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61. Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Tofacitinib (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 July 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. A18-28 Tofacitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-28 Version 1.0 Tofacitinib (rheumatoid arthritis) 27 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tofacitinib (rheumatoid arthritis) – Benefit assessment according

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

62. Bosutinib (chronic myeloid leukaemia) - Benefit assessment according to §35a Social Code Book V

Bosutinib (chronic myeloid leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bosutinib (chronische myeloische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 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. A18-33 Bosutinib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-33 Version 1.0 Bosutinib (chronic myeloid leukaemia) 29 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Bosutinib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

63. Cariprazine (schizophrenia) - Benefit assessment according to §35a Social Code Book V

Cariprazine (schizophrenia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Cariprazin (Schizophrenie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 July 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. A18-25 Cariprazine (schizophrenia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-25 Version 1.0 Cariprazine (schizophrenia) 12 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cariprazine (schizophrenia) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

64. Extract from Cannabis sativa (spasticity due to multiple sclerosis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Extract from Cannabis sativa (spasticity due to multiple sclerosis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Extrakt aus Cannabis sativa (Spastik aufgrund von multipler Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 26 July 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. A18-27 Extract from Cannabis sativa (spasticity due to multiple sclerosis) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-27 Version 1.0 Extract from Cannabis sativa (spasticity due to multiple sclerosis) 26 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Cabozantinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Cabozantinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 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. A18-37 Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-37 Version 1.0 Cabozantinib (renal cell carcinoma) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

66. Dolutegravir/rilpivirine (HIV infection) - Benefit assessment according to §35a Social Code Book V

Dolutegravir/rilpivirine (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Dolutegravir/Rilpivirin (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 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. A18-34 Dolutegravir/rilpivirine (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-34 Version 1.0 Dolutegravir/rilpivirine (HIV infection) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/rilpivirine (HIV infection) – Benefit assessment according to §35a Social

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

67. Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 13 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. A18-40 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-40 Version 1.0 Nivolumab (melanoma) 13 September 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

68. Olaparib (ovarian, fallopian tube, peritoneal cancer) - Benefit assessment according to §35a Social Code Book V

Olaparib (ovarian, fallopian tube, peritoneal cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Olaparib (Ovarialkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Zulassungserweiterung / Ablauf Befristung) (Version 1.0; Status: 13 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. A18-36 Olaparib (ovarian cancer) – Benefit assessment according to §35a Social Code Book V 1 (extension of approval/ expiry of decision) Extract of dossier assessment A18-36 Version 1.0 Olaparib (ovarian cancer) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Olaparib (ovarian cancer

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Pertuzumab (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Pertuzumab (Mammakarzinom) – 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. A18-41 Pertuzumab (breast cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-41 Version 1.0 Pertuzumab (breast cancer) 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: Pertuzumab (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

70. Bezlotoxumab (Clostridium difficile infection) - Benefit assessment according to §35a Social Code Book V

Bezlotoxumab (Clostridium difficile infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bezlotoxumab (Clostridium-difficile- Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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. A18-23 Bezlotoxumab (Clostridium difficile infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-23 Version 1.0 Bezlotoxumab (Clostridium difficile infection) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Bezlotoxumab (Clostridium difficile infection) – Benefit assessment

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

71. General medicine: When to include clinical study reports and regulatory documents in systematic reviews

General medicine: When to include clinical study reports and regulatory documents in systematic reviews When to include clinical study reports and regulatory documents in systematic reviews | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . Log in using your username and password For personal accounts (...) OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here When to include clinical study reports and regulatory documents in systematic reviews Article Text Research methods and reporting General medicine When to include clinical study reports and regulatory

2018 Evidence-Based Medicine

72. 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)

73. 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)

74. 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)

75. 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)

76. 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)

77. 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)

78. 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)

79. 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)

80. 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)

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