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Ocrelizumab (Ocrevus) - early primary progressive multiplesclerosis (PPMS) 1 Published 13 January 2020 1 SMC2223 ocrelizumab 300mg concentrate for solution for infusion (Ocrevus®) Roche Products Ltd 6 December 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission assessed under (...) the orphan medicine process ocrelizumab (Ocrevus ® ) is accepted for use within NHSScotland. Indication under review: for the treatment of adult patients with early primary progressive multiplesclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. In a randomised, double-blind, phase III study, the risk of disability progression was significantly reduced in patients who received ocrelizumab compared with placebo
Fampridine (Fampyra) - multiplesclerosis Final Appraisal Recommendation Advice No: 1919 – December 2019 Fampridine (Fampyra ® ) 10 mg prolonged-release tablets Submission by Biogen Idec Ltd In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 3942), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR (...) , clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Fampridine (Fampyra ® ) is recommended as an option for use within NHS Wales for the improvement of walking in adult patients with multiplesclerosis with walking disability (Expanded Disability Status Scale [EDSS] 4 to 7
Disease modifying treatments for relapsing remitting multiplesclerosis. A health economic evaluation Disease modifying treatments for relapsing remitting multiplesclerosis - NIPH Search for: Søk Menu To top level Close Infectious diseases & Vaccines Mental & Physical health Environment & Lifestyle Health in Norway Quality & Knowledge Research & Access to data About NIPH Close Disease modifying treatments for relapsing remitting multiplesclerosis Order Download: Key message The Norwegian (...) Institute of Public health has previously assessed the efficacy, safety and cost effectiveness of drugs for relapsing remitting multiplesclerosis. In this report, three new drugs (cladribine, ocrelizumab and rituximab) are included. Effectiveness, safety and legal aspects are reported in a separate publication, as is ethical considerations. This report assesses the included drugs in light of the Norwegian priority setting criteria (benefit, resource use and disease severity). Relapsing remitting
Disease-modifying treatments for relapsing remitting multiplesclerosis, including rituximab Disease-modifying treatments for relapsing remitting multiplesclerosis, including rituximab. A health technology assessment. - NIPH Search for: Søk Menu To top level Close Infectious diseases & Vaccines Mental & Physical health Environment & Lifestyle Health in Norway Quality & Knowledge Research & Access to data About NIPH Close Disease-modifying treatments for relapsing remitting multiplesclerosis (...) , including rituximab. A health technology assessment. Order Download: Key message We have systematically collected and reviewed the evidence for clinical effectiveness and general safety issues for disease modifying treatments for relapsing remitting multiplesclerosis, synthesised evidence from randomised controlled trials and non-randomised registry-based studies using network meta-regression, and carefully interpreted the findings. We included rituximab in our analysis as it is used off-label
Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiplesclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial Ozanimod is a sphingosine 1-phosphate receptor modulator, which selectively binds to sphingosine 1-phosphate receptor subtypes 1 and 5 with high affinity. In the RADIANCE phase 2 study in participants with relapsing multiplesclerosis, ozanimod was associated with better efficacy than placebo on MRI measures and was well tolerated. The RADIANCE (...) phase 3 study aimed to confirm the safety and efficacy of ozanimod versus interferon beta-1a in individuals with relapsing multiple sclerosis.We did a 24-month, multicentre, double-blind, double-dummy phase 3 trial in participants with relapsing multiplesclerosis at 147 medical centres and clinical practices in 21 countries. Participants were aged 18-55 years, had multiplesclerosis according to 2010 McDonald criteria, a relapsing clinical course, brain MRI lesions consistent with multiple
Autologous haematopoietic stem cell transplant for patients with highly active relapsing remitting multiplesclerosis not responding to high efficacy disease modifying therapies SHTG Advice | 1 SHTG Advice Number 07 October 2019 In response to an enquiry from the Strategic Planning and Clinical Priorities Team, Planning and Quality Division, Scottish Government Autologous haematopoietic stem cell transplant for patients with highly active relapsing remitting multiplesclerosis not responding (...) to high-efficacy disease modifying therapies Advice for NHSScotland Where patients understand and are willing to accept the demands, risks and uncertainties of treatment, autologous haematopoietic stem cell transplant (AHSCT) should be considered as a treatment option for patients with relapsing-remitting multiplesclerosis (RRMS) who have evidence of significant inflammatory disease activity that has not responded to adequate treatment with licensed high-efficacy disease modifying therapies (DMTs
Minocycline for Relapsing-Remitting MultipleSclerosis and Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines Minocycline for Relapsing-Remitting MultipleSclerosis and Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines | CADTH.ca Find the information you need Minocycline for Relapsing-Remitting MultipleSclerosis and Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines Minocycline for Relapsing-Remitting (...) MultipleSclerosis and Clinically Isolated Syndrome: A Review of Clinical Effectiveness and Guidelines Last updated: September 16, 2019 Project Number: RC1183-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of minocycline for relapsing-remitting multiplesclerosis? What is the clinical effectiveness of minocycline for clinically isolated syndrome? What are the evidence-based guidelines regarding
Second-Line Therapy for Patients with Relapsing-Remitting MultipleSclerosis: A Review of Guidelines Second-Line Therapy for Patients with Relapsing-Remitting MultipleSclerosis: A Review of Guidelines | CADTH.ca Find the information you need Second-Line Therapy for Patients with Relapsing-Remitting MultipleSclerosis: A Review of Guidelines Second-Line Therapy for Patients with Relapsing-Remitting MultipleSclerosis: A Review of Guidelines Last updated: September 26, 2019 Project Number (...) : RC1190-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What are the evidence-based guidelines regarding switching to a second-line therapy in patients with relapsing-remitting multiplesclerosis? Key Message One evidence-based guideline was identified with one strong recommendation regarding switching from an interferon or glatiramer acetate to a second-line therapy in patients with relapsing-remitting multiplesclerosis and evidence
Vaccine-preventable Infections and Immunization in MultipleSclerosis 1 Practice guideline update: Vaccine-preventable infections and immunization in multiplesclerosis Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology Mauricio F. Farez, MD, MPH, 1 Jorge Correale, MD, 1,2 Melissa J. Armstrong, MD, MSc, 3 Alexander Rae-Grant, MD, 4 David Gloss, MD, 5 Diane Donley, MD, 6 Yolanda Holler-Managan, MD, 7 Norman J. Kachuck, MD, 8 (...) . Department of Pediatrics, Neurology Division, Loma Linda University Health Care, CA 13. American Academy of Neurology, Minneapolis, MN 14. US Centers for Disease Control and Prevention, Atlanta, GA 15. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA Address correspondence and reprint requests to American Academy of Neurology: firstname.lastname@example.org This practice guideline was endorsed by the MultipleSclerosis Association of America on January 11, 2019
Fingolimod (multiplesclerosis in children and adolescents) - Addendum to Commission A18-87 1 Translation of addendum A19-42 Fingolimod (multiple Sklerose bei Kindern und Jugendlichen) – Addendum zum Auftrag A18-87 (Version 1.0; Status: 28 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 28 May 2019 1.0 Commission: A19-42 Version: Status (...) : IQWiG Reports – Commission No. A19-42 Fingolimod (multiplesclerosis in children and adolescents) – Addendum to Commission A18-87 1 Addendum A19-42 Version 1.0 Fingolimod – Addendum to Commission A18-87 28 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Fingolimod (multiplesclerosis in children and adolescents) – Addendum to Commission A18-87 Commissioning agency: Federal Joint
Mindfulness-based interventions for mental well-being among people with multiplesclerosis: a systematic review and meta-analysis of randomised controlled trials Impairment of mental well-being (anxiety, depression, stress) is common among people with multiplesclerosis (PwMS). Treatment options are limited, particularly for anxiety. The aim of this study was to update our previous systematic review (2014) and evaluate via meta-analysis the efficacy of mindfulness-based interventions (MBIs
Long-term disability progression of pediatric-onset multiplesclerosis To evaluate long-term disability progression in pediatric-onset multiplesclerosis (POMS) and compare to adult-onset multiplesclerosis (AOMS).This was a retrospective cohort study using prospectively collected clinical information from the Swedish MS Registry. Clinical features were compared and Kaplan-Meier and Cox proportional hazards regression were used to assess the risk of reaching sustained Expanded Disability Status (...) Scale (EDSS) 3, 4, and 6 in POMS (multiplesclerosis [MS] onset <18 years) and AOMS (MS onset ≥18 years).A total of 12,482 persons were included; 549 (4.4%) were classified as POMS. The POMS cohort took longer to reach all 3 disability milestones from their MS onset, but did so at a younger age than the AOMS cohort. Primary progressive course (hazard ratio [HR] 4.63; 95% confidence interval [CI] 1.46-14.7), higher relapse rate in the first 5 years of disease (HR 5.35; 95% CI 3.37-8.49), and complete
Placebo-Controlled Trial of an Oral BTK Inhibitor in MultipleSclerosis. Bruton's tyrosine kinase (BTK) regulates the functions of B cells and myeloid cells that are implicated in the pathogenesis of multiplesclerosis. Evobrutinib is a selective oral BTK inhibitor that has been shown to inhibit B-cell activation both in vitro and in vivo.In this double-blind, randomized, phase 2 trial, we assigned patients with relapsing multiplesclerosis to one of five groups: placebo, evobrutinib (at a dose (...) with relapsing multiplesclerosis who received 75 mg of evobrutinib once daily had significantly fewer enhancing lesions during weeks 12 through 24 than those who received placebo. There was no significant difference with placebo for either the 25-mg once-daily or 75-mg twice-daily dose of evobrutinib, nor in the annualized relapse rate or disability progression at any dose. Longer and larger trials are required to determine the effect and risks of evobrutinib in patients with multiplesclerosis. (Funded
Fingolimod (Gilenya) - highly active relapsing remitting multiplesclerosis Published 10 June 2019 1 Product update SMC2154 fingolimod 0.25mg, 0.5mg hard capsules (Gilenya®) Novartis Pharmaceuticals UK Ltd 5 April 2019 (Issued 10 May 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated (...) submission fingolimod (Gilenya®) is accepted for use within NHSScotland. Indication under review: as a single disease modifying therapy in highly active relapsing remitting multiplesclerosis for the following groups of patients aged 10 to <18 years: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy. or - Patients with rapidly evolving severe relapsing remitting multiplesclerosis defined by two or more disabling relapses
Fingolimod (Gilenya) - highly active relapsing remitting multiplesclerosis Final Appraisal Recommendation Advice No: 0719 – May 2019 Fingolimod (Gilenya ® ) 0.25 mg and 0.5 mg hard capsules Limited submission by Novartis Pharmaceuticals UK Ltd Additional note(s): ? Please refer to the Summary of Product Characteristics for the full licensed indication. ? It is the view of AWMSG that treatment for those aged under 16 years should be initiated and supervised by a paediatric neurologist (...) and will be considered for review every three years. Recommendation of AWMSG Fingolimod (Gilenya®) is recommended as an option for use within NHS Wales as a single disease modifying therapy in highly active relapsing remitting multiplesclerosis for the following groups of paediatric patients aged 10 –17 years: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy; or patients with rapidly evolving severe relapsing remitting multiplesclerosis
Percutaneous transluminal angioplasty for treatment of chronic cerebrospinal venous insufficiency (CCSVI) in people with multiplesclerosis. Multiplesclerosis (MS) is a leading cause of neurological disability in young adults. The most widely accepted hypothesis regarding its pathogenesis is that it is an immune-mediated disease. It has been hypothesised that intraluminal defects, compression, or hypoplasia in the internal jugular or azygos veins may be important factors in the pathogenesis (...) . This is an update of a review first published in 2012.To assess the benefit and safety of venous PTA in people with MS and CCSVI.We searched the Cochrane MultipleSclerosis and Rare Diseases of the Central Nervous System Group's Specialised Register up to 30 August 2018, CENTRAL (in the Cochrane Library 2018, issue 8), MEDLINE up to 30 August 2018, Embase up to 30 August 2018, metaRegister of Controlled Trials, ClinicalTrials.gov., the Australian New Zealand Clinical Trials Registry, and the World Health
Siponimod (Mayzent) - To treat adults with relapsing forms of multiplesclerosis Drug Approval Package: Mayzent (siponimod) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Mayzent (siponimod) Company: Novartis Pharmaceuticals Corporation Application Number: 209884 Approval Date: 03/26/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA