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

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

2017 European Society for Medical Oncology

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

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

2016 Belgian Health Care Knowledge Centre

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. Dolutegravir - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-08 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Ingo Niemetz, diabetological practice (...) randomized controlled trial SAE serious adverse event SDM symptom distress module SGB Sozialgesetzbuch (Social Code Book) SOC Medical Dictionary for Regulatory Activities System Organ Class SPC Summary of Product Characteristics TDF tenofovir Extract of dossier assessment A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

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