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

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 (...) for a cardiologist was to wait too long. Doug and Hennepin (Ernie Ruiz, Joe Clinton, Dave Plummer, and more) taught me long ago that we Emergency Physicians must be the deciders. And that is just one of his countless contributions to EM over a 37 year career. Doug has collected images in EM since 1983 and they are incredible images, classics in EM. Now he has put 500 of these images (344 cases) together in an amazing new book: The Most Fascinating Book in Emergency Medicine History Posted by Steve Smith

2019 Dr Smith's ECG Blog

2. Riociguat (CTEPH) - Benefit assessment according to §35a Social Code Book V

Riociguat (CTEPH) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Riociguat (chronisch thromboembolische pulmonale Hypertonie) – 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. A20-30 Riociguat (chronic thromboembolic pulmonary hypertension) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-30 Version 1.0 Riociguat (chronic thromboembolic pulmonary hypertension) 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 Riociguat (chronic thromboembolic pulmonary hypertension) – Benefit

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

3. Riociguat (PAH) - Benefit assessment according to §35a Social Code Book V

Riociguat (PAH) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Riociguat (pulmonal arterielle Hypertonie) – 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. A20-31 Riociguat (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-31 Version 1.0 Riociguat (pulmonary arterial hypertension) 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 Riociguat (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. Insulin glargine/lixisenatide (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Insulin glargine/lixisenatide (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Insulin glargin/Lixisenatid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 July 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. A20-38 Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-38 Version 1.0 Insulin glargine/lixisenatide (type 2 diabetes mellitus) 13 July 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Insulin glargine/lixisenatide (type 2

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

5. Naldemedine (opioid-induced constipation) - Benefit assessment according to §35a Social Code Book V

Medizinischen Fachgesellschaften (Association of the Scientific Medical Societies in Germany) G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics Extract of dossier assessment A20-45 Version 1.0 Naldemedine (opioid-induced constipation) 13 August 2020 Institute (...) specified by the G-BA. Table 2: Research questions of the benefit assessment of naldemedine Research question Therapeutic indication ACT a 1 Adult patients with opioid-induced constipation and prior laxative treatment b Another non-prescription laxative (in accordance with the Medicinal Products Directive (AM-RL Annex I, No. 1) [1]) or a prescribable medical device for treating constipation (in accordance with AM-RL Section J and Annex V [2]) 2 Adult patients with opioid-induced constipation who

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

6. Ropeginterferon alfa-2b (polycythaemia vera) - Benefit assessment according to §35a Social Code Book V

Ropeginterferon alfa-2b (polycythaemia vera) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ropeginterferon alfa-2b (Polycythaemia vera) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 27 Februar 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. A19-72 Ropeginterferon alfa-2b (polycythaemia vera) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-72 Version 1.1 Ropeginterferon alfa-2b (polycythaemia vera) 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 Ropeginterferon alfa-2b (polycythaemia vera) – Benefit assessment according to §35a Social Code Book V Commissioning

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Avelumab (metastatic Merkel cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Avelumab (metastatic Merkel cell carcinoma) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Avelumab (metastasiertes Merkelzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 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. A20-34 Avelumab (metastatic Merkel cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-34 Version 1.0 Avelumab (metastatic Merkel cell carcinoma) 29 June 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Avelumab (metastatic Merkel cell carcinoma) – Benefit assessment according to §35a

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

8. Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Apalutamid (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 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. A20-36 Apalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A20-36 Version 1.0 Apalutamide (prostate cancer) 29 June 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Apalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

9. Ramucirumab (NSCLC, combination with erlotinib) - Benefit assessment according to §35a Social Code Book V

Ramucirumab (NSCLC, combination with erlotinib) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ramucirumab (NSCLC, Kombination mit Erlotinib) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 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. A20-13 Ramucirumab (NSCLC, combination with erlotinib) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-13 Version 1.0 Ramucirumab (NSCLC, combination with erlotinib) 13 May 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Ramucirumab (NSCLC, combination with erlotinib) – Benefit assessment

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

10. Romosozumab (osteoporosis) - Benefit assessment according to §35a Social Code Book V

Romosozumab (osteoporosis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Romosozumab (Osteoporose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 June 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. A20-24 Romosozumab (...) (osteoporosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-24 Version 1.0 Romosozumab (osteoporosis) 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 Romosozumab (osteoporosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 11 March 2020 Internal Commission No. A20

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

11. Atezolizumab (NSCLC, combination chemotherapy with nab-paclitaxel) - Benefit assessment according to §35a Social Code Book V

Atezolizumab (NSCLC, combination chemotherapy with nab-paclitaxel) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Atezolizumab (NSCLC, Kombination mit nab- Paclitaxel und Carboplatin) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 30 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. A19-84 Atezolizumab (NSCLC, combination with nab-paclitaxel and carboplatin) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-84 Version 1.1 Atezolizumab (NSCLC, combination with nab-paclitaxel and carboplatin) 30 March 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Atezolizumab (NSCLC

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Trifluridine/tipiracil (gastric cancer) - Benefit assessment according to §35a Social Code Book V

Trifluridine/tipiracil (gastric cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Trifluridin/Tipiracil (Magenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 25 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. A19-85 Trifluridine/tipiracil (gastric cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-85 Version 1.1 Trifluridine/tipiracil (gastric cancer) 25 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Trifluridine/tipiracil (gastric cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

13. Siponimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

Siponimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Siponimod (multiple Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 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. A20-10 Siponimod (...) (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-10 Version 1.0 Siponimod (multiple sclerosis) 13 May 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Siponimod (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 5 February 2020 Internal

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Trastuzumab emtansine (breast cancer) - Benefit assessment according to §35a Social Code Book V

. Another 2 data cut-offs were conducted at the request of regulatory authorities: ? About 5 months after the first data cut-off (6 December 2018), a new analysis of safety outcomes (safety update) was conducted at the request of the Food and Drug Administration (FDA). This included only AEs recorded in the follow-up observation phase 30 days after the last administration of the study medication. ? Analysis of data on overall survival at the request of the European Medicines Agency (EMA) (6 May 2019 (...) Trastuzumab emtansine (breast cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Trastuzumab Emtansin (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 14 April 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. A20-07

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

15. Enzalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Enzalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Enzalutamid (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 August 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. A20-46 Enzalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A20-46 Version 1.0 Enzalutamide (prostate cancer) 12 August 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Enzalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

16. Ribociclib (breast cancer; combination with aromatase inhibitors) - Benefit assessment according to §35a Social Code Book V

Ribociclib (breast cancer; combination with aromatase inhibitors) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ribociclib (Mammakarzinom, Kombination mit einem Aromatasehemmer) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 28 May 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. A20-21 Ribociclib (breast cancer, combination with an aromatase inhibitor) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A20-21 Version 1.0 Ribociclib (breast cancer, combination with an aromatase inhibitor) 28 May 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

17. Dupilumab (chronic rhinosinusitis with nasal polyposis) - Benefit assessment according to §35a Social Code Book V

for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice ? Boris Stuck, Clinic for Ear, Nose and Throat Medicine, University Hospital Gießen and Marburg GmbH, Marburg site, Philipps-University Marburg, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. The responsibility for the contents of the dossier assessment lies solely (...) Dupilumab (chronic rhinosinusitis with nasal polyposis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dupilumab (Chronische Rhinosinusitis mit Nasenpolypen) – 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

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

18. Avelumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Avelumab (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 Avelumab (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. A19-95 Avelumab (...) (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-95 Version 1.0 Avelumab (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 Avelumab (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 21 November

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

19. Pembrolizumab (head and neck squamous cell carcinoma, monotherapy) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (head and neck squamous cell carcinoma, monotherapy) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Pembrolizumab (Plattenepithelkarzinom der Kopf- Hals-Region, Monotherapie) – 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. A19-100 Pembrolizumab (head and neck squamous cell carcinoma, monotherapy) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-100 Version 1.0 Pembrolizumab (head and neck squamous cell carcinoma, monotherapy) 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

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

20. Pembrolizumab (head and neck squamous cell carcinoma, combination therapy) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (head and neck squamous cell carcinoma, combination therapy) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Pembrolizumab (Plattenepithelkarzinom der Kopf- Hals-Region, Kombination mit Chemotherapie) – 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. A19-101 Pembrolizumab (head and neck squamous cell carcinoma, combination with chemotherapy) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-101 Version 1.0 Pembrolizumab (HNSCC, combination with chemotherapy) 27 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

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