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141. Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

Nivolumab (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 Nivolumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 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. A15-32 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-32 Version 1.0 Nivolumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 12 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (new therapeutic indication) – Benefit assessment according to §35a SGB V Commissioning

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

142. Edoxaban: benefit assessment according to §35a Social Code Book V (dossier assessment)

Edoxaban: 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 2.5, of the dossier assessment Edoxaban – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 October 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. A15-29 Edoxaban – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-29 Version 1.0 Edoxaban – Benefit assessment acc. to §35a Social Code Book V 28 October 2015 Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Edoxaban – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 20 July 2015 Internal Commission

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

143. Pembrolizumab: benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A15-33 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 A15-33 Version 1.0 Pembrolizumab – Benefit assessment acc. to §35a Social Code Book V 12 November 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Uwe Wollina, Hospital Dresden (...) 1.0 Pembrolizumab – Benefit assessment acc. to §35a Social Code Book V 12 November 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 15 - Table 8: Planned duration of follow-up – RCT, direct comparison, pretreated patients: pembrolizumab vs. individual treatment Study Outcome Planned follow-up KEYNOTE 002 Overall survival Every 3 months until death Symptoms Up to 30 days after the last dose of the study medication or before the start of a new antineoplastic treatment Health

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

144. Nivolumab: 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 A15-27 Version 1.0 Nivolumab – Benefit assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Uwe Wollina, Hospital Dresden-Friedrichstadt, Dresden (...) Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IV intravenous IVRS interactive voice response system MedDRA Medical Dictionary for Regulatory Activities PD-L1 programmed cell death ligand 1 PT Preferred Term QLQ-C30 Quality of Life Questionnaire Core-30 RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class SPC Summary of Product Characteristics ULN upper limit of normal VAS visual analogue scale

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Insulin degludec/liraglutide (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 Insulin degludec/Liraglutid (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11. November 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. A15-30 Insulin degludec/liraglutide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-30 Version 1.0 Insulin degludec/liraglutide (new TI) – Benefit assessment acc. to §35a SGB V 11 Nov 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 (new

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

146. Netupitant/palonosetron: benefit assessment according to §35a Social Code Book V (dossier assessment)

Netupitant/palonosetron: 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 Netupitant/Palonosetron – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 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. A15-28 (...) Netupitant/palonosetron – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-28 Version 1.0 Netupitant/palonosetron– Benefit assessment acc. to §35a SGB V 12 November 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Netupitant/palonosetron – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

147. Lomitapide: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-23 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 A15-23 Version 1.0 Lomitapide – Benefit assessment acc. to §35a Social Code Book V 10 September 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Manfred Gogol, Lindenbrunn Hospital (...) for concomitant treatment with LDL apheresis. The corresponding inclusion criterion merely specified that the present lipid-lowering medication Extract of dossier assessment A15-23 Version 1.0 Lomitapide – Benefit assessment acc. to §35a Social Code Book V 10 September 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 15 - had to be stable for at least 6 weeks before the baseline examination. It could also not be inferred from any further information of the study that only patients

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

148. Secukinumab: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-20 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 A15-20 Version 1.0 Secukinumab – Benefit assessment acc. to §35a Social Code Book V 28 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Michael Weichenthal, University Medical (...) Secukinumab: 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 Secukinumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 August 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. A15-20 Secukinumab – Benefit

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

149. Belatacept: benefit assessment according to § 35a Social Code Book V (dossier assessment)

No.: A15-25 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 A15-25 Version 1.0 Belatacept – Benefit assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Reinhart T. Grundmann, District Hospitals (...) assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 9 - Table 5: Characteristics of the interventions – RCT, direct comparison: belatacept vs. ciclosporin A Study Belatacept Ciclosporin A Prior and concomitant medication BENEFIT Month 0–3: belatacept 10 mg/kg IV on days 1, 5 and in weeks 2, 4, 8 and 12 From month 4: belatacept 5 mg/kg IV every 4 weeks Daily starting dose: ciclosporin A oral 7 ± 3 mg/kg (4–10 mg/kg) Month 1: dose

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

150. Safinamide: 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 A15-18 Version 1.0 Safinamide – 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: ? Rüdiger Mielke, Chair of Neuroscience (...) , but the publications are from the years 1996 to 2003. Additional relevant entacapone study BIA-91067-301 Based on the available information, the BIA-91067-301 study is also generally comparable to the available studies in its patient characteristics and inclusion and exclusion criteria. As in Extract of dossier assessment A15-18 Version 1.0 Safinamide – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 10 - the other studies, patients

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

151. Nintedanib - 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 A15-01 Version 1.0 Nintedanib – 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: ? Marcus Wiedmann, Department of Internal Medicine I, St (...) . to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 11 - Nintedanib 200mg twice daily + docetaxel IV 75mg 2 every 3 weeks Nintedanib 200mg twice daily + docetaxel IV 75mg 2 every 3 weeks Randomization * Treatment discontinuation on disease progression, occurrence of certain predefined AEs or following the patient’s/ investigator’s decision; treatment with other anticancer medication possible on progression Placebo twice daily + docetaxel IV 75mg 2

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

152. Dulaglutide: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-07 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 A15-07 Version 1.0 Dulaglutide – 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: ? Andreas Barthel, Endokrinologikum Ruhr (...) Blood Sugar Survey LOCF last observation carried forward MedDRA Medical Dictionary for Regulatory Activities MMRM mixed-effects model repeated measures NVL Nationale VersorgungsLeitlinie (National Care Guideline) OAD oral antidiabetic PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A15-07 Version 1.0 Dulaglutide

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

153. 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)

154. 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)

155. 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)

156. 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)

157. 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)

158. 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)

159. 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)

160. 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)

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