Shire Pharmaceuticals/Johnson & Johnson 16 December 2005
|
|
- Rolf Curtis
- 6 years ago
- Views:
Transcription
1 Shire Pharmaceuticals/Johnson & Johnson 16 December 2005 Comments on Addenda to MRC report on clinical efficacy and NICE Technical Report 2; Drugs for the Treatment of Alzheimer s Disease (review)
2 Executive Summary Shire Pharmaceuticals/Johnson & Johnson have reviewed the documents sent by NICE on 08 December 2005 and in the short review time available have assembled the response detailed below. The evidence provided in the addendum to Technical Report no. 2 does not present substantive new information that should have a bearing on reimbursement of AChEIs in the NHS, above data already provided to the committee in the earlier reports and responses. In common with almost all clinical trials, placebo effects are present in clinical trials of galantamine however galantamine has demonstrated statistically significant effect vs. placebo in all relevant trials identified by NICE. Placebo effects are most apparent in mild AD patients, while galantamine s effect is consistently observed across mild, moderate and advanced moderate AD patients The placebo response in the Nordic study reflects the particular issues in that trial. New evidence from two other 12-month placebo-controlled trials in AD showed a smaller proportion of placebo patients responding according to NICE guidance criteria (20% vs. 34%), a lower magnitude of effect at six months, and a less sustained long-term profile (both responder groups below baseline by month 12). Scenario G is ill conceived and unrealistic as a policy option for the NHS, while the economic modelling is inadequate both in conception and implementation, reducing only drug benefits for placebo effect but assuming that such placebo effect, including monitoring and assessment by the NHS, is costless.
3 1. Introduction The original submission to NICE (June 2004) 1 and additional data submitted on 21 October provide a transparent and comprehensive exploration of the clinical efficacy of galantamine across 7 placebo-controlled trials and 3389 patients. The data re-confirm significant treatment effect in patients with mild, moderate and advanced moderate Alzheimer s disease (AD). On 09 December 2005 Shire and Johnson & Johnson submitted a response to NICE to the MRC report on clinical efficacy and NICE Technical Report no. 2, presenting additional commentary on the clinical effectiveness and a series of new costeffectiveness estimates for galantamine. NICE have issued, at short notice on 08 December 2005, addenda to the MRC report on clinical efficacy and NICE Technical Report no. 2. In order to be as transparent and responsive as possible, Shire and Johnson & Johnson detail their further comments below on these addenda for consideration by the appraisal committee. New data are supplied to support claims made in the text below. 2. Placebo responses It is well established that placebo responses occur in clinical trials and that such responses can be substantial within the CNS and pain therapeutic areas 3;4. In the large galantamine database, responses to placebo treatment in terms of recognised efficacy parameters were observed across the range of clinical trials - but such responses were significantly exceeded in magnitude by treatment with galantamine in all trials. Various authors have debated the occurrence and ethical issues of the placebo response in Alzheimer s and other CNS diseases. Goldney and Stoffel reviewed the use of placebo in clinical controlled trials in AD and have raised ethical issues regarding use of placebo against active AChEIs in such trials 5. Placebo effects are thought to be related to expectation of clinical benefit; and mechanisms of placebo response involving modulation of neurotransmitter activity have been explored. Investigations in Parkinson s disease in particular have suggested inducement of dopamine release to explain a placebo effect 6. In common with other disease areas placebo patients in AD demonstrate a response. This reflects both trial based effects on clinical care such as the treatment of psychiatric or cardiovascular symptoms or even simple interventions such as the removal of earwax. In addition a placebo effect also exists where patients respond to the treatment. The placebo response is most typically observed in patients with milder AD at study baseline. Such patients may experience an improvement in anxiety and depression that had affected cognitive performance as well as being capable of producing learning effects on study instruments. In more advanced patients where diagnosis and disease course are better established, the relative placebo effect is much lower.
4 The addendum to Technical Report no 2 implicitly attributes much of the improvement observed in AChEIs to a placebo effect. If this was the case then a decrease in the proportion of responders would be expected in both drug and treatment groups at more advanced disease levels. While the expected reduction in response is observed for placebo treatment, the response to galantamine is consistent and the drug vs. placebo effect is more apparent in more advanced patients, as demonstrated by additional analyses (figure 1 & 2 attached excel file) from GAL-INT1, GAL-USA-1, GAL-USA-10 and GAL-INT-10). Figure 1: Probability of Response (NICE Definition) by Baseline MMSE Score (Logistic Regression Model) AD Trials: INT-1, INT-10, USA-1, USA-10 GAL 24 mg Placebo 3. The Nordic Study and long-term placebo responses - alternative evidence The new data presented in the addendum to Technical Report no. 2 were inspired by the Donepezil Nordic Study 7. However, the placebo response observed in this single study may not be typical of the longer-term placebo response in AD. We note that the placebo responders were on average milder (higher MMSE at baseline) compared to the remainder of the placebo group. The response observed in placebo responders therefore reflects in part the slower natural decline in AD at this disease stage as well as milder patients increased propensity to show trial-related and placebo-related improvements in cognition. Evidence from two other large-scale 12-month placebo controlled trials 8 in AD that used the ADAS-Cog rather than the MMSE did not replicate the placebo response observed in the Nordic Study (figure 3 & 4 attached excel file).
5 The proportion of responders [following the NICE guidance definition was 19% in SAB-INT-12 and 20% in SAB-USA-25 was lower than that observed in the Nordic Study (34%). The magnitude of response at six months is also smaller than that observed in the Nordic study (taking into account of course the difference between ADAS and MMSE scaling) The response among placebo responders was also less sustained that in the Nordic study with the small group of placebo responders in both studies having fallen back below their baseline values by 12 months. 4. Scenario G is not a relevant option for NHS policy Scenario G does not present a valid clinical scenario for the committee. The reality of the choice facing the committee is whether patients with AD should continue to have access to AChEIs or whether such treatment be withdrawn from funding by the NHS. Scenario G is predicated upon the placebo responses observed in clinical trials but absent in usual clinical practice in the NHS. The scenario would require that the NHS distribute placebo pills to patients but that clinicians, pharmacists, caregivers and patients should be blinded to whether the pills were active or not. Beyond the clear practical and conceptual limitations of this proposed approach, the analyses from technical team is also inappropriate since on one hand they reduced drug benefits to take account of placebo effects, but on the other side of the equation fail to include the costs for the manufacture, distribution, prescription and clinical monitoring of placebo drug therapy to the NHS. Scenario G is therefore not a valid option upon which the committee should make a policy decision. The clear comparison is between current guidance that allows responders to continue on treatment versus patients remaining untreated (Scenario A). This option already has an element of placebo effect built in and can therefore be considered as conservative. We note that the costs of galantamine have been altered since the 25 th November 2005 Technical report but draw the committee s attention to the additional issue as yet unaddressed issue which is the use of the higher costs for the 24mg maintenance dose rather than the more appropriate weighted average of the costs for the 24mg and the less costly 16mg maintenance dose for long-term treatment costs. 5. Summary Shire Pharmaceuticals/Johnson & Johnson have reviewed the documents sent by NICE on 08 December 2005 and in the short review time available have assembled the response detailed below. The evidence provided in the addendum to Technical Report no. 2 does not present substantive new information that should have a bearing on reimbursement of AChEIs in the NHS, above data already provided to the committee in the earlier reports.
6 Placebo effects are present but galantamine s significant effect vs. placebo has been demonstrated in 8 trials. Placebo effect is most easily observed in mild AD patients, while galantamine treatment effect is consistently observed in mild, moderate and advanced moderate AD patients The placebo response in the Nordic study reflects the particular issues in that trial. New evidence from two other 12-month placebo-controlled trials in AD showed a smaller proportion of placebo patients responding according to NICE guidance criteria (20% vs. 34%), a lower magnitude of treatment effect at six months, and a less sustained long-term profile (with both responder groups below baseline by month 12). Scenario G is ill conceived and unrealistic as a policy option while the economic modelling is inadequate in conception and implementation. The scenario reduces only drug benefits for placebo effect but assumes that such placebo effects, including monitoring and assessment by the NHS, are costless.
7 Reference List 1. Shire Pharmaceuticals and Johnson & Johnson. Drugs for the treatment of Alzheimer's Disease: submission to the National Institute of Clinical Excellence Ref Type: Report 2. Shire Pharmaceuticals and Johnson & Johnson. Response to the National Institute of Clinical Excellence (NICE) Request for Additional Analyses of July 2005: Additional Analyses Using Studies of galantamine in Subjects with Dementia of the Alzheimer's Type Ref Type: Report 3. Benedetti F, Mayberg HS, Wager TD, Stohler CS, Zubieta JK. Neurobiological mechanisms of the placebo effect. J Neurosci. 2005;25: Zubieta JK, Yau WY, Scott DJ, Stohler CS. Belief or Need? Accounting for individual variations in the neurochemistry of the placebo effect. Brain Behav.Immun. 2005;%19;.. 5. Goldney RD,.Stoffell BF. Ethical issues in placebo-controlled trials in Alzheimer's disease. Med J Aust. 2000;173: Fuente-Fernandez R, Schulzer M, Stoessl AJ. Placebo mechanisms and reward circuitry: clues from Parkinson's disease. Biol.Psychiatry 2004;56: Winblad B, Engedal K, Soininen H, Verhey F, Waldemar G, Wimo A et al. A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology 2001;57: Feldman HH, Van Baelen B, Kavanagh SM, Torfs KE. Cognition, function, and caregiving time patterns in patients with mild-to-moderate Alzheimer disease: a 12-month analysis. Alzheimer Dis Assoc Disord. 2005;19:29-36.
8 Figure 2: Galantamine and placebo response by severity group % of patients responding (NICE definition) mg 16mg placebo N = 200 N = 45 N = 118 N = 320 N = 78 N = 136 N = 94 N = 19 N = 29 Mild Moderate Advanced Moderate Severity
Please note that these comments and the identity of the sender will be published unless a specific justified objection is received.
30 July 2016 Submission of comments on 'Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer s disease and other dementias ' (EMA/CHMP/539931/2014) Comments from: Name
More informationDonepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer s disease (amended)
Issue date: November 2006 (amended September 2007) Review date: September 2009 Donepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer s disease (amended) Includes a
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (Review of TA 111) Appraisal
More informationALZHEIMER S DISEASE - MAIN ISSUES FROM ACD-2 CONSULTATION
ALZHEIMER S DISEASE - MAIN ISSUES FROM ACD-2 CONSULTATION - The responses in the table below are from Consultees and Commentators to the appraisal. - The table is currently sorted on subject matter as
More informationDementia of the Alzheimer Type: the Drug Treatment Debate
Dementia of the Alzheimer Type: the Drug Treatment Debate I have no financial conflict of interest. Many years ago I was given a trip to San Fran and taught to use a slide set from the drug company. I
More informationRecommendations on Screening for Cognitive Impairment in Older Adults 2015
Recommendations on Screening for Cognitive Impairment in Older Adults 2015 Canadian Task Force on Preventive Health Care (CTFPHC) Putting Prevention into Practice Canadian Task Force on Preventive Health
More informationLiterature Scan: Alzheimer s Drugs
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationNATIONAL INSTITUTE FOR CLINICAL EXCELLENCE SCOPE. Dementia: the management of dementia, including the use of antipsychotic medication in older people
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE 1 Guideline title SCOPE Dementia: the management of dementia, including the use of antipsychotic medication in older people 1.1 Short title Dementia 2 Background
More informationAcetylcholinesterase inhibitors: donepezil, rivastigmine, tacrine or galantamine for non-alzheimer s dementia
STEER 2002; Vol 2: No.2 Acetylcholinesterase inhibitors: donepezil, rivastigmine, tacrine or galantamine for non-alzheimer s dementia Bunmi Fajemisin Evidence search date: November 2001 www.signpoststeer.org
More informationDonepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (review of TA 111)
National Institute for Health and Clinical Excellence Health Technology Appraisal Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (review of TA 111) Response
More informationSHARED CARE PROTOCOL CHOLINESTERASE INHIBITORS IN ALZHEIMER S DEMENTIA
SHARED CARE PROTOCOL CHOLINESTERASE INHIBITORS IN ALZHEIMER S DEMENTIA Introduction Alzheimer s disease is the most common cause of dementia. It is characterised by an insidious onset of global mental
More information42-Lowering Agent, in Alzheimer s s Disease: A Phase 2 Trial of up to 24 Months of Treatment. Gordon K. Wilcock*, University of Oxford, UK
Efficacy and Safety of Tarenflurbil (Flurizan ), a Selective Aβ42A 42-Lowering Agent, in Alzheimer s s Disease: A Phase 2 Trial of up to 24 Months of Treatment Gordon K. Wilcock*, University of Oxford,
More informationPrescribing Framework for Galantamine in the Treatment and Management of Dementia
Hull & East Riding Prescribing Committee Prescribing Framework for Galantamine in the Treatment and Management of Dementia Patients Name:.. NHS Number: Patients Address:... (Use addressograph sticker)
More informationMedications for treating people with dementia: summary of evidence on cost-effectiveness
Medications for treating people with dementia: summary of evidence on cost-effectiveness Martin Knapp, A-La Park and Alistair Burns PSSRU, London School of Economics and Political Science v4 23 July 2017
More informationTechnology appraisal guidance Published: 30 August 2017 nice.org.uk/guidance/ta471
Eluxadoline for treating irritable bowel syndrome with diarrhoea Technology appraisal guidance Published: 30 August 2017 nice.org.uk/guidance/ta471 NICE 2017. All rights reserved. Subject to Notice of
More informationPrescribing Framework for Rivastigmine in the Treatment and Management of Dementia
Hull & East Riding Prescribing Committee Prescribing Framework for Rivastigmine in the Treatment and Management of Dementia Patients Name:.. NHS Number: Patients Address:... (Use addressograph sticker)
More informationSUBMISSION TO THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL (MTA)
ARICEPT (DONEPEZIL) SUBMISSION TO THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL (MTA) Prepared by: Eisai Ltd Mosquito Way, Hatfield, Hertfordshire, AL10 9SN Company
More informationTechnology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta493
Cladribine tablets for treating relapsing remitting multiple sclerosis Technology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta493 NICE 2018. All rights reserved. Subject to Notice
More informationKnown as both a thief and murderer,
&A Dementia Drugs: When Should They Be Stopped? Ron Keren, MD, FRCPC As presented at the University of Toronto s Primary Care Conference, Toronto, Ontario (May 25) Known as both a thief and murderer, Alzheimer
More informationTechnology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta442
Ixekizumab for treating moderate to severe ere plaque psoriasis Technology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta442 NICE 2017. All rights reserved. Subject to Notice of rights
More informationManufacturer Comments Clinical Evidence Review Report and Supplemental Update and Pharmacoeconomic Review Report
Manufacturer Comments Clinical Evidence Review Report and Supplemental Update and Pharmacoeconomic Review Report Drug Product Generic name (Brand name) Manufacturer (Distributor if applicable) Alzheimer
More informationTitle: The role of expectations and patients' decision making process. Keywords: Decision making process; Patients; Placebo effect;
Title: The role of expectations and patients' decision making process Authors: Bergonzini, C.; 1 * Ippoliti, R.; 2 Type: Original Article Keywords: Decision making process; Patients; Placebo effect; Abstract
More informationAppendix K: Evidence review flow charts
K.1 Dementia diagnosis K.1.1 Dementia diagnosis What are the most effective methods of primary assessment to decide whether a person with suspected dementia should be referred to a dementia service? What
More informationReview Article Broader Considerations of Higher Doses of Donepezil in the Treatment of Mild, Moderate, and Severe Alzheimer s Disease
International Alzheimer s Disease Volume 2012, Article ID 707468, 4 pages doi:10.1155/2012/707468 Review Article Broader Considerations of Higher Doses of Donepezil in the Treatment of Mild, Moderate,
More informationMonth/Year of Review: September 2013 Date of Last Review: February 2012
Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Copyright 2012 Oregon State University. All Rights
More informationCholinesterase inhibitors for Alzheimer s disease (Review)
Birks J This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2008, Issue 3 http://www.thecochranelibrary.com 1 T A B L E O
More informationTitle of Study: Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
SYNOPSIS Name of Sponsor/Company Name of Finished Product REMINYL Name of Active Ingredient(s) Galantamine hydrobromide Issue Date: 18 October 2013 Protocol No.: Title of Study: Evaluation of Efficacy
More informationBRISTOL-MYERS SQUIBB and ASTRAZENECA v SANOFI
CASE AUTH/2638/9/13 and AUTH/2639/9/13 BRISTOL-MYERS SQUIBB and ASTRAZENECA v SANOFI Promotion of Lyxumia Bristol-Myers Squibb and AstraZeneca jointly complained about cost comparison claims in a Lyxumia
More informationNICE Quality Standards and commissioning dementia care
NICE Quality Standards and commissioning dementia care 1 What is NICE? World leader in producing guidance and setting standards for high quality care and for promoting healthy living From April 2013 a
More informationThe response to the Committee request for additional analyses in section 1.4, MSD follows:
MSD Hertford Road Hoddesdon, Hertfordshire EN11 9BU, UK Telephone +44 (0)1992 452644 Facsimile +44 (0)1992 468175 1 Kate Moore Technology Appraisals Project Manager National Institute for Health and Clinical
More informationCombination therapy compared to monotherapy for moderate to severe Alzheimer's Disease. Summary
Combination therapy compared to monotherapy for moderate to severe Alzheimer's Disease Summary Mai 17 th 2017 Background Alzheimer s disease is a serious neurocognitive disorder which is characterized
More informationDrug Update. Treatments for Cognitive Impairment in the Older Adult. William Solan, M.D. Karen Sanders, Ph.D. Northwest Hospital Seattle
Drug Update Treatments for Cognitive Impairment in the Older Adult William Solan, M.D. Karen Sanders, Ph.D. Northwest Hospital Seattle Current Drug Treatments for Alzheimer s Disease Cholinesterase Inhibitors:
More informationNational Institute for Health and Clinical Excellence. Health Technology Appraisal. Prucalopride for the treatment of chronic constipation in women
Health Technology Appraisal Summary form Prucalopride for the treatment of chronic constipation in women Comment 1: the draft remit Appropriateness Movetis Movetis entirely welcomes the opportunity to
More informationTechnology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340
Ustekinumab for treating active psoriatic arthritis Technology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationSupplementary Online Content
Supplementary Online Content Atri A, Frölich L, Ballard C, et al. Effect of idalopirdine as adjunct to cholinesterase inhibitors on in cognition in patients with Alzheimer disease: three randomized clinical
More informationLong-term associations between cholinesterase inhibitors and memantine use and health outcomes among patients with Alzheimer s disease
Alzheimer s & Dementia 9 (2013) 733 740 Long-term associations between cholinesterase inhibitors and memantine use and health outcomes among patients with Alzheimer s disease Carolyn W. Zhu a, *, Elayne
More informationMEMANTINE FOR THE TREATMENT OF MODERATE TO SEVERE ALZHEIMER S DISEASE Lundbeck Response to the Technology Assessment Report
MEMANTINE FOR THE TREATMENT OF MODERATE TO SEVERE ALZHEIMER S DISEASE Lundbeck Response to the Technology Assessment Report 4 th August 2010 Abbreviations AChEI Acetylcholinesterase inhibitor AD ADAS-Cog
More informationlevetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd
Scottish Medicines Consortium Resubmission levetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd 11 January 2008 The Scottish Medicines
More informationCommissioning Policy
Commissioning Policy Abbott FreeStyle Libre Flash Glucose Monitoring System Individual Funding Request Date Adopted: 09 September 2018 Version: 1819.1.02 Title of document: Authors job title(s): Document
More informationValue Based Health Care in the UK: NICE, VBP and the Cost-effectiveness Threshold. Eldon Spackman, MA, PhD
Value Based Health Care in the UK: NICE, VBP and the Cost-effectiveness Threshold Eldon Spackman, MA, PhD Background to NICE NICE s current position on the threshold Two concepts of the threshold Why the
More informationTechnology appraisal guidance Published: 28 September 2016 nice.org.uk/guidance/ta411
Necitumumab for untreated advanced or metastatic squamous non-small-cell lung cancer Technology appraisal guidance Published: 28 September 2016 nice.org.uk/guidance/ta411 NICE 2017. All rights reserved.
More informationTechnology appraisal guidance Published: 14 December 2016 nice.org.uk/guidance/ta420
Ticagrelor for preventingenting atherothrombotic events ents after myocardial infarction Technology appraisal guidance Published: 14 December 2016 nice.org.uk/guidance/ta420 NICE 2018. All rights reserved.
More informationAlzheimer s disease affects approximately. Cholinesterase inhibitors in Alzheimer s disease an update. Pathology and mechanism of action
Cholinesterase inhibitors in Alzheimer s disease an update Alzheimer s disease affects an ever growing number of people, with almost half a million patients in the UK alone. Unfortunately approaches to
More informationhe Case for QALY s: US Decision- Making for Pharmaceuticals Disadvantages? Christopher Leibman Sr. Director Pharmacoeconomics Elan Pharmaceuticals
he Case for QALY s: US Decision- Making for Pharmaceuticals Disadvantages? Christopher Leibman Sr. Director Pharmacoeconomics Elan Pharmaceuticals What s wrong with QALYs, they seem so nice? Apologies
More informationRoflumilast for the management of severe chronic obstructive pulmonary disease
Roflumilast for the management of severe chronic obstructive pulmonary disease Issued: January 2012 guidance.nice.org.uk/ta244 NICE has accredited the process used by the Centre for Health Technology Evaluation
More informationCost-effectiveness of tolvaptan (Jinarc ) for the treatment of autosomal dominant polycystic kidney disease (ADPKD)
Cost-effectiveness of tolvaptan (Jinarc ) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) The NCPE has issued a recommendation regarding the cost-effectiveness of tolvaptan (Jinarc
More informationExecutive Summary. The Royal Australasian College of Physicians July 2012 Page 1 of 5
PBAC Review of Pharmaceutical Benefits Scheme anti-dementia drugs to treat Alzheimer s disease Submission by The Royal Australasian College of Physicians July 2012 The Royal Australasian College of Physicians
More informationEvidence-Based Interventions to Improve Caregiver and Patient Outcomes in Dementia
Evidence-Based Interventions to Improve Caregiver and Patient Outcomes in Dementia Alan B. Stevens, PhD Professor, Department of Medicine Vernon D. Holleman-Lewis M. Rampy Centennial Chair in Gerontology
More informationCost effectiveness analysis of dopamine agonists in the treatment of Parkinson's disease in Japan Shimbo T, Hira K, Takemura M, Fukui T
Cost effectiveness analysis of dopamine agonists in the treatment of Parkinson's disease in Japan Shimbo T, Hira K, Takemura M, Fukui T Record Status This is a critical abstract of an economic evaluation
More informationSetting The setting was institutional and tertiary care in London, Essex and Hertfordshire in the UK.
Cognitive stimulation therapy for people with dementia: cost-effectiveness analysis Knapp M, Thorgrimsen L, Patel A, Spector A, Hallam A, Woods B, Orrell M Record Status This is a critical abstract of
More informationTechnology appraisal guidance Published: 23 March 2011 nice.org.uk/guidance/ta217
Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease Technology appraisal guidance Published: 23 March 2011 nice.org.uk/guidance/ta217 NICE 2017. All rights reserved.
More informationTechnology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta440
Pegylated liposomal irinotecan for treating pancreatic cancer after gemcitabine Technology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta440 NICE 2017. All rights reserved. Subject
More informationTechnology appraisal guidance Published: 15 December 2010 nice.org.uk/guidance/ta211
Prucalopride for the treatment of chronic constipation in women Technology appraisal guidance Published: 15 December 2010 nice.org.uk/guidance/ta211 NICE 2018. All rights reserved. Subject to Notice of
More informationACNP Annual Meeting Submission Site User Guide
Visit http://acnp.societyconference.com Clicking Log In will open the below pop-up window. Select Start a New Abstract These are your current submissions. You can access the submission by clicking the
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Technology Appraisals. Patient Access Scheme Submission Template
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Technology Appraisals Patient Access Scheme Submission Template Bevacizumab in combination with fluoropyrimidine-based chemotherapy for the first-line
More informationMentis Cura November
Mentis Cura November 29 2012 www.mentiscura.com New Facts on Alzheimer s Death rank nr. 2-5 in western countries Fastest growing disease in: Cost Incedence Death rate People with Alzheimer s 2012 36 million
More informationEBM Journal Club: Does Ginkgo Biloba improve memory in elder group
EBM Journal Club: Does Ginkgo Biloba improve memory in elder group R2 0 Memory loss in elder >> Dementia Defination Diagnosis Prognosis 1 Why so serious? 2 Any way to improve memory in elder??? 3 Any way
More informationCost-effectiveness of lesinurad (Zurampic ) for the treatment of adult patients with gout
Cost-effectiveness of lesinurad (Zurampic ) for the treatment of adult patients with gout The NCPE has issued a recommendation regarding the cost-effectiveness of Lesinurad (Zurampic ) in combination with
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Scope for Partial Update
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Scope for Partial Update 1 Guideline title Anxiety: management of generalised anxiety disorder in adults in primary, secondary and community care (update)
More informationAlcohol and Drug Commissioning Framework for Northern Ireland Consultation Questionnaire.
Alcohol and Drug Commissioning Framework for Northern Ireland 2013-16 Consultation Questionnaire. This questionnaire has been designed to help stakeholders respond to the above framework. Written responses
More informationCost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia
Cost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia The NCPE has issued a recommendation regarding the cost-effectiveness of evolocumab (Repatha ). Following NCPE assessment of the applicant
More informationTechnology appraisal guidance Published: 22 February 2012 nice.org.uk/guidance/ta247
Tocilizumab for the treatment of rheumatoid arthritis Technology appraisal guidance Published: 22 February 2012 nice.org.uk/guidance/ta247 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationThe Spectrum of Lewy Body Disease: Dementia with Lewy Bodies and Parkinson's Disease Dementia
Disclosures Research support, Parkinson Society Canada, Canadian Institutes of Health Research, Ministry of Economic Development and Innovation, Teva Novartis clinical trial, Principal Investigator CME
More informationCost-effectiveness of apremilast (Otezla )
Cost-effectiveness of apremilast (Otezla ) alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis in adult patients who have had an
More informationTechnology appraisal guidance Published: 23 November 2016 nice.org.uk/guidance/ta418
Dapagliflozin in triple therapy for treating type 2 diabetes Technology appraisal guidance Published: 23 November 2016 nice.org.uk/guidance/ta418 NICE 2018. All rights reserved. Subject to Notice of rights
More informationPRIMARY CARE MEDICAL DIRECTOR v PFIZER
CASE AUTH/2378/12/10 PRIMARY CARE MEDICAL DIRECTOR v PFIZER Promotion of Champix A primary care medical director complained about the conduct of a Pfizer representative who presented at a smoking cessation
More informationLessons learned from placebo research in medicine
Lessons learned from placebo research in medicine Prof. Ulrike Bingel Department of Neurology University Hospital Essen 1 ulrike.bingel@uk-essen.de Overview Definition and efficacy Psychological mechanisms
More informationThe cost-benefit of cholinesterase inhibitors in mild to moderate dementia: a willingness-topay
The cost-benefit of cholinesterase inhibitors in mild to moderate dementia: a willingness-topay approach Wu G, Lanctot K L, Herrmann N, Moosa S, Oh P I Record Status This is a critical abstract of an economic
More informationDementia Care Pathway
Document level: West Locality Code: CC41 Issue number: 1 Dementia Care Pathway Lead executive Authors details Type of document Target audience Document purpose Medical Director Dr Anushta Sivananthan Dr
More informationTechnology appraisal guidance Published: 6 September 2017 nice.org.uk/guidance/ta476
Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer Technology appraisal guidance Published: 6 September 2017 nice.org.uk/guidance/ta476 NICE 2018. All
More informationTechnology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta441
Daclizumab for treating relapsing remitting multiple sclerosis Technology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta441 NICE 2017. All rights reserved. Subject to Notice of rights
More informationCurrent Treatments for Dementia and Future Prospects. James Warner St Charles Hospital, London
Current Treatments for Dementia and Future Prospects James Warner St Charles Hospital, London Dementia Cognitive Non-cognitive (BPSD) Memory orientation language other cognitive abilities praxis planning
More informationRoflumilast for the management of severe chronic obstructive pulmonary disease
Roflumilast for the management of severe chronic obstructive pulmonary disease Issued: January 2012 www.nice.org.uk/ta244 NHS Evidence has accredited the process used by the Centre for Health Technology
More informationTechnology appraisal guidance Published: 24 July 2013 nice.org.uk/guidance/ta292
Aripiprazole for treating moderate to severe ere manic episodes in adolescents with bipolar I disorder Technology appraisal guidance Published: 24 July 2013 nice.org.uk/guidance/ta292 NICE 2018. All rights
More informationAlzheimer s Disease Update: From Treatment to Prevention
Alzheimer s Disease Update: From Treatment to Prevention Jeffrey M. Burns, MD Edward H. Hashinger Professor of Medicine Co-Director, KU Alzheimer s Disease Center Director, Clinical and Translational Science
More informationAXOVANT SCIENCES LTD. JEFFERIES HEALTHCARE CONFERENCE. Axovant Sciences Corporate Presentation -- June 2017 For Investor Use Only
AXOVANT SCIENCES LTD. JEFFERIES HEALTHCARE CONFERENCE JUNE 7, 2017 FORWARD-LOOKING STATEMENTS Statements made in this presentation contain forward-looking statements, including statements regarding Axovant
More informationCancer Transformation Programme
Cancer Transformation Programme Introduction to and supporting documentation for VALUE BASED TRANSFORMATION FUNDING SITE SELECTION November 2016 1 Introduction and Contents The Planning Guidance for 2017-2019
More informationActive Learning Strategies for Mastering Geriatric Assessment Tools
Active Learning Strategies for Mastering Geriatric Assessment Tools Sara McCumber, MS, RN, CNP, CNS Family Nurse Practitioner & Adult-Gerontological Primary Care NP The College of St. Scholastica Nursing
More informationFit Minds Interact Individual Program and TBI Using Cognitive Coaching for Impact
Fit Minds Interact Individual Program and TBI Using Cognitive Coaching for Impact Caring. Connected. Inspired. Presentation Overview Brain Science Primer Cognitive Stimulation Therapy Review Coach Approach
More informationIQWiG Reports - Commission No. A05-19B. Executive Summary
IQWiG Reports - Commission No. A05-19B Ginkgo in Alzheimer s disease 1 Executive Summary 1 Translation of the executive summary of the final report Ginkgohaltige Präparate bei Alzheimer Demenz (Version
More informationThe prevalence of Alzheimer s disease
GERIATRIC MEDICINE Maintaining Patients With Alzheimer s Disease in the Home Environment David S. Geldmacher, MD ABSTRACT The prevalence of the most common form of dementia, Alzheimer s disease (AD), is
More informationHTA. Smoking-cessation treatments. Executive summary
The clinical effectiveness and cost-effectiveness of bupropion and nicotine replacement therapy for smoking cessation: a systematic review and economic evaluation Smoking-cessation treatments NF Woolacott
More informationScottish Medicines Consortium
Scottish Medicines Consortium levetiracetam, 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra ) No. (394/07) UCB Pharma Limited 10 August 2007 The Scottish Medicines Consortium
More informationGenomind and The Genecept Assay
Genomind and The Genecept Assay A Growing Problem of Psychiatric Conditions One in four adults, approximately 61.5 M American adults suffer from mental illness 1 ; depression will become the largest health
More informationNICE appraisal consultation document for teriflunomide [ID548]
NICE appraisal consultation document for teriflunomide [ID548] Response from the Multiple Sclerosis Trust 9 th October 2013 Please find below comments from the MS Trust in relation to the Appraisal Consultation
More informationAntiviral Prescribing and NICE Guidelines
Antiviral Prescribing and NICE Guidelines Influenza Team, Health Protection Agency Centre for Infections, London 21 May 7 Introduction Guidance was issued by the National Institute of Clinical Excellence
More informationNuplazid. Nuplazid (pimavanserin) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.03 Subject: Nuplazid Page: 1 of 4 Last Review Date: June 22, 2018 Nuplazid Description Nuplazid (pimavanserin)
More information1. Comparative effectiveness of vedolizumab
Cost-effectiveness of vedolizumab (Entyvio ) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were
More informationCorporate Presentation August 6, 2015
Corporate Presentation August 6, 2015 Creating the Next Generation of CNS Drugs Forward-Looking Statement This presentation contains forward-looking statements. These statements relate to future events
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Memantine ER (Namenda XR), galantamine (Razadyne, Razadyne ER) Reference Number: CP.CPA.102 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See
More informationNATIONAL INSTITUTE FOR CLINICAL EXCELLENCE SCOPE. Nutrition support in adults: oral supplements, enteral and parenteral feeding.
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE 1 Guideline title SCOPE Nutrition support in adults: oral supplements, enteral and parenteral feeding. 1.1 Short title Nutrition support 2 Background a) The National
More informationAccess to newly licensed medicines. Scottish Medicines Consortium
Access to newly licensed medicines Scottish Medicines Consortium Modifiers The Committee has previously been provided with information about why the SMC uses modifiers in its appraisal process and also
More informationAlzheimer Disease Agents Drug Class Prior Authorization Protocol
Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Alzheimer Disease Agents Drug Class Prior Authorization Protocol This policy has been developed through review
More informationThe Importance of Full and Informed Consent (Authorisation)
The Importance of Full and Informed Consent (Authorisation) 20 th November 2009 Tracey Millar University of Edinburgh Tracey.Millar@ed.ac.uk www.edinburghbrainbanks.ed.ac.uk Why are Brains needed for Research?
More informationMichael A. Lobatz MD The Neurology Center Scripps Rehabilitation Center
Michael A. Lobatz MD The Neurology Center Scripps Rehabilitation Center Dementia an acquired syndrome consisting of a decline in memory and other cognitive functions Alzheimer s Disease Fronto temporal
More informationTechnology appraisal guidance Published: 7 February 2018 nice.org.uk/guidance/ta505
Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma Technology appraisal guidance Published: 7 February 2018 nice.org.uk/guidance/ta505 NICE 2018. All rights
More informationTechnology appraisal guidance Published: 26 September 2012 nice.org.uk/guidance/ta264
Alteplase for treating acute ischaemic stroke Technology appraisal guidance Published: 26 September 2012 nice.org.uk/guidance/ta264 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationTechnology appraisal guidance Published: 28 October 2009 nice.org.uk/guidance/ta183
Topotecan for the treatment of recurrent and stage IVB cervical cancer Technology appraisal guidance Published: 28 October 2009 nice.org.uk/guidance/ta183 NICE 2018. All rights reserved. Subject to Notice
More informationDementia NICE Guidelines Update. Key points for primary care - NICE guideline (June 2018 update ) 26 September 2018
Dementia NICE Guidelines Update Key points for primary care - NICE guideline (June 2018 update ) 26 September 2018 How NICE guidelines are reviewed Multidisciplinary guideline committee established Review
More informationTechnology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta456
Ustekinumab for moderately to severelyerely active Crohn s disease after previous treatment Technology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta456 NICE 2017. All rights reserved.
More information