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161. Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia

conclusions 40 5 Implementation 47 6 Recommendations for research 48 7 Appraisal committee members, guideline representatives and NICE project team 49 NICE project team 49 Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (TA393) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 501 1 Recommendations Recommendations 1.1 Alirocumab is recommended as an option for treating primary (...) OPTIONS I was a randomised, double-blind study in 355 people with non-familial hypercholesterolaemia or heterozygous-familial hypercholesterolaemia and a history of coronary heart disease, risk of cardiovascular disease or diabetes with target organ damage, whose LDL -C levels were not adequately controlled with atorvastatin 20 mg to 40 mg. Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (TA393) © NICE 2018. All rights reserved. Subject to Notice of rights (https

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

162. Belimumab for treating active autoantibody-positive systemic lupus erythematosus

Belimumab for treating active autoantibody-positive systemic lupus erythematosus Belimumab for treating activ Belimumab for treating active e autoantibody-positiv autoantibody-positive systemic lupus e systemic lupus erythematosus erythematosus T echnology appraisal guidance Published: 22 June 2016 nice.org.uk/guidance/ta397 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility (...) equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Belimumab for treating active autoantibody-positive systemic lupus erythematosus (TA397) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

163. Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis

Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis Rux Ruxolitinib for treating disease-related olitinib for treating disease-related splenomegaly or symptoms in adults with splenomegaly or symptoms in adults with m my yelofibrosis elofibrosis T echnology appraisal guidance Published: 23 March 2016 nice.org.uk/guidance/ta386 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y (...) to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis (TA386) © NICE 2018. All rights reserved. Subject to Notice of rights (https

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

164. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction

team 55 Appraisal committee members 55 NICE project team 57 8 Sources of evidence considered by the Committee 58 Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction (TA388) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 601 1 Recommendations Recommendations 1.1 Sacubitril valsartan is recommended as an option for treating symptomatic chronic heart failure (...) Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction Sacubitril valsartan for treating Sacubitril valsartan for treating symptomatic chronic heart failure with symptomatic chronic heart failure with reduced ejection fr reduced ejection fraction action T echnology appraisal guidance Published: 27 April 2016 nice.org.uk/guidance/ta388 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

165. Elosulfase alfa for treating mucopolysaccharidosis type Iva

and Personal Social Services 28 Value for money 30 Impact of the technology beyond direct health benefits and on delivery of the specialised service 36 Conclusion 37 Summary of Evaluation Committee's key conclusions 38 6 Implementation 45 7 Review of guidance 46 8 Evaluation Committee members, guideline representatives and NICE project team 47 Evaluation Committee members 47 NICE project team 48 9 Sources of evidence considered by the Committee 49 About this guidance 52 Elosulfase alfa for treating (...) be exacerbated by limitations on income caused by difficulty working. Elosulfase alfa for treating mucopolysaccharidosis type IVa (HST2) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 7 of 52MPS IVa also significantly affects the families of people with the condition. Many parents struggle to continue working as care needs increase. Patient groups highlighted testimonies from families involved in clinical trials

2016 National Institute for Health and Clinical Excellence - Highly specialised technology

166. Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

of Appraisal Committee's key conclusions 42 5 Implementation 48 6 Recommendations for further research 50 7 Review of guidance 51 8 Appraisal Committee members, guideline representatives and NICE project team 52 Appraisal Committee members 52 NICE project team 53 9 Sources of evidence considered by the Committee 55 About this guidance 57 Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (TA373) © NICE 2019. All rights reserved. Subject to Notice of rights (https (...) Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Abatacept, adalimumab, etanercept and Abatacept, adalimumab, etanercept and tocilizumab for treating juv tocilizumab for treating juvenile enile idiopathic arthritis idiopathic arthritis T echnology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

167. Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy

members 59 NICE project team 62 8 Sources of evidence considered by the Committee 63 About this guidance 65 Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (TA374) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 66This guidance replaces TA175 and TA162. 1 1 Guidance Guidance 1.1 Erlotinib is recommended as an option for treating locally advanced (...) Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy Erlotinib and gefitinib for treating non- Erlotinib and gefitinib for treating non- small-cell lung cancer that has small-cell lung cancer that has progressed after prior chemother progressed after prior chemotherap apy y T echnology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta374 © NICE 2018. All rights reserved. Subject to Notice of rights (https

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

168. Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts

-of-rights). Page 2 of 36Contents Contents 1 Recommendations 4 2 The technology 5 3 Evidence 6 Clinical effectiveness 6 Cost effectiveness 11 ERG's comments 12 ERG's exploratory analysis 14 4 Committee discussion 17 Clinical effectiveness 18 Cost effectiveness 20 Summary of appraisal committee's key conclusions 26 5 Implementation 34 6 Appraisal committee members and NICE project team 35 Appraisal committee members 35 NICE project team 35 Azacitidine for treating acute myeloid leukaemia with more than 30 (...) Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts Azacitidine for treating acute m Azacitidine for treating acute my yeloid eloid leukaemia with more than 30% bone leukaemia with more than 30% bone marrow blasts marrow blasts T echnology appraisal guidance Published: 27 July 2016 nice.org.uk/guidance/ta399 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

169. Lumacaftor-ivacaftor for treating cystic fibrosis homozygous for the F508del mutation

Lumacaftor-ivacaftor for treating cystic fibrosis homozygous for the F508del mutation Lumacaftor–ivacaftor for treating cystic Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del fibrosis homozygous for the F508del mutation mutation T echnology appraisal guidance Published: 27 July 2016 nice.org.uk/guidance/ta398 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our (...) , to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del mutation (TA398) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

170. Ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene

and depression of knowing their child will probably die at a young age. The devastating impact of the disease and its prognosis often leads to isolation from friends and family members. Parents and carers described the financial impact of looking after a person with DMD. They described giving up work to look after their child full time. In addition, out-of- pocket expenses can be very high (for example, moving house to ensure the home is wheelchair accessible). Ataluren for treating Duchenne muscular (...) for money 32 Impact of the technology beyond direct health benefits and on the delivery of the specialised service 36 Conclusion 37 Summary of evaluation committee's key conclusions 39 6 Implementation 45 7 Evaluation committee members and NICE project team 46 Evaluation committee members 46 NICE project team 46 Ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene (HST3) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk

2016 National Institute for Health and Clinical Excellence - Highly specialised technology

171. Trifluridine-tipiracil for previously treated metastatic colorectal cancer

of 23Contents Contents 1 Recommendations 4 2 The technology 5 3 Evidence 6 4 Committee discussion 7 Patients' perspective 7 Position in the treatment pathway 7 Clinical effectiveness 8 Cost effectiveness 10 End-of-life considerations 12 Pharmaceutical Price Regulation Scheme 2014 14 Summary of appraisal committee's key conclusions 14 5 Implementation 21 6 Appraisal committee members and NICE project team 22 Appraisal committee members 22 NICE project team 22 Trifluridine–tipiracil for previously treated (...) by patients and their families. 4.1 Clinical need of patients, including the availability of alternative treatments The committee was aware that there is no positive NICE guidance on third- or subsequent-line treatments. 4.2 The technology The technology Trifluridine–tipiracil for previously treated metastatic colorectal cancer (TA405) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 15 of 23The patient experts stated

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

172. Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer

Appraisal committee members 28 NICE project team 28 Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer (TA403) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 291 1 Recommendations Recommendations 1.1 Ramucirumab, in combination with docetaxel, is not recommended within its marketing authorisation for treating locally advanced or metastatic non-small- cell lung cancer (...) Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer Ramucirumab for pre Ramucirumab for previously treated viously treated locally advanced or metastatic non-small- locally advanced or metastatic non-small- cell lung cancer cell lung cancer T echnology appraisal guidance Published: 24 August 2016 nice.org.uk/guidance/ta403 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

173. Degarelix for treating advanced hormone-dependent prostate cancer

Evidence 6 4 Committee discussion 7 Clinical effectiveness 9 Cost effectiveness 17 Summary of appraisal committee's key conclusions 25 5 Implementation 36 6 Recommendations for research 37 7 Appraisal committee members and NICE project team 38 Appraisal committee members 38 NICE project team 38 Degarelix for treating advanced hormone-dependent prostate cancer (TA404) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 (...) Degarelix for treating advanced hormone-dependent prostate cancer Degarelix for treating advanced Degarelix for treating advanced hormone-dependent prostate cancer hormone-dependent prostate cancer T echnology appraisal guidance Published: 24 August 2016 nice.org.uk/guidance/ta404 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

174. Bosutinib for previously treated chronic myeloid leukaemia

Committee discussion 7 Clinical effectiveness 9 Cost effectiveness 12 Cancer Drugs Fund reconsideration 22 End-of-life considerations 24 Equality issues 25 Summary of appraisal committee's key conclusions 25 5 Implementation 34 6 Appraisal committee members and NICE project team 35 Appraisal committee members 35 NICE project team 35 Bosutinib for previously treated chronic myeloid leukaemia (TA401) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms (...) ). Bosutinib for previously treated chronic myeloid leukaemia (TA401) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 4 of 362 2 The technology The technology Description of Description of the technology the technology Bosutinib (Bosulif, Pfizer) is a second-generation tyrosine kinase inhibitor that inhibits Abl-kinases, including Bcr-Abl kinase. It also inhibits the Src family kinases, which have been implicated

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

175. ENDURALIFE powered CRT-D devices for treating heart failure

powered CRT-D devices for treating heart failure (MTG33) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 26Contents Contents 1 Recommendations 4 2 The technology 5 Description of the technology 5 Current management 6 3 Clinical evidence 8 Summary of clinical evidence 8 4 NHS considerations 17 System impact 17 5 Cost considerations 18 Cost evidence 18 6 Conclusions 25 7 Committee members and NICE project team 26 (...) Committee members 26 NICE project team 26 ENDURALIFE powered CRT-D devices for treating heart failure (MTG33) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 261 1 Recommendations Recommendations 1.1 The case for adopting ENDURALIFE-powered cardiac resynchronisation therapy-defibrillator (CRT-D) devices for treating heart failure is supported by the published evidence. Extended battery life is of clinical

2017 National Institute for Health and Clinical Excellence - Medical technologies

176. Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes

Committee discussion 31 Clinical effectiveness 32 Cost effectiveness 34 Summary of appraisal committee's key conclusions 38 5 Implementation 45 6 Appraisal committee members and NICE project team 46 Appraisal committee members 46 NICE project team 46 Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (TA390) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 471 1 (...) Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes Canagliflozin, dapagliflozin and Canagliflozin, dapagliflozin and empagliflozin as monother empagliflozin as monotherapies for apies for treating type 2 diabetes treating type 2 diabetes T echnology appraisal guidance Published: 25 May 2016 nice.org.uk/guidance/ta390 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

177. Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel

and NICE project team 46 Appraisal committee members 46 NICE project team 46 Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel (TA391) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 47This guidance replaces TA255. 1 1 Recommendations Recommendations 1.1 Cabazitaxel in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone-relapsed (...) experts about their experience of metastatic hormone-relapsed prostate cancer. The patient experts stated that, at this stage of disease, patients and their families value treatments which extend life, even if for a short period, and the hope that this offers. The committee also heard that patients want treatments that improve quality of life. The committee heard from the patient experts that cabazitaxel is usually well tolerated and is therefore an important option for treating people with metastatic

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

178. Vortioxetine for treating major depressive episodes

Vortioxetine for treating major depressive episodes V Vortio ortiox xetine for treating major etine for treating major depressiv depressive episodes e episodes T echnology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta367 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived at after (...) and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Vortioxetine for treating major depressive episodes (TA367) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 64Contents Contents 1 Guidance 4 2 The technology 5 3 The company's submission 6 Clinical effectiveness

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

179. Ledipasvir-sofosbuvir for treating chronic hepatitis C

transplant 60 Innovation 60 NHS England 61 Pharmaceutical Price Regulation Scheme 63 Equality issues 64 Summary of Appraisal Committee's key conclusions 65 5 Implementation 75 6 Review of guidance 76 7 Appraisal Committee members, guideline representatives and NICE project team 77 Appraisal Committee members 77 Ledipasvir–sofosbuvir for treating chronic hepatitis C (TA363) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page (...) Ledipasvir-sofosbuvir for treating chronic hepatitis C L Ledipasvir–sofosbuvir for treating edipasvir–sofosbuvir for treating chronic hepatitis C chronic hepatitis C T echnology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta363 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

180. Tolvaptan for treating autosomal dominant polycystic kidney disease

Tolvaptan for treating autosomal dominant polycystic kidney disease T T olvaptan for treating autosomal olvaptan for treating autosomal dominant poly dominant polycystic kidne cystic kidney disease y disease T echnology appraisal guidance Published: 28 October 2015 nice.org.uk/guidance/ta358 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance (...) inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. T olvaptan for treating autosomal dominant polycystic kidney disease (TA358) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 48Contents Contents 1 Guidance 4 2 The technology 5 3

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

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