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21. Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Atezolizumab (Urothelkarzinom Erstlinientherapie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 March 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A18-88 Atezolizumab (urothelial carcinoma first- line treatment) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A18-88 Version 1.0 Atezolizumab (urothelial carcinoma first-line treatment) 27 March 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Atezolizumab (urothelial

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Address of publisher: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A19-26 Version 1.0 Emicizumab (haemophilia A) 13 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Wolfgang Eberl, Braunschweig Hospital, Clinic for Paediatric and Adolescent Medicine, Braunschweig (...) Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Emicizumab (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 June 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-26 Emicizumab (haemophilia

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

23. Rucaparib (ovarian, fallopian tube or peritoneal cancer; treatment) - Benefit assessment according to §35a Social Code Book V

Rucaparib (ovarian, fallopian tube or peritoneal cancer; treatment) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Rucaparib (Ovarialkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A19-22 Rucaparib (ovarian cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-22 Version 1.0 Rucaparib (ovarian cancer) 29 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rucaparib (ovarian cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 26

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

24. Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V

Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lumacaftor/Ivacaftor (zystische Fibrose bei Kindern zwischen 2 und 5 Jahren) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. IQWiG Reports – Commission No. A19-13 Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-13 Version 1.0 Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) 13 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lumacaftor/ivacaftor

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

25. Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dapagliflozin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 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. A17-65 Dapagliflozin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-65 Version 1.0 Dapagliflozin (type 2 diabetes mellitus) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

26. Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 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 A17-66 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-66 Version 1.0 Dapagliflozin/metformin (type 2 diabetes mellitus) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

27. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Elvitegravir/Cobicistat/Emtricitabin/Tenofovir- alafenamid (HIV-Infektion bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 April 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. A18-01 Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV-infected children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-01 Version 1.0 EVG/COBI/FTC/TAF (HIV-infected children) 12 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Alectinib (non-small cell 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 Alectinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (neues Anwendungsgebiet) (Version 1.0; Status: 28 March 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. A17-67 Alectinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 (new therapeutic indication) Extract of dossier assessment A17-67 Version 1.0 Alectinib (non-small cell lung cancer) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Alectinib (non-small cell lung cancer) – Benefit assessment according to §35a

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

29. Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V

Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lumacaftor/Ivacaftor (zystische Fibrose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 April 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. A18-08 Lumacaftor/ivacaftor (cystic fibrosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-08 Version 1.0 Lumacaftor/ivacaftor (cystic fibrosis) 27 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lumacaftor/ivacaftor (cystic fibrosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

30. Sonidegib (basal cell carcinoma) – Benefit assessment according to §35a Social Code Book V

Sonidegib (basal 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 Sonidegib (Basalzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 May 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. A18-10 Sonidegib (...) (basal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-10 Version 1.0 Sonidegib (basal cell carcinoma) 9 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sonidegib (basal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 14 February

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

31. Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Ipilimumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ipilimumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 May 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. A18-12 Ipilimumab (melanoma) – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-12 Version 1.0 Ipilimumab (melanoma) 9 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 February 2018 Internal Commission No.: A18-12 Address of publisher

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

32. Ixekizumab (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V

Ixekizumab (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ixekizumab (Psoriasis Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 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. A18-14 Ixekizumab (...) (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-14 Version 1.0 Ixekizumab (psoriatic arthritis) 30 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ixekizumab (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 20 February 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

33. Benralizumab (asthma) - Benefit assessment according to §35a Social Code Book V

Benralizumab (asthma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Benralizumab (Asthma) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 May 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. A18-11 Benralizumab (asthma) – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-11 Version1.0 Benralizumab (asthma) 9 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Benralizumab (asthma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 February 2018 Internal Commission No.: A18-11 Address of publisher

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

34. Abiraterone acetate (prostate cancer) - Benefit assessment according to §35a Social Code Book V

of Medicine, Rhine-Westphalian Technical University (RWTH) Aachen, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. The responsibility for the contents of the dossier assessment lies solely with IQWiG. IQWiG employees involved in the dossier assessment: ? Anke Penno ? Christiane Balg ? Catharina Brockhaus ? Michaela Florina Kerekes ? Regine Potthast ? Min Ripoll (...) Abiraterone acetate (prostate cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Abirateronacetat (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 March 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. A17-64

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

35. Guselkumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V

Guselkumab (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 Guselkumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 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. A17-60 Guselkumab (...) (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-60 Version 1.0 Guselkumab (plaque psoriasis) 27 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Guselkumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 23 November 2017

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

36. Cladribine (multiple sclerosis) - Benefit assessment according to §35a Social Code Book (SGB) V

Cladribine (multiple sclerosis) - Benefit assessment according to §35a Social Code Book (SGB) V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Cladribin (multiple Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 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. A17-62 (...) Cladribine (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-62 Version 1.0 Cladribine (multiple sclerosis) 27 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cladribine (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 30

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

37. Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book (SGB) V

Dimension G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) ITT intention to treat MedRA Medical Dictionary for Regulatory Activities Peak Pruritus NRS Peak Pruritus Numerical Rating Scale POEM Patient-Oriented Eczema Measure RCT randomized controlled trial SAE serious adverse event SCORAD Scoring Atopic Dermatitis SGB Sozialgesetzbuch (Social Code Book) SOC System Organ (...) Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book (SGB) V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (atopische Dermatitis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 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. A17-63

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Olaparib (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 Olaparib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 October 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-57 Olaparib (breast cancer (...) ) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-57 Version 1.0 Olaparib (breast cancer) 11 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Olaparib (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 11 July 2019 Internal Commission No.: A19-57

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

39. Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, ab 2 Jahre, mit Gating-Mutationen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. IQWiG Reports – Commission No. A19-67 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-67 Version 1.0 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ivacaftor (cystic

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

40. Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

was generally prohibited in the studies DRI12544 and QUEST. According to the study protocol, mepolizumab and benralizumab were explicitly excluded as pre- and concomitant medications and were not available to patients as an option for treatment escalation in the VENTURE study. Nevertheless, it is assumed that the studies presented included a relevant number of patients for whom mepolizumab, reslizumab or benralizumab were suitable options for treatment escalation. In the subpopulations considered (...) Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (Asthma) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. 19-74 Dupilumab (asthma) – Benefit

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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