Indications the indications below including fdaapproved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. In an appraisal undertaken by the national institute for health and care excellence nice, the company roche presented the evidence for ocrelizumab used in patients with ppms, which came from one single randomised controlled trial rct comparing ocrelizumab. Interrupting rituximab treatment in relapsingremitting. Turning science into patient benefits alan hippe, cfo roche group. Kolme tuoretta kliinista tutkimusta osoittaa, etta ocrelizumab voi merkittavasti vahentaa uusia pahenemisvaiheita aaltoilevasti etenevaa rrms mstautia sairastavilla seka. Please click on the link below to search for individual criteria for use.
More recently, three oral drugs and several infused. Points will made about the use of methotrexate in the rheumatoid arthritis ocrelizumab trial populations. Ocrevus and coronavirus disease covid19 in multiple. As neuro doc points out in his previous comment, it appears that ocrevus reduces csf t cells by 60%, so its not only affecting t cell populations. Ocrelizumab may cause unpleasant side effects while the medicine is injected, or up to 24 hours later. Ocrelizumab is a recombinant humanised anticd20 monoclonal antibody. This is the first ever approval of a diseasemodifying therapy dmt for individuals living with primaryprogressive ms and marks a big step forward in progressive ms research. Ocrelizumab ocrevus is indicated for the treatment of adult patients with. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. A manometric respirometry test according to oecd guideline no.
Length of authorization coverage will be provided for 6 months and is eligible for renewal. Ms summit june 11, 2016 national multiple sclerosis society. Ocrevus is a medicine for treating multiple sclerosis an inflammatory disease of the nervous system that causes symptoms such as weakness, difficulty walking and problems with vision. This document responds to your request for information on the coronavirus disease 2019 covid19 and the use of ocrevus ocrelizumab in patients with multiple sclerosis. Browse through our extensive list of forms and find the right one for your needs. Marika talabova2 1neurologicka klinika lf uk a fn plzen 2neurologicka klinika lf uk a fn hradec kralove ocrelizumab ocrevus je humanizovana monoklonalni protilatka, ktera byla schvalena americkym uradem food.
Binding potencies of ocrelizumab for the highaffinity fcg receptor, fcgria and for the lowaffinity fc g receptors, fcg riia and fc g riib were very similar to those of rituximab. Inbrief clinical experience we are aware of multiple reports of. Pdf converter is a online webbased document to pdf converter software. Studies show it may work better to lower relapses and to slow your ms than some interferon beta drugs. The association is strongest for igg and less so for igm or iga. Clinical guidance criteria for use the content on this page has been incorporated into the va national formulary search tool. Bsa by gender and dose following bsabased dosing simulation with estimated parameters from the population pk model was performed to predict exposure following a fixed dosing regimen. Submit medical drug prior authorization requests online. While patients and others may access this document. Patients originally received placebo, lowdose 600 mg, or highdose 2000 mg ocrelizumab, given in two doses on day 1 and day 15, or interferon beta1a 30 microg one time per week, intramuscularly.
Talk to your doctor before you are given ocrevus if any of the. Patient is not receiving ocrelizumab in combination with any of the following. These white blood cells play a role in multiple sclerosis by attacking the sheaths around the nerves in. Expected to reduce immunogenicity has a modified fc portion that potentially reduces side effects related to complement activation cw rituximab greater adcc and less cdc than rituximab genetic variants of fc riiia in humans may impact. Page 5 of 42 relapsing remitting multiple sclerosis rrms ocrevus ocrelizumab is indicated. Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy. Multiple sclerosis research mcgovern medical school. Ocrelizumab and pml as of may 2019, there have been 7 confirmed cases of carryover pmla in ms patients treated with ocrelizumab, out of more than 100,000 patients treated globally clinical trials and postmarketing experience. First in a twopart series on readers comments about ocrevus ocrelizumab. Examples of unacceptable toxicity include the following. Ocrevus ocrelizumab dosing, indications, interactions. Comprehensive and uptodate drug news for both consumers and healthcare professionals.
Ocrelizumab for treating primary progressive multiple sclerosis 3 of 17 to gain further insight into the views of those affected, we conducted an online survey of people with ppms, their families and specialist ms health professionals, receiving nearly 500. Ocrelizumab for treating patients with primary progressive. Ocrelizumab for treating primary progressive multiple sclerosis nice. Ocrelizumab, sold under the brand name ocrevus, is a humanized anticd20 monoclonal antibody. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Ocrelizumab 300mg x 2 2 weeks apart iv every 24 weeks vs placebo for 120 weeks monoclonal antibody targeting b cells cd20.
Drug prior authorization form ocrevus ocrelizumab the purpose of this form is to obtain information required to assess your drug claim. Ocrelizumab rochebiogen idec is a humanized anticd20 monoclonal antibody that targets mature b lymphocytes. Uuden laakkeen osoitettiin kolmessa kliinisessa kokeessa vahentavan uusia oireita ja hidastavan taudin etenemista. Safety data per study and the results of a metaanalysis of serious infectious events sies are presented. May 07, 2019 is this the only news of interest from aan 2019. Ocrelizumab for treating primary progressive multiple. Applications and forms for health care professionals in the aetna network and their patients can be found here. Corporate medical policy blue cross and blue shield of.
Your claim assessment will be delayed if this form is. Because of this property, ocrelizumab acts as an immunomodulatory drug by targeting and removing potentially harmful b cells in. Ocrevus ocrelizumab initial dose two infusions 300 mg10 ml sdv vials are diluted in ns to a final concentration of 1. Over 6 years of ocrelizumab treatment, an increasing reduction in serum ig levels is observed, with an apparent association with increased rates of sis. A large phase ii clinical trial in patients with relapsingremitting ms rrms designed to explore the effects of two doses of ocrelizumab 600 mg and 2000 mg. Approval for coverage of this drug may be reassessed at any time at greatwest lifes discretion. Rankin professorships of neurology, was a member of the faculty of the graduate school of biomedical sciences, and served as. Tell your caregivers if you have unpleasant side effects such as dizziness, nausea, skin rash, chest tightness, or trouble breathing within 24 hours after your injection ocrelizumab affects your immune system.
Wolinsky, md is professor emeritus in the department of neurology at the mcgovern medical school, the university of texas health science center at houston uthealth. Treatment with ocrevus ocrelizumab should be initiated and. Highlights of prescribing information these highlights do not include all the information needed to use orencia safely and effectively. Ocrevus ocrelizumab commercial medical benefit drug.
Jun 15, 2018 multiple sclerosis recent guidelines 2018 dr. Any modification of this document without the express written consent of canada life is strictly prohibited. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their nhs clinician consider it appropriate to stop. Specialty guideline management ocrevus ocrelizumab policy i. Australian public assessment report for ocrelizumab. The active substance in ocrevus, ocrelizumab, is a monoclonal antibody designed to recognise and attach to a target called cd20 on the surface of certain types of white blood cells so called b cells. Ocrelizumab is a monoclonal antibody that specifically targets cd20, a protein that is found on the surface of white blood cells called b lymphocytes or b cells. This form is to be used by participating physicians to obtain coverage for ocrevus. Objective the objective was to determine the safety of ocrelizumab ocr in patients with rheumatoid arthritis ra. How do i view different file formats pdf, doc, ppt, mpeg on this site. Ocrelizumab and rituximab exhibited similar e quilibrium binding affinities for binding to cd20 on wil2s cells study 0303870349.
Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Ocrelizumab versus interferon beta1a in relapsing multiple sclerosis article pdf available in new england journal of medicine 3763 december 2016 with 305 reads how we measure reads. For commercial members only, please complete this form and submit via fax to 18773255979. Patient has not received a dose of ocrelizumab within the past 5 months. Ocrelizumab is a recombinant humanised anticd20 monoclonal antibody produced in chinese hamster ovary cells by recombinant dna technology. If you wish to participate in any of the trials or have general questions please contact our research coordinator at 75007045. Protocol this trial protocol has been provided by the authors to give readers additional information about their work. Ocrelizumab is a monoclonal antibody and targets b cells that damage nerves. Inbrief clinical experience we are aware of multiple reports of ocrevustreated patients who have tested positive for. No known genetic factors affect the pk of ocrelizumab, and the word genetic. Submission pm20160158011 extract from the clinical evaluation report for ocrelizumab page 8 of 171 1. Ocrelizumab is indicated for relapsing remitting and primary progressive multiple sclerosis rrms and ppms, respectively. Results of a fortyeightweek randomized, doubleblind, placebocontrolled, parallelgroup phase iii trial.
The information contained in this document is a statement of. And absence of unacceptable toxicity from the drug. The median dose of 2 mg was chosen for the simulation. Ocrelizumab is the active pharmaceutical ingredient used in the roche product ocrevus 6. Highlights of prescribing information hypocalcemia may worsen. Ocrelizumab for treating relapsing multiple sclerosis id937 consultation on the appraisal consultation document deadline for comments 17. Interrupting rituximab treatment in relapsingremitting multiple sclerosis. Niosh list of antineoplastic and other hazardous drugs in. I switched diseasemodifying therapies and began treatment with ocrevus ocrelizumab in june. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. This clinical policy is effective as of the date determined by the health plan.
Corporate medical policy page 1 of 5 an independent licensee of the blue cross and blue shield association ocrelizumab ocrevus file name. Highlights of prescribing information these highlights do not include all the information needed to use gazyva safely and effectively. Design of the ocrelizumab pregnancy registry to assess maternal. Convert and create pdf from various types of files like word doc, excel xls, powerpoint ppt. Ocrevus referral form required documents please fax 1. Department of health and human services, centers for disease control and prevention, national institute for occupa. Learn about ocrevus ocrelizumab, a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis. It is approved for primary progressive and relapsing forms of multiple sclerosis 7. The public inspection page may also include documents scheduled for later issues, at the request of the issuing agency. Ocrevustm ocrelizumab injection, for intravenous use.
Faq ocrelizumab ocrevus for primary progressive multiple sclerosis ppms updated march 2018 1. Ocrevus ocrelizumab commercial medical benefit drug policy. Ocrevus ocrelizumab page 1 of 6 unitedhealthcare oxford clinical policy effective 06012018. Instruct the patient of the importance of contacting their doctor if they develop any. To download multiple files at once, select the checkbox next to each file you would like to download from the list below then click download selected. Methods this was an analysis of the doubleblind, placebocontrolled periods and longterm followup of 4 ocr phase iii trials in ra script, stage, film and feature.
Aex32 print centers for disease control and prevention. Pdf ocrelizumab versus interferon beta1a in relapsing. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. The information in this document is intended to help canadian health care decisionmakers, health care professionals, health systems leaders, and policymakers make wellinformed decisions and thereby improve the quality of health care services. Diseasemodifying medications are the best strategy currently available to slow the natural course of ms. May 28, 2019 points will made about the use of methotrexate in the rheumatoid arthritis ocrelizumab trial populations. Hsv2 encephalitis with ocrelizumab multiple sclerosis. Ocrelizumab ocrelizumab is a fully humanized igg1 anticd20 lytic.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. This helps to reduce the immune response by stopping these cells from attacking and damaging myelin. Importantly, patients receiving remicade who developed malignancies in clinical trials or the postmarketing setting. Feb 03, 2014 tak pp, mease pj, genovese mc, kremer j, haraoui b, et al. Gazyva obinutuzumab injection, for intravenous use initial u. Demographic and insurance information a copy of the front and back of the card, and subscribers. Ocrelizumab is a monoclonal antibody that specifically targets cd20, a protein found on the surface of white blood cells called b lymphocytes or b cells. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Ocrelizumab for treating relapsing multiple sclerosis id937. Ocrelizumab was licensed by the european medicines agency in january 2018 for people with relapsing ms and for people with early primary progressive ms. It targets cd20 marker on b lymphocytes and hence is an immunosuppressive drug.
Other policies and coverage determination guidelines may. Ocrelizumab for treating primary progressive multiple sclerosis ta585. To reduce the risk of infusion reaction, your doctor or nurse will give you. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Ocrelizumab works by targeting a type of immune cell called a b cell.
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