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161. 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)

162. 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)

163. 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)

164. 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)

165. 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)

166. 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)

167. 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)

168. 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)

169. 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)

170. 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)

171. 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)

172. ESMO Consensus Conference on Malignant Lymphoma: General Perspectives and Recommendations for Prognostic Tools in Mature B-cell Lymphomas and Chronic Lymphocytic Leukaemia

ESMO Consensus Conference on Malignant Lymphoma: General Perspectives and Recommendations for Prognostic Tools in Mature B-cell Lymphomas and Chronic Lymphocytic Leukaemia ESMOconsensusconferenceonmalignantlymphoma: generalperspectivesandrecommendationsfor prognostictoolsinmatureB-celllymphomasand chroniclymphocyticleukaemia M. Ladetto 1 *, C. Buske 2 , M. Hutchings 3 , M. Dreyling 4 , G. Gaidano 5 , S. Le Gouill 6 , S. Luminari 7,8 , C. Pott 9 , A. Zam o 10 , E. Zucca 11 & the ESMO Lymphoma (...) Lymphoma Unit, Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland Received 9 June 2016; revised 11 August 2016; accepted 23 August 2016 The European Society for Medical Oncology (ESMO) consensus conference on mature B-cell lymphomas and chronic lymphocytic leukaemia (CLL) was held on 20 June 2015 in Lugano, Switzerland, and included a multidisciplinary panel of 25 leading experts. The aim of the conference was to develop recommendations on critical subjects dif

2017 European Society for Medical Oncology

173. Multi-criteria decision analysis for the appraisal of medical needs: a pilot study

medicament” (CAIT)) and the College of Medical Directors. The list should allow the General Council to roughly estimate the budget possibly needed to fund the possible future cohort decisions of the College of Medical Directors. The development of a methodology for defining relative priorities on this list is the focus of the current study. In year T, pharmaceutical companies, the Minister of Health, the Minister of Social Affairs and the College of Medical Directors can submit a request for the early (...) needs. Therefore, the CAIT / CATT assesses whether the product targets an unmet medical need, based on the list of unmet medical needs defined by the General Council of the RIZIV / INAMI. It also makes an appraisal of the usual criteria used by the Drug Reimbursement Committee during the regular procedure: the products’ added value, its cost-effectiveness, its price, its budget impact, its place in daily clinical practice. d The cohort decisions of the College of Medical Directors specify

2016 Belgian Health Care Knowledge Centre

174. 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)

175. 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)

176. 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)

177. 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)

178. 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)

179. 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)

180. 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)

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