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

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-16 Version 1.0 Vildagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic (...) Vildagliptin - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment “Vildagliptin – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 27 June 2013). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A13-16 Vildagliptin – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

182. Sitagliptin - Benefit assessment according to § 35a Social Code Book V

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-02 Version 1.0 Sitagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic (...) insulin treatment IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LOCF last observation carried forward MedDRA Medical Dictionary of Regulatory Activities OAD oral antidiabetic drug OR odds ratio RCT randomized controlled trial RR relative risk 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

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-01 Version 1.0 Saxagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Institute for Diabetes Research and Metabolic (...) . General methods: version 4.0 [online]. 23.09.2011 [accessed: 05.05.2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract; commission no. A11-02 [online]. 29.09.2011 [accessed: 05.05.2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. Extract of dossier assessment A13-01 Version 1.0 Saxagliptin – Benefit assessment

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Vandetanib - Re-assessment of benefit according to § 35a, Paragraph 5b, Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Vandetanib – Erneute Nutzenbewertung gemäß § 35a Absatz 5b SGB V” (Version 1.0; Status: 13 June 2013). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A13-09 Vandetanib (...) – Re-assessment of benefit according to § 35a, Paragraph 5b, Social Code Book V 1 Extract of dossier assessment A13-09 Version 1.0 Vandetanib – Re-assessment of benefit acc. to § 35a Para 5b SGB V 13 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Vandetanib – Re-assessment of benefit according to § 35a, Paragraph 5b, Social Code Book V Contracting agency: Federal Joint Committee

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

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

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-08 Version 1.0 Aflibercept (Zaltrap) – Benefit assessment acc. to § 35a Social Code Book V 29.05.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Robert Dengler, Haematology and Oncology Practice (...) Version 1.0 Aflibercept (Zaltrap) – Benefit assessment acc. to § 35a Social Code Book V 29.05.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 6 - Table 4: Characteristics of the interventions – RCT, direct comparison – aflibercept + FOLFIRI vs. placebo + FOLFIRI Study Intervention Comparison Concomitant medication VELOUR FOLFIRI + aflibercept 4 mg/kg administered i.v. over 1 hour FOLFIRI + placebo Concomitant medication: All supportive interventions to guarantee the optimum care

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

187. Lixisenatide - Benefit assessment according to § 35a Social Code Book V

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-11 Version 1.0 Lixisenatide – Benefit assessment acc. to § 35a Social Code Book V 13 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Matthias Breidert, Altmühltal Clinics, Kösching Hospital, Teaching (...) Lixisenatide - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment “Lixisenatid – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 13 June 2013). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A13-11 Lixisenatide – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

188. Ingenol mebutate - Benefit assessment according to § 35a Social Code Book V

-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 A13-04 Version 1.0 Ingenol mebutate – Benefit assessment acc. to § 35a Social Code Book V 11.04.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Prof. Markus Böhm, Polyclinic (...) Ingenol mebutate - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Ingenolmebutat – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 11.04.2013). 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. 13-04 Ingenol mebutate – Benefit assessment

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Apixaban (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. “Apixaban (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 27.03.2012). 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. A12-20 (...) Apixaban (new therapeutic indication) – Benefit assessment according to § 35a Social Code Book V 1 Extract of dossier assessment A12-20 Version 1.0 Apixaban (new therapeutic indication) – Benefit assessment acc. to § 35a SGB V 27.03.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Apixaban (new therapeutic indication) – Benefit assessment according to § 35a Social Code Book V Contracting

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-34 Version 1.0 Vemurafenib – Benefit assessment acc. to § 35a Social Code Book V 11 December 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: The dossier assessment was prepared under (...) serine/threonine-protein kinase B-Raf (rapidly accelerated fibrosarcoma – isoform B) CTCAE Common Terminology Criteria for Adverse Events G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MedDRA Medical Dictionary for Regulatory Activities RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class Extract of dossier assessment A13-34

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

. to § 35a Social Code Book V Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: The dossier assessment was prepared under consideration of external medical and scientific expertise. For this assessment, IQWiG used information that it had recently received in the framework of the assessment of the established drug market of gliptins (including saxagliptin in combination with other antidiabetics) (commissions A13-01, A13-02, A13-03, A13-16 and A13-17 (...) stated above. References for English extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General methods: version 4.0 [online]. 23 September 2011 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 [accessed: 5 May

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

192. Vismodegib - Benefit assessment according to § 35a Social Code Book V

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-27 Version 1.0 Vismodegib – Benefit assessment acc. to § 35a Social Code Book V 13 November 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Professor Dr Michael Weichenthal, Kiel University (...) extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General methods: version 4.0 [online]. 23 September 2011 [accessed: 29 August 2013]. URL: https://www.iqwig.de/download/General_Methods_4-0.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 [accessed: 5 May 2013]. URL: https://www.iqwig.de

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A13-33 Version 1.0 Enzalutamide – Benefit assessment according to §35a Social Code Book V 28 Nov 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Medical Faculty of RWTH 2 Aachen (...) Enzalutamide - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Enzalutamid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 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. A13-33 Enzalutamide – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LOCF last observation carried forward MedDRA Medical Dictionary for Regulatory Activities PT MedDRA Preferred Term RCT randomized controlled trial RNA ribonucleic acid SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC MedDRA System Organ Class TDF tenofovir disoproxil fumarate TLOVR time to loss of virologic (...) Elvitegravir fixed combination - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment “Elvitegravir-Fixkombination – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 12 September 2013). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A13-25

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

. General methods: version 4.0 [online]. 23 September 2011 [accessed: 19 June 2013]. URL: https://www.iqwig.de/download/General_Methods_4-0.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. 3. Shire. A phase 3b, double-blind, randomised, active-controlled (...) Lisdexamfetamine dimesylate - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Lisdexamfetamindimesilat – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 29 August 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. A13-24 Lisdexamfetamine

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Commission No.: A12-19 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 A12-19 Version 1.0 Aflibercept (Eylea) – Benefit assessment acc. to § 35a Social Code Book V 13.03.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Daniela Claessens (...) reference list. 1. Institute for Quality and Efficiency in Health Care. General methods: version 4.0 [online]. 23.09.2011 [accessed 05.05.2012]. URL: https://www.iqwig.de/download/General_Methods_4-0.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract; commission no. A11-02 [online]. 29.09.2011 [accessed 05.05.2012]. URL: https://www.iqwig.de/download/A11- 02_Extract_of_dossier_assessment_Ticagrelor.pdf. 3. European

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

197. Abiraterone acetate (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V

assessment acc. to § 35a Social Code Book V Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Medical Faculty, Aachen University (Rheinisch-Westfälische Technische Hochschule), Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. Individual sections and conclusions in the dossier assessment therefore (...) castration had to receive an LH-RH analogue in addition to the study medication. Extract of dossier assessment A13-06 Version 1.0 Abiraterone acetate (new therapeutic indication) – 11.04.2013 Benefit assessment acc. to § 35a Social Code Book V Institute for Quality and Efficiency in Health Care (IQWiG) - 8 - This treatment had to be started at least 4 weeks prior to the initiation of the treatment with the study medication. 94% of the 1088 randomized patients received this treatment after randomization

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

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 A13-05 Version 1.0 Fidaxomicin – Benefit assessment acc. to § 35a Social Code Book V A13-05 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Henning Schulze-Bergkamen, National Center for Tumor Diseases, Heidelberg University Hospital, Germany IQWiG thanks (...) patients; n: relevant subpopulation; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A13-05 Version 1.0 Fidaxomicin – Benefit assessment acc. to § 35a Social Code Book V A13-05 Institute for Quality and Efficiency in Health Care (IQWiG) - 10 - Table 4: Characteristics of the interventions – RCT, direct comparison: fidaxomicin vs. vancomycin Study Fidaxomicin Vancomycin Concomitant medication 101.1.C003 2 x 200 mg/day 4 x 125 mg/day Other drugs that can be used

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

199. Pixantrone - 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 A12-17 Version 1.0 Pixantrone – Benefit assessment acc. to § 35a Social Code Book V 27.02.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Angelika Böhme, Onkologikum Frankfurt am Museumsufer, Frankfurt am Main, Germany (...) Pixantrone - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Pixantron – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 27.02.2013). 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. A12-17 Pixantrone – Benefit assessment according to § 35a

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

200. Crizotinib - 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 A12-15 Version 1.0 Crizotinib – Benefit assessment acc. to § 35a Social Code Book V 13.02.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Frank Griesinger, Pius Hospital, Oldenburg, Germany IQWiG thanks the medical (...) : non-small cell lung cancer; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A12-15 Version 1.0 Crizotinib – Benefit assessment acc. to § 35a Social Code Book V 13.02.2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 9 - Table 6: Characteristics of the interventions – RCT, direct comparison – crizotinib vs. chemotherapy, chemotherapy population Study Study arm Study treatment Concomitant medication: dexamethasone Other concomitant medication Supportive

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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