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Treating Family Members

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121. 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

122. Treating Opioid Use Disorder During Pregnancy: Guideline Supplement

. The application of the recommendations in this guideline does not override the responsibility of health care professionals to make decisions appropriate to the circumstances of an individual patient, in consultation with that patient and their guardian(s) or family members, and, when appropriate, external experts (e.g., specialty consultation). Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. Legal Disclaimer While the individuals (...) Treating Opioid Use Disorder During Pregnancy: Guideline Supplement 1 Guideline Supplement Treatment of Opioid Use Disorder During2 THIS IS A BLANK PAGE3 A Guideline for the Clinical Management of Opioid Use Disorder—Pregnancy Supplement The BC Centre on Substance Use (BCCSU) is a provincially networked platform mandated to develop, imple- ment, and evaluate evidence-based approaches to substance use and addiction. The BCCSU’s focus is on three strategic areas including research and evaluation

2018 British Columbia Perinatal Health Program

123. 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

124. Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens

members and NICE project team 24 Appraisal committee members 24 NICE project team 24 Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens (TA423) © 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 replaces TA250. This guidance should be read in conjunction with TA515. 1 1 Recommendations Recommendations 1.1 Eribulin is recommended as an option (...) with locally advanced or metastatic breast cancer, whose disease has progressed after at least 2 chemotherapy regimens. The committee concluded that eribulin is particularly valuable, and has been more widely used, for HER2-negative disease because this has fewer treatment options. It also recognised that the availability of additional treatment options for advanced disease would be valued by patients and their families. 4.1 to 4.3 The technology The technology Eribulin for treating locally advanced

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

125. Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia

guidance 241) 19 Cancer Drugs Fund partial reconsideration of NICE technology appraisal guidance 241 19 Summary of appraisal committee's key conclusions 21 5 Implementation 31 6 Appraisal committee members and NICE project team 32 Appraisal committee members 32 NICE project team 32 Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia (TA425) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms (...) Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia Dasatinib, nilotinib and high-dose Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or imatinib for treating imatinib-resistant or intoler intolerant chronic m ant chronic my yeloid leukaemia eloid leukaemia T echnology appraisal guidance Published: 21 December 2016 nice.org.uk/guidance/ta425 © NICE 2018. All rights reserved. Subject to Notice of rights

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

126. 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

127. 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

128. 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

129. Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment

of Massachusetts, Worcester Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Information provided by (Responsible Party): Elizabeth Epstein, University of Massachusetts, Worcester Study Details Study Description Go to Brief Summary: The specific aims of the ABCT_Military project are as follows: 1) To modify the existing, Alcohol Behavioral Couple Therapy (ABCT) model to treat service members in the reconstitution (post deployment, reintegration, or separation) stage of service (...) the client's ideal number of sessions and length of treatment, with scores ranging from 1 to 24 sessions and 1-12 months. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout

2018 Clinical Trials

130. How do biosimilar medications compare to their corresponding originator biologic medications in treating patients with conditions like rheumatoid arthritis or inflammatory bowel disease?

How do biosimilar medications compare to their corresponding originator biologic medications in treating patients with conditions like rheumatoid arthritis or inflammatory bowel disease? Tools for Practice is proudly sponsored by the Alberta College of Family Physicians (ACFP). ACFP is a provincial, professional voluntary organization, representing more than 4,800 family physicians, family medicine residents, and medical students in Alberta. Established over sixty years ago, the ACFP strives (...) for excellence in family practice through advocacy, continuing medical education and primary care research. www.acfp.ca May 27, 2019 It’s all in the details... or is it? Biosimilars versus biologics for inflammatory conditions. Clinical Question: How do biosimilar medications compare to their corresponding originator biologic medications in treating patients with conditions like rheumatoid arthritis or inflammatory bowel disease? Bottom Line: For patients with rheumatoid arthritis, other inflammatory

2019 Tools for Practice

131. Pharmacologic Treatment of Hypertension in Adults Aged 60 Years or Older to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians Full Text available with Trip Pro

the journal. The guideline had a peer-review process through the journal and was posted online for comments from ACP Regents and Governors, who represent physician members at the national and international level. The guideline was also reviewed by members of AAFP's Commission on Health of the Public and Science. Benefits of Treating Higher Versus Lower BP Targets in Older Adults Across all trials, treating high BP in older adults was beneficial. However, most of the evidence came from studies of patients (...) Pharmacologic Treatment of Hypertension in Adults Aged 60 Years or Older to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians Pharmacologic Treatment of Hypertension in Adults | Annals of Internal Medicine | American College of Physicians '); } Sign in below to access your subscription for full content INDIVIDUAL SIGN IN | You will be directed to acponline.org to register and create

2017 American College of Physicians

132. Homozygous familial hypercholesterolaemia in Vietnam: Case series, genetics and cascade testing of families. (Abstract)

Homozygous familial hypercholesterolaemia in Vietnam: Case series, genetics and cascade testing of families. Familial hypercholesterolaemia has not been previously described in the Vietnamese population. We aimed to describe the features of patients with homozygous familial hypercholesterolaemia (hoFH) in Vietnam and the outcomes of screening family members using genetic and cholesterol testing.Mutation testing by massively parallel sequencing for genes causative of FH was undertaken in five (...) index cases presenting to a single cardiac center with a presumptive diagnosis of hoFH. Cascade testing of all available family members was subsequently undertaken. The number of new cases of FH detected and commenced on lipid-lowering treatment was evaluated.All five index cases had true homozygous mutations in the LDL receptor gene (LDLR). Cascade screening was undertaken in four families. 107 relatives were screened and FH was identified in 56 relatives (52%), including 3 new cases of hoFH. Only

2018 Atherosclerosis

133. Family Physicians Managing Medical Requests From Family and Friends Full Text available with Trip Pro

Family Physicians Managing Medical Requests From Family and Friends Although guidelines generally state that physicians should not treat their family members or friends (nonpatients), physicians regularly receive medical requests from nonpatients. We aimed to explore junior and senior family physicians' experiences with and attitudes toward managing medical requests from nonpatients.We conducted a qualitative study with 7 focus groups with junior and senior physicians. We performed a thematic (...) nonpatients. Facilitated group discussions during which experiences are shared can help junior physicians become more confident in dealing with these complex issues as they formulate their own personal strategy regarding provision of medical advice or treatment to family and friends.© 2018 Annals of Family Medicine, Inc.

2018 Annals of family medicine

134. Antipsychotic medicines for treating agitation, aggression and distress in people living with dementia

Antipsychotic medicines for treating agitation, aggression and distress in people living with dementia Decision aid for Dementia: assessment, management and support for people living with dementia and their carers © NICE 2018. All rights reserved. Subject to Notice of rights. Last updated June 2018 Page 1 of 4 Decision aid Antipsychotic medicines for treating agitation, aggression and distress in people living with dementia Information to help people living with dementia, their family members (...) and an increased risk of death. The diagrams on pages 3 and 4 show how likely this is to happen. It is not possible to know in advance what will happen to any individual person. Other things to think about How are antipsychotics taken? Antipsychotics are usually taken as a tablet or a liquid medicine, once or twice a day. Off-label use of antipsychotics Only risperidone (for up to 6 weeks use) and haloperidol have a licence to treat these sorts of problems in people living with dementia. Other antipsychotics

2018 Health Information and Quality Authority

135. Elagolix for Treating Endometriosis

Elagolix for Treating Endometriosis ©Institute for Clinical and Economic Review, 2018 Elagolix for Treating Endometriosis Final Evidence Report August 03, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 Page i Final Evidence Report– Elagolix for Treating Endometriosis ICER Staff/Consultants University of Colorado Skaggs School of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH Director, Primary Care Research and Quality Improvement Network Massachusetts General Hospital (...) and Economic Review, 2018 Page ii Final Evidence Report– Elagolix for Treating Endometriosis About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its work, ICER seeks to help create a future in which collaborative efforts to move evidence into action provide

2018 California Technology Assessment Forum

136. Identifying and Assessing Core Components of Collaborative-care Models for Treating Mental and Physical Health Conditions

that $2.75 billion is spent on treating individuals with multiple illnesses.(18) From the perspective of service providers included in one study, many family physicians indicated that they feel ill-equipped to care for patients with comorbid physical and mental health and/or substance use problems. This stems in part from the continued “siloed” approach to training mental health professionals compared to other health professionals. A recent survey of family physicians in 10 Commonwealth countries found (...) Identifying and Assessing Core Components of Collaborative-care Models for Treating Mental and Physical Health Conditions McMaster Health Forum McMaster Health Forum 1 Evidence >> Insight >> Action Knowledge Synthesis: Identifying and Assessing Core Components of Collaborative-care Models for Treating Mental and Physical Health Conditions 31 March 2017 Identifying and Assessing Core Components of Collaborative-Care Models for Treating Mental and Physical Health Conditions 2 Evidence >> Insight

2017 McMaster Health Forum

137. Cerliponase alfa (Brineura) - for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease)

Cerliponase alfa (Brineura) - for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease) 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 21 April 2017 EMA/31226/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Brineura International non-proprietary name: cerliponase alfa Procedure No. EMEA/H/C (...) Isoelectric Focusing IT-C Intrathecal-cisternal IT-L Intrathecal-lumbar ITT Intent-to-treat IVC Intracerebroventricularly LCA Limit of in vitro cell age Assessment report EMA/312226/2017 Page 5/95 MALLs Multi angle laser light scattering MCB Master Cell Bank MedDRA Medical Dictionary for Regulatory Activities MRI Magnetic resonance imaging MRS Magnetic resonance spectroscopy NAA N-acetylaspartate Nab Neutralizing anti-TPP1 antibody NCI National Cancer Institute NCL Neuronal ceroid lipofuscinosis NOR

2017 European Medicines Agency - EPARs

138. Elagolix for Treating Endometriosis

Elagolix for Treating Endometriosis ©Institute for Clinical and Economic Review, 2018 Elagolix for Treating Endometriosis Evidence Report June 15, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 Page i Evidence Report– Elagolix for Treating Endometriosis ICER Staff/Consultants University of Colorado Skaggs School of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH Director, Primary Care Research and Quality Improvement Network Massachusetts General Hospital Geri Cramer, BSN (...) , 2018 Page ii Evidence Report– Elagolix for Treating Endometriosis About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its work, ICER seeks to help create a future in which collaborative efforts to move evidence into action provide the foundation for a more

2018 California Technology Assessment Forum

139. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy Full Text available with Trip Pro

outpatients with FN do not defervesce after 2 to 3 days of an initial, empirical, broad-spectrum antibiotic regimen, should they be considered for hospitalization or continue to be treated on an outpatient basis? METHODS Section: Guideline Update Development Process This systematic review–based guideline product was developed by an Expert Panel with multidisciplinary expertise (Appendix , online only). A patient representative and an ASCO guidelines staff member with health research methodology experience (...) , including frequent clinic visits ○Family member or caregiver at home 24 h/d ○Access to a telephone and transportation 24 h/d ○No history of noncompliance with treatment protocols •The following additional measures are recommended: ○Frequent evaluation for at least 3 days in clinic or at home ○Daily or frequent telephone contact to verify (by home thermometry) that fever resolves ○Monitoring of ANC and platelet count for myeloid reconstitution ○Frequent return visits to clinic •Patients should

2018 Infectious Diseases Society of America

140. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Full Text available with Trip Pro

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLE Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2017.77.6385 Journal of Clinical (...) Oncology - published online before print February 14, 2018 PMID: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline x Julie R. Brahmer , x Christina Lacchetti , x Bryan J. Schneider , x Michael B. Atkins , x Kelly J. Brassil , x Jeffrey M. Caterino , x Ian Chau , x Marc S. Ernstoff , x Jennifer M. Gardner , x Pamela Ginex , x Sigrun Hallmeyer , x Jennifer Holter Chakrabarty , x

2018 American Society of Clinical Oncology Guidelines

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