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241. Tafluprost/Timolol: benefit assessment according to §35a Social Code Book V (dossier assessment)

December 2014 Internal Commission No.: A14-49 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-49 Version 1.0 Tafluprost/timolol – Benefit assessment acc. to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice (...) : available population; ND: no data; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A14-49 Version 1.0 Tafluprost/timolol – Benefit assessment acc. to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 8 - Table 5: Characteristics of the interventions – RCT, direct comparison: tafluprost/timolol vs. tafluprost + timolol Study Intervention Comparison Concomitant medication 201051 In the affected eye(s) for 6 months: ? once daily

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Enzalutamide (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Enzalutamid (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A14-48 Enzalutamide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-48 Version 1.0 Enzalutamide (new TI) – Benefit assessment acc. to §35a SGB V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Enzalutamide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

243. Sports Medicine Books

." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Related Topics in General About FPnotebook.com is a rapid access, point-of-care medical reference for primary care and emergency clinicians. Started in 1995, this collection now contains 6656 interlinked topic pages divided into a tree of 31 specialty books and 728 chapters. Content is with systematic literature reviews and conferences. Although access to this website (...) Sports Medicine Books Sports Medicine Books Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Sports Medicine Books Sports Medicine

2018 FP Notebook

244. Emergency Medicine Books

) These images are a random sampling from a Bing search on the term "Emergency Medicine Books." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Related Topics in General About FPnotebook.com is a rapid access, point-of-care medical reference for primary care and emergency clinicians. Started in 1995, this collection now contains 6656 interlinked topic pages divided into a tree of 31 specialty books and 728 chapters. Content (...) Emergency Medicine Books Emergency Medicine Books Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Emergency Medicine Books Emergency

2018 FP Notebook

245. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Full Text available with Trip Pro

Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Opportunities From the Greater Use of Generic Medications | Annals of Internal Medicine | American College of Physicians '); } '); })(); Sign in below to access your subscription for full content INDIVIDUAL SIGN IN | You will be directed to acponline.org (...) to register and create your Annals account INSTITUTIONAL SIGN IN | | Subscribe to Annals of Internal Medicine . You will be directed to acponline.org to complete your purchase. Search Clinical Guidelines | 5 January 2016 Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Free Niteesh K. Choudhry, MD, PhD; Thomas D. Denberg

2015 American College of Physicians

246. 2018 Book List: A (non-medical) year in review

number score: I don’t know By Jeanne Lenzer An absolute must read, whether you are in medicine or not. Medical science has been broken in so many ways by the involvement of industry money. Using interesting stories about medical devices, this book chronicles many of those deficiencies. Arbitrary number score: 88 By Josiah Bancroft Not nearly as good as the first book (Senlin Ascends) but OK for a light, fun read. Arbitrary number score: 71 By Somerset Maugham I have considered this one of my favorite (...) 2018 Book List: A (non-medical) year in review 2018 Book List: A (non-medical) year in review - First10EM Search 2018 Book List: A (non-medical) year in review by | Published - Updated | I tend to read a lot. In previous years, one of the things I have found frustrating is forgetting which books I have already read when when hunting for my next read (especially with long series or authors with a huge number of titles). Therefore, this year I decided to keep track of the books I read. Looking

2018 First10EM

247. Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, 6 bis < 12 Monate, mit Gating-Mutationen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 March 2020). 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. Extract IQWiG Reports – Commission No. A19-105 Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-105 Version 1.0 Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) 12 March 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Ivacaftor (cystic fibrosis

2020 Plant signaling & behavior

248. Neratinib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Neratinib (breast cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Neratinib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 February 2020). 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. Extract IQWiG Reports – Commission No. A19-98 Neratinib (breast (...) cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-98 Version 1.0 Neratinib (breast cancer) 27 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Neratinib (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 29 November 2019 Internal Commission

2020 Plant signaling & behavior

249. Brolucizumab (neovascular age-related macular degeneration) - Benefit assessment according to §35a Social Code Book V

Brolucizumab (neovascular age-related macular degeneration) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Brolucizumab (neovaskuläre altersabhängige Makuladegeneration) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 June 2020). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English- language readers. However, solely the German original text (...) is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A20-23 Brolucizumab (neovascular age-related macular degeneration) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-23 Version 1.0 Brolucizumab (neovascular age-related macular degeneration) 10 June 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Brolucizumab

2020 Plant signaling & behavior

250. Cobicistat (HIV infection) - Benefit assessment according to §35a Social Code Book V

Cobicistat (HIV infection) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Cobicistat (HIV-Infektion bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 June 2020). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract (...) IQWiG Reports – Commission No. A20-37 Cobicistat (HIV infection in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-37 Version 1.0 Cobicistat (HIV infection in adolescents) 26 June 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Cobicistat (HIV infection in adolescents) – Benefit assessment according to §35a Social Code Book V

2020 Plant signaling & behavior

251. Pembrolizumab (combination with axitinib, renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (combination with axitinib, renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Pembrolizumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 February 2020). 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. Extract IQWiG (...) Reports – Commission No. A19-99 Pembrolizumab (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-99 Version 1.0 Pembrolizumab (renal cell carcinoma) 27 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Pembrolizumab (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2020 Plant signaling & behavior

252. 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

253. 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)

254. 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)

255. 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)

256. 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)

257. 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)

258. 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)

259. 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)

260. 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)

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