Multiple Sclerosis Agents

Transcription

1 Multiple Sclerosis Agents Policy Number: Last Review: 09/2018 Origination: 07/2014 Next Review: 09/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for the following Multiple Sclerosis agents when it is determined to be medically necessary because the following criteria are met. Medication impacted include: Avonex (interferon beta-1a injection, intramuscular Biogen Idec) Betaseron (interferon beta-1b injection Bayer) Copaxone (glatiramer acetate injection [20 mg/ml and 40 mg/ml] Teva, generics) Extavia (interferon beta-1b injection Novartis) Glatopa (glatiramer acetate injection 20 mg/ml Sandoz, generic) Plegridy (peginterferon beta-1a injection Biogen Idec) Rebif (interferon beta-1a injection, subcutaneous Serono) Aubagio (teriflunomide tablets Genzyme/Sanofi) Gilenya (fingolimod capsules Novartis) Tecfidera (dimethyl fumarate delayed-release capsules Biogen Idec) When Policy Topic is covered Step 1: generic glatiramer 20 mg/ml, generic glatiramer 40 mg/ml Step 2: Copaxone 20 mg/ml, Copaxone 40 mg/ml, Glatopa 20 mg/ml Avonex, Betaseron, Extavia, Rebif, Plegridy, Aubagio, Gilenya, Tecfidera. Recommended Criteria Trade Name Avonex Avonex PA Policy criteria; AND i. The patient has been established on Avonex for 120 days; OR

2 Trade Name Betaseron Copaxone 20 mg/ml Copaxone 40 mg/ml Glatopa 20 mg/ml Betaseron/Extavia PA Policy criteria; AND i. The patient has been established on Betaseron for 120 days; OR b) The patient has an unacceptable toxicity and/or suboptimal Copaxone/Glatopa PA Policy criteria; AND B) The patient meets both of the following (i and ii): i. The patient has tried one Step 1 product (generic glatiramer 20 mg/ml or generic glatiramer 40 mg/ml); AND ii. Brand Copaxone 20 mg/ml is being requested due to a formulation difference in the inactive ingredient(s) [e.g., preservatives] between the Brand and the bioequivalent generic product which, per the prescribing physician, has or would result in a significant allergy or serious adverse reaction. Copaxone/Glatopa PA Policy criteria; AND B) The patient meets both of the following (i and ii): i. The patient has tried one Step 1 product (generic glatiramer 20 mg/ml or generic glatiramer 40 mg/ml); AND ii. Brand Copaxone 40 mg/ml is being requested due to a formulation difference in the inactive ingredient(s) [e.g., preservatives] between the Brand and the bioequivalent generic product which, per the prescribing physician, has or would result in a significant allergy or serious adverse reaction. Copaxone/Glatopa PA Policy criteria; AND B) The patient meets both of the following (i and ii): i. The patient has tried one Step 1 product (generic glatiramer 20 mg/ml or generic glatiramer 40 mg/ml); AND ii. Brand Glatopa 20 mg/ml is being requested due to a formulation difference in the inactive ingredient(s) [e.g., preservatives] between the Brand and the bioequivalent generic product which, per the prescribing physician, has or would result in a significant allergy or serious adverse reaction.

3 Trade Name Extavia Rebif Plegridy Aubagio Betaseron/Extavia PA Policy criteria; AND i. The patient has been established on Extavia for 120 days; OR efficacy according to the prescribing physician. (Note: Prior use of Brand Name Copaxone 20 mg/ml, Copaxone 40 mg/ml, or Glatopa 20 mg/ml with unacceptable toxicity and/or suboptimal efficacy [according to the prescribing physician] also counts). Rebif PA Policy criteria; AND i. The patient has been established on Rebif for 120 days; OR Plegridy PA Policy criteria; AND i. The patient has been established on Plegridy for 120 days; OR Aubagio PA for PSM and Care Value Policy criteria; AND i. The patient has been established on Aubagio for 120 days; OR ii. The patient meets both of the following (a and b):

4 Trade Name Gilenya Tecfidera Gilenya PA for PSM and Care Value Policy criteria; AND i. The patient has been established on Gilenya for 120 days; OR ii. The patient meets both of the following (a and b): or glatiramer 40 mg/ml); AND Tecfidera PA for PSM and Care Value Policy criteria; AND i. The patient has been established on Tecfidera for 120 days; OR ii. The patient meets both of the following (a and b): Considerations Oral and self-injectable agents for Multiple Sclerosis require prior authorization through the Clinical Pharmacy Department. This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers. Guidelines Evidence-based guidelines that extensively review the clinical literature regarding therapies for MS have not been updated recently. In 2008 the National Clinical Advisory Board of the National MS Society published an expert opinion paper regarding treatment recommendations for physicians. 5 Initiation of therapy with an interferon beta medication (i.e., Avonex [interferon beta-1a, intramuscular {IM}]), Rebif, Betaseron /Extavia [interferon beta-1b SC]), or Copaxone (glatiramer acetate injection SC) should be considered as soon as possible after a definitive diagnosis of MS with active, relapsing disease, and may be considered for selected patients with a first attack who are at high risk of MS. Therapy should be continued indefinitely unless it is not tolerated or benefit is not obtained. The oral disease-modifying agents approved for relapsing forms of MS have not been incorporated into the expert opinion paper. Tysabri (natalizumab injection for intravenous [IV] use) is generally recommended for patients who have had an inadequate response to, or are unable to tolerate other MS therapies. Treatment with mitoxantrone injection may be considered for selected relapsing patients with worsening disease or patients with secondary-progressive MS with worsening, whether or not relapses are occurring.

5 Rerefences 1. Betaseron injection for subcutaneous use [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; April 2. Extavia injection for subcutaneous use [prescribing information]. East Hanover, NJ: Novartis; May 3. Avonex intramuscular injection [prescribing information]. Cambridge, MA: Biogen, Inc.; March 4. Rebif subcutaneous injection [prescribing information]. Rockland, MA: EMD Serono, Inc; November Copaxone injection for subcutaneous use [prescribing information]. Overland Park, KS and North Wales, PA Teva Neuroscience/Pharmaceuticals, Inc.; August 6. Plegridy subcutaneous injection [prescribing information]. Cambridge, MA: Biogen Idec, Inc.; July 7. Glatopa injection for subcutaneous use [prescribing information]. Princeton, NJ: Sandoz; April 8. Glatiramer acetate injection 20 mg/ml [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; February Glatiramer acetate injection 40 mg/ml [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; April Gilenya capsules [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 11. Aubagio tablets [prescribing information]. Cambridge, MA: Genzyme Corporation (a Sanofi company); November 12. Tecfidera delayed-release capsules [prescribing information]. Cambridge, MA: Biogen Idec, Inc; January Rebif Prior Authorization Policy. Express Scripts Holding Company. Updated 08/02/ Avonex Prior Authorization Policy. Express Scripts Holding Company. Updated 08/02/ Copaxone/Glatopa Prior Authorization Policy. Express Scripts Holding Company. Updated 08/02/ Betaseron/Extavia Prior Authorization Policy. Express Scripts Holding Company. Updated 08/02/ Plegridy Prior Authorization Policy. Express Scripts Holding Company. Updated 08/02/ Aubagio Prior Authorization for Preferred Specialty Management/Care Value Policy. Express Scripts Holding Company. Updated 08/02/ Gilenya Prior Authorization for Preferred Specialty Management/Care Value Policy. Express Scripts Holding Company. Updated 08/02/ Tecfidera Prior Authorization Policy for Preferred Specialty Management/Care Value Policy. Express Scripts Holding Company. Updated 08/02/2017. Billing Coding/Physician Documentation Information NA Oral and self-injectables are considered a pharmacy benefit Additional Policy Key Words Policy Policy Implementation/Update Information 09/2018 Policy updated to merge individual oral and MS policies

6 State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.