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161. Aclidinium/formoterol: benefit assessment according to §35a Social Code Book V (dossier assessment)

. Institute for Quality and Efficiency in Health Care. General Methods: version 4.1 [online]. 28 November 2013 [accessed: 1 February 2015]. 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 (...) Aclidinium/formoterol: 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 Aclidiniumbromid/Formoterol – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 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. A15-06

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

162. Dasabuvir: 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 A15-03 Version 1.0 Dasabuvir – Benefit assessment acc. to §35a Social Code Book V 29 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Christoph F. Dietrich, Caritas Hospital Bad Mergentheim (...) Dasabuvir: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dasabuvir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 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. A15-03 Dasabuvir – Benefit assessment

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

163. Ombitasvir/paritaprevir/ritonavir: benefit assessment according to §35a Social Code Book V (dossier assessment)

Ombitasvir/paritaprevir/ritonavir: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Ombitasvir/Paritaprevir/Ritonavir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 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. A15-04 Ombitasvir/paritaprevir/ ritonavir – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-04 Version 1.0 Ombitasvir/paritaprevir/ritonavir – Benefit assessment acc. to §35a SGB V 29 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ombitasvir/paritaprevir/ritonavir – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Insulin degludec/liraglutide: 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 Insulin degludec/Liraglutid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 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. A15-15 (...) Insulin degludec/liraglutide – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-15 Version 1.0 Insulin degludec/liraglutide – Benefit assessment acc. to §35a SGB V 30 July 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 – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

165. Afatinib: 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 A15-17 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Ingo Schmidt-Wolf, Centre for Integrated Oncology (CIO), Bonn (...) - up visit). ECOG PS: Eastern Cooperative Oncology Group Performance Status; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A15-17 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 16 - The data of all patients were included in the analysis of overall survival also after discontinuation of the study medication and possible treatment switching. The recording of other data

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

166. Mirabegron - 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 A14-19 Version 1.0 Mirabegron – 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: ? Gerhard Jakse, Medical Faculty of Rhine-Westphalian (...) : full text view [online]. In: ClinicalTrials.gov. 16 September 2013 [accessed: 3 March 2014]. URL: http://ClinicalTrials.gov/show/NCT01043666. Extract of dossier assessment A14-19 Version 1.0 Mirabegron – Benefit assessment acc. to §35a Social Code Book V 28 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 45 - References for English extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General Methods

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Vedolizumab - 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 Vedolizumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 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. A14-23 Vedolizumab – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-23 Version 1.0 Vedolizumab – Benefit assessment acc. to §35a Social Code Book V 13 October 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Vedolizumab – Benefit assessment according to §35a Social Code Book V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Internal Commission No.: A14-25 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 A14-25 Version 1.0 Eribulin – Benefit assessment acc. to §35a Social Code Book V 31 October 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rolf Kreienberg, Women’s (...) Eribulin (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 Eribulin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 31 October 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. A14-25

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Fingolimod (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 Fingolimod (neues Anwendungsgebiet – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 September 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. A14-21 Fingolimod (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-21 Version 1.0 Fingolimod (new TI) – Benefit assessment acc. to §35a SGB V 26 September 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Fingolimod (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

170. Umeclidinium/vilanterol - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Umeclidinium/vilanterol - 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 Umeclidinium/Vilanterol – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 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. A14-22 (...) Umeclidinium/vilanterol – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-22 Version 1.0 Umeclidinium/vilanterol – Benefit assessment acc. to §35a SGB V 13 Oct 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Umeclidinium/vilanterol – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

171. Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Internal Commission No.: A14-41 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 A14-41 Version 1.0 Simoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 11 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Bernd Pötzsch (...) . 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

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Commission No.: A14-46 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 A14-46 Version 1.0 Vildagliptin – Benefit assessment acc. to §35a Social Code Book V 25 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Tübingen (...) were included in the benefit assessment. Extract of dossier assessment A14-46 Version 1.0 Vildagliptin – Benefit assessment acc. to §35a Social Code Book V 25 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - 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

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

No.: A14-36 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 A14-36 Version 1.0 Albiglutide – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Barthel, Endokrinologikum Ruhr (...) ACT appropriate comparator therapy AE adverse event BMI body mass index DPP-4 dipeptidyl peptidase 4 G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GLP-1 glucagon-like-peptide 1 HbA1c glycosylated haemoglobin A1c 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 SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

174. Lurasidone - 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 A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rüdiger Mielke, Chair of Neuroscience (...) the 120 mg arm of Study 231 and the 160 mg arm of Study 233. The patients in Study 233 also received a dose of 120 mg only for the first 2 days. The analyses mentioned were conducted for the PANSS total score and for the 3 PANSS subscales (positive scale, negative scale, general psychopathology scale) on the basis of the Extract of dossier assessment A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

175. Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dolutegravir/Abacavir/Lamivudin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 18 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 (...) – Commission No. A14-34 Dolutegravir/abacavir/ lamivudine – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-34 Version 1.0 Dolutegravir/abacavir/lamivudine – Benefit assessment acc. to §35a SGB V 18 Dec 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/abacavir/lamivudine – Benefit assessment according to §35a SGB V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Idelalisib - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.9, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Idelalisib – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 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 – Commission No. A14-35 Idelalisib – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-35 Version 1.0 Idelalisib – Benefit assessment acc. to §35a Social Code Book V 22 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Idelalisib – Benefit assessment according to §35a Social Code Book V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

177. Sipuleucel-T - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A14-38 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 A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Rhine (...) sizes. The methods used for this purpose are explained in the General Methods of IQWiG [1]. Extract of dossier assessment A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 28 - The approach for deriving an overall conclusion on added benefit based on the aggregation of conclusions derived at outcome level is a proposal by IQWiG. The G-BA decides on the added benefit. 2.5.1 Assessment

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

178. Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Sucroferric oxyhydroxide - 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 Sucroferric Oxyhydroxid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 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 – Commission No. A14-37 (...) Sucroferric oxyhydroxide – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-37 Version 1.0 Sucroferric oxyhydroxide – Benefit assessment acc. to §35a SGB V 22 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sucroferric oxyhydroxide – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

179. Tafluprost/Timolol: benefit assessment according to §35a Social Code Book V (dossier assessment)

December 2014 Internal Commission No.: A14-49 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 A14-49 Version 1.0 Tafluprost/timolol – Benefit assessment acc. to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice (...) : available population; ND: no data; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A14-49 Version 1.0 Tafluprost/timolol – Benefit assessment acc. to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 8 - Table 5: Characteristics of the interventions – RCT, direct comparison: tafluprost/timolol vs. tafluprost + timolol Study Intervention Comparison Concomitant medication 201051 In the affected eye(s) for 6 months: ? once daily

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Enzalutamide (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 Enzalutamid (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 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. A14-48 Enzalutamide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-48 Version 1.0 Enzalutamide (new TI) – Benefit assessment acc. to §35a SGB V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Enzalutamide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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