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161. 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)

162. 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)

163. 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)

164. 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)

165. 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)

166. Turoctocog alfa - Benefit assessment according to §35a Social Code Book V

No.: A14-04 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 A14-04 Version 1.0 Turoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 10 April 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Bernd Pötzsch, University Hospital Bonn (...) with the third-generation octocog alfa from the fact that turoctocog alfa can temporarily be stored at temperatures of up to 30 °C, in contrast to 25 °C for octocog alfa. This advantage is supposed to be particularly beneficial during the summer months and during travels to warmer countries Extract of dossier assessment A14-04 Version 1.0 Turoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 10 April 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - and thus enable

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

167. Canagliflozin - 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 A14-12 Version 1.0 Canagliflozin – Benefit assessment acc. to §35a Social Code Book V 12 June 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Tübingen University, Tübingen (...) was to be maintained during the entire study. ? Other antidiabetics were not allowed. ? Systemic administration of glucocorticoids for more than 14 consecutive days was not allowed. ? Glycaemic rescue medication with pioglitazone b (continued) Extract of dossier assessment A14-12 Version 1.0 Canagliflozin – Benefit assessment acc. to §35a Social Code Book V 12 June 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 13 - Table 6: Characteristics of the interventions – RCT, direct comparison

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

168. Rilpivirine/emtricitabine/ tenofovir (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

and Efficiency in Health Care (IQWiG) - 10 - 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: 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 (...) Rilpivirine/emtricitabine/ tenofovir (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 Rilpivirin/Emtricitabin/Tenofovir (neues Anwendungsgebiet) – 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

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

169. Trastuzumab emtansine - Benefit assessment according to §35a Social Code Book V

Trastuzumab emtansine - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Trastuzumab Emtansin – 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. A14-01 Trastuzumab emtansine – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-01 Version 1.0 Trastuzumab emtansine – 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: Trastuzumab emtansine – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27 November 2013 Internal

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

170. Dapagliflozin/metformin - Benefit assessment according to §35a Social Code Book V

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 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. 3. TEVA (...) Dapagliflozin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 May 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. A14-07 Dapagliflozin/metformin

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

171. 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)

172. 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)

173. Sofosbuvir - 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 A14-05 Version 1.0 Sofosbuvir – Benefit assessment acc. to §35a Social Code Book V 29 April 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: Following requests by the Institute, no medical and scientific advisor (...) Sofosbuvir - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sofosbuvir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 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. A14-05 Sofosbuvir – Benefit assessment according to §35a

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

174. 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)

175. 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)

176. Afatinib - 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 A13-41 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 February 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Georg Jacobs, Oncology Practice and Clinic Saarbrücken, Saarbrücken, Germany (...) -41 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 February 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 11 - Table 7: Characteristics of the interventions – RCT, direct comparison: afatinib vs. cisplatin + pemetrexed, ECOG PS 0-1 Study Intervention Comparison Concomitant medication LUX-Lung 3 Afatinib: starting dose 40 mg/day a orally, once daily, use up to disease progression or intolerance; up-titration to 50 mg/day possible after 21 days

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

177. 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)

178. Regorafenib - 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 A13-37 Version 1.0 Regorafenib – Benefit assessment acc. to §35a Social Code Book V 19 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Robert Dengler, Haematology and Oncology Practice (...) . 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 2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. 3. Martín Andrés

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

179. 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)

180. 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)

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