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261. Teriflunomide - Benefit assessment according to §35a Social Code Book V

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 A13-38 Version 1.0 Teriflunomide – Benefit assessment acc. to §35a Social Code Book V 20 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Bernd C. Kieseier, Heinrich-Heine University (...) : randomized controlled trial; vs.: versus Extract of dossier assessment A13-38 Version 1.0 Teriflunomide – Benefit assessment acc. to §35a Social Code Book V 20 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 14 - The risk of bias of the relevant outcomes – except for all-cause mortality – was rated as high because of the lack of blinding of patient and treating staff and the subjective component generally present in the recording of the outcomes. This deviates from

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

262. Dabrafenib - Benefit assessment according to § 35a Social Code Book V

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 A13-35 Version 1.0 Dabrafenib – Benefit assessment acc. to § 35a Social Code Book V 23 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Uwe Wollina, Hospital Dresden-Friedrichstadt (...) Dabrafenib – Benefit assessment acc. to § 35a Social Code Book V 23 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy CTCAE Common Terminology Criteria for Adverse Events ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EQ-5D European Quality of Life-5 Dimensions G-BA

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

263. Aflibercept (Eylea, new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Aflibercept (Eylea, new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Aflibercept (Eylea, neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 19 December 2013). 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. A13-36 Aflibercept (Eylea, new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A13-36 Version 1.0 Aflibercept (Eylea, new indication) – Benefit assessment acc. to §35a SGB V 19 Dec 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Aflibercept (Eylea, new therapeutic indication) – Benefit assessment according to §35a

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

264. Indacaterol/glycopyrronium - Benefit assessment according to §35a Social Code Book V

Indacaterol/glycopyrronium - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Indacaterol/Glycopyrronium – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 February 2014). 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. A13-40 Indacaterol (...) /glycopyrronium – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A13-40 Version 1.0 Indacaterol/glycopyrronium – Benefit assessment acc. to §35a SGB V 12 February 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Indacaterol/glycopyrronium – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

265. Radium-223 dichloride - Benefit assessment according to §35a Social Code Book V

Radium-223 dichloride - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Radium-223-dichlorid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 2014). 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. A14-02 Radium-223 dichloride – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-02 Version 1.0 Radium-223 dichloride – Benefit assessment acc. to §35a SGB V 28 March 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Radium-223 dichloride – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 16 December 2013 Internal

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

266. Insulin degludec (Type 1 diabetes mellitus) ? Benefit assessment according to §35a Social Code Book V

(IQWiG) - I.8 - References for English extract Please see full assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General Methods: version 4.1 [online]. 28 November 2013 [accessed: 7 February 2014]. URL: https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-1.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to §35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 (...) Insulin degludec (Type 1 diabetes mellitus) ? Benefit assessment according to §35a Social Code Book V 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 – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

267. Perampanel (epilepsy and seizures) ? Benefit assessment according to §35a Social Code Book V

No.: A14-16 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 A14-16 Version 1.0 Perampanel – Benefit assessment acc. to §35a Social Code Book V 13 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rüdiger Mielke, Chair for Neuroscience (...) adjustments were also not allowed. Other antiepileptics were only permitted as rescue Extract of dossier assessment A14-16 Version 1.0 Perampanel – Benefit assessment acc. to §35a Social Code Book V 13 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - medication in severe and uncontrollable seizures. To assess the added benefit, the company selected those subpopulations from the 3 placebo-controlled studies in which at least one of the 10 drugs specified by the G-BA was already

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

268. Dimethyl fumarate (multiple sclerosis ? relapsing-remitting) ? Benefit assessment according to §35a Social Code Book V

awarded on: 30 April 2014 Internal Commission No.: A14-14 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 A14-14 Version 1.0 Dimethyl fumarate – Benefit assessment acc. to §35a Social Code Book V 30 July 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific (...) follows that of the full dossier assessment. Extract of dossier assessment A14-14 Version 1.0 Dimethyl fumarate – Benefit assessment acc. to §35a Social Code Book V 30 July 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy DMF dimethyl fumarate GA glatiramer acetate G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GLMM generalized linear mixed model IFN-ß1a interferon beta-1a IFN-ß1b interferon

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

269. Ruxolitinib (primary myelofibrosis, splenomegaly) ? Benefit assessment according to §35a Social Code Book V

Commission No.: A14-17 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 A14-17 Version 1.0 Ruxolitinib – Benefit assessment acc. to §35a Social Code Book V 12 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: After enquiries by the Institute (...) Standardized Medical Dictionary for Regulatory Activities Query SOC System Organ Class SPC Summary of Product Characteristics TSS total symptom score Extract of dossier assessment A14-17 Version 1.0 Ruxolitinib – Benefit assessment acc. to §35a Social Code Book V 12 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

270. Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Apixaban (extension of approval) - 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 Apixaban (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 November 2014). 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. A14-28 Apixaban (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-28 Version 1.0 Apixaban (new therapeutic indication) – Benefit assessment acc. to §35a SGB V 26 Nov 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Apixaban (new therapeutic indication) – Benefit assessment according to §35a SGB V

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

271. Dolutegravir - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-08 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 A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Ingo Niemetz, diabetological practice (...) randomized controlled trial SAE serious adverse event SDM symptom distress module SGB Sozialgesetzbuch (Social Code Book) SOC Medical Dictionary for Regulatory Activities System Organ Class SPC Summary of Product Characteristics TDF tenofovir Extract of dossier assessment A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

272. Ipilimumab (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

Ipilimumab (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 Ipilimumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status 13 March 2014). 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. A13-44 Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A13-44 Version 1.0 Ipilimumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 13 March 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

273. Propranolol - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-29 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 A14-29 Version 1.0 Propranolol – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Wolfgang Rascher, University Hospital (...) Medical Dictionary for Regulatory Activities PT MedDRA Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC MedDRA System Organ Class SPC Summary of Product Characteristics Extract of dossier assessment A14-29 Version 1.0 Propranolol – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

274. Canagliflozin/metformin - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Canagliflozin/metformin - 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 Canagliflozin/Metformin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 2014). 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. A14-27 (...) Canagliflozin/metformin – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-27 Version 1.0 Canagliflozin/metformin – Benefit assessment acc. to §35a SGB V 13 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Canagliflozin/metformin – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

275. Nalmefene - Benefit assessment according to §35a Social Code Book V (dossier assessment)

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 A14-30 Version 1.0 Nalmefene – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Gründer, Rhine-Westphalian Technical (...) – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 11 - References for English extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General Methods: version 4.1 [online]. 28 November 2013 [accessed: 1 August 2014]. URL: https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-1.pdf. 2. Institute for Quality and Efficiency in Health Care

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

276. Daclatasvir - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A14-31 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 A14-31 Version 1.0 Daclatasvir – Benefit assessment acc. to §35a Social Code Book V 27 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Christoph F. Dietrich, Caritas (...) . Institute for Quality and Efficiency in Health Care. General Methods: version 4.1 [online]. 28 November 2013 [accessed: 1 August 2014]. URL: https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-1.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to §35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

277. Aflibercept (extension of approval) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

: ? patients can receive aflibercept IVT as needed if defined criteria e are met. Study eye: ? any other treatment for DMO besides the study medication was prohibited in the course of the study. (continued) Extract of dossier assessment A14-32 Version 1.0 Aflibercept (new TI) – Benefit assessment acc. to §35a Social Code Book V 11 Dec 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 13 - Table 6: Characteristics of the interventions – RCT, indirect comparison: aflibercept vs. ranibizumab (...) Aflibercept (extension of approval) - 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 Aflibercept (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 December 2014). 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

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

278. Benefit assessment according to §35a Social Code Book V (dossier assessment)

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 A14-18 Version 1.0 Simeprevir – Benefit assessment acc. to §35a Social Code Book V 28 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Christoph F. Dietrich, Caritas Hospital Bad Mergentheim, Bad (...) hepatocellular carcinoma HCV hepatitis C virus HIV human immunodeficiency virus IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MedDRA Medical Dictionary for Regulatory Activities PEG pegylated interferon alpha (2a or 2b) PLC placebo PT Preferred Term RBV ribavirin RCT randomized controlled trial RNA ribonucleic acid SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SIM simeprevir SOC System Organ Class SPC Summary

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

279. Discrepancies in general surgery medical terminology between South and North Korea Full Text available with Trip Pro

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

2018 Korean journal of medical education

280. Joanna Verran: The Bad Bugs Book Club—a study in infectious disease . . . and humanity

Joanna Verran: The Bad Bugs Book Club—a study in infectious disease . . . and humanity Joanna Verran: The Bad Bugs Book Club—a study in infectious disease . . . and humanity - The BMJ ---> Microbiologist Joanna Verran set up a book club to encourage discussion about infectious disease using fiction, never anticipating the impact that it would have on her own learning As a microbiology academic, and a university professor with a lifelong career in teaching and research, I was somewhat taken (...) the reader, while scientific writing is deliberately objective. In medical writing, case studies that focus on the individual are impartial descriptors of symptoms. How much more memorable are those symptoms when the case is constructed as a story? This got me thinking about how a fictional narrative and its emotional engagement can encourage learning about and engagement with science. Can fiction be useful as a vehicle for scientists to practise science communication through conversation with non

2020 The BMJ Blog

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