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1. Scientific elaboration of concepts for the generation of data related to clinical practice and their evaluation for the purpose of benefit assessments of drugs §35a Social Code Book V - Rapid report

Scientific elaboration of concepts for the generation of data related to clinical practice and their evaluation for the purpose of benefit assessments of drugs §35a Social Code Book V - Rapid report 1 Translation of the executive summary of the rapid report A19-43 Konzepte zur Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach §35a SGB V (Version 1.0; Status: 10 January 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. A19-43 Concepts for the generation of routine practice data and their analysis for the benefit assessment of drugs according to §35a Social Code Book V (SGB V) 1 Extract of rapid report A19-43 Version 1.0 Routine practice data for the benefit assessment of drugs 10 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. 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

3. Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V

next generation sequencing NSCLC non-small cell lung cancer NTRK neurotrophic tyrosine receptor kinase PedsQL Pediatric Quality of Life Inventory RCT randomized controlled trial RECIST Response Evaluation Criteria in Solid Tumours RT-PCR reverse transcriptase polymerase chain reaction SAE serious adverse event SAP statistical analysis plan SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A19-90 Version 1.0 (...) analysis, the following methods for detection of NTRK gene fusion were accepted: next generation sequencing (NGS), fluorescence in situ hybridization (FISH) or reverse transcriptase polymerase chain reaction (RT-PCR). The testing methods used cover the methods recommended by the European Society for Medical Oncology (ESMO) to detect NTRK gene fusions [4]. If NGS was used for detection, it had to be clear from the pathology report that fusion between one of the NTRK genes (NTRK1, NTRK2, NTRK3

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. Patient safety and the annulment of medical clearance exams for hearing aids: Are we "closing the book" too soon? (Abstract)

Patient safety and the annulment of medical clearance exams for hearing aids: Are we "closing the book" too soon? To determine the utility of medical clearance exams by otolaryngologists prior to the distribution of hearing aids to patients with hearing loss.Medical records of 313 consecutive hearing-impaired individuals seeking financial assistance for hearing aids from the Lions Hearing Center of Michigan and who presented for medical clearance exams between January 2014 and May 2017 were (...) of patients with hearing loss prior to receiving hearing aids. With the impending arrival of over-the-counter hearing aids in the United States, special consideration should be placed on educating the general public about the importance of the medical evaluation prior to purchasing any type of hearing aid.Copyright © 2020 Elsevier Inc. All rights reserved.

2020 American Journal of Otolaryngology

5. The use of comic books, graphic novels, and fotonovelas as a health promotion tool

P, Rengifo J, Valverde I, et al. Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. Alzheimer Disease & Associated Disorders. 2015;29(2):146–53. Towey F. Conference: Comics and medicine. Lancet Oncology. 2014;15(9):927–8. Waite M. Writing medical comics. Journal of Visual Communication in Medicine. 2019;42(3):144–50. Suggested citation Rapid Response Service. The use of comic books, graphic novels, and fotonovelas as a health promotion tool (...) , and fotonovelas as health promotion tools (including HIV and STIs)? Key take-home messages Comics — including graphic novels, comic books, and fotonovelas — are one way to learn and teach about illness (1) as the reader can relate words and images to personal experience (2, 3). Generally, comics focused on health can fall into two different categories: memoirs about personal health or an experience of illness, and comics that consist of instructional content designed for education (4). The Undetectables

2020 Ontario HIV Treatment Network

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

Abbreviation Meaning ACT appropriate comparator therapy AE adverse event AJCC American Joint Committee on Cancer CI confidence interval CTCAE Common Terminology Criteria for Adverse Events G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions FACT-G Functional Assessment of Cancer Therapy-General FKSI-DRS Functional Assessment of Cancer Therapy – Kidney Symptom Index – Disease-Related Symptoms IMDC International Metastatic Renal (...) Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ipilimumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). 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. A19-12 Ipilimumab

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Melatonin (Schlafstörungen bei Kindern und Jugendlichen mit Autismus-Spektrum-Störung und/oder Smith-Magenis-Syndrom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 April 2019). 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. A19-04 Melatonin (Insomnia in children and adolescents with autism spectrum disorder and/or Smith-Magenis syndrome) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-04 Version 1.0 Melatonin (Insomnia in children and adolescents with ASD and/or SMS) 11 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency

2019 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 Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Apalutamide (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 2019). 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. A19-09 Apalutamide (...) (prostate cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-09 Version 1.0 Apalutamide (prostate cancer)) 24 April 2019 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 Commissioning agency: Federal Joint Committee Commission awarded on: 24 January 2019 Internal

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

9. Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V

Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Glecaprevir/Pibrentasvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 July 2019). 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. A19-33 Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-33 Version 1.0 Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) 11 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Glecaprevir/pibrentasvir (chronic hepatitis C

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

10. Rucaparib (ovarian, fallopian tube or peritoneal cancer; maintenance treatment) - Benefit assessment according to §35a Social Code Book V

EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions ESMO European Society for Medical Oncology FACT Functional Analysis of Cancer Therapy FOSI-18 FACT Ovarian Symptom Index-18 G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HRD homologous recombination deficiency IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MID minimally important difference MRI magnetic resonance imaging non-tBRCA (...) ”, among other aspects, the European Medicines Agency (EMA) granted conditional approval for rucaparib. This also corresponds to the recommendations of the European Society for Medical Oncology (ESMO) Consensus Conference of 2017, according to which results on PFS should always be interpreted together with results on additional outcomes including patient-reported outcomes. Considering the results on PFS alone is deemed inadequate, however. Implementation of the appropriate comparator therapy

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

11. Galcanezumab (migraine) - Benefit assessment according to §35a Social Code Book V

Galcanezumab (migraine) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Galcanezumab (Migräne) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2019). 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. A19-28 Galcanezumab (migraine (...) ) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Galcanezumab (migraine) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 March 2019 Internal Commission No.: A19-28 Address

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Radium-223 dichloride (mCRPC) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Radium-223 dichloride (mCRPC) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Radium-223-dichlorid (Prostatakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 July 2019). 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. A19-32 Radium 223 dichloride (prostate cancer) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A19-32 Version 1.0 Radium 223 dichloride (prostate cancer) 11 July 2019 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 (prostate cancer) – Benefit assessment according to §35a Social Code Book V

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

-Core 30 QLQ-MY20 Quality of Life Questionnaire-Multiple Myeloma Module 20 RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMQ Standardized Medical Dictionary for Regulatory Activities Query SPC Summary of Product Characteristics Extract of dossier assessment A19-50 Version 1.0 Pomalidomide (multiple myeloma) 12 September 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit (...) Pomalidomide (multiple myeloma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Pomalidomid (multiples Myelom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 September 2019). 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. A19-50

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Lisdexamfetamine (ADHD) - Benefit assessment according to §35a Social Code Book V

of the added benefit [28,29]. Because of the chronic course of ADHD, the European Medicines Agency (EMA) also recommends at least one controlled long- term study with a minimum duration of 6 months in addition to short-term studies [30]. The General Methods of IQWiG also describe that short-term studies for the evaluation of interventions for the treatment of chronic diseases are not usually suitable to achieve a complete benefit assessment [1]. This especially applies if treatment is required for several (...) - investigation-medicinal-products-treatment-attention-deficit-hyperactivity_en.pdf. 31. Shire. Elvanse Adult: Fachinformation [online]. 03.2019 [Accessed: 09.05.2019]. URL: https://www.fachinfo.de. 32. Lilly. Strattera: Fachinformation [online]. 06.2015 [Accessed: 13.05.2019]. URL: https://www.fachinfo.de. 33. Medice. Medikinet adult: Fachinformation [online]. 03.2018 [Accessed: 14.05.2019]. URL: https://www.fachinfo.de. 34. Gemeinsamer Bundesausschuss. Anlage III: Übersicht über Verordnungseinschränkungen

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

15. Dacomitinib (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

Dacomitinib (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dacomitinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 2019). 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. A19-39 Dacomitinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-39 Version 1.0 Dacomitinib (non-small cell lung cancer) 30 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dacomitinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

16. Nintedanib (idiopathic pulmonary fibrosis) - Benefit assessment according to §35a Social Code Book V

Nintedanib (idiopathic pulmonary fibrosis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nintedanib (idiopathische Lungenfibrose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 July 2019). 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. A19-36 Nintedanib (idiopathic pulmonary fibrosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-36 Version 1.0 Nintedanib (idiopathic pulmonary fibrosis) 11 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nintedanib (idiopathic pulmonary fibrosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

17. Lenvatinib (thyroid carcinoma) - Benefit assessment according to §35a Social Code Book V

carcinoma ECOG PS Eastern Cooperative Oncology Group Performance Status EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions FACT-G Functional Assessment of Cancer Therapy-General FDA Food and Drug Administration G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IU international units PFS progression-free survival RAI radioactive iodine RCT randomized (...) assessment). EQ-5D: European Quality of Life-5 Dimensions; FACT-G: Functional Assessment of Cancer Therapy- General; ND: no data; PFS: progression-free survival; RCT: randomized controlled trial; VAS: visual analogue scale; vs.: versus The observation periods for the outcomes on side effects were systematically shortened because they were only recorded for the time period of treatment with the study medication (plus 30 days). To be able to draw a reliable conclusion on the total study period or the time

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

18. Pembrolizumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Pembrolizumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2018). 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. A19-29 Pembrolizumab (melanoma (...) ) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-29 Version 1.0 Pembrolizumab (melanoma) 27 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pembrolizumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 March 2019 Internal Commission No.: A19-29 Address

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

therapy AE adverse event AJCC American Joint Committee on Cancer CI confidence interval CTCAE Common Terminology Criteria for Adverse Events G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions FACT-G Functional Assessment of Cancer Therapy-General FKSI-DRS Functional Assessment of Cancer Therapy – Kidney Symptom Index – Disease-Related Symptoms IMDC International Metastatic Renal Cell Carcinoma Database Consortium IQWiG (...) Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). 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. A19-11 Nivolumab

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

20. Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Damoctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 March 2019). 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. A18-86 (...) Damoctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-86 Version 1.0 Damoctocog alfa pegol (haemophilia A) 27 March 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Damoctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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