Remicade RX Policy - Blue Cross Blue Shield

REMICADE (infliximab) Pharmacy Coverage Policy P&T Review Date: 09/20/2013 UMC Revision Date: 08/29/2013 Reviewer Initials: GSY Effective Date: 01/01/2014

Brand Name REMICADE

Generic Name Infliximab

Policy type: PA with QL Program type: Standard Specialty: Yes Line of Business: Commercial

GPI 52-50-50-40-00-21-20

Drug Class TNF inhibitor

CRITERIA FOR COVERAGE/NONCOVERAGE REMICADE® (infliximab) will be considered for coverage under the pharmacy benefit program when the following criteria are met: Crohn’s Disease Patient is ≥ 6 years of age AND Patient has a diagnosis of moderate to severe Crohn’s disease AND Patient has had inadequate responses to, is intolerant to, or is contraindicated to conventional therapy with two or more of the following: o Corticosteroids (i.e., prednisone, methylprednisolone) o Non-biologic DMARDs (i.e., azathioprine, methotrexate, mercaptopurine; see Table 1) AND For patient ≥ 18 years of age, documented inadequate response to, is intolerant to, or is contraindicated to HUMIRA and CIMZIA OR Patient is 18 years of age or older AND Patient has a diagnosis of fistulizing Crohn’s disease Ulcerative Colitis Patient is ≥ 6 years of age AND Patient has a diagnosis of moderate to severe ulcerative colitis AND Patient has had inadequate responses to, is intolerant to, or is contraindicated to conventional therapy with two or more of the following: o Corticosteroids (i.e. prednisone, methylprednisolone) o 5-ASAs (i.e. mesalamine, sulfasalazine, balsalazide, olsalazine) o Non-biologic DMARDs (i.e. azathioprine, methotrexate, mercaptopurine; see Table 1) AND For patient ≥ 18 years of age, documented inadequate response to, is intolerant to, or is contraindicated to HUMIRA Rheumatoid Arthritis Patient is ≥ 18 years of age AND Patient has a diagnosis of moderate to severe rheumatoid arthritis AND

CATAMARAN, INC. - CONFIDENTIAL AND PROPRIETARY © COPYRIGHT 2012, Catamaran, Inc. All rights reserved. Disclaimer: This document is for informational purposes only. Individual pharmacy benefit plan designs and contract language take precedence over coverage policies. Coverage may vary for Medicare or Medicaid plans. Coverage policies are reviewed and updated periodically.

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REMICADE (infliximab) Pharmacy Coverage Policy Patient has had inadequate response to, intolerance to, or contraindication to one or more nonbiologic disease modifying anti-rheumatic drugs (DMARDs; see Table 1) for at least 3 consecutive months AND Patient has documented inadequate response to, is intolerant to, or is contraindicated to both of the following: HUMIRA AND CIMZIA AND Patient will be on concomitant methotrexate therapy Psoriatic Arthritis Patient has a diagnosis of psoriatic arthritis AND Patient is ≥ 18 years of age AND Patient has had inadequate response to, intolerance to, or contraindication to methotrexate AND Patient has documented inadequate response to, is intolerant to, or is contraindicated to HUMIRA AND CIMZIA. Ankylosing Spondylitis Patient is ≥ 18 years of age AND Patient has a diagnosis of ankylosing spondylitis AND Patient has had inadequate response to, intolerance to, or contraindication to one or more nonsteroidal anti-inflammatory drugs (NSAIDs) AND Patient has documented inadequate response to, is intolerant to, or is contraindicated to HUMIRA AND CIMZIA. Plaque Psoriasis Patient is ≥ 18 years of age AND Patient has a diagnosis of chronic severe plaque psoriasis (affecting more than 10% of body surface area (BSA) or affecting crucial body areas such as the hands, feet, face, or genitals) AND Patient has had an inadequate response to, is intolerant to, or is contraindicated to conventional therapy with at least one of the following: o Phototherapy (including, but not limited to, Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA]) for at least one continuous month OR o One or more oral systemic treatments (i.e., methotrexate, cyclosporine, acitretin, sulfasalazine) for at least three consecutive months AND Patient has documented inadequate response to, is intolerant to, or is contraindicated to HUMIRA.


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REMICADE (infliximab) Pharmacy Coverage Policy Table 1: Non-biologic Disease-Modifying Anti-rheumatic Drugs (DMARDs) Drug Treatment Period Usual Maintenance Dose Hydroxychloroquine 2 to 6 months 200 mg twice daily Sulfasalazine 1 to 3 months 1000 mg 2 to 3 times daily Methotrexate 1 to 2 months 7.5-20 mg weekly Leflunomide 4 to 12 weeks 10-20 mg daily Azathioprine 2 to 3 months 50-150 mg daily Cyclosporine 2 to 4 months 2.5-4 mg/kg/day

AND Patient does not have an active serious infection (including tuberculosis [TB]) AND Patient has been tested for TB infection. o Latent TB infection has been ruled out or is being treated as per guidelines AND Patients with moderate to severe heart failure will not receive REMICADE at doses > 5 mg/kg. Initial authorization for CD will be for 18 weeks. Initial authorization for all other indications will be for 12 months. Authorization for continued coverage will confirm the following: Patient has stable disease or has improved while on therapy (e.g., For RA, improvement in tender/swollen joint count, improvement in ACR scoring; For PsA, improvement in number of swollen/tender joints, pain, stiffness; For AS, improvement in AS symptoms, such as stiffness and back pain; For CD, symptomatic remission; For UC, clinical remission, reduction in steroid use). REMICADE is considered experimental/investigational for conditions not listed in this coverage policy section.


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