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21. 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)

22. 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)

23. 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)

24. 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)

25. 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)

26. 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)

27. 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)

28. 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)

29. 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)

30. 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)

31. 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)

32. 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)

33. 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)

34. 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)

35. 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)

36. 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)

37. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians

Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Opportunities From the Greater Use of Generic Medications | Annals of Internal Medicine | American College of Physicians '); } '); })(); Sign in below to access your subscription for full content INDIVIDUAL SIGN IN | You will be directed to acponline.org (...) to register and create your Annals account INSTITUTIONAL SIGN IN | | Subscribe to Annals of Internal Medicine . You will be directed to acponline.org to complete your purchase. Search Clinical Guidelines | 5 January 2016 Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Free Niteesh K. Choudhry, MD, PhD; Thomas D. Denberg

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2015 American College of Physicians

38. Responsible use of high-risk medical devices: the example of 3D printed medical devices

) Participation in scientific or experimental research as an initiator, principal investigator or researcher: Philip Tack (IWT Project ‘Roadmap’ about medical 3D Printing (part Health economy: PHD traject), Jan Schrooten (Projects KU Leuven – generative medicine / VLAIO feasibility assessment Antheron BV.B.A.), Stefaan Nijs (3D modelling in shoulder althea prof. (UZ Leuven – KU Leuven)) A grant, fees or funds for a member of staff or another form of compensation for the execution of research described above (...) EUDAMED European Databank on Medical Devices EUIPO EUnetHTA European Union Intellectual Property Office European Network for Health Technology Assessment EUTM DD DMCA FAMHP European Union Trade Mark Directive on the legal protection of designs Digital Millennium Copyright Act Federal Agency for Medicines and Health Products (FAGG-AFMPS) FDA Food and Drug Administration GDPR General Data Protection Regulation HSR HTA Health Services Research Health Technology Assessment IC IDEAL INAHTA Insurance

2018 Belgian Health Care Knowledge Centre

39. Richard Smith: Why We Sleep—one of those rare books that changes your worldview and should change society and medicine

Richard Smith: Why We Sleep—one of those rare books that changes your worldview and should change society and medicine Richard Smith: Why We Sleep—one of those rare books that changes your worldview and should change society and medicine - The BMJ ---> One of the professors at Edinburgh Medical School, where I was taught from 1970-76, was a world expert on sleep, but I remember hearing little about sleep at medical school. We were taught about sleeping pills, and I remember routinely (...) prescribing them for patients undergoing surgery the next day—with no understanding of the damage I was doing. In my 25 years at The BMJ I remember publishing little on sleep, although we did publish an ABC of Sleep Disorders , with the emphasis on the disorders. Generally, like most doctors, I thought little about sleep. Now I read in Matthew Walker’s book Why We Sleep: The New Science of Sleep and Dreams that: “ [The] silent sleep loss epidemic is the greatest public health challenge we face

2018 The BMJ Blog

40. Is Your Generic Medication Made In China and Is It Safe?

Is Your Generic Medication Made In China and Is It Safe? Is Your Generic Medication Made In China and Is It Safe? | The Skeptical Cardiologist Primary Menu Search for: , , , Is Your Generic Medication Made In China and Is It Safe? Last week the FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen (see .) Since then I have switched many patients from the bad valsartan to losartan or valsartan from presumably safe (...) manufacturers. It didn’t really occur to me that this could be just the tip of the iceberg until I received a reader comment which I will copy below. As I thought about it, I realized that I have no idea where the generic ramipril I am taking is manufactured. It very well could be in China or India. This from The Epoch Times confirms that Americans are becoming more and more reliant on medications manufactured in China and that many researchers feel this poses a significant security threat. The Food

2018 The Skeptical Cardiologist

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