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

Ipilimumab (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 Ipilimumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status 13 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. A13-44 Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A13-44 Version 1.0 Ipilimumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 13 March 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

182. Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Apixaban (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 Apixaban (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 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. A14-28 Apixaban (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-28 Version 1.0 Apixaban (new therapeutic indication) – Benefit assessment acc. to §35a SGB V 26 Nov 2014 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 SGB V

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

183. 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)

184. 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)

185. 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)

186. Dimethyl fumarate (multiple sclerosis ? relapsing-remitting) ? Benefit assessment according to §35a Social Code Book V

awarded on: 30 April 2014 Internal Commission No.: A14-14 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 A14-14 Version 1.0 Dimethyl fumarate – Benefit assessment acc. to §35a Social Code Book V 30 July 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific (...) follows that of the full dossier assessment. Extract of dossier assessment A14-14 Version 1.0 Dimethyl fumarate – Benefit assessment acc. to §35a Social Code Book V 30 July 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy DMF dimethyl fumarate GA glatiramer acetate G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GLMM generalized linear mixed model IFN-ß1a interferon beta-1a IFN-ß1b interferon

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

187. Ruxolitinib (primary myelofibrosis, splenomegaly) ? Benefit assessment according to §35a Social Code Book V

Commission No.: A14-17 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 A14-17 Version 1.0 Ruxolitinib – Benefit assessment acc. to §35a Social Code Book V 12 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: After enquiries by the Institute (...) Standardized Medical Dictionary for Regulatory Activities Query SOC System Organ Class SPC Summary of Product Characteristics TSS total symptom score Extract of dossier assessment A14-17 Version 1.0 Ruxolitinib – Benefit assessment acc. to §35a Social Code Book V 12 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

188. 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)

189. 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)

190. 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)

191. 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)

192. 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)

193. 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 (...) Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LDH lactate dehydrogenase MAPK mitogen-activated protein kinase MedDRA Medical Dictionary for Regulatory Activities MMRM mixed-effects model repeated measures PFS progression-free survival RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class SPC Summary of Product Characteristics Extract

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

194. 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)

195. 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)

196. 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)

197. 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)

198. 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)

199. 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)

200. Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review

of included study bibliographies and review articles (n=2). After applying eligibility criteria, 25 articles (representing 19 unique studies) were included in the review. Of the 19 studies, 16 (13 trials) evaluated SMA interventions in patients with diabetes mellitus and 3 (2 trials) evaluated SMAs in older adults with high utilization of medical resources. SMAs were generally led by teams of 1 to 3 clinicians that usually included a physician and/ or a registered nurse. Typically, sessions involved fixed (...) when using a disease-specific measure. Three observational studies examined a more limited set of outcomes, with findings 4 Shared Medical Appointments for Chronic Medical Conditions Evidence-based Synthesis Program generally consistent with those of the randomized trials. The effects of SMAs on hospital admissions and emergency department visits were explored in five studies on patients with diabetes. In three of these, admission rates were lower with SMAs, but the result was statistically

2012 Veterans Affairs Evidence-based Synthesis Program Reports

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