№ files_lp_3_process_9_55962
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Regulatory submission providing detailed evaluation of ocrelizumab’s use, dosage, patient eligibility, clinical evidence, and pricing within the Australian Highly Specialised Drugs program for PPMS treatment.
Year:
2017
Region / Country:
Australia
Document type:
Regulatory submission
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Manufacturer:
Roche Products Pty Ltd
Drug name:
Ocrelizumab (Ocrevus®)
Condition:
Primary progressive multiple sclerosis (PPMS)
Treatment phase:
Initial and continuation
Dosage form:
Solution concentrate for I.V. infusion 300 mg in 10 mL
Administration criteria:
Must be treated by a neurologist; clinical diagnosis of PPMS confirmed; specific MRI or CSF evidence required for initial treatment; previous treatment and tolerance required for continuation
Regulatory status:
TGA registered 13 July 2017
Program category:
Section 100 Highly Specialised Drugs program
Pricing arrangement:
Special Pricing Arrangement proposed
Clinical trial reference:
ORATORIO
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Institution:
University of Manchester
System:
PPMS (research facility management system)
Document Type:
User registration guide
Audience:
Researchers and facility managers
Access Requirements:
University single sign-on credentials
Registration Process:
Completion of registration form and approval by Facility Manager
Contact Information Required:
Phone number, default finance code, lab group
Approval:
Facility Manager confirmation
Usage Control:
Permission to book instruments or services managed by Facility Managers
URL:
https://corefacilities.manchester.ac.uk/areq/
Registration Details:
Pre-filled first name, last name, email, SPOTID; user enters additional data as required
Note:
Year
Document type:
Shared Care Guideline
Organization / Institution:
North Central London Joint Formulary Committee
Target Audience:
Primary Care Prescribers
Year:
2023
Region / Country:
Australia
Drug:
Edaravone (Radicava®)
Type of Document:
Pharmaceutical Benefits Submission
Regulatory Body:
Therapeutic Goods Administration (TGA)
Submission Purpose:
PBS Section 100 Highly Specialised Drugs Listing
Indication:
Amyotrophic lateral sclerosis (ALS)
Treatment Phase:
Initial and Continuing treatment
Prescriber Type:
Medical Practitioners, Nurse Practitioners (continuing therapy only)
Clinical Criteria:
Diagnosis by neurologist, disease duration ≤ 2 years, FVC or SVC ≥ 80% predicted, ambulatory or upper limb/swallowing ability, ALSFRS-R ≥ 2 on each item, no tracheostomy or respiratory failure
Population:
Adult patients (≥18 years)
Pricing:
Special Pricing Arrangements apply
Regulatory Dates:
Orphan designation 17 August 2021, TGA registration 15 February 2023
Comparator:
Standard of care with or without riluzole
Outcomes Measured:
ALS Functional Rating Scale – Revised (ALSFRS-R) after 6 months
Year:
2019
Region / City:
South East London
Subject:
Shared care prescribing guidelines for spasticity treatment
Document type:
Clinical guideline
Author:
Not specified
Target audience:
General Practitioners (GPs), specialists, healthcare providers
Period of validity:
Ongoing
Approval date:
Not specified
Date of modifications:
Not specified
Year:
2023
Region / city:
UK
Theme:
Respiratory issues, multiple sclerosis (MS), physiotherapy
Document type:
Guidance
Organization / institution:
MS Trust
Author:
Jody Barber, Michelle Davies, Michelle Koch, Wendy Hendrie, Rhian O’Halloran, Ruth O’Regan
Target audience:
Physiotherapists, healthcare professionals
Action period:
Ongoing
Approval date:
March 2023
Revision date:
None mentioned
Year of Discovery:
1870s
Location of Discovery:
Paris, France
Medical Field:
Neurology
Document Type:
Informational article
Author:
Samantha Budge
Target Audience:
General public, students of human biology
Affected Population:
Mostly active adults
Symptoms:
Muscle weakness, poor balance, speech and swallowing difficulties, fatigue
Progression:
Loss of mobility, respiratory support needed, dietary adjustments
Life Expectancy:
Typically 2–8 years, occasionally over 10 years
Treatment Approaches:
Medications for spasms and cramps, physical therapy, rest, dietary management
Date Information Sheet Produced:
2 March 2022
Project Title:
Facilitators and barriers to adherence to a physical activity for people with Multiple Sclerosis (MS) in New Zealand: A narrative inquiry
Researcher:
Debbie Skilton
Qualification:
MPhil in Sport & Exercise (post graduate student)
Project Supervisor:
Gemma Alder
Institution:
Auckland University of Technology
Ethics Committee:
Auckland University of Technology Ethics Committee (AUTEC)
AUTEC Reference Number:
22/101
Date of Ethics Approval:
9 June 2022
Research Institute:
Health & Rehabilitation Research Institute (HRRI)
Country:
New Zealand
Study Design:
Narrative inquiry
Data Collection Method:
One-on-one interview (in person or online)
Interview Duration:
Approximately 1 hour
Recording Method:
Audio recording and written notes
Target Population:
Adults diagnosed with Multiple Sclerosis living in New Zealand
Eligibility Criteria:
Diagnosed with MS more than 3 months ago; stable symptoms; physically active; not an elite athlete; not undertaking structured rehabilitation; no cognitive or communication difficulties; able to communicate in English
Participation:
Voluntary with right of withdrawal
Data Storage Period:
6 years at AUT premises
Confidentiality:
De-identified and confidential data accessible only to the research team
Support Services:
AUT Health Counselling and Wellbeing (Auckland area)
Feedback to Participants:
Summary of findings and transcript review available upon request
Title:
Sample Letter of Medical Necessity for a Treatment-Naïve Patient
Product Name:
TYSABRI® (natalizumab)
Indication:
Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Target Population:
Adult patients with RMS
Document Type:
Sample letter template and prescribing safety information
Program:
TOUCH® Prescribing Program (REMS)
Risk Information:
Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML)
Contraindications:
History of PML; hypersensitivity to TYSABRI
Safety Topics:
PML, JCV infection, IRIS, herpes encephalitis and meningitis, acute retinal necrosis, hepatotoxicity
Monitoring Requirements:
MRI monitoring, anti-JCV antibody testing, clinical surveillance for neurological symptoms
Intended Users:
Healthcare providers
Purpose:
Support for medical necessity appeals and safety guidance for prescribing
Organisation:
Business Disability Forum
Related condition:
Multiple Sclerosis (MS)
Document type:
Workplace adjustment agreement template
Purpose:
Record of reasonable adjustments between employee and line manager
Scope:
Workplace accommodations and sickness absence procedures
Parties involved:
Employee; Line Manager; HR Team
Review occasions:
One-to-one meetings; return to work meetings; six monthly or annual appraisals; changes in role or circumstances
Includes:
Adjustment record; emergency contacts; keeping in touch arrangements; return to work planning; unauthorised absence procedure
Intended users:
Employees with MS and their line managers
Associated resources:
Work and MS tool kit; Understanding your work situation sheet
Year:
2023
Region / City:
Oxford, England
Topic:
Multiple Sclerosis, Patient Advocacy, Health Awards
Document Type:
Award Announcement
Organization:
Oxford Health Policy Forum
Author:
Not specified
Target Audience:
MS patients, healthcare professionals, advocacy groups
Date of Approval:
25 May 2023
Period of Validity:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
Galway, Ireland
Theme:
Cognitive Rehabilitation, Multiple Sclerosis, Health Research
Document Type:
Job Advertisement
Institution:
National University of Ireland, Galway
Author:
Dr. Sinéad Hynes
Target Audience:
Researchers, Academic Professionals, Health Practitioners
Duration:
4 months
Approval Date:
N/A
Modification Date:
N/A
Published Date:
Monday 23 April 2018
Last Reviewed:
Monday 23 April 2018
Authors:
Helen Cliffe; Marium Ahmed; Helen Ford; Mark Igra
Topic:
MRI surveillance and PML screening in multiple sclerosis
Type of Document:
Clinical audit protocol
Target Population:
Adult patients with highly active multiple sclerosis receiving Natalizumab (Tysabri)
Regulatory Framework:
European Medicines Agency recommendations; Summary of Product Characteristics for Tysabri
Clinical Focus:
Progressive multifocal leukoencephalopathy risk monitoring
Imaging Requirements:
Baseline MRI within 3 months prior to treatment; annual MRI surveillance including T1, T2/proton density, FLAIR, DWI and T1 post contrast
Risk Stratification:
JC virus antibody status; treatment duration over 2 years; prior immunosuppressant use
Audit Targets:
100% baseline MRI; 100% annual MRI; 100% protocol adherence
Suggested Cohort Size:
30–100 patients depending on hospital size
Referenced Guidance:
NICE Technology Appraisal TA127 (22 August 2007)
Producing organisation:
Bristol Technology Assessment Group
Document type:
Addendum to systematic review and economic model
Subject:
Clinical and cost effectiveness of natalizumab and its biosimilar in highly active relapsing-remitting multiple sclerosis
Interventions assessed:
Natalizumab (intravenous and subcutaneous) and natalizumab biosimilar (Tyruko)
Population:
Adults with highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy
Study inclusion criteria:
Randomised controlled trials comparing eligible interventions or placebo
Comparators considered:
Alemtuzumab, cladribine tablets, fingolimod, ocrelizumab, ofatumumab, ponesimod, interferon beta formulations, peginterferon beta 1a, glatiramer acetate
Manufacturers involved:
Biogen and Sandoz
Assessment components:
Clinical effectiveness review, network meta-analysis, cost-effectiveness modelling
Data sources:
Company submissions, published literature, previous technology appraisals
Economic perspective:
Cost-comparison submissions and EAG base case model
Geographical context:
United Kingdom
Regulatory context:
NICE technology appraisal process
Year:
2023
Type of document:
Supplemental Material
Authors:
Nola Chambers, Tosca-Marie Heunis, Sugnet Gardner-Lubbe, Jamie K Capal, Stacey Bissell, Anna W Byars, Sebastián Cukier, Peter E Davis, Jennifer Flinn, Tanjala T Gipson, J Chris Kingswood, Aubrey J Kumm, Eva Schoeters, Catherine Smith, Shoba Srivastava, Megumi Takei, Stephanie Vanclooster, Agnies M van Eeghen, Robert Waltereit, Darcy A Krueger, Mustafa Sahin, Liesbeth De Waele, Anna C Jansen, Petrus J de Vries
Field:
Neurodevelopmental Disorders
Focus:
Internal consistency and discriminant validity of TAND-SQ clusters
Population:
Individuals with Tuberous Sclerosis Complex (TSC)
Sample size:
92 (individuals), 66 (caregivers)
Data type:
Self-report checklist
Reference studies:
Alperin et al., 2021; de Vries et al., 2021; Leclezio et al., 2018; de Vries et al., 2020; Heunis et al., 2023
Year:
Not specified
Field of study:
Neuroscience; Neuroimmunology; Molecular Biology
Topic:
Meningeal inflammation and immune cell interactions in multiple sclerosis
Document type:
PhD research project description
Institution:
Imperial College London
Faculty:
Faculty of Medicine
Author / Supervisor:
Roberta Magliozzi
Research focus:
Multi-omic analysis of meningeal immune landscape and tertiary lymphoid-like structures in progressive multiple sclerosis
Methods:
Spatial transcriptomics; Mass spectrometry; Genome-wide association data integration; In-vitro cell culture models using hiPSC-derived neuronal and glial cells
Biological material:
Post-mortem meninges from multiple sclerosis donors and neurologically healthy controls
Sample size:
20 multiple sclerosis cases and 10 control individuals
Research objectives:
Identification of immune signatures, cellular interactions and molecular pathways associated with neuro-axonal damage and disease progression
Experimental models:
Human-induced pluripotent stem cell-derived neuronal and glial cell lines
Funding:
UKRI stipend and Faculty of Medicine course fees for three years with additional research consumables funding
Target applicants:
Graduates with honours degree in Biomedical Sciences and background in neuroscience, computer science, molecular biology or cell culture
Application materials:
Curriculum vitae and cover letter with contact details of two referees
Contact person:
Roberta Magliozzi
Year:
2022
Region / city:
Italy, United Kingdom
Topic:
Sero-epidemiology, Multiple Sclerosis, Herpesviruses
Document type:
Research Protocol
Organization / institution:
N/A
Author:
Bruno Gran, Peter Maple, Chris Tench
Target audience:
Researchers, Medical professionals
Duration:
N/A
Approval date:
05 September 2022
Modification date:
N/A