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41. 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)

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

Ledipasvir/sofosbuvir (hepatitis C) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ledipasvir/Sofosbuvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG (...) Reports – Commission No. A17-41 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-41 Version 1.0 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

43. 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

44. 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

45. 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

46. 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

47. Discrepancies in general surgery medical terminology between South and North Korea (PubMed)

Discrepancies in general surgery medical terminology between South and North Korea The purpose of this study was to categorize surgery-related medical terminologies used in South and North Korea and to compare and analyze discrepancies observed in the terms.This study collected medical terminology used in the North Korean medical book "Surgery" and compared it to medical terminology found in the medical glossary of South Korea. The order of the subtitle was described according (...) to the Instruction to Authors.In total, there were 2,168 individual medical terms, of which only 1,004 words (46.3%) were identical to South Korean medical terms. There were 581 similar terms (26.8%), 265 different terms (12.2%), and 318 terms that are nonexistent in South Korea (14.7%).Less than half of the medical terms used in North Korea match those used in South Korea. It is expected that the prolongation of the current division of South and North Korea will only worsen this discrepancy. Further efforts

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2018 Korean journal of medical education

48. New Book Published by Dr. Wang: ECG Self-Study Book

Center. As of March 10, 2018, I've decided to run ads here. All ad revenue will go to my ECG research projects. We need funding. Up until now, my wife and I have funded the PERFECT (Paced ECG Requiring Fast Emergent Coronary Therapy) study by making her the full time coordinator without pay. Dr. Smith's Book Recommended Resources More basic books for the less advanced learner: Comments not appropriate for general posting, or interesting ECGs, may be sent here (do this judiciously!) Always send ECGs (...) New Book Published by Dr. Wang: ECG Self-Study Book Dr. Smith's ECG Blog: New Book Published by Dr. Wang: ECG Self-Study Book Friday, December 27, 2013 ECG Self-Study Book is a practical guide to help trainees interpret ECGs and recognize cardiac abnormalities. Divided into thirty sections, each part describes twelve cases illustrating a related set of abnormalities seen in different heart diseases, along with their interpretation. The book presents 400 practice ECG tracings, with explanations

2014 Dr Smith's ECG Blog

49. Axitinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Axitinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Axitinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 June 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. A17-12 Axitinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A17-12 Version 1.0 Axitinib (renal cell carcinoma) 29 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Axitinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Baricitinib (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 Baricitinib (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 June 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. A17-14 (...) Baricitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-14 Version 1.0 Baricitinib (rheumatoid arthritis) 29 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Baricitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

51. Dolutegravir (HIV infection) - Benefit assessment according to §35a Social Code Book V

Dolutegravir (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dolutegravir (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 June 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. A17-11 Dolutegravir (HIV (...) infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-11 Version 1.0 Dolutegravir (HIV infection) 28 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir (HIV infection) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 17 March 2017 Internal Commission

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

52. Tenofovir alafenamide (chronic hepatitis B) ? Benefit assessment according to §35a Social Code Book V

Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IU international unit MedDRA Medical Dictionary for Regulatory Activities PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMQ Standardized MedDRA Query SOC System Organ Class TAF tenofovir alafenamide TDF tenofovir disoproxil (fumarate) Extract of dossier assessment A17-13 Version 1.0 Tenofovir alafenamide (chronic hepatitis B) 29 June 2017 Institute (...) Tenofovir alafenamide (chronic hepatitis B) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Tenofoviralafenamid (chronische Hepatitis B) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 June 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

). The patients were treated until disease progression, unacceptable side effects, or study discontinuation due to decision by the physician or the patient. Treatment was generally restricted by the maximum number of allowed cycles. Following discontinuation of the study Extract of dossier assessment A17-06 Version 1.0 Pembrolizumab (non-small cell lung cancer) 10 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - medication (e.g. due to disease progression), the patients in both (...) Pembrolizumab (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 Pembrolizumab (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 May 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

54. Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V

Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Vandetanib (Schilddrüsenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 June 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. A17-01 Vandetanib (thyroid cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-01 Version 1.1 Vandetanib (thyroid cancer) 1 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Vandetanib (thyroid cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

55. Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Nivolumab (klassisches Hodgkin-Lymphom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 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. A16-76 (...) Nivolumab (classical Hodgkin lymphoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-76 Version 1.0 Nivolumab (classical Hodgkin lymphoma) 30 March 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (classical Hodgkin lymphoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events EQ-5D European Quality of Life-5 Dimensions ER oestrogen receptor FACT-B Functional Assessment of Cancer Therapy-Breast Cancer FACT-G Functional Assessment of Cancer Therapy-General G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HER2 human epidermal growth factor receptor 2 HR hormone receptor IQWiG Institut für Qualität und (...) Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 23 February 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. A16-74 Palbociclib

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

57. Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Secukinumab (plaque psoriasis) - 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 Secukinumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 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. A17-08 Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-08 Version 1.0 Secukinumab (plaque psoriasis) 30 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

58. Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V

Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Macitentan (pulmonal arterielle Hypertonie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 January 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. A16-67 Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-67 Version 1.0 Macitentan (pulmonary arterial hypertension) 9 January 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

59. Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.6, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Insulin degludec (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 May 2015). 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. A15-10 Insulin degludec (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-09 Version 1.0 Insulin degludec (new TI) – Benefit assessment acc. to §35a SGB V 28 May 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

60. Ticagrelor (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

disorders 267 (5.0) 268 (5.0) General disorders and administration site conditions 695 (13.1) 775 (14.5) Non-cardiac chest pain 268 (5.0) 302 (5.7) Investigations 328 (6.2) 322 (6.0) Injury, poisoning and procedural complications 428 (8.0) 399 (7.5) a: MedDRA version 17.0. AE: adverse event; ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial (...) and urinary disorders 53 (1.0) 50 (0.9) General disorders and administration site conditions 118 (2.2) 135 (2.5) Non-cardiac chest pain 71 (1.3) 79 (1.5) Injury, poisoning and procedural complications 91 (1.7) 71 (1.3) a: MedDRA version 17.0. ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial; SAE: serious adverse event; SOC: System Organ Class

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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