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141. 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)

142. 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)

143. 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)

144. 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)

145. 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)

146. 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)

147. 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)

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

Lonoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V 1 Translation of addendum A16-66 Elotuzumab (multiples Myelom) – Addendum zum Auftrag A16-32 (Version 1.0; Status: 9 November 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. Addendum 9 November 2016 1.0 Commission: A16-66 Version: Status: IQWiG Reports – Commission (...) Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) ISS International Staging System MID minimally important difference MMRM mixed-effects model repeated measures PFS progression-free survival SAE serious adverse event SD standard deviation SGB Sozialgesetzbuch (Social Code Book) Addendum A16-66 Version 1.0 Elotuzumab – Addendum to Commission A16-32 9 November 2016 Institute

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Idelalisib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Idelalisib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 5 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. A16-64 Idelalisib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-64 Version 1.1 Idelalisib (chronic lymphocytic leukaemia) 5 January 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Idelalisib (chronic lymphocytic leukaemia) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MSKCC Memorial Sloan Kettering Cancer Center PFS progression-free survival PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMQ Standardized Medical Dictionary for Regulatory Activities Query SOC System Organ Class SPC Summary of Product Characteristics VEGF vascular endothelial growth factor Extract of dossier assessment A16-63 Version (...) the last dose of the study medication. Table 12 shows the risk of bias at study level. Table 12: Risk of bias at study level – RCT, direct comparison: lenvatinib + everolimus vs. everolimus Study Adequate random sequence generation Allocation concealment Blinding Reporting independent of the results No additional aspects Risk of bias at study level Patient Treating staff Study 205 Yes Yes No No Yes Yes Low RCT: randomized controlled trial; vs.: versus The risk of bias at study level for study 205

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

and scientific advice: ? Henning Schulze-Bergkamen, Clinic of Internal Medicine II, Marien-Hospital gGmbH, Wesel, 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 2 : ? Stefan Kobza ? Christiane Balg ? Charlotte Guddat ? Michaela (...) Trifluridine/tipiracil (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Trifluridin/Tipiracil (Kolorektalkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 November 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

152. Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V

Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Saxagliptin/Metformin (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. A16-43 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A16-43 Version 1.0 Saxagliptin/metformin (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/metformin (type 2 diabetes mellitus) – Benefit assessment according

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

153. Baricitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V

Baricitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Baricitinib (Rheumatoide Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 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. A17-14 (...) Baricitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-14 Version 1.0 Baricitinib (rheumatoid arthritis) 29 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Baricitinib (rheumatoid arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

154. Tenofovir alafenamide (chronic hepatitis B) ? Benefit assessment according to §35a Social Code Book V

Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IU international unit MedDRA Medical Dictionary for Regulatory Activities PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SMQ Standardized MedDRA Query SOC System Organ Class TAF tenofovir alafenamide TDF tenofovir disoproxil (fumarate) Extract of dossier assessment A17-13 Version 1.0 Tenofovir alafenamide (chronic hepatitis B) 29 June 2017 Institute (...) Tenofovir alafenamide (chronic hepatitis B) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Tenofoviralafenamid (chronische Hepatitis B) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

155. Axitinib (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Axitinib (renal cell carcinoma) - 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 Axitinib (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 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. A17-12 Axitinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 (expiry of the decision) Extract of dossier assessment A17-12 Version 1.0 Axitinib (renal cell carcinoma) 29 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Axitinib (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Dolutegravir (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dolutegravir (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 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. A17-11 Dolutegravir (HIV (...) infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-11 Version 1.0 Dolutegravir (HIV infection) 28 June 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir (HIV infection) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 17 March 2017 Internal Commission

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

). The patients were treated until disease progression, unacceptable side effects, or study discontinuation due to decision by the physician or the patient. Treatment was generally restricted by the maximum number of allowed cycles. Following discontinuation of the study Extract of dossier assessment A17-06 Version 1.0 Pembrolizumab (non-small cell lung cancer) 10 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - medication (e.g. due to disease progression), the patients in both (...) Pembrolizumab (non-small cell 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 Pembrolizumab (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) KRAS Kirsten rat sarcoma viral oncogene homologue MEK mitogen-activated extracellular signal-regulated kinase NGM Network Genomic Medicine NSCLC non-small cell lung cancer ORR objective response rate PFS progression-free survival RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics UICC Union for International Cancer Control (...) therapy from several options, the respective choice of the company is printed in bold. b: It is assumed for the present therapeutic indication that the NSCLC patients have stage IIIB to IV disease (staging according to IASLC, UICC), without a medical indication for curative resection, radiotherapy or radiochemotherapy. c: This applies especially to patients for whom nivolumab or cytotoxic chemotherapy is not an option due to their reduced general condition – in particular, these can be patients

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) KRAS Kirsten rat sarcoma viral oncogene homologue MEK mitogen-activated extracellular signal-regulated kinase NGM Network Genomic Medicine NSCLC non-small cell lung cancer ORR objective response rate PFS progression-free survival RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics UICC Union for International Cancer Control (...) Dabrafenib (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 Dabrafenib (nicht kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 July 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

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

160. Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V

Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Plattenepithelkarzinom des Kopf-Hals- Bereichs) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 August 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. A17-24 Nivolumab (squamous cell carcinoma of the head and neck) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-24 Version 1.0 Nivolumab (squamous cell carcinoma of the head and neck) 30 August 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (squamous cell carcinoma of the head and neck) – Benefit

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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