This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only.

Transcription

1 This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only. Multiple Sclerosis Agents Ampyra Aubagio Avonex Betaseron Copaxone Extavia Gilenya Glatopa Plegridy Rebif Tysabri COVERAGE POLICY COVERAGE POLICY Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria below must be met in order to obtain coverage of Ampyra, Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, Rebif, Tysabri For Ampyra o o A documented diagnosis of multiple sclerosis AND ALL of the following: Member is 18 years or older, and Normal creatinine clearance (> 50 ml/ min), and No past medical history of seizures, and Member has sustained walking impairment, and Member is able to walk 25 feet without assistance For renewal at 3 months and every 12 months thereafter: Member has continued therapeutic response to Ampyra For Aubagio of ALL of the following: Coventry Health Care, Inc. Page 1

2 Discontinuation of other therapies used for treating multiple sclerosis (Note: Recent (within 6 months) complete blood count (CBC) Recent (within 6 months) liver transaminase and bilirubin levels Recent Tuberculin skin test (within 6 months) to check for latent Tuberculosis Blood pressure monitoring at initiation and during treatment If Female, confirmation of negative pregnancy test at initiation of therapy and confirmation that reliable contraception will be used during treatment with Aubagio adequate trial* of 3 preferred alternatives, including Glatopa or Copaxone 40mg, Rebif, and Gilenya * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is For Avonex of all of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: adequate trial* of 3 preferred alternatives, including Glatopa or Copaxone 40mg and Rebif and Gilenya * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is For Betaseron, Extavia, and Plegridy of all of the following: Coventry Health Care, Inc. Page 2

3 Discontinuation of other therapies used for treating multiple sclerosis (Note: adequate trial* of 3 preferred alternatives, including Glatopa or Copaxone 40mg and Rebif and Gilenya * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is For Copaxone 20 mg o A documented diagnosis of one of the following AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Clinically isolated syndrome (CIS) suggestive of multiple sclerosis(ms) (i.e. persons who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS)) Relapsing, remitting multiple sclerosis (Note: Does not include diagnosis of chronic progressive multiple sclerosis(ms)) adequate trial* of the preferred alternative Glatopa For Copaxone 40 mg o A documented diagnosis of one of the following AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Clinically isolated syndrome (CIS) suggestive of multiple sclerosis(ms) (i.e. persons who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS)) Relapsing, remitting multiple sclerosis (Note: Does not include diagnosis of chronic progressive multiple sclerosis(ms)) For Gilenya For new starts or restarts after 6 months or more of treatment interruption: o A documented diagnosis of relapsing, remitting multiple sclerosis AND documentation of ALL of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: Recent (within 6 months) complete blood count (CBC) Recent (within 6 months) liver transaminase and bilirubin levels Coventry Health Care, Inc. Page 3

4 A documented EKG (i.e. electrocardiogram that measures rate and regularity of heartbeats) prior to the first dose AND a documented EKG at the end of the observation period AND documented to have NONE of the following: Recent (within the last 6 months) occurrence of myocardial infarction (i.e. heart attack), unstable angina, stroke, transient ischemic attack (i.e. mini stroke), decompensated heart failure requiring hospitalization, or Class III/IV heart failure* History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome syndrome (these are specific types of heart rhythm problems), unless patient has a pacemaker Baseline QTc interval 500 ms (as measured on most recent EKG) Treatment with Class Ia or Class III anti-arrhythmic drugs** A documented baseline ophthalmologic examination A documented history of chicken pox or administration of the varicella zoster vaccine (VZV) (If history of chicken pox or administration of VZV is unknown then titers should be drawn and if low VZV should be considered) If female, a documented negative pregnancy test For restarts after treatment interruption of less than 6 months: o If re-initiating Gilenya after treatment interruption of less than 6 months, then a documented EKG prior to the first re-initiated dose AND a documented EKG at the end of the observation period will be required For Glatopa o A documented diagnosis of one of the following AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Clinically isolated syndrome (CIS) suggestive of multiple sclerosis(ms) (i.e. persons who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS)) Relapsing, remitting multiple sclerosis (Note: Does not include diagnosis of chronic progressive multiple sclerosis(ms)) For Rebif o A documented diagnosis of relapsing remitting multiple sclerosis AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) For Tecfidera of all of the following: Discontinuation of other therapies used for treating multiple sclerosis while on therapy with Tecfidera (Note: This does NOT require having to discontinue Ampyra) Recent (within 6 months) complete blood count (CBC) adequate trial* of 3 preferred alternatives, including Glatopa or Copaxone 40mg and Rebif and Gilenya Coventry Health Care, Inc. Page 4

5 * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is AUTHORIZATION PERIOD AND LIMITATIONS Aubagio Avonex Betaseron Copaxone Extavia Gilenya Glatopa TM Plegridy Rebif Tysabri MS Agent Initial Approval One year Extended Approval One year Ampyra Six months Six months NON-COVERAGE 1. Use not approved by the FDA ; and 2. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see Off-Label Use Policy for determining accepted use ) 3. Combination use of interferons and/or glatiramer, and/or Gilenya and/or Aubagio and/or Tysabri REFERENCES 1. Avonex Prescribing Information. Biogen Idec. Cambridge, MA. February Betaseron Prescribing Information. Bayer HealthCare Pharmaceuticals, Wayne, NJ. December Copaxone Prescribing Information. Teva Neuroscience. Kansas City, MO. August Extavia Prescribing Information. Novartis Pharmaceuticals Corporation, East Hanover, NJ. March Rebif Prescribing Information. Biogen Idec. Cambridge, MA. May Tysabri Prescribing Information. Elan Pharmaceuticals. South San Francisco, CA. June Gilenya (fingolimod) Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. May Gilenya (fingolimod) Dossier. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. Sept Goodin DS, Frohman EM, Garmany GP Jr, Halper J, Likosky WH, Lublin FD, Silberberg DH, Stuart WH, van den Noort S. 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 2002 Jan 22;58(2): Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002; 359:1453. Coventry Health Care, Inc. Page 5

6 11. Koch-Henriksen N, Sørensen PS, Christensen T, et al. A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis. Neurology 2006; 66: Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial. Neurology 2002; 59: O'Connor P, Filippi M, Arnason B, et al. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol 2009; 8: Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 2008; 7: Cadavid D, Wolansky LJ, Skurnick J, et al. Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology 2009; 72: Cohen JA, Imrey PB, Calabresi PA, et al. Results of the Avonex Combination Trial (ACT) in relapsingremitting MS. Neurology 2009; 72: Aubagio Prescribing Information. Bridgewater, NJ: Sanofi aventis. Sept O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. The New England journal of medicine. Oct ;365(14): Tysabri Important Safety Information. Biogen Idec. Accessed September National Institute for Health and Clinical Excellence (NICE). Final appraisal determination. Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis. June NICE Website. Accessed on 1/26/ Goodin, DS, et al. The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidencebased review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008; 71: Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5): Gold R, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367: Fox RJ, et al. Placebo-controlled phase 3 study of oral BG-12 or Glatiramer in Multiple Sclerosis. N Engl J Med. 2012; 367: National Multiple Sclerosis Society. Just the facts: Available at: National Clinical Advisory Board of the National Multiple Sclerosis Society. Disease management Consensus Statement. Available at: Glatopa Prescribing Information. Sandoz, Inc. Princeton, NJ. June Ampyra (dalfampridine) prescribing information. Acorda Therapeutics, Inc. Hawthorne, NY. December Ampyra Dossier. Acorda Therapeutics, Inc (developed by Formulary Resources, LLC). Mercer Island, WA. 02/ Goodman AD, Brown TR, et.al. Sustained-release oral fampridine in multiple sclerosis: a randomized, double-blind, controlled trial. Lancet 2009; 373: Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: Cohen RA, Kessler HR, et.al. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. Journal of the Neurological Science Apr; 115(2): Disclaimer: Coventry Health Care, Inc. (CHC) medical policies, technology assessments, and medical reviews (collectively CHC Policies ) are developed by CHC to provide guidance in administering plan benefits and constitute neither offers of coverage nor medical advice. Access to CHC Policies is provided for general reference purposes only and does not infer guaranteed coverage. CHC does not provide health care services or supplies. Providers are expected to exercise their independent medical judgment in rendering the most Coventry Health Care, Inc. Page 6

7 appropriate care. State and federal law, as well as benefit plan terms and conditions and CHC Policies in effect on the date that any service is rendered, including but not limited to definitions and specific inclusions/exclusions, take precedence over clinical policy and must be considered first in determining eligibility for coverage. The terms of the member's benefit plan shall determine coverage. Some benefit plans exclude coverage for services or supplies that Coventry may consider medically necessary. If there is a discrepancy between this policy and a member's benefit plan, the benefit shall govern. Coverage may also differ for CHC Medicare and/or Medicaid members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determination (NCD), Local Medical Review Policies (LMRP), and/or Local Coverage Determinations (LCD). As clinical technology is continually updated, CHC policies are subject to periodic updates. Do not rely on printed versions of CHC policies as they may be outdated. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or means without the written consent of CHC. Coventry Health Care, Inc. Page 7