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

Pertuzumab (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Pertuzumab (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 September 2018). 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. IQWiG (...) Reports – Commission No. A18-41 Pertuzumab (breast cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-41 Version 1.0 Pertuzumab (breast cancer) 27 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pertuzumab (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

142. Sitagliptin - Benefit assessment according to §35a Social Code Book V

Sitagliptin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 30 September 2016). 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. A16-44 (...) Sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-44 Version 1.0 Sitagliptin (type 2 diabetes mellitus) 30 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

143. Ibrutinib (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Ibrutinib (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 Ibrutinib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 September 2016). 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. A16-39 Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-39 Version 1.0 Ibrutinib (chronic lymphocytic leukaemia) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

144. Rilpivirine (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

assessment A15-55 Version 1.0 Rilpivirine (new TI) – Benefit assessment acc. to §35a Social Code Book V 30 March 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - Conclusions on the added benefit based on one-arm study designs are only possible in the presence of very large effects (so-called dramatic effects) regarding patient-relevant outcomes. To derive such an effect, the C213 study first would have to be generally suitable to provide information on rilpivirine for the research (...) Rilpivirine (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 (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2016). 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. A15

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

145. Saxagliptin - Benefit assessment according to §35a Social Code Book V

Saxagliptin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Saxagliptin (Diabetes mellitus Typ 2 – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 September 2016). 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. A16-42 (...) Saxagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-42 Version 1.0 Saxagliptin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Saxagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Sitagliptin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sitagliptin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 30 September 2016). 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. A16-45 Sitagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-45 Version 1.0 Sitagliptin/metformin (type 2 diabetes mellitus) 30 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

147. Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.6, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Insulin degludec (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 May 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. A15-10 Insulin degludec (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-09 Version 1.0 Insulin degludec (new TI) – Benefit assessment acc. to §35a SGB V 28 May 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

148. Ticagrelor (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

disorders 267 (5.0) 268 (5.0) General disorders and administration site conditions 695 (13.1) 775 (14.5) Non-cardiac chest pain 268 (5.0) 302 (5.7) Investigations 328 (6.2) 322 (6.0) Injury, poisoning and procedural complications 428 (8.0) 399 (7.5) a: MedDRA version 17.0. AE: adverse event; ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial (...) and urinary disorders 53 (1.0) 50 (0.9) General disorders and administration site conditions 118 (2.2) 135 (2.5) Non-cardiac chest pain 71 (1.3) 79 (1.5) Injury, poisoning and procedural complications 91 (1.7) 71 (1.3) a: MedDRA version 17.0. ASA: acetylsalicylic acid; MedDRA: Medical Dictionary for Regulatory Activities; n: number of patients with (at least one) event; N: number of analysed patients; PT: Preferred Term; RCT: randomized controlled trial; SAE: serious adverse event; SOC: System Organ Class

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

149. Emtricitabine/tenofovir alafenamide - Benefit assessment according to §35a Social Code Book V

Emtricitabine/tenofovir alafenamide - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Emtricitabin/Tenofoviralafenamid (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 29 September 2016). 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. A16-30 Emtricitabine/ tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-30 Version 1.1 Emtricitabine/tenofovir alafenamide (HIV infection) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Emtricitabine/tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

150. Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Nivolumab (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 Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 September 2016). 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. A16-35 Nivolumab (...) (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-35 Version 1.0 Nivolumab (melanoma) 12 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 8 June 2016 Internal Commission No.: A16-35

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

151. Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V

Vandetanib (medullary thyroid carcinoma in children and adolescents from the age of 5) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Vandetanib (Schilddrüsenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 June 2017). 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. A17-01 Vandetanib (thyroid cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-01 Version 1.1 Vandetanib (thyroid cancer) 1 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Vandetanib (thyroid cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

152. Reslizumab (severe eosinophilic asthma) ? Benefit assessment according to § 35a Social Code Book V

Reslizumab (severe eosinophilic asthma) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Reslizumab (Asthma) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 April 2017). 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. A17-02 Reslizumab (...) (asthma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-02 Version 1.0 Reslizumab (asthma) 11 April 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Reslizumab (asthma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 16 January 2017 Internal Commission No.: A17-02

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

153. Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Nivolumab (klassisches Hodgkin-Lymphom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2017). 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. A16-76 (...) Nivolumab (classical Hodgkin lymphoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-76 Version 1.0 Nivolumab (classical Hodgkin lymphoma) 30 March 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (classical Hodgkin lymphoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

154. Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Secukinumab (plaque psoriasis) - 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 Secukinumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 2017). 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. A17-08 Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-08 Version 1.0 Secukinumab (plaque psoriasis) 30 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events EQ-5D European Quality of Life-5 Dimensions ER oestrogen receptor FACT-B Functional Assessment of Cancer Therapy-Breast Cancer FACT-G Functional Assessment of Cancer Therapy-General G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HER2 human epidermal growth factor receptor 2 HR hormone receptor IQWiG Institut für Qualität und (...) Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Palbociclib (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 23 February 2017). 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. A16-74 Palbociclib

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

156. Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V

Macitentan (pulmonary arterial hypertension) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Macitentan (pulmonal arterielle Hypertonie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 9 January 2017). 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. A16-67 Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-67 Version 1.0 Macitentan (pulmonary arterial hypertension) 9 January 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Macitentan (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

157. Ibrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

Ibrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ibrutinib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 December 2016). 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. A16-60 Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-60 Version 1.0 Ibrutinib (chronic lymphocytic leukaemia) 28 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ibrutinib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

158. Crizotinib (lung cancer) - Benefit assessment according to §35a Social Code Book V

Crizotinib (lung cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Crizotinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-59 (...) Crizotinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-59 Version 1.0 Crizotinib (non-small cell lung cancer) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Crizotinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

159. Opicapone (Parkinson disease) - Benefit assessment according to §35a Social Code Book V

Opicapone (Parkinson disease) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Opicapon (Parkinsonkrankheit) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-61 Opicapone (...) (Parkinson disease) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-61 Version 1.0 Opicapone (Parkinson disease) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Opicapone (Parkinson disease) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 September 2016

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

160. Ceritinib (lung cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Ceritinib (lung cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ceritinib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2016). 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. A16-62 Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-62 Version 1.0 Ceritinib (non-small cell lung cancer) 22 December 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ceritinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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