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

Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ribociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 December 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. A17-45 Ribociclib (breast (...) cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-45 Version 1.0 Ribociclib (breast cancer) 13 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ribociclib (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 5 September 2017 Internal

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

42. Ledipasvir/sofosbuvir (hepatitis C) ? Benefit assessment according to §35a Social Code Book V

Ledipasvir/sofosbuvir (hepatitis C) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ledipasvir/Sofosbuvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 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. A17-41 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-41 Version 1.0 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

43. Carfilzomib (multiple myeloma) ? Benefit assessment according to §35a Social Code Book V

Carfilzomib (multiple myeloma) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Carfilzomib (multiples Myelom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 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. A17-38 (...) Carfilzomib (multiple myeloma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-38 Version 1.0 Carfilzomib (multiple myeloma) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Carfilzomib (multiple myeloma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 August

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

44. Glecaprevir/pibrentasvir (chronic hepatitis C) ? Benefit assessment according to § 35a Social Code Book V

Glecaprevir/pibrentasvir (chronic hepatitis C) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Glecaprevir/Pibrentasvir (chronische Hepatitis C) – 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. 17-34 Glecaprevir/Pibrentasvir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment 17-34 Version 1.0 Glecaprevir/Pibrentasvir (chronic hepatitis C) 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: Glecaprevir/Pibrentasvir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

45. Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V

Bundesausschuss (Federal Joint Committee) HAQ-DI Health Assessment Questionnaire-Disability Index IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MOS Medical Outcome Study MTX Methotrexate RCT randomized controlled trial SAE serious adverse event SF-36v2 Short Form (36) version 2 Health Survey SF-36v2 acute Short Form (36) version 2 Health Survey acute SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class VAS Visual analogue (...) Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Tofacitinib (Rheumatoide Arthritis) – 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. A17-18

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

46. Sofosbuvir (hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V

Sofosbuvir (hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Sofosbuvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 January 2018). 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. A17-55 Sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-55 Version 1.0 Sofosbuvir (chronic hepatitis C in adolescents) 11 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

47. Nonacog beta pegol (haemophilia B) ? Benefit assessment according to §35a Social Code Book V

Nonacog beta pegol (haemophilia B) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nonacog beta pegol (Hämophilie B) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 January 2018). 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. A17-57 (...) Nonacog beta pegol (haemophilia B) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-57 Version 1.0 Nonacog beta pegol (haemophilia B) 26 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nonacog beta pegol (haemophilia B) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

48. Elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil (HIV-1 in adolescents) ? Benefit assessment according to §35a Social Code Book (SGB) V

Elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil (HIV-1 in adolescents) ? Benefit assessment according to §35a Social Code Book (SGB) V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Elvitegravir/Cobistat/Emtricitabin/ Tenofovirdisoproxil (HIV-Infektion bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 7 February 2018). 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. A17-59 Elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil (HIV infection in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-59 Version 1.0 EVG/COBI/FTC/TDF (HIV infection in adolescents) 7 February 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Tivozanib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Tivozanib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 January 2018). 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. A17-58 Tivozanib (...) (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-58 Version 1.0 Tivozanib (renal cell carcinoma) 29 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tivozanib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 2

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

50. Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Darunavir/Cobicistat/Emtricitabine/Tenofoviralafenamid (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 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. A17-48 Darunavir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-48 Version 1.0 Darunavir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV infection) 22 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Darunavir

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

51. Perampanel (epilepsy) - Benefit assessment according to §35a Social Code Book (SGB) V

ACT a 1 Adjunctive therapy for primary generalized tonic- clonic seizures in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy an individual antiepileptic adjunctive therapy, if medically indicated and if no pharmacoresistance/intolerance and contraindications are known yet, with one of the following drugs: lamotrigine, levetiracetam, valproic acid b , topiramate, clobazam Treatment is to be chosen by the doctor depending on the basic and prior therapy/therapies (...) to 3 different antiepileptic drugs; reportedly, they had at least 3 primary generalized tonic-clonic seizures during the 8 weeks before randomization. They were administered either perampanel or placebo as study medication in addition to their ongoing antiepileptic basic therapy. Thereby, perampanel was administered as maintenance dose of Extract of dossier assessment A17-61 Version 1.0 Perampanel (epilepsy) 26 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - 8 mg/day

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

52. Brodalumab (plaque psoriasis) ? Benefit assessment according to §35a Social Code Book V

Brodalumab (plaque psoriasis) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Brodalumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 December 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. A17-42 Brodalumab (...) (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-42 Version 1.1 Brodalumab (plaque psoriasis) 1 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Brodalumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 1 September 2017

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Atezolizumab (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 Atezolizumab (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 December 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. A17-50 Atezolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-50 Version 1.0 Atezolizumab (non-small cell lung cancer) 27 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Atezolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

54. Sarilumab (rheumatoid arthritis) ? Benefit assessment according to §35a Social Code Book V

Sarilumab (rheumatoid arthritis) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sarilumab (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 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. A17-39 (...) Sarilumab (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-39 Version 1.0 Sarilumab (rheumatoid arthritis) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sarilumab (rheumatoid arthritis) – 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)

55. Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V

Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Glycopyrroniumbromid (Sialorrhö) – 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. A18-22 Glycopyrronium bromide (sialorrhoea) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-22 Version 1.0 Glycopyrronium bromide (sialorrhoea) 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: Glycopyrronium bromide (sialorrhoea) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

56. Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Insulin glargin/Lixisenatid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 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. A18-16 Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-16 Version 1.0 Insulin glargine/lixisenatide (type 2 diabetes mellitus) 20 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin glargine/lixisenatide (type

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

57. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Emicizumab (Hämophilie A) – 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. A18-20 Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-20 Version 1.0 Emicizumab (haemophilia A) 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: Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

58. Hydrocortisone (adrenal insufficiency) - Benefit assessment according to §35a Social Code Book V

Hydrocortisone (adrenal insufficiency) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Hydrocortison (Nebenniereninsuffizienz bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 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. A18-29 Hydrocortisone (adrenal insufficiency in children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-29 Version 1.0 Hydrocortisone (adrenal insufficiency in children) 10 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Hydrocortisone (adrenal insufficiency in children

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

59. Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Ertugliflozin/Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 6 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. A18-31 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-31 Version 1.1 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) 6 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ertugliflozin/sitagliptin (type 2

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

60. Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Rurioctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 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. A18-32 Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-32 Version 1.0 Rurioctocog alfa pegol (haemophilia A) 13 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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