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101. 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)

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

Olaparib (ovarian 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 (Ovarialkarzinom; Erstlinie Erhaltung) – 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. A19-56 (...) Olaparib (ovarian cancer: first-line maintenance) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-56 Version 1.0 Olaparib (ovarian cancer: first-line maintenance) 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 (ovarian cancer: first-line maintenance) – Benefit assessment according to §35a Social Code Book V Commissioning

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

103. 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

104. 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

105. 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)

106. 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)

107. 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)

108. 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)

109. 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)

110. 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)

111. 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)

112. 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)

113. 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)

114. 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)

115. 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)

116. 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)

117. 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)

118. 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)

119. 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)

120. 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)

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