Tysedmus, a Registry of Multiple Sclerosis patients exposed to Natalizumab
|
|
- Merry Marilyn Carroll
- 6 years ago
- Views:
Transcription
1 PHARMACOVIGILANCE AND REGISTRY PROGRAMMES Tysedmus, a Registry of Multiple Sclerosis patients exposed to Natalizumab Eric Van Ganse Pharmacoepidemiology, CHU-Lyon France
2 OUTLINE I. GOOD REGISTRY PRACTICE (GRP) II. TYSEDMUS: CREATION, OPERATION III. TYSEDMUS VS GRP : EVALUATION IV CONCLUSIONS
3 OUTLINE I. GOOD REGISTRY PRACTICE (GRP)
4 I. GOOD REGISTRY PRACTICE 1. CREATING REGISTRIES 2. OPERATING REGISTRIES 3. EVALUATING REGISTRIES
5 AHRQ (1/3)
6 AHRQ (2/3)
7 AHRQ (3/3)
8 1. CREATING REGISTRIES
9 1. CREATION (1/12) A patient registry is an organized system that uses observational methods to collect uniform data to evaluate specified outcomes for a population, and that serves one or more predetermined scientific, clinical, or policy purposes
10 1. CREATION (2/12) DESIGN
11 1. CREATION (3/12) Pre-inclusion (medical history)
12 1. CREATION (4/12) SAMPLING Probability sampling (random selection): census, stratified sampling, multistage sampling, Non-probability sampling (when PS not possible): convenience, quota,
13 1. CREATION (5/12) Pre-inclusion (patients)
14 1. CREATION (6/12) Pre-inclusion (Economics)
15 1. CREATION (7/12) Follow-up: primary outcomes
16 1. CREATION (8/12) Follow-up: secondary outcomes
17 1. CREATION (9/12) Data Sources : patient data
18 1. CREATION (10/12) Data Sources : other data Clinicians data Medical Chart extractions Electronic Health Records Claims Databases Other databases (F: PMSI) Other registries Death database
19 1. CREATION 11/12) Other aspects of creation Ethics Data ownership Privacy Populations
20 1. CREATION (12/12) POPULATIONS
21 2. OPERATING REGISTRIES (1/3) PHYSICIAN RECRUITMENT
22 2. OPERATING REGISTRIES (2/3) DATA MANAGEMENT
23 2. OPERATING REGISTRIES (3/3) ADVERSE EVENT MANAGEMENT
24 3. ANALYSING REGISTRIES Next Piperska Course!
25 OUTLINE II. TYSEDMUS: CREATION, OPERATION
26 MS Inflammatory demyelinating disease of the central nervous system Seems to be autoimmune in nature Neurological dysfunctions accumulating disability Women vs men: ratio 2/ in France Myelin is lost in multiple areas, leaving scar tissue known as plaques or lesions Geography affects susceptibility: Distance from equator Relapsing-Remitting (RRMS) 85% of patient in their initial disease course During episodes: acute symptoms Secondary Progressive (SPMS) Gradual worsening of neurological symptoms 10 to 20 years after onset of relapsing-remitting MS Primary-Progressive (PPMS) About 15% of MS patients Progressive neurological symptoms from the onset
27 1. CREATION (1/11) Therapy of MS: First line treatments: Beta Interferons: Avonex, Rebif, Betaferon Glatiramer acetate (Copaxone ) Oral immunosupressors, eg Azathioprine (Imurel ), Mycophenolate mofetil (Cellcept ) reduce the number of attacks in RRMS. Second line treatment: Natalizumab (Tysabri ) Third line treatments: Immunoactive treatments like: Mitoxantrone (Novantrone,/Elsep ), Cyclophosphamide (Endoxan )
28 1. CREATION (2/11) Natalizumab Natalizumab has shown interesting efficacy in phase III clinical trials: 68% reduction of mean annualised relapse rate 53% reduction in the progression of disability In 2005, 3 months after MA by FDA, the MA was suspended: 2 cases of progressive multifocal leucoencephalopathy (PML) (PML: Very rare disease caused by reactivation of JC virus in CNS)
29 1. CREATION (3/11) Two years later Natalizumab was re-authorised Today, Natalizumab has been approved both in USA and Europe after Biogen s agreement to implement a risk management plan: TOUCH prescribing program TYGRIS study in Europe
30 1. CREATION (4/11) Natalizumab = Antibody to lymphocyte adhesion molecule receptors, so reducing the migration of lymphocytes across the blood-brain barrier Relapsing-Remitting (RRMS) Best efficacy results ever during clinical trials, compared to all other treatments One infusion per month Cost: 2000 /infusion, ie /patient/year
31 1. CREATION (5/11) Why/when a Risk Management Programme? To identify the «most important» risks Potential «important» risks To identify «important missing» information Safety profile Safe association with other drugs «to be confirmed» Missing information about non studied populations Impact on Benefit/risk balance
32 1. CREATION (6/11) o Tysedmus = Risk Minimisation Project oto actualise the benefit-risk ratio of Natalizumab o To minimise morbidity and mortality (eg, due to PML) through early detection thanks to intensive clinical vigilance o To minimize the risk of PML by treating only patients that are not immunocompromised o To warn against concurrent use of antineoplastics, immunosuppressants or immunomodulators o To determine the incidence and risk factors for PML and other serious opportunistic infections
33 1. CREATION (7/11) Soon after MA of natalizumab in France, AFSSAPS decided to complete the European (EMEA) risk management plan with an national study: TYSEDMUS TYSEDMUS was launched in collaboration with : The French Federation of Neurology (FFN) The EDMUS network
34 1. CREATION (8/11)
35 1. CREATION (9/11) Primary objective: Safety profile of natalizumab in real-world clinical practice (incidence of opportunistic infections and cancer compared to unexposed patients) Secondary objectives: Effectiveness, conditions of use Inclusion Information safety data collection during and between infusions Safety and efficacy data collection SAE Or pregnancy Starting Natalizumab Monthly infusions 6 months In case of
36 1. CREATION (10/11)
37 1. CREATION 11/11)
38 2. OPERATING TYSEDMUS (1/14)
39 2. OPERATING TYSEDMUS (2/14)
40 2. OPERATING TYSEDMUS (3/14)
41 2. OPERATING TYSEDMUS (4/14)
42 2. OPERATING TYSEDMUS (5/14)
43 2. OPERATING TYSEDMUS (6/14)
44 2. OPERATING TYSEDMUS (7/14)
45 2. OPERATING TYSEDMUS (8/14)
46 2. OPERATING TYSEDMUS (9/14)
47 2. OPERATING TYSEDMUS (10/14)
48 2. OPERATING TYSEDMUS (11/14)
49 2. OPERATING TYSEDMUS (12/14)
50 2. OPERATING TYSEDMUS (13/14)
51 2. OPERATING TYSEDMUS (14/14)
52 OUTLINE III. TYSEDMUS VS GRP : EVALUATION
53 Benchmarking of Tysedmus
54 Benchmarking (1/3) Good Registry Practice Primary and secondary stakeholders are established A written plan of the goals, design, target population, method of data collection, etc. Identifying patient outcomes A communication plan is prepared Tysedmus Primary stakeholders are: The French Medicines Agency (AFSSAPS) French Society of Neurology (SFN) Goals and procedures are documented in the protocol of the study at its beginning Occurrence of adverse events (main outcome) No plan has previously been established but the communication during the study is satisfactory. All the neurologists meeting are exploited to emphasise the study. A newsletter is issued periodically Establishment of an advisory board A feasibility study may be useful when studying hard-to-reach populations A special plan for quality assurance before starting Thinking about who will owns the data in the end of the registry The Scientific Committee of the AFSSAPS is the advisory board No need for a pilot test study since the concerned population is known and quantified in the EDMUS network Quality assurance procedures are listed in the protocol It is forecasted that AFSSAPS and EDMUS network will both own the data at the end
55 Benchmarking (2/3) Good Registry Practice Review of the literature to guide appropriate data collection Description of the target population, and inclusion/exclusion criteria are specified Selection of a responsible person for the integrity of data in each center Use of a data coding dictionary to provide explicit definitions Tysedmus EDMUS Network is a leader of multiple sclerosis research and management in France Inclusion criterion is treated Multiple Sclerosis The target population is defined in the No direct personnel responsible for data protocol integrity, yet Data are coded using the MedDRA dictionary Quality control Manual and automated data cleaning Training of data collectors in a structured manner An electronic data cleaning is made by Tysedmus software for abnormal values. The primary data cleaning is manual and it generates periodic queries reports Training clinical research associates during specific meeting is planned but not yet performed
56 Benchmarking (3/3) Good Registry Practice Tysedmus Ethics and Privacy Obtaining individual consent Protecting privacy, Submission to Ethics Committee at the start of the registry All participants in Tysedmus study have been informed about the use of their healthcare information All the data are received anonymously from study sites Tysedmus is under review of the Data Protection Authority CNIL Study organisation Multiplying the methods of data collection may limit the participation of some sites Both paper or electronic forms are available for the participant sites Double data entry by different persons from the study team Occasionally during verifications To be organized systematically
57 OUTLINE I. II. III. IV. CONCLUSIONS
58 Conclusions (1/4) The first time ever that an exposure registry is funded in France The first time ever that an exposure registry is funded in France by Afssaps More than 1000 patients included and monitored after 18 months of activity Investigators have shown a real enthousiasm to participate Obvious heterogeneity of site participation Some errors/limitations in creating/operating Tysedmus
59 Conclusions (2/4) Some limitations of Tysedmus : A full team in the coordinating center as well as in regional sites. An early submission to the French data protection authority CNIL, all the more that time to get formal approval is long. A long-term funding plan including all predicted expenditures. Such a plan must consider the growth of needs due to increase number of patients. A plan for dissemination of information has to be prepared upfront, especially for this study which depends on the goodwill of neurologists.
60 Conclusions (3/4) The budget had to be revised upward, allowing eg : Recruitment of more personal Audits in regional sites Improved communication strategy Improvement of software and hardware supports Preparation of statistical analysis
61 Conclusions (4/4) Data quality had to be improved with: Better data cleaning using double data entry Early and immediate feedback of data in generating queries reports Handling missing data Overall, big efforts, but big rewards, eg quality and quantity of data, and potential use of data
National Horizon Scanning Centre. Cladribine (Movectro) for multiple sclerosis; relapsing-remitting. April 2008
Cladribine (Movectro) for multiple sclerosis; relapsing-remitting April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not
More informationS.E.A.R.C.H. SM Patient Workbook
S.E.A.R.C.H. SM Patient Workbook How to S.E.A.R.C.H. SM for the Right MS Therapy For You! What is S.E.A.R.C.H. SM? The first treatment for relapsing-remitting multiple sclerosis (RRMS) was approved by
More informationA blood sample will be collected annually for up to 2 years for JCV antibody testing.
Mellen Center Currently Enrolling Non-Treatment Trials STRATIFY-2 JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri Primary Investigator:
More informationIntroducing MN-166 Multiple Sclerosis. July 9, 2008
Introducing MN-166 A New Treatment Paradigm for Multiple Sclerosis July 9, 2008 MediciNova, Inc. 2008 Forward-Looking Statements Statements in this presentation that are not historical in nature constitute
More informationLemtrada (alemtuzumab)
Lemtrada (alemtuzumab) Policy Number: 5.02.517 Last Review: 7/2018 Origination: 8/2015 Next Review: 7/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Lemtrada
More informationApproval of a drug under this criteria document does not ensure full coverage of the drug.
Criteria Document: Reference #: PC/B016 Page: 1 of 4 and Therapeutics Quality PRODUCT APPLICATIO: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne
More informationAubagio (teriflunomide tablets) Policy Number: Last Review: 07/2017 Origination: 07/2014 Next Review: 07/2018
Aubagio (teriflunomide tablets) Policy Number: 5.01.614 Last Review: 07/2017 Origination: 07/2014 Next Review: 07/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for
More informationNational MS Society Information Sourcebook
National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook Interferons The interferons are a group of natural proteins that are produced by human cells in response to viral infection
More informationPipeline Drug Evidence Review: Ocrevus (ocrelizumab) vs. Tysabri, Lemtrada, Rebif and Tecfidera June 8, 2016
For more information contact us Pipeline Drug Evidence Review: Ocrevus (ocrelizumab) vs. Tysabri, Lemtrada, Rebif and Tecfidera June 8, 2016 Copyright. 2016 Advera Health Analytics, Inc. All rights reserved.
More informationOpexa Therapeutics, Inc.
Opexa Therapeutics, Inc. November 2011 Neil Warma President & CEO Forward-Looking Statements This presentation contains forward-looking statements which are made pursuant to the safe harbor provisions
More informationMedication Prior Authorization Form
(Orelizumab) Policy Number: 1073 Policy History Approve Date: 05/19/2017 Effective Date: 05/19/2017 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Alemtuzumab, dimethyl fumarate, laquinimod and teriflunomide for the treatment of relapsing forms of multiple
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Betaseron, Extavia) Reference Number: CP.CPA.331 Effective Date: 06.01.18 Last Review Date: 05.18 Line of Business: Commercial Coding Implications Revision Log See Important Reminder
More informationBeta interferon and glatiramer acetate for treating multiple sclerosis (review of TA32)
Public slides part 1 (Redacted) Beta interferon and glatiramer acetate for treating multiple sclerosis (review of TA32) 3 rd Appraisal Committee meeting Committee B, 16 th November 2017 Previous Appraisal
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 6 April 2011
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 6 April 2011 COPAXONE 20 mg/ml, solution for injection, pre-filled syringe B/28 (CIP code: 363 840-1) Applicant: SANOFI-AVENTIS
More informationCIBMTR Center Number: CIBMTR Recipient ID: RETIRED. EBMT Center Identification Code (CIC): Today s Date:
Multiple Sclerosis Pre-HSCT Data EBMT Center Identification Code (CIC): Today s Date: Sequence Number: Date Received: Registry Use Only Date of HSCT for which this form is being completed: & 20 20 HSCT
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Betaseron, Extavia) Reference Number: CP.PHAR.256 Effective Date: 08.01.16 Last Review Date: 05.18 Line of Business: Medicaid Coding Implications Revision Log See Important Reminder at
More informationApproved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Department of Origin: Pharmacy. Date approved: 06/21/17
Integrated Healthcare Services and Criteria Document: Reference #: PC/B016 Page: 1 of 4 PRODUCT APPLICATION: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA
More informationDrug Name (select from list of drugs shown) Tysabri (natalizumab) Quantity Frequency Strength Route of Administration
04/30/2014 Prior Authorization Form MERCY CARE PLAN (MEDICAID) Tysabri (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and
More informationForm 2043 R3.0: Multiple Sclerosis Pre-HSCT data
Key Fields Sequence Number: Date Received: - - CIBMTR Center Number: CIBMTR Recipient ID: EBMT Center Identification Code (CIC): Today's Date: - - Date of HSCT for which this form is being completed: -
More informationRESEARCH/CLINICAL UPDATE
National Multiple Sclerosis Society 733 Third Avenue New York, New York 10017-3288 Tel +1 212.986.3240 Fax +1 212.986.7981 E-mail nat@nmss.org nationalmssociety.org October 30, 2007 RESEARCH/CLINICAL UPDATE
More informationMultiple Sclerosis Agents
Multiple Sclerosis Agents Policy Number: 5.01.614 Last Review: 09/2018 Origination: 07/2014 Next Review: 09/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tysabri) Reference Number: CP.CPA.206 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Coding Implications Revision Log See Important Reminder at the end
More informationClinical Policy: Ocrelizumab (Ocrevus) Reference Number: CP.PHAR.335 Effective Date: Last Review Date: 05.18
Clinical Policy: (Ocrevus) Reference Number: CP.PHAR.335 Effective Date: 04.01.17 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationUpdate on New MS Therapeutics
Update on New MS Therapeutics William Meador, MD Assistant Professor AAN August 2017 Meeting Disclosures Clinical Trial Involvement: SPRINT-MS Trial MediciNova, ibudilast LemCog Sanofi/Genzyme, alemtuzumab
More informationAntibody therapy of multiple sclerosis Prof. Alastair Compston Dr. Alasdair Coles
Antibody therapy of multiple sclerosis & Department of Clinical Neurosciences, School of Clinical Medicine, University of Cambridge, U.K. 1 The story of multiple sclerosis: 1838-1993 2 The symptoms of
More informationThe Role of the Pharmacist in Pharmacovigilance A Regulatory Perspective
The Role of the Pharmacist in Pharmacovigilance A Regulatory Perspective Almath Spooner, Irish Medicines Board Pharmaceutical Society of Ireland National Pharmacy Summit, November 2008. Presentation Topics
More informationTechnology appraisal guidance Published: 27 August 2014 nice.org.uk/guidance/ta320
Dimethyl fumarate ate for treating relapsing-remitting multiple sclerosis Technology appraisal guidance Published: 27 August 2014 nice.org.uk/guidance/ta320 NICE 2018. All rights reserved. Subject to Notice
More informationBiogen Idec Neurology Pipeline. Alfred Sandrock, MD, PhD SVP, Neurology Research & Development
Biogen Idec Neurology Pipeline Alfred Sandrock, MD, PhD SVP, Neurology Research & Development March 25, 2009 Robust Neurology Pipeline Neurology Multiple Sclerosis Discovery Pre-Clinical Phase 1 Phase
More informationSESSION VI THE CHALLENGE OF NEW TREATMENTS THE PHARMA INDUSTRY
SESSION VI THE CHALLENGE OF NEW TREATMENTS THE PHARMA INDUSTRY Bruno C. Musch, MD PhD Baveno, Italy November 30th, 2013 DISCLOSURE OF INTEREST Dr.Musch is currently Medical Director in GENENTECH/Roche,
More informationClinical Policy: Natalizumab (Tysabri) Reference Number: CP.PHAR.259
Clinical Policy: (Tysabri) Reference Number: CP.PHAR.259 Effective Date: 07/16 Last Review Date: 07/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
More informationThere are currently 4 US Food and Drug
DISEASE-MODIFYING THERAPIES IN RELAPSING-REMITTING MULTIPLE SCLEROSIS* Benjamin M. Greenberg, MD, MHS ABSTRACT Four major disease-modifying therapies are discussed within the context of relapsing and remitting
More informationTechnology appraisal guidance Published: 22 January 2014 nice.org.uk/guidance/ta303
Teriflunomide for treating relapsing remitting multiple sclerosis Technology appraisal guidance Published: 22 January 2014 nice.org.uk/guidance/ta303 NICE 2018. All rights reserved. Subject to Notice of
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Ocrevus) Reference Number: CP.PHAR.335 Effective Date: 07.01.18 Last Review Date: 05.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy
More informationThe MS Disease- Modifying Medications. General information
The MS Disease- Modifying Medications General information Current as of April 2013. This online brochure is updated with breaking news as required. If you have a printed a copy of this publication, please
More informationClinical Policy: Teriflunomide (Aubagio) Reference Number: CP.PHAR.262 Effective Date: Last Review Date: 05.18
Clinical Policy: (Aubagio) Reference Number: CP.PHAR.262 Effective Date: 08.01.16 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Aubagio) Reference Number: CP.PHAR.262 Effective Date: 07.01.18 Last Review Date: 05.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy
More informationMycophenolate mofetil in combination with interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis: a preliminary study
Received: 20.6.2010 Accepted: 5.8.2010 Original Article Mycophenolate mofetil in combination with interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis: a preliminary study Masoud
More informationThe TOUCH program and natalizumab: Fundamental flaw in patient protection [version 3; referees: 2 approved, 1 approved with reservations]
OPINION ARTICLE The TOUCH program and natalizumab: Fundamental flaw in patient protection [version 3; referees: 2 approved, 1 approved with reservations] Jagannadha Avasarala Department of Medicine/Division
More informationThe Latest Therapies for MS: Weighing Respective Benefits and Risks
Transcript Details This is a transcript of an educational program accessible on the ReachMD network. Details about the program and additional media formats for the program are accessible by visiting: https://reachmd.com/programs/frontlines-multiple-sclerosis/the-latest-therapies-for-ms-weighingrespective-benefits-and-risks/9639/
More informationCladribine. Spirella Building, Letchworth, SG6 4ET reg charity no
Cladribine Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Cladribine Date of issue: February 2009 Contents Section Page 1. Introduction 1 2. How cladribine
More informationEvidence Review Group s Report Dimethyl fumarate for treating relapsing-remitting multiple sclerosis
Evidence Review Group s Report Dimethyl fumarate for treating relapsing-remitting multiple sclerosis Produced by CRD and CHE Technology Assessment Group Authors Gill Norman, Research Fellow, CRD Stephen
More informationNatalizumab (Tysabri) Humanized, MAb Against α 4 subunit of α 4 β 1 Integrin. Multiple Sclerosis Treatment Update
Natalizumab (Tysabri) Humanized, MAb Against α 4 subunit of α 4 β 1 Integrin Complementarity-Determining Regions (CDRs) Multiple Sclerosis Treatment Update CDR grafted from murine Ab Human IgG 4 framework
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Multiple Sclerosis Agents Page 1 of 18 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Multiple Sclerosis Agents Tysabri (natalizumab) and Lemtrada (alemtuzumab),
More informationMultiple sclerosis (MS) is a chronic, unpredictable
Prescription Utilization by Multiple Sclerosis Patients in the United States Drug Trends Anna A. Theodorou, RPh, MBA; Kelly M. Johnson, MBA; Stacey Ruf, PhD; and John A. Szychowski, AAS, BS Multiple sclerosis
More informationWe remid you that your TYSABRIi1 RiskMAP (called TOUCHT~ is an important part of the. include each of the following components:
, ~,,+,,~'''~S'R..V.I..C..E..'.S.'.''..S.~... i. "... :.' 'õ ~ -: Pj",;:...E..... DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 Our STN: BL
More informationMS Injectable Drugs
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: MS Injectable Drugs Page: 1 of 5 Last Review Date: November 30, 2018 MS Injectable Drugs Description
More informationMAY 2018 RESEARCH U P D A T E
MAY 2018 MS RESEARCH U P D A T E MS RESEARCH U P D A T E Written and compiled by Tom Garry with Stephen Krieger, MD and Michelle Fabian, MD Reviewed by Jack Burks, MD Edited by Susan Courtney The 2018
More informationMultiple Sclerosis Agents Drug Class Prior Authorization Protocol
Multiple Sclerosis Agents Drug Class Prior Authorization Protocol Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 This policy has been developed through review
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Tysabri, (natalizumab), Lemtrada (alemtuzumab), Page 1 of 21 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See Also: Tysabri (natalizumab), Lemtrada (alemtuzumab),
More informationOutline. References. Marshall,1
Outline Multiple Sclerosis: More Than Your ABC s Janene L. Marshall, PharmD, BCPS Clinical Associate Professor Internal Medicine Clinical Pharmacist Chicago State University College of Pharmacy J-marshall@csu.edu
More informationA Multiple Treatment Comparison of Eleven Disease- Modifying Drugs Used for Multiple Sclerosis
Original Article J Clin Med Res. 2018;10(2):88-105 A Multiple Treatment Comparison of Eleven Disease- Modifying Drugs Used for Multiple Sclerosis Vida Hamidi a, Elisabeth Couto a, Tove Ringerike a, Marianne
More informationSWOG
SWOG http://swog.org Page 1 of 5 pages Original Release Date: July 1985 Departments Affected: All Revision Date: April 2018 Introduction SERIOUS ADVERSE EVENTS The timely reporting of serious adverse events
More informationRWE from pre-clinical to launch. RWE from pre-clinical to launch. Standard of care Unmet needs. Disease burden Budget impact.
Real Real World World Data Data Across Across the the Product Product Lifecycle: Lifecycle: RWE from pre-clinical to launch RWE from pre-clinical to launch Standard of care Unmet needs Disease burden Budget
More informationMAY 2017 RESEARCH U P D A T E
MAY 2017 MS RESEARCH U P D A T E MS RESEARCH U P D A T E Written and compiled by Michelle Fabian, MD and Stephen Krieger, MD Includes additional material by Margaret M. McCormick, RN, BSN, MSCN Reviewed
More informationGetReal - Project No
GetReal - Project No. 115546 WP1: Deliverable 1.5 (Case Study Review: Multiple Sclerosis) Lead Organisations: NICE, Novartis IMI GetReal Deliverable 1.5: Case Study on MS Disease and Treatment Overview
More informationIR Thematic Call on Multiple Sclerosis
Teresa, Multiple Sclerosis, United States IR Thematic Call on Multiple Sclerosis October 3 rd, 2013 Forward Looking Statements This presentation contains forward-looking statements as defined in the Private
More informationClinical Utility of Glatiramer Acetate in the Management of Relapse Frequency in Multiple Sclerosis
Journal of Central Nervous System Disease Review Open Access Full open access to this and thousands of other papers at http://www.la-press.com. Clinical Utility of Glatiramer Acetate in the Management
More informationDisclosures and Acknowledgments
214 Cooperative Meeting of the Consortium of Multiple Sclerosis Centers and Americas Committee for Treatment and Research in Multiple Sclerosis Dallas, Texas DX1 Disability Progression in Multiple Sclerosis
More informationOptions for Wheeled Mobility Resource Detectives Program Achievements MSAA. Summer Research UPDATE
Options for Wheeled Mobility Resource Detectives Program Achievements MSAA Summer 2009 MS Research UPDATE 2009 Volunteering Opportunities from MSAA Volunteering with MSAA offers multiple opportunities
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) GLATIRAMER ACETATE (GLATECT PENDOPHARM) Indication: Relapsing-Remitting Multiple Sclerosis RECOMMENDATION: The CADTH
More informationWhat are the real-world evidence tools and how can they support decision making?
What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day 22 nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology
More informationExtending Our Leadership Position in Multiple Sclerosis. December 12, 2018
Extending Our Leadership Position in Multiple Sclerosis December 12, 2018 1 Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to: our strategy
More informationUnified understanding of MS disease is required for drug development. National Multiple Sclerosis Society, 733 Third Avenue, New York, NY USA 2
COMMENT Unified understanding of MS disease is required for drug development Timothy Coetzee 1 and Alan J Thompson 2 1 National Multiple Sclerosis Society, 733 Third Avenue, New York, NY 10017 USA 2 Faculty
More informationMultiple Sclerosis International Federation December 2018
MSIF WHO EML APPLICATION Multiple Sclerosis Disease-Modifying Therapies 1. Summary statement of the proposal for inclusion In 2015, an application for widening the indication of azathioprine to cover multiple
More informationOral NT-KO-003 for the Treatment of Multiple Sclerosis
Oral for the Treatment of Multiple Sclerosis Madrid, 27 de noviembre de 2013 Content 1. The Company 2. The Product a) Target Indications b) Innovative mechanisms of action c) Differential features facing
More informationThe compassionate use of medicinal products. An example: the French ATU system. 0ff label use in France
0 The compassionate use of medicinal products. An example: the French ATU system 0ff label use in France C. Bélorgey Head of Department of evaluation of Clinical Trials and medicinal products of special
More informationSERIOUS ADVERSE EVENTS
EVENTS Introduction Timely reporting of Serious Adverse Events (SAEs) is required by regulations of the Food and Drug Administration (FDA) and the National Cancer Institute (NCI). Such reporting is not
More informationLegislative and Regulatory Modernization for Therapeutic Products
Legislative and Regulatory Modernization for Therapeutic Products Maurica Maher Associate Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada Presented
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report October 2014 Drug Teriflunomide (Aubagio) (14 mg film-coated tablet) Indication Teriflunomide is indicated as monotherapy for the treatment of patients
More informationSharing Data: Recovering Registry Addict
Sharing Data: Observations From a Recovering Registry Addict Christopher Bredeson, MD, MSc., FRCPC Director, Hematologic Malignancies Professor of Medicine Medical College of Wisconsin DBV06_1.ppt TODAY
More informationVaccine Safety Monitoring, Reporting and Analysis. GBC 2017, Yun Chon, Ph. D
Vaccine Safety Monitoring, Reporting and Analysis GBC 2017, Yun Chon, Ph. D Disclaimer This presentation is based on my own opinion and is not representing the opinion of International Vaccine Institute.
More informationAdopted by the ENCePP Steering Group on 01/07/2016
Doc.Ref. EMA/540136/2009 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Adopted by the ENCePP Steering Group on 01/07/2016 The European Network of Centres for Pharmacoepidemiology
More informationPharmacovigilance. Training session for patients and consumers involved in EMA activities, 25 November Presented by: Priya Bahri
Pharmacovigilance Training session for patients and consumers involved in EMA activities, 25 November 2014 Presented by: Priya Bahri An agency of the European Union 2 Pharmacovigilance - the science concerned
More informationPrior Authorization Form
5/2/2017 Prior Authorization Form INTOTAL HEALTH PLAN (SPC) Multiple Sclerosis MMT SGM This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign
More informationEMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9).
EMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9). Responsible, under the Head of Unit for the Post-Authorisation Evaluation of Medicinal Products
More informationEvidence Review Group s Report Template This template should be completed with reference to NICEs Guide to the Methods of Single Technology Appraisal
Evidence Review Group s Report Template This template should be completed with reference to NICEs Guide to the Methods of Single Technology Appraisal Title: Fingolimod for the treatment of relapsing remitting
More informationNuts & Bolts of Clinical Trials, DSMBs, Event Committees, Core Labs and Data Standards
Nuts & Bolts of Clinical Trials, DSMBs, Event Committees, Core Labs and Data Standards Ron Waksman, MD Professor of Medicine, Georgetown University Associate Chief of Cardiology, Washington Hospital Center
More informationPharmacovigilance Practice in Pharmaceutical Industry. From Adverse Event Collection Risk Management
Pharmacovigilance Practice in Pharmaceutical Industry From Adverse Event Collection Risk Management Hani Mickail, MD Head Global Clinical Safety Operations - Novartis Pharmacovigilance Workshop 23-24 October
More informationInternational Transfers of Personal Data at sanofi-aventis R & D
International Transfers of Personal Data at sanofi-aventis R & D Pierre-Yves Lastic, PhD Senior Director, Standards Management & Data Privacy Sanofi-aventis R&D CONFERENCE ON INTERNATIONAL TRANSFERS OF
More informationEmerging Therapies for the Management of Multiple Sclerosis
Clinical Medicine Insights: Therapeutics R e v i e w Open Access Full open access to this and thousands of other papers at http://www.la-press.com. Emerging Therapies for the Management of Multiple Sclerosis
More informationStrengthening the prospective discussions on post-licensing evidence generation
Strengthening the prospective discussions on post-licensing evidence generation Industry stakeholder platform on research and development support Presented by Jane Moseley on Senior Scientific Officer
More informationDocument number (version): RMP.NUS (3.0) Page 63 of 95
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology The immune system is the body s frontline defence to fight infection by viruses, bacteria, and other foreign organisms/materials.
More informationLeveraging Big Data for Better Health Outcomes: The Need for a Collaborative Space and Common Solutions
Leveraging Big Data for Better Health Outcomes: The Need for a Collaborative Space and Common Solutions Author: Richard Bergstrom * Date: 14.11.2016 * Version: 1 Disruption 2 Why this discussion now Definitions.
More information1 New MS treatments and updates on established treatments
Teaching Course 1 Disease modifying treatment Chairs: R.J. Fox (Cleveland, US) L. Kappos (Basel, CH) 1 New MS treatments and updates on established treatments R.J. Fox (Cleveland, US) 2 Assessing and mitigating
More informationThijs J Giezen, PharmD, MSc, PhD The Netherlands
Thijs J Giezen, PharmD, MSc, PhD The Netherlands Hospital Pharmacist, Foundation Pharmacy for Hospitals in Haarlem, The Netherlands Member of the Biosimilar Medicinal Product Working Party of European
More informationConducting and reporting a GCP Inspection. Gunnar Danielsson Medical Products Agency
Conducting and reporting a GCP Inspection Gunnar Danielsson Medical Products Agency Preparation for an inspection Inspection plan Create worksheets for the inspection general project specific study specific
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Multiple Sclerosis Agents Page 1 of 17 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Multiple Sclerosis Agents Tysabri (natalizumab) and Lemtrada (alemtuzumab)
More informationField trial with veterinary vaccine
١ Field trial with veterinary vaccine Saeedeh Forghani,, M.D. Clinical Trial and Ethics Department Human Health Management Deputy of Quality Assurance 89/4/2 ٢ ٣ Introduction: The efficacy and safety shall
More informationRisk Based Approach To Complaint Handling
Risk Based Approach To Complaint Handling Khaudeja Bano, M.D. Senior Medical Director, Medical Device Safety Head, AbbVie Inc. Life Sciences Product Complaints Congress Europe Dublin, Ireland December
More informationClinical Policy: Multiple Sclerosis Reference Number: CP.CPA.206 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: Reference Number: CP.CPA.206 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory
More informationThe Economics of New Drug Development: Costs, Risks, and Returns
The Economics of New Drug Development: Costs, Risks, and Returns Joseph A. DiMasi, Ph.D. Tufts Center for the Study of Drug Development Tufts University The New England Drug Metabolism Group Spring Meeting
More informationReal World Evidence Generation in the 21 st Century: National Evaluation System for health Technology (NEST)
Real World Evidence Generation in the 21 st Century: National Evaluation System for health Technology (NEST) Bill Murray, President & CEO IDEAL Conference Presentation May 5, 2017 1 www.mdic.org Vision
More informationHealth Canada s NHP Vigilance Activities
Health Canada s NHP Vigilance Activities Canadian Health Food Association (CHFA) East October 3, 2013 Scott Sawler Director General Marketed Health Products Directorate Overview NHP Program & MHPD Activities
More informationNew WHO Report: Access to new medicines in Europe: Technical review of policy initiatives and opportunities for collaboration and research
New WHO Report: Access to new medicines in Europe: Technical review of policy initiatives and opportunities for collaboration and research Hanne Bak Pedersen Programme Manager Health Technologies and Pharmaceuticals
More informationSpecialty medicine: Pearls from the PBMI conference, Scottsdale, Arizona Dr. Elsa Badenhorst
Specialty medicine: Pearls from the PBMI conference, Scottsdale, Arizona 2012 Dr. Elsa Badenhorst The Magic Bullet Paul Ehrlich (1854-1915) if a compound could be made that selectively targeted a diseasecausing
More informationTo document the review procedures for a submission regarding compassionate/treatment use of investigational drugs, biologics and devices.
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD COMPASSIONATE/TREATMENT USE OF MEDICAL DRUGS, BIOLOGICS AND DEVICES I. PURPOSE To document the review procedures for a submission
More informationEffective Auditing of PV Interfaces
Outline Effective Auditing of PV Interfaces SQA Meeting March 29, 2017 Larry Thomas, RQAP-GLP, CQA Bayer Pharmaceuticals Whippany, NJ Audit Process Planning/Preparation, Execution and Reporting Functions
More informationRoche to present new data at AAN reinforcing efficacy and safety of newly FDAapproved OCREVUS (ocrelizumab) in two types of multiple sclerosis
Investor Update Basel, 19 April 2017 Roche to present new data at AAN reinforcing efficacy and safety of newly FDAapproved OCREVUS (ocrelizumab) in two types of multiple sclerosis Data presentations will
More informationby Sara Bernstein fighting disease activity in MS is the immune system, which launches attacks on
Research Now is a special feature of Momentum, produced by the Society s Research Programs Department. Sara Bernstein, Editor, Research Now Cathy Carlson, Senior Director, Research Information INSIDE:
More information