/metformin (type 2 diabetes mellitus) 25 October 2017 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 to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

79. Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Urothelkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 September 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. A17-29 Nivolumab (...) (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-29 Version 1.0 Nivolumab (urothelial carcinoma) 28 September 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 3 July 2017

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Dabrafenib (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 Dabrafenib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 July 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. A17-17 Dabrafenib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-17 Version 1.0 Dabrafenib (non-small cell lung cancer) 28 July 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dabrafenib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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