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181. 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)

182. 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)

183. 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

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

. to § 35a Social Code Book V Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: The dossier assessment was prepared under consideration of external medical and scientific expertise. For this assessment, IQWiG used information that it had recently received in the framework of the assessment of the established drug market of gliptins (including saxagliptin in combination with other antidiabetics) (commissions A13-01, A13-02, A13-03, A13-16 and A13-17 (...) stated above. 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 4.0 [online]. 23 September 2011 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.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

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

185. Vemurafenib - 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 A13-34 Version 1.0 Vemurafenib – Benefit assessment acc. to § 35a Social Code Book V 11 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: The dossier assessment was prepared under (...) serine/threonine-protein kinase B-Raf (rapidly accelerated fibrosarcoma – isoform B) CTCAE Common Terminology Criteria for Adverse Events G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MedDRA Medical Dictionary for Regulatory Activities RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class Extract of dossier assessment A13-34

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

186. Vismodegib - 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 A13-27 Version 1.0 Vismodegib – Benefit assessment acc. to § 35a Social Code Book V 13 November 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Professor Dr Michael Weichenthal, Kiel University (...) extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General methods: version 4.0 [online]. 23 September 2011 [accessed: 29 August 2013]. URL: https://www.iqwig.de/download/General_Methods_4-0.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 2013]. URL: https://www.iqwig.de

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

187. Elvitegravir fixed combination - Benefit assessment according to § 35a Social Code Book V

Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LOCF last observation carried forward MedDRA Medical Dictionary for Regulatory Activities PT MedDRA Preferred Term RCT randomized controlled trial RNA ribonucleic acid SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC MedDRA System Organ Class TDF tenofovir disoproxil fumarate TLOVR time to loss of virologic (...) Elvitegravir fixed combination - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment “Elvitegravir-Fixkombination – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 12 September 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. A13-25

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

188. Lisdexamfetamine dimesylate - Benefit assessment according to § 35a Social Code Book V

: ? Wolfgang Rascher, University Hospital, Department of Paediatrics and Adolescent Medicine, Erlangen, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. Individual sections and conclusions in the dossier assessment therefore do not necessarily reflect his opinion. IQWiG employees involved in the dossier assessment: 2 ? Raphaela Gorris ? Katharina Biester (...) to discontinue the medication because they had achieved symptom remission. The company's arguments did not result in an acceptance of a short-term study as sufficient for assessing the added benefit of a drug for the treatment of a chronic disease. The European Extract of dossier assessment A13-24 Version 1.0 Lisdexamfetamine dimesylate – Benefit assessment acc. to § 35a SGB V 29 August 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 9 - Medicines Agency (EMA [11]) distinguishes between

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

189. Enzalutamide - 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 A13-33 Version 1.0 Enzalutamide – Benefit assessment according to §35a Social Code Book V 28 Nov 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Medical Faculty of RWTH 2 Aachen (...) Enzalutamide – Benefit assessment according to §35a Social Code Book V 28 Nov 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 17 - other data cut-offs (31 January 2102 and 29 June 2012) took place at the same time as the data cut-offs to produce reports for the regulatory authorities as part of the pharmacovigilance process. The results of the last 2 data cut-offs can be found in the Day 150 Report of the European Medicines Agency [4]. No information about the treatment at the time

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

190. Linaclotide - Benefit assessment according to § 35a Social Code Book V

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 A13-21 Version 1.0 Linaclotide – Benefit assessment acc. to § 35a Social Code Book V 30 July 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Matthias Breidert, Hospitals in the Altmühltal Nature Park (...) with “2” as numbering follows that of the full dossier assessment. Extract of dossier assessment A13-21 Version 1.0 Linaclotide – Benefit assessment acc. to § 35a Social Code Book V 30 July 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AGA American Gastroenterological Association EMA European Medicines Agency G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IBS-C irritable bowel syndrome

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

191. Pertuzumab - Benefit assessment according to § 35a Social Code Book V

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 A13-10 Version 1.0 Pertuzumab – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Monika Nothacker, Association of Scientific Medical Societies (AWMF (...) of dossier assessment A13-10 Version 1.0 Pertuzumab – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - origin. 78% of the patients had visceral cancer, i.e. visceral organs like the lungs or the liver were affected. In the other patients, non-visceral organs such as skin, bones or brain were affected. Overall, the general condition of the patients, which was rated with the Eastern Cooperative Oncology Group (ECOG) status

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

192. Vildagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

March 2013 Internal Commission No.: A13-17 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 A13-17 Version 1.0 Vildagliptin/metformin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice (...) - 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 4.0 [online]. 23 September 2011 [accessed: 05 May 2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.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 May 2011 [accessed: 05 May 2012]. URL: https

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

193. Ocriplasmin - Benefit assessment according to § 35a Social Code Book V

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 A13-20 Version 1.0 Ocriplasmin – Benefit assessment acc. to § 35a Social Code Book V 30 July 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Daniela Claessens, Group Ophthalmological Practice, Cologne (...) Ocriplasmin - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Ocriplasmin – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 30 July 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. A13-20 Ocriplasmin – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

194. Sitagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

March 2013 Internal Commission No.: A13-03 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 A13-03 Version 1.0 Sitagliptin/metformin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice (...) of dossier assessment A13-03 Version 1.0 Sitagliptin/metformin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) CT conventional insulin treatment G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HbA1c glycosylated haemoglobin A1c

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

195. Colestilan - Benefit assessment according to § 35a Social Code Book V

: 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 A13-15 Version 1.0 Colestilan – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Georg Schlieper, Rhine-Westphalian Technical University (RWTH), Aachen (...) Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - Table 6: Characteristics of the interventions – RCT, direct comparison: colestilan vs. sevelamer hydrochloride (subindication AII) Study Intervention Comparison Concomitant medication MCI-196-E07 Colestilan: different dosages, starting dose 6 g/day, max. 15 g/day, up- or down-titration depending on the serum phosphate level every 3 weeks possible to achieve a target serum phosphate level of between 1.13 and 1.78

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

196. Vildagliptin - Benefit assessment according to § 35a Social Code Book V

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 A13-16 Version 1.0 Vildagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic (...) Vildagliptin - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment “Vildagliptin – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 27 June 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. A13-16 Vildagliptin – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

197. Vandetanib - Re-assessment of benefit according to § 35a, Paragraph 5b, Social Code Book V

://www.iqwig.de/download/General_Methods_4-0.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]. 29.09.2011 [accessed: 05.05.2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. 3. European Medicines Agency. Caprelsa: European public assessment report; product information [online]. 28.02.2013 [accessed: 31.05.2013]. URL: http://www.ema.europa.eu (...) Vandetanib - Re-assessment of benefit according to § 35a, Paragraph 5b, Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Vandetanib – Erneute Nutzenbewertung gemäß § 35a Absatz 5b SGB V” (Version 1.0; Status: 13 June 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. A13-09 Vandetanib

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

198. Saxagliptin - Benefit assessment according to § 35a Social Code Book V

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 A13-01 Version 1.0 Saxagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic (...) . General methods: version 4.0 [online]. 23.09.2011 [accessed: 05.05.2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.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]. 29.09.2011 [accessed: 05.05.2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. Extract of dossier assessment A13-01 Version 1.0 Saxagliptin – Benefit assessment

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

199. Saxagliptin/metformin (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V

assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic Diseases, University Hospital Tübingen, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. Individual sections and conclusions in the dossier (...) assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 9 - 2.6 List of included studies Not applicable as the studies included by the company were unsuitable for conducting an indirect comparison for the relevant therapeutic indication versus the ACT for the reasons stated above. References for English extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General methods

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

200. Aflibercept (Zaltrap) - Benefit assessment according to § 35a Social Code Book V

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 A13-08 Version 1.0 Aflibercept (Zaltrap) – Benefit assessment acc. to § 35a Social Code Book V 29.05.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Robert Dengler, Haematology and Oncology Practice (...) Version 1.0 Aflibercept (Zaltrap) – Benefit assessment acc. to § 35a Social Code Book V 29.05.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 6 - Table 4: Characteristics of the interventions – RCT, direct comparison – aflibercept + FOLFIRI vs. placebo + FOLFIRI Study Intervention Comparison Concomitant medication VELOUR FOLFIRI + aflibercept 4 mg/kg administered i.v. over 1 hour FOLFIRI + placebo Concomitant medication: All supportive interventions to guarantee the optimum care

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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