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161. 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)

162. 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)

163. 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)

164. 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)

165. 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)

166. 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)

167. 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)

168. 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)

169. 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)

170. 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)

171. 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)

172. Responsible use of high-risk medical devices: the example of 3D printed medical devices

) Participation in scientific or experimental research as an initiator, principal investigator or researcher: Philip Tack (IWT Project ‘Roadmap’ about medical 3D Printing (part Health economy: PHD traject), Jan Schrooten (Projects KU Leuven – generative medicine / VLAIO feasibility assessment Antheron BV.B.A.), Stefaan Nijs (3D modelling in shoulder althea prof. (UZ Leuven – KU Leuven)) A grant, fees or funds for a member of staff or another form of compensation for the execution of research described above (...) EUDAMED European Databank on Medical Devices EUIPO EUnetHTA European Union Intellectual Property Office European Network for Health Technology Assessment EUTM DD DMCA FAMHP European Union Trade Mark Directive on the legal protection of designs Digital Millennium Copyright Act Federal Agency for Medicines and Health Products (FAGG-AFMPS) FDA Food and Drug Administration GDPR General Data Protection Regulation HSR HTA Health Services Research Health Technology Assessment IC IDEAL INAHTA Insurance

2018 Belgian Health Care Knowledge Centre

173. One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine

or opinions expressed herein do not necessarily reflect the views or opinions of Hennepin County Medical Center. As of March 10, 2018, I've decided to run ads here. All ad revenue will go to my ECG research projects. We need funding. Up until now, my wife and I have funded the PERFECT (Paced ECG Requiring Fast Emergent Coronary Therapy) study by making her the full time coordinator without pay. Dr. Smith's Book Recommended Resources More basic books for the less advanced learner: Comments not appropriate (...) One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine Dr. Smith's ECG Blog: One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine Tuesday, January 8, 2019 Doug Brunette is one of the finest Emergency Physicians, if not the finest, whom I have ever known. He was one of the early Hennepin greats, and one of my first and best teachers. He has always been passionate about teaching and practicing

2019 Dr Smith's ECG Blog

174. Vildagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

March 2013 Internal Commission No.: A13-17 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 A13-17 Version 1.0 Vildagliptin/metformin – 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 (...) - 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: 05 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 May 2011 [accessed: 05 May 2012]. URL: https

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

175. Linaclotide - 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 A13-21 Version 1.0 Linaclotide – Benefit assessment acc. to § 35a Social Code Book V 30 July 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Matthias Breidert, Hospitals in the Altmühltal Nature Park (...) in comparison with the ACT of the G-BA. None of the 3 studies of the company was suitable for assessing the added benefit of linaclotide in comparison with the ACT of the G-BA. Table 3 and Table 4 show the characteristics of the studies and of the interventions included by the company. Table 5 contains an overview of the information on medically advised dietary changes in the studies. Extract of dossier assessment A13-21 Version 1.0 Linaclotide – Benefit assessment acc. to § 35a Social Code Book V 30 July

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

176. Pertuzumab - 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 A13-10 Version 1.0 Pertuzumab – 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: ? Monika Nothacker, Association of Scientific Medical Societies (AWMF (...) of dossier assessment A13-10 Version 1.0 Pertuzumab – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - origin. 78% of the patients had visceral cancer, i.e. visceral organs like the lungs or the liver were affected. In the other patients, non-visceral organs such as skin, bones or brain were affected. Overall, the general condition of the patients, which was rated with the Eastern Cooperative Oncology Group (ECOG) status

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

177. Ocriplasmin - 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 A13-20 Version 1.0 Ocriplasmin – Benefit assessment acc. to § 35a Social Code Book V 30 July 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Daniela Claessens, Group Ophthalmological Practice, Cologne (...) Ocriplasmin - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment “Ocriplasmin – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 30 July 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. A13-20 Ocriplasmin – Benefit assessment according

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

178. Sitagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

March 2013 Internal Commission No.: A13-03 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 A13-03 Version 1.0 Sitagliptin/metformin – 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 (...) of dossier assessment A13-03 Version 1.0 Sitagliptin/metformin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) CT conventional insulin treatment G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HbA1c glycosylated haemoglobin A1c

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

179. Colestilan - 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 A13-15 Version 1.0 Colestilan – 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: ? Georg Schlieper, Rhine-Westphalian Technical University (RWTH), Aachen (...) Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - Table 6: Characteristics of the interventions – RCT, direct comparison: colestilan vs. sevelamer hydrochloride (subindication AII) Study Intervention Comparison Concomitant medication MCI-196-E07 Colestilan: different dosages, starting dose 6 g/day, max. 15 g/day, up- or down-titration depending on the serum phosphate level every 3 weeks possible to achieve a target serum phosphate level of between 1.13 and 1.78

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

180. 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)

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