Neuromyelitis Optica Spectrum Disorder
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Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0). -
SPECIALTY MEDICATION ADMINISTRATION – SITE of CARE REVIEW GUIDELINES Policy Number: PHARMACY 276.15 T2 Effective Date: September 1, 2017
UnitedHealthcare® Oxford Clinical Policy SPECIALTY MEDICATION ADMINISTRATION – SITE OF CARE REVIEW GUIDELINES Policy Number: PHARMACY 276.15 T2 Effective Date: September 1, 2017 Table of Contents Page Related Policies INSTRUCTIONS FOR USE .......................................... 1 Actemra® (Tocilizumab) Injection for Intravenous CONDITIONS OF COVERAGE ...................................... 1 Infusion BENEFIT CONSIDERATIONS ...................................... 2 Entyvio® (Vedolizumab) COVERAGE RATIONALE ............................................. 2 Exondys 51™ (Eteplirsen) DEFINITIONS .......................................................... 3 Home Health Care DESCRIPTION OF SERVICES ...................................... 3 Infliximab (Remicade®, Inflectra™, Renflexis™) CLINICAL EVIDENCE ................................................. 3 ® REFERENCES ........................................................... 4 Orencia (Abatacept) Injection for Intravenous POLICY HISTORY/REVISION INFORMATION ................. 5 Infusion Radicava™ (Edaravone) Simponi Aria® (Golimumab) Injection for Intravenous Infusion Soliris® (Eculizumab) INSTRUCTIONS FOR USE This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford -
New Biological Therapies: Introduction to the Basis of the Risk of Infection
New biological therapies: introduction to the basis of the risk of infection Mario FERNÁNDEZ RUIZ, MD, PhD Unit of Infectious Diseases Hospital Universitario “12 de Octubre”, Madrid ESCMIDInstituto de Investigación eLibraryHospital “12 de Octubre” (i+12) © by author Transparency Declaration Over the last 24 months I have received honoraria for talks on behalf of • Astellas Pharma • Gillead Sciences • Roche • Sanofi • Qiagen Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Paul Ehrlich (1854-1915) • “side-chain” theory (1897) • receptor-ligand concept (1900) • “magic bullet” theory • foundation for specific chemotherapy (1906) • Nobel Prize in Physiology and Medicine (1908) (together with Metchnikoff) Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author 1981: B-1 antibody (tositumomab) anti-CD20 monoclonal antibody 1997: FDA approval of rituximab for the treatment of relapsed or refractory CD20-positive NHL 2001: FDA approval of imatinib for the treatment of chronic myelogenous leukemia Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Functional classification of targeted (biological) agents • Agents targeting soluble immune effector molecules • Agents targeting cell surface receptors -
International Consensus Guidance for Management of Myasthenia Gravis 2020 Update
VIEWS & REVIEWS OPEN ACCESS LEVEL OF RECOMMENDATION International Consensus Guidance for Management of Myasthenia Gravis 2020 Update Pushpa Narayanaswami, MBBS, DM, Donald B. Sanders, MD, Gil Wolfe, MD, Michael Benatar, MD, Correspondence Gabriel Cea, MD, Amelia Evoli, MD, Nils Erik Gilhus, MD, Isabel Illa, MD, Nancy L. Kuntz, MD, Janice Massey, MD, Dr. Narayanaswami Arthur Melms, MD, Hiroyuki Murai, MD, Michael Nicolle, MD, Jacqueline Palace, MD, David Richman, MD, and pnarayan@ Jan Verschuuren, MD bidmc.harvard.edu Neurology® 2021;96:114-122. doi:10.1212/WNL.0000000000011124 Abstract Objective To update the 2016 formal consensus-based guidance for the management of myasthenia gravis (MG) based on the latest evidence in the literature. Methods In October 2013, the Myasthenia Gravis Foundation of America appointed a Task Force to develop treatment guidance for MG, and a panel of 15 international experts was convened. The RAND/UCLA appropriateness method was used to develop consensus recommendations pertaining to 7 treatment topics. In February 2019, the international panel was reconvened with the addition of one member to represent South America. All previous recommendations were reviewed for currency, and new consensus recommendations were developed on topics that required inclusion or updates based on the recent literature. Up to 3 rounds of anonymous e-mail votes were used to reach consensus, with modifications to recommendations between rounds based on the panel input. A simple majority vote (80% of panel members voting “yes”) was used to approve minor changes in grammar and syntax to improve clarity. Results The previous recommendations for thymectomy were updated. New recommendations were developed for the use of rituximab, eculizumab, and methotrexate as well as for the following topics: early immunosuppression in ocular MG and MG associated with immune checkpoint inhibitor treatment. -
Neuromyelitis Optica News
Neuromyelitis Optica News Gloria von Geldern, MD Assistant Professor of Neurology University of Washington Multiple Sclerosis Center Multiple Sclerosis Regional Summit June 13, 2020 Disclosures ▪ No conflict of interest ▪ Off-label treatments will be mentioned Current research funding Patient-Centered Outcomes Research Institute (PCORI) What is New in NMO? Natalia Rost, MD Chair scientific committee AAN Neuromyelitis Optica (NMO) Neuromyelitis Optica Spectrum Disease (NMOSD) ▪ Inflammatory disorder of the central nervous system ▪ Predominantly involving optic nerves and spinal cord ▪ Severe demyelination and axonal damage ▪ Rare disease: 0.5-10/100,000, ~8,000 patients in the US ▪ Black > Asian > White ▪ Female > Male Flanagan et al., 2016 Bukhari et al. 2017 Hor et al. 2018 (Guthy-Jackson Charitable Foundation) Multiple Sclerosis vs NMO Pittock and Lucchinetti 2016 History 1894: Clinical case descriptions 2004: AQP4 antibody identified by Devic and Gault by Lennon, Weinshenker et al. Eugene Devic (1858–1930) Lancet2004; 364: 2106–12; Journal of Neuroinflammation 2013, 10:8 Diagnostic Criteria Wingerchuk et al. 2015 Myelin Oligodendrocyte (MOG) Antibody ▪ More common in men and whites ▪ Bilateral optic neuritis, caudal myelitis ▪ Better recovery compared to AQP4-Ab pos NMO ▪ MRI brain without NMO findings ▪ Assay now commercially available at Mayo Sato et al. 2014; van Pelt et al. 2016 Auto-Antibody to Aquaporin 4 Water channel protein in ▪ Astrocytic foot processes at the blood-brain barrier ▪ Spinal cord grey matter ▪ Periaqueductal and periventricular regions ▪ Mueller cells in the retina Amiry-Moghaddam and Otterson 2003 Bystander Oligodendrocyte Injury Tradtrantip et al 2017 Pathology Extensive demyelination Perivascular & parenchymal Complement activation Axonal injury, necrosis eosinophils & granulocytes rosette and rim pattern Jacob et al. -
HY 2021 Results
Roche HY 2021 results Basel, 22 July 2021 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected. -
Biologic Immunomodulators Pa Summary
GEORGIA MEDICAID FEE-FOR-SERVICE BIOLOGIC IMMUNOMODULATORS PA SUMMARY Preferred Non-Preferred Arcalyst (rilonacept) Actemra Subcutaneous (tocilizumab) Benlysta subcutaneous (belimumab) Cimzia (certolizumab) Enbrel (etanercept) Cosentyx (secukinumab) Humira (adalimumab) Dupixent (dupilumab) Ilaris (canakinumab) Enspryng (satralizumab-mwge) Xeljanz (tofacitinib) Fasenra Pen (benralizumab autoinjector) Xeljanz XR (tofacitinib extended-release) Kevzara (sarilumab) Kineret (anakinra) Nucala Pen (mepolizumab autoinjector) Olumiant (baricitinib) Orencia Subcutaneous (abatacept) Otezla (apremilast) Rinvoq (upadacitinib) Siliq (brodalumab) Simponi (golimumab) Stelara (ustekinumab) Skyrizi (risankizumab) Taltz (ixekizumab) Tremfya (guselkumab) The drug names above include all available oral or subcutaneous formulations under the same primary name. LENGTH OF AUTHORIZATION: Varies NOTES: ▪ All preferred and non-preferred products require prior authorization. Intravenous (IV) formulations of the biologic immunomodulators are not covered under Pharmacy Services. ▪ The criteria details below are for the outpatient pharmacy program. If a medication is being administered in a physician’s office or clinic, then the medication must be billed through the DCH physician services program and not the outpatient pharmacy program. Information regarding the physician services program is located at www.mmis.georgia.gov. PA CRITERIA: Actemra Subcutaneous ❖ Approvable for members 2 years of age or older with a diagnosis of moderately to severely active polyarticular -
Middle Level IM-MS and CIU Experiments for Improved Therapeutic Immunoglobulin Subclass Fingerprinting ACS Paragon Plus Environment Analytical Chemistry T
Middle level IM-MS and CIU experiments for improved therapeutic immunoglobulin subclass fingerprinting ACS Paragon Plus Environment Analytical Chemistry T. Botzanowski, O. Hernandez-Alba, M. Malissard, E. Wagner-Rousset, E. Desligniere, O. Colas, F. Haeuw J., A. Beck, S. Cianferani To cite this version: T. Botzanowski, O. Hernandez-Alba, M. Malissard, E. Wagner-Rousset, E. Desligniere, et al.. Middle level IM-MS and CIU experiments for improved therapeutic immunoglobulin subclass fingerprinting ACS Paragon Plus Environment Analytical Chemistry. Analytical Chemistry, American Chemical Society, 2020, 92 (13), pp.8827-8835. 10.1021/acs.analchem.0c00293. hal-02960844 HAL Id: hal-02960844 https://hal.archives-ouvertes.fr/hal-02960844 Submitted on 8 Oct 2020 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Analytical Chemistry This document is confidential and is proprietary to the American Chemical Society and its authors. Do not copy or disclose without written permission. If you have received this item in error, notify the sender and delete all copies. -
Submission of Eculizumab for NMOSD to PBAC Meeting November 2020
PBAC Secretariat MDP 952 Department of Health and Ageing GPO Box 9848 Canberra ACT 2601 7 October 2020 Re: Submission of eculizumab for NMOSD to PBAC meeting November 2020 This is a joint submission to the Pharmaceutical Benefits Advisory Committee (PBAC) in relation to eculizumab (Soliris) for neuromyelitis optica spectrum disorder (NMOSD) from MS Research Australia, the Centre for Community-Driven Research and MS Australia. • MS Research Australia is the largest national not-for-profit organisation dedicated to funding MS discoveries and coordinating MS research in Australia. • The Centre for Community-Driven Research is a non-profit organisation with expertise in gathering patient experience and expectations data. • MS Australia is the national voice for people with multiple sclerosis. MS Australia works in advocacy and communications and collaborates with their stakeholders to benefit thousands of people affected by MS across the country. MS Research Australia and MS Australia are writing to support the inclusion of eculizumab on the Pharmaceutical Benefits Scheme (PBS) for people with NMOSD. The Centre for Community-Driven Research is keen to inform the PBAC about the experience of people with NMOSD and their expectations of new treatments. The NMOSD community in Australia is not represented by a national peak body and as NMOSD and MS have some similarities, we are proud to advocate on behalf of those living with NMOSD. One area we are all particularly passionate about is the provision of affordable and accessible treatments that can improve the lives of people with NMOSD. About NMOSD NMOSD is a recently defined inflammatory disorder of the central nervous system (CNS) that was previously either misdiagnosed as MS or identified as Devic’s disease. -
Cimzia (Certolizumab Pegol) AHM
Cimzia (Certolizumab Pegol) AHM Clinical Indications • Cimzia (Certolizumab Pegol) is considered medically necessary for adult members 18 years of age or older with moderately-to-severely active disease when ALL of the following conditions are met o Moderately-to-severely active Crohn's disease as manifested by 1 or more of the following . Diarrhea . Abdominal pain . Bleeding . Weight loss . Perianal disease . Internal fistulae . Intestinal obstruction . Megacolon . Extra-intestinal manifestations: arthritis or spondylitis o Crohn's disease has remained active despite treatment with 1 or more of the following . Corticosteroids . 6-mercaptopurine/azathioprine • Certollizumab pegol (see note) is considered medically necessary for persons with active psoriatic arthritis who meet criteria in Psoriasis and Psoriatic Arthritis: Biological Therapies. • Cimzia, (Certolizumab Pegol), alone or in combination with methotrexate (MTX), is considered medically necessary for the treatment of adult members 18 years of age or older with moderately-to-severely active rheumatoid arthritis (RA). • Cimzia (Certolizumab pegol is considered medically necessary for reducing signs and symptoms of members with active ankylosing spondylitis who have an inadequate response to 2 or more NSAIDs. • Cimzia (Certolizumab Pegol) is considered investigational for all other indications (e.g.,ocular inflammation/uveitis; not an all-inclusive list) because its effectiveness for indications other than the ones listed above has not been established. Notes • There are several brands of targeted immune modulators on the market. There is a lack of reliable evidence that any one brand of targeted immune modulator is superior to other brands for medically necessary indications. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Simponi (golimumab), Simponi Aria (golimumab intravneous), and Stelara (ustekinumab) brands of targeted immune modulators ("least cost brands of targeted immune modulators") are less costly to the plan. -
CDER Breakthrough Therapy Designation Approvals Data As of December 31, 2020 Total of 190 Approvals
CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2020 Total of 190 Approvals Submission Application Type and Proprietary Approval Use Number Number Name Established Name Applicant Date Treatment of patients with previously BLA 125486 ORIGINAL-1 GAZYVA OBINUTUZUMAB GENENTECH INC 01-Nov-2013 untreated chronic lymphocytic leukemia in combination with chlorambucil Treatment of patients with mantle cell NDA 205552 ORIGINAL-1 IMBRUVICA IBRUTINIB PHARMACYCLICS LLC 13-Nov-2013 lymphoma (MCL) Treatment of chronic hepatitis C NDA 204671 ORIGINAL-1 SOVALDI SOFOSBUVIR GILEAD SCIENCES INC 06-Dec-2013 infection Treatment of cystic fibrosis patients age VERTEX PHARMACEUTICALS NDA 203188 SUPPLEMENT-4 KALYDECO IVACAFTOR 21-Feb-2014 6 years and older who have mutations INC in the CFTR gene Treatment of previously untreated NOVARTIS patients with chronic lymphocytic BLA 125326 SUPPLEMENT-60 ARZERRA OFATUMUMAB PHARMACEUTICALS 17-Apr-2014 leukemia (CLL) for whom fludarabine- CORPORATION based therapy is considered inappropriate Treatment of patients with anaplastic NOVARTIS lymphoma kinase (ALK)-positive NDA 205755 ORIGINAL-1 ZYKADIA CERITINIB 29-Apr-2014 PHARMACEUTICALS CORP metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients NDA 206545 ORIGINAL-1 ZYDELIG IDELALISIB GILEAD SCIENCES INC 23-Jul-2014 for whom rituximab alone would be considered appropriate therapy due to other co-morbidities -
Soliris (Eculizumab) NON HEMATOLOGY POLICY Intravenous Department: PHA
Policy Title: Soliris (eculizumab) NON HEMATOLOGY POLICY Intravenous Department: PHA Effective Date: 01/01/2020 Review Date: 09/18/2019, 12/20/2019, 1/22/2020, 12/2020, 5/27/2021 Revision Date: 09/18/2019, 1/22/2020, 12/2020 Purpose: To support safe, effective and appropriate use of Soliris (eculizumab). Scope: Medicaid, Commercial, Medicare-Medicaid Plan (MMP) Policy Statement: Soliris (eculizumab) is covered under the Medical Benefit when used within the following guidelines. Use outside of these guidelines may result in non-payment unless approved under an exception process. For Hematology indications, please refer to the NHPRI Soliris Hematology Policy Procedure: Coverage of Soliris (eculizumab) will be reviewed prospectively via the prior authorization process based on criteria below. Initial Criteria: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements. Neuromyelitis optica spectrum disorder (NMOSD) Submission of medical records (e.g., chart notes, laboratory values, etc.) to support the diagnosis of neuromyelitis optica spectrum disorder (NMOSD) by a neurologist confirming all of the following: Past medical history of one of the following: . Optic neuritis . Acute myelitis . Area postrema syndrome: episode of otherwise unexplained hiccups or nausea and vomiting . Acute brainstem syndrome . Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD- typical diencephalic MRI lesions . Symptomatic cerebral syndrome with NMOSD-typical brain