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

Atezolizumab (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 Atezolizumab (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 December 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. A17-50 Atezolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-50 Version 1.0 Atezolizumab (non-small cell lung cancer) 27 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Atezolizumab (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

122. Sarilumab (rheumatoid arthritis) ? Benefit assessment according to §35a Social Code Book V

Sarilumab (rheumatoid arthritis) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sarilumab (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 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. A17-39 (...) Sarilumab (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-39 Version 1.0 Sarilumab (rheumatoid arthritis) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sarilumab (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

123. Pembrolizumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V

Pembrolizumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Pembrolizumab (Urothelkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 December 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. A17-46 (...) Pembrolizumab (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-46 Version 1.0 Pembrolizumab (urothelial carcinoma) 13 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Pembrolizumab (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

124. Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V

and Efficiency in Health Care) LLT Lowest Level Term MedDRA Medical Dictionary for Regulatory Activities NYHA New York Heart Association PS Performance Status PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class Extract of dossier assessment A17-51 Version 1.0 Atezolizumab (urothelial carcinoma, first-line treatment) 22 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 (...) Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment (Urothelkarzinom Erstlinientherapie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Cabozantinib (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 Cabozantinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 11 January 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. A17-56 Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A17-56 Version 1.0 Cabozantinib (renal cell carcinoma) 11 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

126. Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V

Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Glycopyrroniumbromid (Sialorrhö) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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. A18-22 Glycopyrronium bromide (sialorrhoea) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-22 Version 1.0 Glycopyrronium bromide (sialorrhoea) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Glycopyrronium bromide (sialorrhoea) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

127. 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 Extract 1 Translation of the executive summary of the dossier assessment Insulin glargin/Lixisenatid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 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. A18-16 Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-16 Version 1.0 Insulin glargine/lixisenatide (type 2 diabetes mellitus) 20 May 2018 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

128. Bezlotoxumab (Clostridium difficile infection) - Benefit assessment according to §35a Social Code Book V

Bezlotoxumab (Clostridium difficile infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bezlotoxumab (Clostridium-difficile- Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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. A18-23 Bezlotoxumab (Clostridium difficile infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-23 Version 1.0 Bezlotoxumab (Clostridium difficile infection) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Bezlotoxumab (Clostridium difficile infection) – Benefit assessment

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

129. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Emicizumab (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 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. A18-20 Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-20 Version 1.0 Emicizumab (haemophilia A) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

130. Hydrocortisone (adrenal insufficiency) - Benefit assessment according to §35a Social Code Book V

Hydrocortisone (adrenal insufficiency) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Hydrocortison (Nebenniereninsuffizienz bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 August 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. A18-29 Hydrocortisone (adrenal insufficiency in children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-29 Version 1.0 Hydrocortisone (adrenal insufficiency in children) 10 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Hydrocortisone (adrenal insufficiency in children

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

131. Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Ertugliflozin/Sitagliptin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 6 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. A18-31 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-31 Version 1.1 Ertugliflozin/sitagliptin (type 2 diabetes mellitus) 6 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ertugliflozin/sitagliptin (type 2

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

132. Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Tofacitinib (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 July 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. A18-28 Tofacitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-28 Version 1.0 Tofacitinib (rheumatoid arthritis) 27 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tofacitinib (rheumatoid arthritis) – Benefit assessment according

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

133. Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Rurioctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 August 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. A18-32 Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-32 Version 1.0 Rurioctocog alfa pegol (haemophilia A) 13 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

134. Cariprazine (schizophrenia) - Benefit assessment according to §35a Social Code Book V

Cariprazine (schizophrenia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Cariprazin (Schizophrenie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 July 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. A18-25 Cariprazine (schizophrenia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-25 Version 1.0 Cariprazine (schizophrenia) 12 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cariprazine (schizophrenia) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

135. Extract from Cannabis sativa (spasticity due to multiple sclerosis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Extract from Cannabis sativa (spasticity due to multiple sclerosis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Extrakt aus Cannabis sativa (Spastik aufgrund von multipler Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 26 July 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. A18-27 Extract from Cannabis sativa (spasticity due to multiple sclerosis) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-27 Version 1.0 Extract from Cannabis sativa (spasticity due to multiple sclerosis) 26 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

136. Bosutinib (chronic myeloid leukaemia) - Benefit assessment according to §35a Social Code Book V

Bosutinib (chronic myeloid leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Bosutinib (chronische myeloische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 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. A18-33 Bosutinib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-33 Version 1.0 Bosutinib (chronic myeloid leukaemia) 29 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Bosutinib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Cabozantinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Cabozantinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 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. A18-37 Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-37 Version 1.0 Cabozantinib (renal cell carcinoma) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Cabozantinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

138. Dolutegravir/rilpivirine (HIV infection) - Benefit assessment according to §35a Social Code Book V

Dolutegravir/rilpivirine (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Dolutegravir/Rilpivirin (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 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. A18-34 Dolutegravir/rilpivirine (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-34 Version 1.0 Dolutegravir/rilpivirine (HIV infection) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/rilpivirine (HIV infection) – Benefit assessment according to §35a Social

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

139. Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Extract 1 Translation of the executive summary of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 13 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. A18-40 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A18-40 Version 1.0 Nivolumab (melanoma) 13 September 2018 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

140. Olaparib (ovarian, fallopian tube, peritoneal cancer) - Benefit assessment according to §35a Social Code Book V

Olaparib (ovarian, fallopian tube, peritoneal cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Olaparib (Ovarialkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Zulassungserweiterung / Ablauf Befristung) (Version 1.0; Status: 13 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. A18-36 Olaparib (ovarian cancer) – Benefit assessment according to §35a Social Code Book V 1 (extension of approval/ expiry of decision) Extract of dossier assessment A18-36 Version 1.0 Olaparib (ovarian cancer) 13 September 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Olaparib (ovarian cancer

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

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