Medication Policy Manual. Topic: Gilenya, fingolimod Date of Origin: November 22, 2010

Size: px
Start display at page:

Download "Medication Policy Manual. Topic: Gilenya, fingolimod Date of Origin: November 22, 2010"

Transcription

1 Medication Policy Manual Policy No: dru229 Topic: Gilenya, fingolimod Date of Origin: November 22, 2010 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective Date: January 1, 2016 IMPORTANT REMINDER This Medication Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medication policy is to provide a guide to coverage. Medication Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Fingolimod (Gilenya) is an oral medication used to prevent or lessen the severity of multiple sclerosis attacks. It works by preventing certain immune cells in the body from attacking the brain and/or spinal cord. dru229.8 Page 1 of 8

2 Policy/Criteria I. Most contracts require prior authorization approval of fingolimod prior to coverage. Fingolimod may be considered medically necessary when all of the following criteria A, B, and C are met: A. A definitive diagnosis of a relapsing form of multiple sclerosis (relapsingremitting or secondary progressive multiple sclerosis) that has been established by a specialist in neurology or multiple sclerosis. AND B. Fingolimod is prescribed by, or in consultation with, a specialist in neurology or multiple sclerosis. AND C. An interferon beta product (see Appendix A) and one additional preferred disease modifying therapy [either glatiramer acetate (Copaxone) or natalizumab (Tysabri)] were documented in clinical notes to be ineffective, contraindicated, or not tolerated. Ineffectiveness is defined as meeting at least two of the following three criteria (1, 2 or 3) during treatment with one of these agents. 1. The patient continues to have clinical relapses (at least one clinical relapse within the past 12 months). 2. The patient continues to have CNS lesion progression as measured by MRI. 3. The patient continues to have worsening disability. Examples of worsening disability include, but are not limited to, decreased mobility, decreased ability to perform activities of daily living due to disease progression or an EDSS score >3.5. II. Administration, Quantity Limitations, and Authorization Period A. OmedaRx considers fingolimod to be a self-administered medication. B. When prior authorization is approved, fingolimod may be authorized in quantities of up to 30 capsules per month. C. Authorization may be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective. III. IV. Fingolimod is considered investigational when used concomitantly with other diseasemodifying multiple sclerosis therapies (see Appendix A). Fingolimod is considered not medically necessary when used for primary progressive multiple sclerosis (PPMS). V. Fingolimod is considered investigational when used for all other conditions, including but not limited to: A. Acute ischemic stroke B. Progressive relapsing multiple sclerosis (PRMS) dru229.8 Page 2 of 8

3 Position Statement Summary - Fingolimod is used in the treatment of relapsing-remitting multiple sclerosis (RRMS). It helps decrease the frequency and severity of multiple sclerosis (MS) attacks and may delay progression of disability due to the disease. - While considered to be effective, fingolimod (Gilenya) is associated with safety concerns that are not present with other products. - Serious adverse effects, including cardiac events resulting in sudden death, have been reported with fingolimod. Careful monitoring is required. - The safety and effectiveness of fingolimod have not been studied in combination with other disease-modifying MS medications. - Fingolimod has not been studied in progressive-relapsing MS. - Safety and effectiveness of fingolimod (Gilenya) for the treatment of other conditions, including acute ischemic stroke, have not been established. - Fingolimod (Gilenya) has not been shown to be effective for the treatment of primary progressive multiple sclerosis (PPMS). - Fingolimod doses greater than 0.5 mg (one capsule) orally daily have not been shown to provide additional benefit but are associated with an increased risk of side effects. Clinical Efficacy FINGOLIMOD IN RELAPSING-REMITTING MULTIPLE SCLEROSIS - Three large, randomized controlled trials studied fingolimod in the treatment of subjects with relapsing-remitting multiple sclerosis (RRMS). * Two trials studied the risk of MS relapses and progression of disability over two years in subjects who were taking fingolimod or placebo. Approximately 60%-75% of subjects were naïve to prior disease-modifying MS therapy. [1,2] Results for reducing the risk of MS relapse were statistically significant in both study. Results for slowing the progression of disability were inconsistent. * The third study was designed to show that fingolimod is more effective than interferon beta-1a (Avonex) in preventing MS attacks and slowing the progression of disability due to MS. [3] *. * Each phase three study was two years in length, thus efficacy beyond two years is unknown. - A 2015 Cochrane network meta-analysis concluded that alemtuzumab (Lemtrada), natalizumab (Tysabri), fingolimod (Gilenya), and mitoxantrone are more effective than other drugs at preventing relapse than other agents based on moderate to high quality evidence. The authors also concluded that only natalizumab (Tysabri) shows a beneficial effect on disability progression based on moderate quality data. Alemtuzumab (Lemtrada) and mitoxantrone were also found to be more effective than other treatments at slowing disability progression but the quality of evidence was lower. dru229.8 Page 3 of 8

4 - Fingolimod has not been studied in combination with other disease-modifying MS therapies. FINGOLIMOD (GILENYA) IN OTHER FORMS OF MS - Fingolimod (Gilenya) has not been shown to be effective for PPMS. In a large, phase 3 trial in patients with PPMS, fingolimod (Gilenya) failed to reduce the risk of sustained disability progression compared to placebo. [4] - Fingolimod (Gilenya) has not been studied in PRMS Background on Multiple Sclerosis (MS) [5] - There are four clinical courses of multiple sclerosis (characterized in Table 1 below). [5] - Relapsing-remitting multiple sclerosis accounts for up to 85% of cases. Table 1: Multiple Sclerosis Forms/Clinical Course Definitions [5] Relapsing-remitting (RRMS) Secondary progressive (SPMS) Primary progressive (PPMS) Progressive relapsing (PRMS) Characterized by acute relapses that are followed by some degree of recovery; patients do not develop worsening of disability between relapses. The American Academy of Neurology (AAN) defines RRMS as the first clinical course of MS and is characterized by self-limited attacks of neurologic dysfunction. These attacks develop acutely, evolving over days to weeks. Over the next several weeks to months, most patients experience a recovery of function that is often (but not always) complete. Between attacks the patient is neurologically and symptomatically stable. Defined as sustained progression of physical disability occurring separately from relapses, in patients who previously had RRMS. The AAN defines SPMS as the second clinical course which begins as RRMS, but at some point the attack rate is reduced and the course becomes characterized by a steady deterioration in function unrelated to acute attacks. Defined as progression of disability from onset without superimposed relapses. The AAN defines PPMS as the third clinical type characterized by a steady decline in function from the beginning without acute attacks. Defined as primary progressive patients who develop acute relapses well after disease onset. The AAN defines PRMS as the fourth clinical type which also begins with a progressive course although these patients also experience occasional attacks. Safety - There is a Risk Evaluation and Mitigation Strategy (REMS) program in place for fingolimod to educate physicians and patients on some of the unique risks associated dru229.8 Page 4 of 8

5 with its use. [6] - These risks include bradyarrhythmia and atrioventricular block (slowed heart rate and delays in heart rhythm), increased risk of infections, macular edema, decrease in lung function, decreased liver function, and fetal risk. [6] - Transient asystole and unexplained death have been reported within 24 hours of the first dose of fingolimod in the post-marketing setting. - Patients must be observed for at least 6 hours after the first dose of fingolimod to monitor for signs of bradyarrhythmia and atrioventricular block. - In August 2015, the FDA released a drug safety communication stating that two cases of progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, have occurred in patients taking fingolimod (Gilenya). The prescribing information has been updated to reflect these warnings. [7,8] - Other less severe adverse effects that occur more commonly with fingolimod than placebo include headache, lower respiratory tract infections, diarrhea, back pain, hypertension, and paresthesia. [8] Guidelines The National Institute for Health and Clinical Excellence (NICE) developed guidelines to address the use of fingolimod in relapsing-remitting multiple sclerosis. [9] - Fingolimod (Gilenya) is recommended as an option for highly active relapsing-remitting multiple sclerosis (RRMS) in adult patients, or if there are ongoing severe relapses compared with the previous year despite treatment with interferon beta. - The population evaluated in this guideline is very specific and may not reflect clinical use of fingolimod (Gilenya). Additionally, the guideline was developed from the perspective of NICE, which includes cost effectiveness and manufacturer discounts into their recommendations. Other conditions - Fingolimod (Gilenya) has been studied in patients with acute ischemic stroke. Although initial results indicate some benefit, the study was very small and primarily evaluated surrogate markers. Additional larger, well-designed studies are need to confirm safety and efficacy in patients with acute ischemic stroke. [10] Dosing Considerations [8] - The FDA-approved dose of fingolimod (Gilenya) is 0.5 mg orally once per day. - Higher doses of fingolimod (Gilenya) do not provide additional benefit but are associated with a greater risk of adverse effects. - dru229.8 Page 5 of 8

6 Appendix A: Disease-Modifying Agents Used in the Treatment of Multiple Sclerosis (MS) Alemtuzumab (Lemtrada ) Fingolimod (Gilenya ) Dimethyl fumarate (Tecfidera ) Glatiramer acetate (Copaxone ) Interferon beta-1a (Avonex, Rebif ) Interferon beta-1b (Betaseron, Extavia ) Mitoxantrone (Novantrone ) Natalizumab (Tysabri ) Peginterferon beta-1a (Plegridy ) Teriflunomide (Aubagio ) Cross References Aubagio, teriflunomide, Medication Manual, Policy No. 283 Betaseron /Extavia, interferon beta-1b, Medication Manual, Policy No. 108 Lemtrada TM, alemtuzumab, Medication Manual, Policy No. 381 Plegridy TM, peginterferon beta-1a, Medication Policy Manual, policy No.376 Tecfidera, dimethyl fumarate, Medication Manual, Policy No. 299 Tysabri, natalizumab, Medication Manual, Policy No. 111 Codes Number Description HCPCS J8499 Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified HCPCS J2323 Injection, natalizumab, 1 mg HCPCS J3590 Unclassified Biologics ICD-10 G35 Multiple sclerosis dru229.8 Page 6 of 8

7 References 1. Calabresi, PA, Radue, EW, Goodin, D, et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. The Lancet Neurology Jun;13(6): PMID: Kappos, L, Radue, EW, O'Connor, P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. The New England journal of medicine Feb 4;362(5): PMID: Cohen, JA, Barkhof, F, Comi, G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. The New England journal of medicine Feb 4;362(5): PMID: Novartis provides update on fingolimod Phase III trial in primary progressive MS (PPMS). [cited 11/12/2015]; Available from: https://www.novartis.com/news/mediareleases/novartis-provides-update-fingolimod-phase-iii-trial-primary-progressive-msppms 5. Goodin, DS, Frohman, EM, Garmany, GP, Jr., et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology Jan 22;58(2): PMID: Risk Evaluation and Mitigation Strategy (REMS) for Gilenya (fingolimod) 0.5 mg capsules. [cited October 25, 2010]; Available from: atientsandproviders/ucm pdf 7. FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs. [cited 11/13/2015]; Available from: 8. Gilenya [prescribing information]. East Hanover, NJ: Novartis; August National Institute for Health and Clinical Evidence (NICE). NICE technology appraisal guidance 254: Fingolimod for treatment of highly active relapsing-remitting multiple sclerosis. Issue date: April [cited 9/11/2014]; Available from: 10. Fu, Y, Zhang, N, Ren, L, et al. Impact of an immune modulator fingolimod on acute ischemic stroke. Proc Natl Acad Sci U S A. 2014;111: PMID: Revision Date Revision Summary 12/11/2015 Revised definition of interferon beta ineffectiveness from two clinical relapses in the past 12 months to one clinical relapse in the past 12 months. Moved PPMS from investigational to not medically necessary dru229.8 Page 7 of 8

8 Revision Date Revision Summary Added acute ischemic stroke as an investigational use dru229.8 Page 8 of 8

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective Date: January

More information

Committee Approval Date: December 12, 2014 Next Review Date: December 2015

Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Medication Policy Manual Policy No: dru299 Topic: Tecfidera, dimethyl fumarate Date of Origin: May 16, 2013 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Medication Policy Manual. Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014

Medication Policy Manual. Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014 Medication Policy Manual Policy No: dru376 Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective

More information

Medication Policy Manual. Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004

Medication Policy Manual. Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004 Medication Policy Manual Policy No: dru108 Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

MEDICAL POLICY STATEMENT

MEDICAL POLICY STATEMENT MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 10/01/2013 10/1/2015 08/25/2015 Policy Name Policy Number Multiple Sclerosis Therapy Class SRx-0022

More information

Committee Approval Date: December 12, 2014 Next Review Date: December 2015

Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Medication Policy Manual Policy No: dru381 Topic: Lemtrada TM, alemtuzumab Date of Origin: December 12, 2014 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Which injectable medication should I take for relapsing-remitting multiple sclerosis?

Which injectable medication should I take for relapsing-remitting multiple sclerosis? Which injectable medication should I take for relapsing-remitting multiple sclerosis? A decision aid to discuss options with your doctor This decision aid is for you if you: Have multiple sclerosis Have

More information

Progress in MS: Current and Emerging Therapies

Progress in MS: Current and Emerging Therapies Progress in MS: Current and Emerging Therapies Presented by: Dr. Kathryn Giles, MD MSc FRCPC The MS Society gratefully acknowledges the grant received from Biogen Idec Canada, which makes possible the

More information

Lemtrada (alemtuzumab)

Lemtrada (alemtuzumab) Lemtrada (alemtuzumab) Policy Number: 5.02.517 Last Review: 08/2015 Origination: 08/2015 Next Review: 08/2016 Policy BCBSKC will provide coverage for Lemtrada (alemtuzumab) when it is determined to be

More information

Multiple Sclerosis (MS) Class Update

Multiple Sclerosis (MS) Class Update Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Multiple Sclerosis (MS) Class Update Month/Year of

More information

Integrating New Treatments: A Case Based Approach

Integrating New Treatments: A Case Based Approach Integrating New Treatments: A Case Based Approach JILL CONWAY, MD, MA, MSCE DIRECTOR, MS CENTER DIRECTOR, NEUROLOGY CLERKSHIP AT UNCSOM- CHARLOTTE CAMPUS CAROLINAS HEALTHCARE CENTER Objectives Provide

More information

Literature Scan: Oral Multiple Sclerosis Drugs

Literature Scan: Oral Multiple Sclerosis Drugs Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119

More information

Disease Modifying Therapies for MS

Disease Modifying Therapies for MS Disease Modifying Therapies for MS The term disease-modifying therapy (DMT) means a drug that can modify or change the course of a disease. In other words a DMT should be able to reduce the number of attacks

More information

New treatments in MS What s here and what s nearly here

New treatments in MS What s here and what s nearly here 5 th MS Research Day, June 14 th 2014 New treatments in MS What s here and what s nearly here David Miller Queen Square MS Centre at UCL and UCLH Course of MS and its treatment Relapsing remitting Disability

More information

fingolimod, 0.5mg, hard capsules (Gilenya ) SMC No. (992/14) Novartis Pharmaceuticals UK

fingolimod, 0.5mg, hard capsules (Gilenya ) SMC No. (992/14) Novartis Pharmaceuticals UK fingolimod, 0.5mg, hard capsules (Gilenya ) SMC No. (992/14) Novartis Pharmaceuticals UK 08 August 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises

More information

Information About Medicines for Multiple Sclerosis

Information About Medicines for Multiple Sclerosis Information About Medicines for Multiple Sclerosis Information About Medicines for Multiple Sclerosis What is multiple sclerosis? 1 Multiple sclerosis (MS) is a lifelong disease that affects your brain

More information

New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents

New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents William Tyor, M.D. Chief, Neurology Atlanta VA Medical Center Professor, Department of Neurology Emory University School of Medicine

More information

fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya ) SMC No. (763/12) Novartis Pharmaceuticals UK Ltd

fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya ) SMC No. (763/12) Novartis Pharmaceuticals UK Ltd fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya ) SMC No. (763/12) Novartis Pharmaceuticals UK Ltd 10 February 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the

More information

Information about medicines for multiple sclerosis

Information about medicines for multiple sclerosis Information about medicines for multiple sclerosis Information about medicines for multiple sclerosis What is multiple sclerosis? 1 Multiple sclerosis (MS) is a lifelong disease that affects your brain

More information

Disease Modifying Therapies for MS

Disease Modifying Therapies for MS Disease Modifying Therapies for MS The term disease-modifying therapy means a drug that can modify or change the course of a disease. In other words a DMT should be able to reduce the number of attacks

More information

Drug Class Review Disease-modifying Drugs for Multiple Sclerosis

Drug Class Review Disease-modifying Drugs for Multiple Sclerosis Drug Class Review Disease-modifying Drugs for Multiple Sclerosis Final Update 3 Report May 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness

More information

Disease Modifying Therapies (DMTs) in Multiple Sclerosis

Disease Modifying Therapies (DMTs) in Multiple Sclerosis Disease Modifying Therapies (DMTs) in Multiple Sclerosis Gary Stobbe, MD Medical Director, MS Project ECHO Clinical Assistant Professor, UW Neurology Conflict of Interest Dr. Stobbe has no conflicts of

More information

The MS Disease- Modifying Medications GENERAL INFORMATION

The MS Disease- Modifying Medications GENERAL INFORMATION The MS Disease- Modifying Medications GENERAL INFORMATION Current as of March 2014. This online brochure is updated with breaking news as required. If you have a printed a copy of this publication, please

More information

Pharmacotherapy of Multiple Sclerosis

Pharmacotherapy of Multiple Sclerosis PHARMACY / MEDICAL POLICY 5.01.565 Pharmacotherapy of Multiple Sclerosis Effective Date: July 1, 2016 Last Revised: June 14, 2016 Replaces: Extracted from 5.01.550 RELATED MEDICAL POLICIES: 5.01.556 Rituximab:

More information

A neurologist would assess your eligibility and suitability for the DMTs.

A neurologist would assess your eligibility and suitability for the DMTs. Choices Disease Modifying Treatments Disease modifying treatments (DMTs) are medications which modify the disease course. They target inflammation and are designed to reduce the damage caused by relapses.

More information

Relapsing-remitting multiple sclerosis Ambulatory with or without aid

Relapsing-remitting multiple sclerosis Ambulatory with or without aid AVONEX/BETASERON/COPAXONE/EXTAVIA/GILENYA/REBIF/TYSABRI Applicant must be covered on an Alberta Government sponsored drug program. Page 1 of 5 PATIENT INFMATION Surname First Name Middle Initial Sex Date

More information

Growth in revenue from MS drugs has been driven largely by price increases over the last several years.

Growth in revenue from MS drugs has been driven largely by price increases over the last several years. March 4, 2013 Ben Weintraub, PhD Are Injectable MS Drugs Finished? Market Ready for Tecfidera Companies: Biogen (BIIB) Sanofi (SNY) Teva (TEVA) Novartis (NVS) Merck Serono Bayer Schering Products: Tecfidera

More information

Multiple Sclerosis Update. Bridget A. Bagert, MD, MPH Director, Ochsner Multiple Sclerosis Center

Multiple Sclerosis Update. Bridget A. Bagert, MD, MPH Director, Ochsner Multiple Sclerosis Center Multiple Sclerosis Update Bridget A. Bagert, MD, MPH Director, Ochsner Multiple Sclerosis Center None Disclosures First of All. Why is my talk in the Neurodegenerative hour? I respectfully object! Case

More information

Treatments for MS: Immunotherapy. Gilenya (fingolimod) Glatiramer acetate (Copaxone )

Treatments for MS: Immunotherapy. Gilenya (fingolimod) Glatiramer acetate (Copaxone ) Treatments for MS: Immunotherapy There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity

More information

The MS Disease- Modifying Medications

The MS Disease- Modifying Medications The MS Disease- Modifying Medications National MS Society 1 Current as of November 2014. This online brochure is updated with breaking news as required. If you have a printed a copy of this publication,

More information

The MS Disease- Modifying Drugs. Gener al information

The MS Disease- Modifying Drugs. Gener al information The MS Disease- Modifying Drugs Gener al information Current as of October 30, 2009. This online version is updated as breaking news requires. If you have downloaded and printed a copy from the web, please

More information

New Treatment Options for MS Patients: Understanding risks versus benefits

New Treatment Options for MS Patients: Understanding risks versus benefits New Treatment Options for MS Patients: Understanding risks versus benefits By Michael A. Meyer, MD Department of Neurology, Sisters Hospital, Buffalo, NY Objectives: 1. to understand fundamentals of MS

More information

ORAL MEDICATIONS FOR MS! Gilenya and Aubagio

ORAL MEDICATIONS FOR MS! Gilenya and Aubagio ORAL MEDICATIONS FOR MS! Gilenya and Aubagio Champions against MS 4/20/13 Alexandra Goodyear, MD Stanford University Oral Medications Since 2010, 3 new oral medications for MS: Gilenya 2010 Aubagio 2012

More information

The MS Disease- Modifying Medications

The MS Disease- Modifying Medications The MS Disease- Modifying Medications National MS Society 1 Current as of January 2015. This online brochure is updated with breaking news as required. If you have a printed a copy of this publication,

More information

The submission positioned dimethyl fumarate as a first-line treatment option.

The submission positioned dimethyl fumarate as a first-line treatment option. Product: Dimethyl Fumarate, capsules, 120 mg and 240 mg, Tecfidera Sponsor: Biogen Idec Australia Pty Ltd Date of PBAC Consideration: July 2013 1. Purpose of Application The major submission sought an

More information

National Multiple Sclerosis Society. Disease Modification in Multiple Sclerosis. Current as of January 2, 2013

National Multiple Sclerosis Society. Disease Modification in Multiple Sclerosis. Current as of January 2, 2013 National Multiple Sclerosis Society Disease Modification in Multiple Sclerosis Current as of January 2, 2013 Since 1993, the U.S. Food and Drug Administration (FDA) has approved several medications for

More information

NHS BOURNEMOUTH AND POOLE AND NHS DORSET

NHS BOURNEMOUTH AND POOLE AND NHS DORSET NHS BOURNEMOUTH AND POOLE AND NHS DORSET COMMISSIONING STATEMENT ON THE USE OF BETA-INTERFERON IN RELAPSING-REMITTING MULTIPLE SCLEROSIS OR SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS, WHERE RELAPSES ARE

More information

this 7^ day of September 2014 by Randall S. Gregg Special Deputy Director

this 7^ day of September 2014 by Randall S. Gregg Special Deputy Director r STATE OF MICHIGAN DEPARTMENT OF INSURANCE AND FINANCIAL SERVICES Before the Director of Insurance and Financial Services In the matter of: Petitioner, v File No. 143525-001 Health Alliance Plan of Michigan,

More information

Original Policy Date

Original Policy Date MP 5.01.20 Tysabri (natalizumab) Medical Policy Section Prescription Drug Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Local Policy/12:2013 Return to Medical Policy Index Disclaimer

More information

Personalised Medicine in MS

Personalised Medicine in MS Personalised Medicine in MS Supportive Evidence from Therapeutic Trials Ludwig Kappos Neurology and Department of Biomedicine University Hospital CH-4031 Basel LKappos@uhbs.ch Established partially effective

More information

teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd.

teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd. teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd. 10 January 2014 (Issued 07 February 2014) The Scottish Medicines Consortium (SMC) has completed its assessment of the above

More information

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market Launch of Several Pipeline Oral Products Could Diminish the Market for Injectable Therapies NEC3-52 November 2014 Contents

More information

Resources for the Primary Care Provider. Please print these out for reference

Resources for the Primary Care Provider. Please print these out for reference Resources for the Primary Care Provider Please print these out for reference Resources for providers American Academy of Neurology www.aan.com Provides education and resources, such as guidelines for clinical

More information

A blood sample will be collected annually for up to 2 years for JCV antibody testing.

A 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 information

Study Support Materials Cover Sheet

Study Support Materials Cover Sheet Study Support Materials Cover Sheet Document Title ESCALATE Patient Brochure Intended Audience This brochure is designed to be given to potentially eligible patients as a take-home summary of key information

More information

Natalizumab (Tysabri)

Natalizumab (Tysabri) Natalizumab (Tysabri) Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Natalizumab (Tysabri) Date of issue: July 2010 Review date: July 2011 Contents Section

More information

SECTION 2. Section 2 Multiple Sclerosis (MS) Drug Coverage

SECTION 2. Section 2 Multiple Sclerosis (MS) Drug Coverage SECTION 2 Multiple Sclerosis (MS) Drug Coverage Section 2 Multiple Sclerosis (MS) Drug Coverage ALBERTA HEALTH AND WELLNESS DRUG BENEFIT LIST Selected Drug Products used in the treatment of patients with

More information

PharmaPoint: Multiple Sclerosis - United Kingdom Drug Forecast and Market Analysis to 2022. Multiple

PharmaPoint: Multiple Sclerosis - United Kingdom Drug Forecast and Market Analysis to 2022. Multiple Brochure More information from http://www.researchandmarkets.com/reports/2541548/ PharmaPoint: Multiple Sclerosis - United Kingdom Drug Forecast and Market Analysis to 2022 Description: PharmaPoint: Multiple

More information

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields

More information

MEDICAL ASSISTANCE BULLETIN

MEDICAL ASSISTANCE BULLETIN ISSUE DATE May 11, 2015 SUBJECT EFFECTIVE DATE May 18, 2015 MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Multiple Sclerosis Agents Pharmacy Service Leesa M. Allen, Deputy Secretary

More information

News on modifying diseases therapies. Michel CLANET CHU Toulouse France ECTRIMS

News on modifying diseases therapies. Michel CLANET CHU Toulouse France ECTRIMS News on modifying diseases therapies Michel CLANET CHU Toulouse France ECTRIMS Current treatment strategies Future oral treatments Future non oral treatments Drug safety and risks CIS at risk of MS Active

More information

Therapeutic Class Overview Multiple Sclerosis Agents

Therapeutic Class Overview Multiple Sclerosis Agents Therapeutic Class Overview Multiple Sclerosis Agents Therapeutic Class Overview/Summary: Several biologic response modifiers are Food and Drug Administration (FDA)- approved for the treatment of relapsing-remitting

More information

Treatment in Relapsing MS: Choosing Among the Options. Donald Negroski, MD

Treatment in Relapsing MS: Choosing Among the Options. Donald Negroski, MD Treatment in Relapsing MS: Choosing Among the Options Donald Negroski, MD Disclosures Research Grants Educational activities and lectures Consulting or other services including Continuing Medical Education

More information

Review Date: March 2012. Issue Status: Approved Issue No: 2 Issue Date: March 2010

Review Date: March 2012. Issue Status: Approved Issue No: 2 Issue Date: March 2010 Title: Multiple Sclerosis guidelines for the use of beta-interferon, glatiramer acetate, natalizumab, mitoxantrone and other disease Authors Name: Dr P Talbot Contact Name: Dr Paul Talbot Contact Phone

More information

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b Version History Policy Title Drugs for MS.Drug facts box Interferon beta 1b for secondary progressive MS (SPMS) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review

More information

Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and Value

Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and Value Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and Value Stakeholder Input: Draft Background and Scope July 1, 2016 This draft scoping document was developed with

More information

Multiple sclerosis disease-modifying drugs second line treatments

Multiple sclerosis disease-modifying drugs second line treatments Great Ormond Street Hospital for Children NHS Foundation Trust: Information for Families Multiple sclerosis disease-modifying drugs second line treatments The following information should be read in conjunction

More information

Uncertainty in Benefit and Risk: Tysabri (natalizumab)

Uncertainty in Benefit and Risk: Tysabri (natalizumab) Uncertainty in Benefit and Risk: Tysabri (natalizumab) Robert J. Temple, M.D. Deputy Center Director for Clinical Science Center for Drug Evaluation and Research U.S. Food and Drug Administration IOM Drug

More information

CNS DEMYLINATING DISORDERS

CNS DEMYLINATING DISORDERS CNS DEMYLINATING DISORDERS Multiple sclerosis A Dutch saint named Lidwina, who died in 1433, may have been one of the first known MS patients. After she fell while ice skating, she developed symptoms such

More information

Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy

Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy Klaus Schmierer, PhD FRCP Blizard Institute, Barts and The London School of Medicine & Dentistry Barts Health

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Health Technology Appraisal Daclizumab for treating relapsing-remitting multiple Draft scope (pre-referral) Draft remit/appraisal objective To

More information

Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary

Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary OBJECTIVE The intent of the Multiple Sclerosis (MS) Agents Step Therapy (ST) program is to encourage the use of preferred multiple

More information

Multiple Sclerosis in Practice. An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report

Multiple Sclerosis in Practice. An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report Multiple Sclerosis in Practice An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report Clinical Context: Multiple Sclerosis in Practice Expert Commentary Jointly Sponsored by: and Clinical

More information

Revised (2009) Association of British Neurologists guidelines for prescribing in multiple sclerosis

Revised (2009) Association of British Neurologists guidelines for prescribing in multiple sclerosis Revised (2009) guidelines for prescribing in multiple sclerosis INTRODUCTION In January 2001, the (ABN) first published guidelines for the use of licensed disease modifying treatments (ß-interferon and

More information

Resources for the Patient. Please print these out and give them to your patients with MS

Resources for the Patient. Please print these out and give them to your patients with MS Resources for the Patient Please print these out and give them to your patients with MS An internet program for persons with MS on the FCM website Multiple Sclerosis: A Toolbox of Information and Resources

More information

Conflict of Interest Declaration. Overview of New Medications for Multiple Sclerosis. Assessment Question. Objectives 4/1/2011

Conflict of Interest Declaration. Overview of New Medications for Multiple Sclerosis. Assessment Question. Objectives 4/1/2011 Conflict of Interest Declaration Overview of New Medications for Multiple Sclerosis I or my spouse have no actual or potential conflict of interest in relation to this activity. Crystal Obering, Pharm.D.,

More information

Department of Health. Rheynn Slaynt. Clinical Recommendations Committee

Department of Health. Rheynn Slaynt. Clinical Recommendations Committee Recommendation 06/13 Department of Health Rheynn Slaynt Clinical Recommendations Committee The Isle of Man Department of Health recommend Gilenya (fingolimod) as a HIGH PRIORITY - as an option for the

More information

Cigna Drug and Biologic Coverage Policy

Cigna Drug and Biologic Coverage Policy Cigna Drug and Biologic Coverage Policy Subject Multiple Sclerosis Therapy Table of Contents Coverage Policy... 1 General Background... 9 Coding/Billing Information... 14 References... 14 Effective Date...

More information

How to S.E.A.R.C.H. SM for the Right MS Therapy For You!

How to S.E.A.R.C.H. SM for the Right MS Therapy For You! How to S.E.A.R.C.H. SM for the Right MS Therapy For You! The Changing Landscape The first treatment for relapsing-remitting multiple sclerosis (RRMS) was approved by the United States Food and Drug Administration

More information

Class Update: Disease Modifying Agents for Multiple Sclerosis

Class Update: Disease Modifying Agents for Multiple Sclerosis Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Copyright 2013 Oregon State University. All Rights

More information

Understanding How Existing and Emerging MS Therapies Work

Understanding How Existing and Emerging MS Therapies Work Understanding How Existing and Emerging MS Therapies Work This is a promising and hopeful time in the field of multiple sclerosis (MS). Many new and different therapies are nearing the final stages of

More information

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Tysabri

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Tysabri MEDICAL ASSISTANCE HBOOK PRI AUTHIZATION OF I. Requirements for Prior Authorization of Tysabri A. Prescriptions That Require Prior Authorization All prescriptions for Tysabri must be prior authorized.

More information

UTAH MEDICAID DUR REPORT FEBRUARY 2015 MULTIPLE SCLEROSIS (MS): ORAL DISEASE-MODIFYING DRUGS

UTAH MEDICAID DUR REPORT FEBRUARY 2015 MULTIPLE SCLEROSIS (MS): ORAL DISEASE-MODIFYING DRUGS UTAH MEDICAID DUR REPORT FEBRUARY 2015 MULTIPLE SCLEROSIS (MS): ORAL DISEASE-MODIFYING DRUGS Teriflunomide (Aubagio ) Fingolimod (Gilenya ) Dimethyl fumarate (Tecfidera ) Drug Regimen Review Center Joanita

More information

Is the Grass Really Greener with New Oral Multiple Sclerosis Treatments? A Clinical Debate

Is the Grass Really Greener with New Oral Multiple Sclerosis Treatments? A Clinical Debate Is the Grass Really Greener with New Oral Multiple Sclerosis Treatments? A Clinical Debate Elizabeth Sebranek Evans, PharmD, BCPS, CGP Alana Whittaker, PharmD, BCPS Roseman University of Health Sciences

More information

PCORI Workshop on Treatment for Multiple Sclerosis. Breakout Group Topics and Questions Draft 3-27-15

PCORI Workshop on Treatment for Multiple Sclerosis. Breakout Group Topics and Questions Draft 3-27-15 PCORI Workshop on Treatment for Multiple Sclerosis Breakout Group Topics and Questions Draft 3-27-15 Group 1 - Comparison across DMTs, including differential effects in subgroups Consolidated straw man

More information

Published by MSAA in March 2013

Published by MSAA in March 2013 Published by MSAA in March 2013 Improving Lives Today! MSAA s MS Research Update is published annually as a service to the MS community. For additional information about MS as well as MSAA s programs and

More information

New Developments in the Treatment and Management of Multiple Sclerosis

New Developments in the Treatment and Management of Multiple Sclerosis New Developments in the Treatment and Management of Multiple Sclerosis Myla D. Goldman, MD, MS For a CME/CEU version of this article, please go to www.namcp.org/cmeonline.htm, and then click the activity

More information

Drug Use Research & Management Program Phone Fax Generic Name: Brand Name (Manufacturer): PDL Class: Comparator Therapies: Dossier received:

Drug Use Research & Management Program Phone Fax  Generic Name:  Brand Name (Manufacturer): PDL Class:  Comparator Therapies: Dossier received: Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-945-5220 Fax 503-947-1119 Generic Name: Fingolimod Brand Name (Manufacturer):

More information

Disease modifying drug therapy

Disease modifying drug therapy Disease modifying drug therapy New edition for 2014-15 We hope you find the information in this book helpful. If you would like to speak with someone about any aspect of MS, contact the MS Trust information

More information

What is MS? 1. disease that affects the central nervous. Is a disease that affects both white and gray matter

What is MS? 1. disease that affects the central nervous. Is a disease that affects both white and gray matter What is MS? 1 Neuron Damaged myelin due to inflammation MS is a chronic immunemediated disease that affects the central nervous system (CNS) Is a disease that affects both white and gray matter Interrupted

More information

Disclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics

Disclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics Mitzi Joi Williams, MD Neurologist MS Center of Atlanta, Atlanta, GA Disclosures Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics

More information

peginterferon 63, 94 and 125 microgram solution for injection in pre-filled syringe (Plegridy ) SMC No. (1018/14) Biogen Idec Ltd.

peginterferon 63, 94 and 125 microgram solution for injection in pre-filled syringe (Plegridy ) SMC No. (1018/14) Biogen Idec Ltd. peginterferon 63, 94 and 125 microgram solution for injection in pre-filled syringe (Plegridy ) SMC No. (1018/14) Biogen Idec Ltd. 05 December 2014 The Scottish Medicines Consortium (SMC) has completed

More information

How to S.E.A.R.C.H. for the Right MS Therapy for You!

How to S.E.A.R.C.H. for the Right MS Therapy for You! How to S.E.A.R.C.H. for the Right MS Therapy for You! How to S.E.A.R.C.H. for the Right MS Therapy for You! Copyright Multiple Sclerosis Association of America, 2012. All rights reserved. This booklet

More information

Drug Class Review. Disease-modifying Drugs for Multiple Sclerosis. Single Drug Addendum: Fingolimod

Drug Class Review. Disease-modifying Drugs for Multiple Sclerosis. Single Drug Addendum: Fingolimod Drug Class Review Disease-modifying Drugs for Multiple Sclerosis Single Drug Addendum: Fingolimod Final Original Report February 2011 The Agency for Healthcare Research and Quality has not yet seen or

More information

Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012. Reference : NHSCB/D4/c/1

Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012. Reference : NHSCB/D4/c/1 Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012 Reference : NHSCB/D4/c/1 NHS Commissioning Board Clinical Commissioning Policy: Disease

More information

National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook

National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook Chemotherapy The literal meaning of the term chemotherapy is to treat with a chemical agent, but the term generally refers

More information

A Letter From the MS Coalition

A Letter From the MS Coalition 0 A Letter From the MS Coalition The treatment of multiple sclerosis (MS) requires a comprehensive management strategy. One important component of that strategy is modifying the disease course. When deciding

More information

Mellen Center Approaches: Choosing First-Line Treatment

Mellen Center Approaches: Choosing First-Line Treatment Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research 216.444.8600 Mellen Center Approaches: Choosing First-Line Treatment Q: Should my patient with newly diagnosed multiple sclerosis

More information

Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants

Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants Brochure More information from http://www.researchandmarkets.com/reports/1841621/ Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants Description: Introduction Beginning with

More information

Novel therapeutic approaches in multiple sclerosis Neuroprotective and remyelinating agents, the future of clinical trials in MS?

Novel therapeutic approaches in multiple sclerosis Neuroprotective and remyelinating agents, the future of clinical trials in MS? Novel therapeutic approaches in multiple sclerosis Neuroprotective and remyelinating agents, the future of clinical trials in MS? Marie Trad, M.D., Lynne Hughes, Cathy VanBelle, Amy Del Medico 3rd International

More information

Alemtuzumab for treating relapsing-remitting multiple sclerosis

Alemtuzumab for treating relapsing-remitting multiple sclerosis Alemtuzumab for treating relapsing-remitting multiple Issued: May 2014 guidance.nice.org.uk/ta NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to produce technology

More information

Multiple Sclerosis Drug Discoveries - What the Future Holds

Multiple Sclerosis Drug Discoveries - What the Future Holds Brochure More information from http://www.researchandmarkets.com/reports/1408035/ Multiple Sclerosis Drug Discoveries - What the Future Holds Description: The recent approval in the US of Novartis' orally

More information

Pharmacologic Therapies for Multiple Sclerosis: From injectable to oral agents

Pharmacologic Therapies for Multiple Sclerosis: From injectable to oral agents Pharmacologic Therapies for Multiple Sclerosis: From injectable to oral agents KIRANPAL SINGH SANGHA, PHARM.D. CLINICAL PHARMACY SPECIALIST CNS THE UNIVERSITY OF CINCINNATI MEDICAL CENTER Objectives List

More information

There are currently 4 US Food and Drug

There 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 information

Report on the Investigation Results

Report on the Investigation Results Report on the Investigation Results June 23, 2016 I. Overview of Product [Non-proprietary name] [Brand name] [Approval holder] [Indications] [Dosage and administration] [Investigating office] Fingolimod

More information

Medication Update. Acknowledgement

Medication Update. Acknowledgement Medication Update Multiple Sclerosis Limited Acknowledgement We acknowledge and pay respect to the traditional custodians past and present on whose lands we meet today. We acknowledge the deep feelings

More information

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis The NCPE has issued a recommendation regarding the cost-effectiveness of teriflunomide

More information

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

RISK EVALUATION AND MITIGATION STRATEGY (REMS) Initial REMS Approval: 9/2010 Most Recent Modification: 05/2015 0.5mg capsules Sphingosine 1-phosphate Receptor Modulator Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936 RISK

More information