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Treating Family Members

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161. 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

162. Bisphosphonates for treating osteoporosis

committee members and NICE project team 24 Appraisal committee members 24 NICE project team 24 Bisphosphonates for treating osteoporosis (TA464) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 25This guidance partially replaces TA160 and TA161. 1 1 Recommendations Recommendations The purpose of this technology appraisal was to establish at what level of absolute fracture risk bisphosphonates are cost-effective (...) a decision support aid to help support this discussion. If the person wishes to try a bisphosphonate, they should be able to start treatment with the least expensive formulation, with no other local formulary or funding restrictions. Bisphosphonates for treating osteoporosis (TA464) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 23 of 255 5 Appr Appraisal committee members and NICE project team aisal committee members

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

163. Cabozantinib for previously treated advanced renal cell carcinoma

Evidence 6 4 Committee discussion 7 Treatment pathway 7 Population and comparators 8 Clinical effectiveness 9 Cost effectiveness 11 End-of-life considerations 17 Results of cost-effectiveness analyses 17 Innovation 19 Pharmaceutical Price Regulation Scheme (PPRS) 2014 19 Summary of appraisal committee's key conclusions 19 5 Implementation 25 6 Appraisal committee members and NICE project team 26 Appraisal committee members 26 NICE project team 26 Cabozantinib for previously treated advanced renal cell (...) curves for all the treatments. However, the committee agreed that it was a more flexible family, which improved the curve fits to the Kaplan–Meier Cabozantinib for previously treated advanced renal cell carcinoma (TA463) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 10 of 27data on overall and progression-free survival for all treatments in the network compared with the original parametric modelling using the log

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

164. Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma

project team 19 Appraisal committee members 19 NICE project team 19 Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma (TA465) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 201 1 Recommendations Recommendations 1.1 Olaratumab, in combination with doxorubicin, is recommended for use within the Cancer Drugs Fund as an option for advanced soft tissue sarcoma in adults, only (...) in combination with doxorubicin for treating advanced soft tissue sarcoma (TA465) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 18 of 206 6 Appr Appraisal committee members and NICE project team aisal committee members and NICE project team Appraisal committee members The technology appraisal committees are standing advisory committees of NICE. This topic was considered by members of the existing standing committees who

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

165. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs

Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs Certolizumab pegol and secukinumab for Certolizumab pegol and secukinumab for treating activ treating active psoriatic arthritis after e psoriatic arthritis after inadequate response to DMARDs inadequate response to DMARDs T echnology appraisal guidance Published: 24 May 2017 nice.org.uk/guidance/ta445 © NICE 2018. All rights reserved. Subject to Notice of rights (https (...) to have due regard to the need 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. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs (TA445) © NICE 2018. All rights

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

166. Obeticholic acid for treating primary biliary cholangitis

discussion 7 Clinical management of primary biliary cholangitis 7 Clinical effectiveness of obeticholic acid 9 Adverse events 10 Cost effectiveness 10 Innovation 15 Other considerations 15 Pharmaceutical Price Regulation Scheme (PPRS) 2014 16 Summary of appraisal committee's key conclusions 16 5 Implementation 22 6 Appraisal committee members and NICE project team 23 Appraisal committee members 23 NICE project team 23 Obeticholic acid for treating primary biliary cholangitis (TA443) © NICE 2018. All (...) of the discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme should be directed to Ruth Nasr on 020 3805 7531 or email ruth.nasr@interceptpharma.com. Obeticholic acid for treating primary biliary cholangitis (TA443) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 22 of 246 6 Appr Appraisal committee me aisal committee members and NICE project team mbers and NICE

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

167. 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

168. Apremilast for treating active psoriatic arthritis

Clinical effectiveness 9 Cost effectiveness 11 Rapid review 18 Summary of appraisal committee's key conclusions 22 5 Implementation 29 6 Appraisal committee members and NICE project team 30 Appraisal committee members 30 NICE project team 30 Apremilast for treating active psoriatic arthritis (TA433) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 31This guidance replaces TA372. 1 1 Recommendations Recommendations (...) Apremilast for treating active psoriatic arthritis Apremilast for treating activ Apremilast for treating active psoriatic e psoriatic arthritis arthritis T echnology appraisal guidance Published: 22 February 2017 nice.org.uk/guidance/ta433 © 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 - Technology Appraisals

169. Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation

of appraisal committee's key conclusions 22 5 Implementation 30 6 Appraisal committee members, guideline representatives and NICE project team 31 Appraisal committee members 31 NICE project team 31 Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation (TA429) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 321 1 Recommendations (...) Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation Ibrutinib for pre Ibrutinib for previously treated chronic viously treated chronic lymphocytic leukaemia and untreated lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p chronic lymphocytic leukaemia with 17p deletion or TP53 mutation deletion or TP53 mutation T echnology appraisal guidance Published: 25 January 2017 nice.org.uk

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

170. 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

171. 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

172. “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

173. “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

174. 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

175. Parent-focused treatment for anorexia in adolescents: more efficient than family-based treatment says new RCT

of the clinical trials that do exist demonstrate that involving family members in treatment often supports more favourable outcomes than treatments with no family involvement. The family that does therapy together, helps one member of that family achieve positive health outcomes together, although that family may have been the cause of the original problems, it’s difficult to say sometimes. This probably won’t catch on as a saying. Current evidence seems to indicate that families can play a role in supporting (...) ), monitoring their mental and medical condition. During parent-focused therapy , the adolescent with anorexia nervosa attends a 15 minute session with the nurse before the parent’s or parents’ session with the therapist. Any pertinent information from the adolescent’s session with the nurse is past onto the therapist when they see the parents for 50 minutes. The therapeutic content of these sessions is the same as in family-based treatment. The family that does therapy separately, helps one member

2016 The Mental Elf

176. Hereditary Colorectal Cancer Syndromes Endorsement of the Familial Risk?Colorectal Cancer ESMO Guideline

and added a few qualifying statements. Recommendations Approximately 5% to 6% of patient cases of CRC are associated with germline mutations that confer an inherited predisposition for cancer. The possibility of a hereditary cancer syndrome should be assessed for every patient at the time of CRC diagnosis. A diagnosis of Lynch syndrome, familial adenomatous polyposis, or another genetic syndrome can influence clinical management for patients with CRC and their family members. Screening for hereditary (...) testimony. In accordance with these procedures, the majority of the members of the panel did not disclose any such relationships (see Author Disclosures of Potential Conflicts of Interest section at the end of the article). CLINICAL QUESTIONS AND TARGET POPULATION Section: The ESMO guidelines addressed clinical questions on prevention, screening, genetics, treatment, and management for people at risk for LS, APC -associated FAP, AFAP, MAP, and familial CRC type X. SUMMARY OF ESMO GUIDELINES DEVELOPMENT

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2014 American Society of Clinical Oncology Guidelines

177. Lojuxta (lomitapide) - familial hypercholesterolaemia

g/l and arterial disease. Individual diagnosis of familial hypercholesterolaemia is the first step in the investigation and management of a family at high risk of cardiovascular disease. It should be done as early as possible, at the silent and reversible phase of arterial disease. Severe familial hypercholesterolaemia is treated by centres specialising in hereditary metabolic disorders. The prognosis is a direct function of the patient's age, LDL-C level and ongoing arterial exposure to a fixed (...) treatments indicated in combination with lipid-lowering treatments at maximum doses in patients with uncontrolled HoFH. The other available medicines for treating HoFH are the following: NAME (INN) Company Same TC* Yes / No Indication Date of opinion AB / IAB (Wording) Reimburs ement Yes/No CRESTOR (rosuvastatin) Astra Zeneca No Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid- lowering treatments (especially LDL apheresis) or if such treatments are not appropriate. 02/02

2014 Haute Autorite de sante

178. Effectiveness of Family and Caregiver Interventions on Patient Outcomes among Adults with Cancer or Memory-Related Disorders

evidence assessing whether family involved interventions improve patient outcomes (i.e., efficacy) and whether specific family involved interventions are better than alternative ones (i.e., specificity or comparative effectiveness). We specifically examined the effects of family-involved interventions on the patients, not on the family members. We assessed if there is evidence that interventions targeted at family members only or both family members and adult care recipients improve the patients (...) ’ outcomes. We limited our focus to family members caring for those with cancer and memory-related conditions since the majority of studies examine one of these two conditions. This project was nominated by Sonja Batten, PhD, Office of Mental Health Services. The key questions and scope were refined with input from a technical expert panel. We addressed the following key questions: Key Question #1. What are the benefits of family and caregiver psychosocial interventions for adult patients with cancer

2013 Veterans Affairs Evidence-based Synthesis Program Reports

179. New year, new thinking about treating obesity

specialist sooner but for a discouraging or judgmental doctor, family member or friend telling them ‘you don’t need a specialist, you just need a diet and exercise more.’ This kind of thinking keeps people from talking about obesity with their doctors and exploring more effective treatments, and it keeps doctors more focused on treating the medical consequences of obesity rather than treating obesity itself. This is particularly concerning when it comes to severe obesity, where diet and exercise alone (...) effective long-term treatment. In fact, nearly 1 in 5 Americans still think it’s a cosmetic procedure, and 24 percent say they would actually oppose a family member’s or close friend’s decision to have it. Obesity medications are even less popular with the American public, with half saying they support their use for someone with obesity. While weight-loss surgery and obesity medications are not for everyone, they are clearly only being used by a fraction of those who could benefit. The American Society

2019 KevinMD blog

180. Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis

Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 09 November 2017 EMA/774645/2017 Assessment report Jorveza International non-proprietary name: budesonide (...) analysis set-double blind (phase) FAS-FU Full analysis set-follow-up (phase) FAS-OLI Full analysis set-open-label induction (phase) FU Follow-up GC Gas Chromatography GERD Gastroesophageal reflux disease hpf High-power field HPLC High performance liquid chromatography ICH International Council for Harmonisation IDMC Independent Data Monitoring Committee IgE Immunoglobulin E IL Interleukin IMP Investigational medicinal product IR Infrared ITT Intention-to-treat LOCF Last observation carried forward LC

2018 European Medicines Agency - EPARs

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