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Treating Family Members

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161. Burosumab for treating X-linked hypophosphataemia in children and young people

Evaluation committee members 29 NICE project team 29 Burosumab for treating X-linked hypophosphataemia in children and young people (HST8) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 301 1 Recommendations Recommendations 1.1 Burosumab is recommended, within its marketing authorisation, for treating X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over (...) to errors in phosphate sensing and increased levels of fibroblast growth factor 23 (FGF23). Excess FGF23 causes impaired phosphate conservation and excessive phosphate excretion. It also supresses vitamin D production, which causes reduced calcium and phosphate absorption. 2.2 Because XLH is a genetic condition, it often affects several members of a family. Skeletal abnormalities such as bowed or bent legs, below average height and irregular growth of the skull are early signs of XLH. Children may also

2018 National Institute for Health and Clinical Excellence - Highly specialised technology

162. Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer

-of-rights). Page 2 of 18Contents Contents 1 Recommendations 4 2 The technology 5 3 Evidence 6 4 Committee discussion 7 Clinical effectiveness 9 Cost effectiveness 10 Innovation 12 End-of-life considerations 13 Conclusions 14 5 Implementation 16 6 Appraisal committee members and NICE project team 17 Appraisal committee members 17 NICE project team 17 Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer (TA509) © NICE 2018. All rights reserved. Subject to Notice of rights (...) enquiries from NHS organisations about the commercial access agreement should be directed to global.pas@roche.com. Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer (TA509) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 16 of 186 6 Appr Appraisal committee members and NICE project team aisal committee members and NICE project team Appraisal committee members The technology appraisal

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

163. Daratumumab monotherapy for treating relapsed and refractory multiple myeloma

of 31Contents Contents 1 Recommendations 4 2 Information about daratumumab 5 3 Evidence 6 4 Committee discussion 7 Nature of the condition 7 Clinical pathway 7 Clinical effectiveness 8 Cost effectiveness 16 Innovation 20 End-of-life considerations 21 Cancer Drugs Fund considerations 21 Summary of appraisal committee's key conclusions 24 5 Implementation 29 6 Appraisal committee members and NICE project team 30 Appraisal committee members 30 NICE project team 30 Daratumumab monotherapy for treating relapsed (...) Daratumumab monotherapy for treating relapsed and refractory multiple myeloma Dar Daratumumab monother atumumab monotherap apy for treating y for treating relapsed and refr relapsed and refractory multiple actory multiple m my yeloma eloma T echnology appraisal guidance Published: 14 March 2018 nice.org.uk/guidance/ta510 © 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

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

164. Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma

for data collection 19 6 Appraisal committee members and NICE project team 20 Appraisal committee members 20 NICE project team 20 Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (TA505) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 211 1 Recommendations Recommendations 1.1 Ixazomib, with lenalidomide and dexamethasone, is recommended for use within the Cancer (...) -1 clinical trial. Data on overall survival and time-on- treatment will be collected through other sources including the Systemic Anti- Cancer Therapy (SACT) dataset. Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (TA505) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 19 of 216 6 Appr Appraisal committee members and NICE project team aisal committee members

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

165. Ibrutinib for treating relapsed or refractory mantle cell lymphoma

3 Evidence 6 4 Committee discussion 7 Clinical effectiveness 7 Cost effectiveness 11 End-of-life considerations 13 Potential equality issues 14 Pharmaceutical Price Regulation Scheme (PPRS) 2014 14 Summary of appraisal committee's key conclusions 14 5 Implementation 20 6 Appraisal committee members and NICE project team 21 Appraisal committee members 21 NICE project team 21 Ibrutinib for treating relapsed or refractory mantle cell lymphoma (TA502) © NICE 2018. All rights reserved. Subject (...) Ibrutinib for treating relapsed or refractory mantle cell lymphoma Ibrutinib for treating relapsed or Ibrutinib for treating relapsed or refr refractory mantle cell lymphoma actory mantle cell lymphoma T echnology appraisal guidance Published: 31 January 2018 nice.org.uk/guidance/ta502 © 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

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

166. Pirfenidone for treating idiopathic pulmonary fibrosis

discussion 7 Review objectives 7 Current practice 7 Comparators 8 Clinical effectiveness 8 Cost effectiveness 11 Cost-effectiveness results and conclusions 16 Potential equality issues 18 The Pharmaceutical Price Regulation Scheme 19 Summary of appraisal committee's key conclusions 19 5 Implementation 24 6 Appraisal committee members, guideline representatives and NICE project team 25 Appraisal committee members 25 NICE project team 25 Pirfenidone for treating idiopathic pulmonary fibrosis (TA504) © NICE (...) Pirfenidone for treating idiopathic pulmonary fibrosis Pirfenidone for treating idiopathic Pirfenidone for treating idiopathic pulmonary fibrosis pulmonary fibrosis T echnology appraisal guidance Published: 6 February 2018 nice.org.uk/guidance/ta504 © 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

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

167. Soluble concentrations of the interleukin receptor family member ST2 and β-blocker therapy in chronic heart failure. (PubMed)

Soluble concentrations of the interleukin receptor family member ST2 and β-blocker therapy in chronic heart failure. Concentrations of soluble (s)ST2 predict prognosis in heart failure. We recently found changing doses of β-blocker (BB) may affect sST2 concentrations. It remains unclear whether sST2 concentrations identify benefit of BB therapy, however.A total of 151 subjects with heart failure attributable to left ventricular systolic dysfunction were examined in this post hoc analysis; >96 (...) sST2/high-dose BB had intermediate outcomes (0.92 and 1.19 events). Patients with high sST2 treated with low-dose BB had the highest cardiovascular event rate (2.08 events) and the highest cumulative hazard. Compared with low sST2/high-dose BB, those with high sST2 treated with low-dose BB had an odds ratio of 6.77 (P<0.001) for a cardiovascular event. Patients with low sST2/low-dose BB or high sST2/high-dose BB had intermediate odds ratios for cardiovascular events (P=0.18 and 0.02). Similar

2013 Circulation. Heart failure Controlled trial quality: uncertain

168. Soluble concentrations of the interleukin receptor family member ST2 and β-blocker therapy in chronic heart failure. (PubMed)

Soluble concentrations of the interleukin receptor family member ST2 and β-blocker therapy in chronic heart failure. Concentrations of soluble (s)ST2 predict prognosis in heart failure. We recently found changing doses of β-blocker (BB) may affect sST2 concentrations. It remains unclear whether sST2 concentrations identify benefit of BB therapy, however.A total of 151 subjects with heart failure attributable to left ventricular systolic dysfunction were examined in this post hoc analysis; >96 (...) sST2/high-dose BB had intermediate outcomes (0.92 and 1.19 events). Patients with high sST2 treated with low-dose BB had the highest cardiovascular event rate (2.08 events) and the highest cumulative hazard. Compared with low sST2/high-dose BB, those with high sST2 treated with low-dose BB had an odds ratio of 6.77 (P<0.001) for a cardiovascular event. Patients with low sST2/low-dose BB or high sST2/high-dose BB had intermediate odds ratios for cardiovascular events (P=0.18 and 0.02). Similar

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2013 Circulation. Heart failure Controlled trial quality: uncertain

169. Oncogenetic testing, diagnosis and follow-up in Birt-Hogg-Dubé syndrome, familial atypical multiple mole melanoma syndrome and neurofibromatosis 1 and 2

, Poppe B. Oncogenetic testing, diagnosis and follow-up in Birt-Hogg-Dubé syndrome, familial atypical multiple mole melanoma syndrome and neurofibromatosis 1 and 2. Brussels: Belgian Health Care Knowledge Centre (KCE). KCE Reports 243. 2015 Authors' objectives This guideline treats the Birt-Hogg-Dubé syndrome, the familial atypical multiple mole melanoma syndrome and neurofibromatosis 1&2. These syndromes only have in common that dermatological manifestations are involved, but implications, risks (...) Oncogenetic testing, diagnosis and follow-up in Birt-Hogg-Dubé syndrome, familial atypical multiple mole melanoma syndrome and neurofibromatosis 1 and 2 Oncogenetic testing, diagnosis and follow-up in Birt-Hogg-Dubé syndrome, familial atypical multiple mole melanoma syndrome and neurofibromatosis 1 and 2. Oncogenetic testing, diagnosis and follow-up in Birt-Hogg-Dubé syndrome, familial atypical multiple mole melanoma syndrome and neurofibromatosis 1 and 2. Robays J, Stordeur S, Hulstaert F

2015 Health Technology Assessment (HTA) Database.

170. “Beholders” or patients and families?

and their families should be driving treatment decisions, supplemented by the evidence from clinical trials and the experience of treating clinicians. References Hutchinson PJ, Kolias AG, Menon DK. Craniectomy for Traumatic Intracranial Hypertension. New England Journal of Medicine. 2016; 375(24):2403-4. [ ] Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocritical Care. 2015; 23(1):127-30. [ ] Hutchinson PJ (...) that many will decline DC unless they know their family members are fiercely independent. Making this decision whilst stricken by grief is an unenviable position to be in as the math makes it very difficult for us to be able to honestly guide them in one direction or another says Thanks David! An issue that hasn’t been discussed in these blogposts – and is outside of the remit of the bedside healthcare professional – are the wider societal implications. In age of exploding healthcare costs, should

2017 Life in the Fast Lane Blog

171. “Beholders” or patients and families?

and their families should be driving treatment decisions, supplemented by the evidence from clinical trials and the experience of treating clinicians. References Hutchinson PJ, Kolias AG, Menon DK. Craniectomy for Traumatic Intracranial Hypertension. New England Journal of Medicine. 2016; 375(24):2403-4. [ ] Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocritical Care. 2015; 23(1):127-30. [ ] Hutchinson PJ (...) that many will decline DC unless they know their family members are fiercely independent. Making this decision whilst stricken by grief is an unenviable position to be in as the math makes it very difficult for us to be able to honestly guide them in one direction or another says Thanks David! An issue that hasn’t been discussed in these blogposts – and is outside of the remit of the bedside healthcare professional – are the wider societal implications. In age of exploding healthcare costs, should

2017 Life in the Fast Lane Blog

172. The Agenda for Familial Hypercholesterolemia (PubMed)

awareness and to lobby for an improved focus on FH care needs in individual countries. Nevertheless, significant challenges to optimizing FH care exist. These include controversy over the value of universal or cascade cholesterol screening for identifying those with FH, lack of prevention research specific to FH distinct from lipid research in the larger community, and lack of integrated case management protocols across the continuum of care for the family with multiple affected members. The Familial (...) , are pathognomonic for homozygous familial hypercholesterolemia. Figure 5. Cholesterol-lowering treatment has been associated with improved outcomes. Cox proportional hazards model with time-varying benefit from statin therapy comparing treated and untreated personyears for ( A ) survival and ( B ) first major adverse cardiovascular event (MACE) in patients with homozygous familial hypercholesterolemia, with year of birth fixed as mean year of birth. Reproduced from Raal et al. Copyright © 2011, American Heart

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2015 American Heart Association

173. Person-and Family-Centred Care

) is intended to replace the RNAO BPG Client Centred Care (2002) and its supplement (2006a). It is to be used by nurses and other members of the interprofessional health-care team G to enhance the quality of their partnerships with individuals accessing care, ultimately improving clinical outcomes and the person and family’s experience G of health care through the use of evidence-based person- and family-centred-care practices. In June 2014, RNAO convened an expert panel consisting of a group of individuals (...) Director Two Rivers Family Health T eam Inc. Cambridge, Ontario Simret Tewolde, RPN Registered Practical Nurse and RPNAO Representative Bridgepoint Health T oronto, Ontario Agnes Wong, RN, BScN, MN Chief of Professional Practice and Quality Y ee Hong Centre for Geriatric Care T oronto, Ontario Registered Nurses’ Association of Ontario Expert Panel Declarations of interest that might be construed as constituting an actual, potential or apparent conflict were made by all members of the Registered Nurses

2015 Registered Nurses' Association of Ontario

174. Eliglustat for treating type 1 Gaucher disease

project team 43 Evaluation committee members 43 NICE project team 43 Eliglustat for treating type 1 Gaucher disease (HST5) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 441 1 Recommendations Recommendations 1.1 Eliglustat is recommended within its marketing authorisation for treating type 1 Gaucher disease, that is, for long-term treatment in adults who are cytochrome P450 2D6 poor, intermediate or extensive (...) Eliglustat for treating type 1 Gaucher disease Eliglustat for treating type 1 Gaucher Eliglustat for treating type 1 Gaucher disease disease Highly specialised technologies guidance Published: 28 June 2017 nice.org.uk/guidance/hst5 © 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 careful

2017 National Institute for Health and Clinical Excellence - Highly specialised technology

175. Asfotase alfa for treating paediatric-onset hypophosphatasia

are likely to spend many days in hospital with their child, which reduces time with other family members and results in time away from work (or stopping work entirely). The daily lives of carers are affected because of the child's seizures and the need to regularly monitor oxygen levels. Patient experts highlighted that because of the limited numbers of centres treating hypophosphatasia in England, long journeys for appointments or inpatient stays may be needed regularly. This sometimes leads to families (...) Conclusion 43 Summary of evaluation committee's key conclusions 44 6 Implementation 52 7 Evaluation committee members and NICE project team 53 Evaluation committee members 53 NICE project team 53 Asfotase alfa for treating paediatric-onset hypophosphatasia (HST6) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 541 1 Recommendations Recommendations 1.1 Asfotase alfa is recommended as an option for treating paediatric

2017 National Institute for Health and Clinical Excellence - Highly specialised technology

176. Migalastat for treating Fabry disease

members 31 NICE project team 31 Migalastat for treating Fabry disease (HST4) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 311 1 Recommendations Recommendations 1.1 Migalastat is recommended, within its marketing authorisation, as an option for treating Fabry disease in people over 16 years of age with an amenable mutation, only if migalastat is provided with the discount agreed in the patient access scheme (...) is taken on by family members. Many people with Fabry disease have had psychological difficulties coming to terms with a lifelong progressive disorder, particularly before the introduction of enzyme replacement therapy (ERT) in 2001. ERT has a number of benefits but it also has limitations. The infusion dosage schedule of every 2 weeks means that people with Fabry disease cannot plan trips away from home. ERT must be kept refrigerated and there are risks of developing an infusion- related infection

2017 National Institute for Health and Clinical Excellence - Highly specialised technology

177. Evidence-based guidelines for treating bipolar disorder

be promoted (II). Identify and try to modify habitual, very irregular patterns of activity, which are common in patients with bipolar disorder: con- sider using diaries or apps to self-monitor mood or activities (III). Since alcohol and drug use are associated with a poor outcome, they require assessment, appropriate advice and treatment (S). Help the patient, family members, and significant others rec- ognize emerging symptoms of manic or depressive episodes so that they may know when to request early (...) intervention (S).502 Journal of Psychopharmacology 30(6) A consistent long-term flexible alliance between the patient, the patient’s family and key members of a psychiatric team, including an effective, appropriately trained psychiatrist, is the ideal arrangement for outpatient care. The input of family mem- bers may also enhance the patient’s treatment adherence (S). (e) Evaluate and manage functional impairments. Full functional recovery seldom occurs within 12 weeks following the remission of mood

2016 British Association for Psychopharmacology

178. Evidence-based Guidelines for Treating Bipolar Disorder

be promoted (II). Identify and try to modify habitual, very irregular patterns of activity, which are common in patients with bipolar disorder: con- sider using diaries or apps to self-monitor mood or activities (III). Since alcohol and drug use are associated with a poor outcome, they require assessment, appropriate advice and treatment (S). Help the patient, family members, and significant others rec- ognize emerging symptoms of manic or depressive episodes so that they may know when to request early (...) intervention (S).502 Journal of Psychopharmacology 30(6) A consistent long-term flexible alliance between the patient, the patient’s family and key members of a psychiatric team, including an effective, appropriately trained psychiatrist, is the ideal arrangement for outpatient care. The input of family mem- bers may also enhance the patient’s treatment adherence (S). (e) Evaluate and manage functional impairments. Full functional recovery seldom occurs within 12 weeks following the remission of mood

2016 British Association for Psychopharmacology

179. Cladribine tablets for treating relapsing?remitting multiple sclerosis

-effectiveness results and conclusion 18 4 Implementation 20 5 Appraisal committee members and NICE project team 21 Appraisal committee members 21 NICE project team 21 Cladribine tablets for treating relapsing–remitting multiple sclerosis (TA493) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 221 1 Recommendations Recommendations 1.1 Cladribine tablets are recommended as an option for treating highly active multiple (...) Cladribine tablets for treating relapsing?remitting multiple sclerosis Cladribine tablets for treating Cladribine tablets for treating relapsing–remitting multiple sclerosis relapsing–remitting multiple sclerosis T echnology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta493 © 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

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

180. Ibrutinib for treating Waldenstrom?s macroglobulinaemia

discussion 7 Clinical effectiveness 7 Cost effectiveness 11 Potential equality issues 15 Pharmaceutical Price Regulation Scheme (PPRS) 2014 15 Summary of appraisal committee's key conclusions 16 5 Implementation 22 6 Recommendation for data collection 23 7 Appraisal committee members and NICE project team 24 Appraisal committee members 24 NICE project team 24 Ibrutinib for treating Waldenstrom’s macroglobulinaemia (TA491) © NICE 2018. All rights reserved. Subject to Notice of rights (https (...) Ibrutinib for treating Waldenstrom?s macroglobulinaemia Ibrutinib for treating W Ibrutinib for treating Waldenstrom aldenstrom’s ’s macroglobulinaemia macroglobulinaemia T echnology appraisal guidance Published: 22 November 2017 nice.org.uk/guidance/ta491 © 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

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

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