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161. Osimertinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

Osimertinib (NSCLC) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Osimertinib (nicht kleinzelliges Lungenkarzinom) – 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. A17-20 (...) Osimertinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the limitation period) Extract of dossier assessment A17-20 Version 1.0 Osimertinib (non-small cell lung cancer) 28 July 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Osimertinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

162. Alectinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

Alectinib (NSCLC) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Alectinib (nicht kleinzelliges Lungenkarzinom) – 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. A17-19 Alectinib (...) (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-19 Version 1.0 Alectinib (non-small cell lung cancer) 28 July 2017 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 Social Code Book V Commissioning agency: Federal Joint Committee Commission

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

163. Rolapitant (prevention of nausea and vomiting in chemotherapy) - Benefit assessment according to §35a Social Code Book V

Rolapitant (prevention of nausea and vomiting in chemotherapy) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Rolapitant (Prävention von Übelkeit und Erbrechen bei Chemotherapie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 August 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. A17-26 Rolapitant (prevention of nausea and vomiting in chemotherapy) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-26 Version 1.0 Rolapitant (prevention of nausea and vomiting in chemotherapy) 30 August 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rolapitant (prevention of nausea and vomiting

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

164. Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V

Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Etelcalcetid (sekundärer Hyperparathyreoidis- mus) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 August 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. A17-25 Etelcalcetide (secondary hyperparathyroidism) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-25 Version 1.0 Etelcalcetide (secondary hyperparathyroidism) 30 August 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Etelcalcetide (secondary hyperparathyroidism) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Nivolumab (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 Nivolumab (Urothelkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 September 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. A17-29 Nivolumab (...) (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-29 Version 1.0 Nivolumab (urothelial carcinoma) 28 September 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 3 July 2017

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

166. Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V

Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Saxagliptin/Metformin (Diabetes mellitus Typ 2) – 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. A17-33 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-33 Version 1.0 Saxagliptin/metformin (type 2 diabetes mellitus) 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: Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Ceritinib (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 Ceritinib (nicht kleinzelliges Lungenkarzinom) – 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. A17-32 Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-32 Version 1.0 Ceritinib (non-small cell lung cancer) 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: Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

168. Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 September 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. A17-27 (...) Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A17-27 Version 1.0 Nivolumab (melanoma) 13 September 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 June

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Pembrolizumab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Pembrolizumab (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 November 2016). 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. A16-55 Pembrolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-55 Version 1.0 Pembrolizumab (non-small cell lung cancer) 10 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pembrolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

170. Cabozantinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Cooperative Oncology Group Performance Status eCRF electronic case report form EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HR hazard ratio IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MSKCC Memorial Sloan Kettering Cancer Center PFS progression-free survival SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SPC Summary (...) Cabozantinib (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 Cabozantinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 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. A16-69

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

171. Machine learning and medicine: book review and commentary Full Text available with Trip Pro

for diagnosis or prognosis of disease, and to call attention to additional requirements for developing diagnostic and prognostic algorithms that are generally useful in medicine. Appendix provides examples that illustrate potential problems with machine learning that are not addressed in the reviewed book. (...) Machine learning and medicine: book review and commentary This article is a review of the book "Master machine learning algorithms, discover how they work and implement them from scratch" (ISBN: not available, 37 USD, 163 pages) edited by Jason Brownlee published by the Author, edition, v1.10 http://MachineLearningMastery.com . An accompanying commentary discusses some of the issues that are involved with use of machine learning and data mining techniques to develop predictive models

2018 Biomedical engineering online

172. Common clinical conditions in aged care (Silver Book)

Common clinical conditions in aged care (Silver Book) RACGP - Silver Book - Part A Search Become a student member today for free and be part of the RACGP community A career in general practice Starting the GP journey Enrolments for the 2019.1 OSCE FRACGP exams closing 29 March 2019 Fellowship FRACGP exams Research Practice Experience Program is a self-directed education program designed to support non vocationally registered doctors on their pathway to RACGP Fellowship Fellowship International (...) for educators Regional Training The Red Book provides the general practice team with guidance on opportunistic and proactive preventive care Guidelines by topic Key RACGP guidelines Handbook of Non-Drug Interventions (HANDI) Send a request for information, a loan, literature search, journal article, book chapter and one-on-one remote training sessions Library services eBooks Journals Databases and resources Subject portals Download the Standards for general practice (5th edition) - a benchmark for quality

2019 The Royal Australian College of General Practitioners

173. 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

174. Books: Biosemiotic Medicine: Healing in the World of Meaning (Studies in Neuroscience, Consciousness and Spirituality): A Paradigm Shift in Biology Full Text available with Trip Pro

Books: Biosemiotic Medicine: Healing in the World of Meaning (Studies in Neuroscience, Consciousness and Spirituality): A Paradigm Shift in Biology 28232356 2018 03 01 1478-5242 67 656 2017 03 The British journal of general practice : the journal of the Royal College of General Practitioners Br J Gen Pract Books: Biosemiotic Medicine: Healing in the World of Meaning (Studies in Neuroscience, Consciousness and Spirituality) : A Paradigm Shift in Biology. 130 10.3399/bjgp17X689761 Partridge

2017 The British Journal of General Practice

175. Books: The State Of Medicine: The Gulf Between Policy and Implementation Full Text available with Trip Pro

Books: The State Of Medicine: The Gulf Between Policy and Implementation 28034944 2017 07 18 2018 01 01 1478-5242 67 654 2017 01 The British journal of general practice : the journal of the Royal College of General Practitioners Br J Gen Pract Books: The State Of Medicine: The Gulf Between Policy and Implementation. 33 10.3399/bjgp17X688717 Jewell David D Bristol. E-mail: mdjewell99@gmail.com. eng Journal Article England Br J Gen Pract 9005323 0960-1643 2016 12 31 6 0 2016 12 31 6 0 2016 12 31

2017 The British Journal of General Practice

176. Edoxaban: benefit assessment according to §35a Social Code Book V (dossier assessment)

Edoxaban: 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 2.5, of the dossier assessment Edoxaban – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 October 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. A15-29 Edoxaban – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-29 Version 1.0 Edoxaban – Benefit assessment acc. to §35a Social Code Book V 28 October 2015 Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Edoxaban – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 20 July 2015 Internal Commission

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

177. Insulin degludec/liraglutide (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec/liraglutide (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Insulin degludec/Liraglutid (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11. November 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. A15-30 Insulin degludec/liraglutide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-30 Version 1.0 Insulin degludec/liraglutide (new TI) – Benefit assessment acc. to §35a SGB V 11 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin degludec/liraglutide (new

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

178. Tiotropium/olodaterol: benefit assessment according to §35a Social Code Book V (dossier assessment)

awarded on: 13 August 2015 Internal Commission No.: A15-31 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-31 Version 1.0 Tiotropium/olodaterol – Benefit assessment acc. to §35a Social Code Book V 12 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical (...) Tiotropium/olodaterol: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Tiotropium/Olodaterol – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 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. A15-31

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

179. Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 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. A15-32 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-32 Version 1.0 Nivolumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 12 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (new therapeutic indication) – Benefit assessment according to §35a SGB V Commissioning

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

180. Netupitant/palonosetron: benefit assessment according to §35a Social Code Book V (dossier assessment)

Group Performance Status EMA European Medicines Agency FLIE Functional Living Index – Emesis G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics Extract of dossier assessment A15-28 Version 1.0 Netupitant/palonosetron (...) Netupitant/palonosetron: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Netupitant/Palonosetron – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 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. A15-28

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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