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21. 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)

22. 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)

23. 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)

24. 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)

25. 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)

26. 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)

27. 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)

28. 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)

29. 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)

30. 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)

31. 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)

32. 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)

33. 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)

34. 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)

35. General Medical Books

Books Aka: General Medical Books , General Medical Resources II. Resources: Primary Care Library Recommendations Pfenninger and Fowler (2010) Procedures, Mosby Moore (2010) Griffith's Instructions for Patients Goroll (2014) Primary Care Medicine, Lippincott III. Resources: Lab Coat Resource Recommendations Godara (2013) Washington Manual, Lippincott IV. Resources: Medical Student Library Recommendations Kasper (2015) Harrison's Internal Medicine Goldman (2015) Goldman-Cecil Medicine Netter (2014 (...) General Medical Books General Medical Books Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 General Medical Books General Medical

2018 FP Notebook

36. Best practice for managing outpatient bookings

and processes for ensuring equitable access for all patients requiring specialist medical outpatient services. This was achieved by providing best-practice waitlist management processes aimed at facilitating treatment of patients within clinically recommended timeframes. The Standard contains information regarding the following: • Internal referrals • Referral validity • Waiting list registration • Waiting list registration information • Waiting list management • Booking and scheduling management (...) . • Application of a systems-thinking approach. • Use of a disciplined approach to system redesign. • Respect for people. • Improving flow • Determining Capacity: Balancing Supply and Demand Flinders Medical Centre, South Australia 6 Flinders Medical Centre used Lean thinking to redesign their Allied Health Outpatient Services. Their aims were to simplify the complex booking & triage system through redesign of clinic booking template, and to release capacity for IP work and OP High Risk service from gains

2019 Monash Health Evidence Reviews

37. Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C) ? Benefit assessment according to §35a Social Code Book V

Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.9 of the dossier assessment Sofosbuvir/Velpatasvir/Voxilaprevir (chronische Hepatitis C) – 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. A17-35 Sofosbuvir/velpatasvir/ voxilaprevir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-35 Version 1.0 Sofosbuvir/velpatasvir/ voxilaprevir (chronic hepatitis C) 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: Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Daratumumab (multiple myeloma) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Daratumumab (multiples Myelom) – Nutzen- bewertung 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. A17-40 (...) Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-40 Version 1.0 Daratumumab (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: Daratumumab (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)

39. Dimethyl fumarate (psoriasis) - Benefit assessment according to §35a Social Code Book V

Dimethyl fumarate (psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dimethylfumarat (Psoriasis vulgaris) – 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. A17-49 (...) Dimethyl fumarate (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-49 Version 1.0 Dimethyl fumarate (plaque psoriasis) 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: Dimethyl fumarate (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Atezolizumab (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 Atezolizumab (Urothelkarzinom nach Chemotherapie) – 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. A17-52 Atezolizumab (urothelial carcinoma after chemotherapy) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-52 Version 1.0 Atezolizumab (urothelial carcinoma after chemotherapy) 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: Atezolizumab (urothelial carcinoma after chemotherapy) – Benefit assessment according to §35a

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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