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41. 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)

42. 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)

43. 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)

44. 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)

45. 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)

46. 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)

47. 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)

48. 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)

49. 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)

50. 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)

51. Empagliflozin/linagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Empagliflozin/linagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Empagliflozin/Linagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 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. A19-49 Empagliflozin/linagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-49 Version 1.0 Empagliflozin/linagliptin (type 2 diabetes mellitus) 29 August 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Empagliflozin/linagliptin (type 2 diabetes mellitus) – Benefit assessment according

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

52. 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)

53. 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)

54. 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)

55. Risankizumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V

Risankizumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Risankizumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 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. A19-41 (...) Risankizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-41 Version 1.0 Risankizumab (plaque psoriasis) 29 August 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Risankizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 2 May

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

56. Lorlatinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

Lorlatinib (NSCLC) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lorlatinib (NSCLC) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 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. A19-48 Lorlatinib (NSCLC) – Benefit (...) assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-48 Version 1.0 Lorlatinib (NSCLC) 29 August 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lorlatinib (NSCLC) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 May 2019 Internal Commission No.: A19-48 Address of publisher: Institut

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

57. Turoctocog alfa pegol - Benefit assessment according to §35a Social Code Book V

of Transfusion Medicine, Cell Therapeutics and Haemostaseology, Clinic for Anaesthesiology, University Hospital Munich (LMU), Munich, 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 with IQWiG. IQWiG employees involved in the dossier assessment: ? Michael Köhler ? Katharina Biester ? Ulrich (...) Turoctocog alfa pegol - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Turoctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 October 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. A19-58 Turoctocog

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

58. Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V

transmembrane conductance regulator CI confidence interval EMA European Medicines Agency FEV1 forced expiratory volume in 1 second G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MMRM mixed-effects model repeated measures RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMD standardized mean difference SPC Summary of Product (...) weeks, the VX12-770-111 study (Part 1) included by the company is unsuitable for a benefit assessment in the therapeutic indication of CF. CF is a chronic disease requiring lifelong treatment. The European Medicines Agency (EMA) guideline recommends a minimum study duration of 6 months for the investigation of a clinical outcome [9]. IQWiG’s General Methods also consider long-term studies to be necessary for the benefit assessment in chronic diseases [1]. Short-term studies are inadequate

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

59. Ravalizumab - Benefit assessment according to §35a Social Code Book V

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LDH lactate dehydrogenase MAVE major adverse vascular event MedDRA Medical Dictionary for Regulatory Activities PNH paroxysmal nocturnal haemoglobinuria pRBC packed red blood cells PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics ULN upper limit of normal Extract of dossier (...) Ravalizumab - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ravulizumab (paroxysmale nächtliche Hämoglobinurie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 October 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. A19-59

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

60. Cemiplimab - Benefit assessment according to §35a Social Code Book V

Cemiplimab - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Cemiplimab (kutanes Plattenepithelkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 October 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. A19-60 Cemiplimab (...) (cutaneous squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-60 Version 1.0 Cemiplimab (cutaneous squamous cell carcinoma) 30 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cemiplimab (cutaneous squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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