Page: 1 of 18 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peer-reviewed medical literature, government agency/program approval status, and other indicia of medical necessity. The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits ( Benefit Plan Contract ) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Subject Medical necessity criteria for the following treatments for arthritis: Actemra (tocilizumab) Orencia (abatacept) Cimzia (certolizumab) Remicade (infliximab) Enbrel (etanercept) Rituxan (rituximab) Humira (adalimumab) Simponi (golimumab) Kineret (anakinra) Xeljanz (tofacitinib) Ilaris (canakinumab) Description The intent of the criteria is to ensure that patients follow selection elements established by Centene medical policy. Table 1. Targeted DMARDs for the Treatment of Arthritis 1-10 Medication Generic Name Class FDA Approved Indications Cimzia certolizumab pegol Rheumatoid arthritis (RA) & Ankylosing spondylitis (AS) Enbrel etanercept RA, polyarticular juvenile TNF inhibitor idiopathic arthritis (PJIA), AS Humira adalimumab RA, PJIA, AS Remicade infliximab RA, AS Simponi golimumab RA, AS
Page: 2 of 18 Medication Generic Name Class FDA Approved Indications Ilaris canakinumab systemic juvenile idiopathic Interleukin (IL)-1 receptor arthritis (SJIA) antagonist Kineret anakinra RA Actemra tocilizumab IL-6 receptor inhibitor RA, PJIA, SJIA Orencia abatacept selective co-stimulation RA, PJIA modulator Rituxan rituximab monoclonal antibody to B RA cells Xeljanz tofactinib JAK inhibitor RA Management Challenge In the United States, nearly 1.5 million people have RA, one of the most common forms of arthritis. 11 RA is an autoimmune disorder of unknown origin that presents as symmetric, erosive synovitis and, in some patients, extraarticular involvement. 11 It is a chronic, progressive disease that may result in joint deformity, disability and premature death. 12 The key treatment goal is to achieve remission, where the patient experiences no active joint inflammation and no erosive or functional deterioration. 12 While complete remission is not always possible, it is important to maintain function for activities of daily living and work, maximize quality of life, preserve recreational activities, and control disease activity. 11 Policy/Criteria It is the policy of Health Plans affiliated with Centene Corporation that the treatment of arthritic conditions is medically necessary for members who meet the following algorithm criteria: Figure 1a: TNF Inhibitors, Actemra, Orencia, and Xeljanz Safety Algorithm Figure 1b: Kineret Safety Algorithm Figure 1c: Rituxan Safety Algorithm Figure 2: Systemic or Polyarticular Juvenile Idiopathic Arthritis Algorithm Figure 3: Ankylosing Spondylitis Algorithm Figure 4a: Rheumatoid Arthritis Algorithm Figure 4b: Rheumatoid Arthritis Algorithm: Use of Rituxan Figure 5: Remicade Initial Authorization Algorithm Figure 6: Re-authorization Algorithm
Page: 3 of 18 Figure 1a: TNF Inhibitors, Actemra, Orencia, and Xeljanz Safety Algorithm Has the patient received a prior biologic or Xeljanz through a Centene benefit? Has patient been screened for LTBI with a TB skin test or an interferon gamma release assay in last 12 months? Document TB test result Positive Has active TB been ruled out? Negative Is patient at risk for HBV infection? Currently receiving or has completed treatment for LTBI? Have an active infection (chronic or localized) or malignant disease? Prior to initiating therapy, has HBV infection been ruled out or treatment initiated? Will it be used in combination with another biologic agent or Xeljanz? Remicade Have unstable moderate to severe heart failure? Has patient previously received treatment with Remicade? Actemra Cimzia Orencia Xeljanz Will it be used in combination with a potent immunosuppressant (eg, azathiopurine, cyclosporine)? Enbrel Humira Simponi Does the prescribed maintenance dose exceed the maximum dose listed in Appendix C? Experienced a severe hypersensitivity reaction? What is the diagnosis? Other pjia sjia AS RA appropriate program policy Figure 2a Figure 2b Figure 3 Figure 4a
Page: 4 of 18 Figure 1b: Kineret Safety Algorithm Have an active infection (chronic or localized)? Will Kineret be used in combination with another biologic agent? Does the prescribed Kineret dose exceed 100 mg per day? What is the diagnosis? RA CAPS Figure 4a Centene CAPS policy
Page: 5 of 18 Figure 1c: Rituxan Safety Algorithm What is the diagnosis? Other RA Age 18 years? Does patient have severe, active infection? Is patient at risk for HBV infection? Prior to initiating therapy, has HBV infection been ruled out or treatment initiated? Will Rituxan be used in combination with another biologic agent? Is patient currently receiving Rituxan through a Centene benefit? Figure 4b Figure 6
Page: 6 of 18 Figure 2: Systemic or Polyarticular Juvenile Idiopathic Arthritis Algorithm What is the prescribed agent? Does the patient meet the age requirement for the prescribed medication? (See Appendix G), pjia Enbrel, Humira Orencia, Illaris Actemra Is prescribing physician a rheumatologist? Currently receiving the prescribed biologic through a Centene benefit? Other Figure 6 Tried and had inadequate response to other biologic for pjia through a Centene benefit? 6 months, sjia Does the patient have active systemic features? Request for Actemra or Ilaris? Tried and had inadequate response to trials of NSAIDS unless not clinically warranted? Prior to therapy, did patient s arthritis involve more than 4 joints?, Humira, Enbrel, Orencia, Actemra Tried and had inadequate response to a trial of corticosteroids? Trial of MTX or leflunomide for at least 3 consecutive months? Contraindication or intolerance to corticosteroids? 6 months Intolerant or contraindication to MTX or leflunomide? Inadequate response to MTX or leflunomide? Trial of other nonbiologic DMARD for at least 3 consecutive months? (see appendix F) Had an inadequate response to such therapy? Adherent to prescribed therapy? Intolerant or contraindicated to such therapy? Document last trial of nonbiologic DMARD 6 months
Page: 7 of 18 Figure 3: Ankylosing Spondylitis Algorithm What is the prescribed agent? Enbrel, Humira, Remicade, Simponi, Cimzia Other Age 18 years? Is prescribing physician a rheumatologist? Currently receiving the prescribed biologic through a Centene benefit? Figure 6 6 months Enbrel, Humira, Simponi, Cimzia Tried and had inadequate response to another biologic for AS through a Centene benefit?, Remicade Figure 5 Does patient have axial or peripheral disease? Axial disease Peripheral disease Trial of an NSAID or COX-2 inhibitor for at least 3 consecutive months? (Appendix E) Trial of MTX or sulfasalazine for at least 3 consecutive months? Intolerant or contraindication to therapy? Inadequate response to such therapy? Intolerant or contraindicated to therapy? Enbrel, Humira Simponi, Cimzia Document last trial of therapy unless contraindicated Remicade Adherent to such therapy? Document last trial of therapy unless contraindicated Remicade Enbrel Humira Simponi Cimzia 6 months Figure 5 Figure 5 6 months
Page: 8 of 18 Figure 4a: Rheumatoid Arthritis Algorithm Is the RA moderate to severely active? Is prescribing physician a rheumatologist? What is the prescribed drug? Simponi Xeljanz Age 18 years? Other biologics Figure 6 Currently receiving the prescribed med through a Centene benefit? 6 months - Other biologics/ Xeljanz Tried and had inadequate response to another biologic or Xeljanz for RA through a Centene benefit? -Remicade Figure 5 Prior to therapy, did patient have 6 or more inflamed joints? Prior to therapy, did patient have at least one of the characteristics in Appendix B? Intolerant or contraindication to either MTX or leflunomide? Had a trial of MTX or leflunomide for at least 3 consecutive months? Inadequate response to either MTX or leflunomide? Trial of other nonbiologic DMARD for at least 3 consecutive months? (see Appendix F) Had an inadequate response to such therapy? Was patient adherent to prescribed therapy? Intolerant or contraindicated to such therapy? Document last trial of nonbiologic DMARD Other biologics, Xeljanz Go to Figure 5 Remicade Simponi Is Simponi being prescribed with methotrexate? 6 months
Page: 9 of 18 Figure 4b: Rituxan for Rheumatoid Arthritis Algorithm Will Rituxan be used with MTX? Prior to therapy, did patients have 6 or more inflamed joints? Prior to therapy, did patient have at least one of the characteristics listed in Appendix B? Trial of either MTX or leflunomide for at least 3 consecutive months? Intolerant or contraindication to either MTX or leflunomide? Inadequate response to MTX or leflunomide? Trial of other nonbiologic DMARD for at least 3 consecutive months? (see appendix F) Inadequate response to such therapy? Adherent to prescribed therapy? Intolerant or contraindication to such therapy? Trial of at least 1 TNF inhibitor for at least 3 consecutive months? (See Appendix D) intolerant or contraindication to TNF inhibitors? Inadequate response to prescribed TNF inhibitor? Approve one course of therapy (2-1000mg IV infusions separated by 2 weeks) Document last trial of TNF inhibitor unless contraindicated Adherent to prescribed TNF inhibitor therapy?
Page: 10 of 18 Figure 5: Remicade Initial Authorization Algorithm Had an adequate trial of Humira OR Enbrel? Inadequate response, intolerance or a confirmed adverse event to Humira OR Enbrel? Contraindication or intolerance to Humira AND Enbrel? Is methotrexate prescribed with Remicade? Will Remicade be given at 0,2, and 6 weeks then every 8 weeks thereafter? 6 months
Page: 11 of 18 Figure 6: Re-authorization Algorithm - Kineret Is patient compliant with Kineret therapy? Actemra, Cimzia, Enbrel, Kineret, Humira, Orencia, Simponi, Xeljanz, Ilaris Did patient demonstrate therapeutic response? - Actemra Enbrel Humira Orencia Simponi Xeljanz Ilaris 12 months What is the prescribed agent? - Cimzia Does prescribed Cimzia dose exceed 400 mg per month? Rituxan Has patient achieved ACR 20 response following Rituxan initial therapy? Has the patient experience any of the following conditions while on Rituxan? (See Appendix H) Has it been at least 6 months since last treatment? Remicade Did patient demonstrate therapeutic response? Approve one additional course of therapy (2-1000mg IV infusions separated by 2 weeks) Experience diminishing efficacy requiring more frequent infusion intervals than every 6 weeks? Does patient have signs and symptoms of liver toxicity? Ankylosing spondylitis What is the diagnosis? RA Will maintenance regimen consist of IV infusion every 8 weeks? 12 months Will maintenance regimen consists of IV infusion every 6 weeks? 12 months
Page: 12 of 18 Background The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) provide recommendations on RA drug management and treatment strategies. 13,14 Treatment is targeted to achieve remission or low disease activity, and early aggressive use of disease-modifying anti-rheumatic drugs (DMARDs) is recommended. 13,14 DMARDs can be classified as nonbiologic or biologic agents. Biologic DMARDs can be further classified as anti-tnf biologics or non-tnf biologics. 13 The nonbiologic DMARDs commonly used today are methotrexate (MTX), leflunomide, hydroxychloroquine, minocycline, and sulfasalazine. 13 EULAR considers MTX to be the cornerstone nonbiologic DMARD and recommends including MTX in the initial treatment strategy for patients with early active RA. 14 For patients with early RA and low to moderate disease activity, ACR recommends nonbiologic DMARD monotherapy or combinations depending on presence or absence of poor prognostic features. 13,14 For those patients with early RA who have high disease activity and features of poor prognosis, the ACR recommends initiating treatment with an anti-tnf biologic agent with or without MTX (except infliximab and golimumab, which should be used with MTX) or combination nonbiologic DMARD therapy. 13 In patients with established RA who have moderate to high disease activity despite nonbiologic DMARD therapy, the ACR recommends adding or switching to an anti-tnf biologic, abatacept, or rituximab. 13 For patients with an inadequate response or a loss of response to an anti-tnf biologic agent, switching to a different anti-tnf biologic or a non-tnf biologic is recommended. 13 Similarly, patients with an inadequate response or a loss of response to a non-tnf biologic should switch to another non-tnf biologic or an anti-tnf biologic. 13 Switching between biologic agents is recommended when patients experience an adverse event to a particular agent but require continued treatment for moderate to high disease activity. 13 Xeljanz is the first drug in a new class called Janus kinase (JAK) inhibitors. 10 Xeljanz is an oral, small-molecule selective inhibitor of JAK1, JAK3, and to a lesser extent, JAK2. 15 Inhibition of JAK1 and JAK3 blocks signaling for several cytokines that are important for lymphocyte function, thereby modulating the immune response. 16 In clinical trials, treatment with Xeljanz resulted in higher response rates and improved physical function compared to treatment with placebo. 10,15,16 Xeljanz represents a novel approach, but its ideal place in therapy has yet to be determined. 17 Additional long-term efficacy (both clinical and radiographic endpoints) and safety data are anticipated. 17 The clinical studies showed efficacies of these agents by comparing them with placebo or while taking them with or without methotrexate to achieve an ACR response improvement of 20% within 6 months or more. Each drug used to treat RA was designed into multiple studies to compare patients who have not tried any therapy, failed MTX therapy, or have failed one anti-tnf. Data
Page: 13 of 18 showed that infliximab and golimumab are the agents that showed an ACR 20 response only while being used with methotrexate. Juvenile idiopathic arthritis (JIA) is chronic joint inflammation that occurs in children before they reach the age of 16 with no known cause. It may involve one or many joints, causing other symptoms such as fever or rash, and eye inflammation. It is estimated to affect about 300,000 children in the U.S. Polyarticular juvenile idiopathic arthritis (PJIA) is a condition of JIA that affects more than 4 joints after six months of illness. Systemic juvenile idiopathic arthritis (SJIA) is a condition of JIA where patients experience symptoms of rash or fever in addition to joint inflammation 20. NSAIDs and DMARDS are first-line treatment options for both PJIA and SJIA. Biologic agents are considered second line. Actemra and Ilaris are the only biologics that are currently approved for SJIA. For PJIA, Humira, Enbrel, Orencia, and Actemra are currently approved for patients that need to meet specific age requirements (see appendix G). The efficacy of Actemra for the treatment of active SJIA was assessed in patients treated with or without MTX. Each treatment group received infusions every two weeks for 12 weeks with either Actemra or placebo. The primary endpoint was the proportion of patients with at least 30% improvement in JIA ACR (JIA ACR 30) at Week 12 and absence of fever 1. Patients who received Actemra had an 85% response while those with placebo had a 24% response. A similar clinical trial was conducted with Ilaris versus placebo. Ilaris showed a 84% response of JIA ACR 30 while placebo showed 10%. 18 The efficacy of Actemra for the treatment of PJIA was assessed in patients taking a 16 week active treatment then 24-week withdrawal period. The primary endpoint was the proportion of patients with a JIA ACR 30 flare at week 40 relative to week 16. Actemra treated patients (2-17 years of age) experienced significantly fewer disease flares compared to placebo (26% vs. 48%). 1 The efficacy of Enbrel for the treatment of PJIA was assessed in a two-part study where all patients (2-17 years of age) received Enbrel twice daily in Part 1. In part 2, patients with a clinical response at day 90 were randomized to remain on Enbrel or receive placebo for 4 months and assessed for disease flare. 24% of patients remaining on Enbrel experienced a disease flare compared to 77% patients taking placebo. 3 A similar study was done with Humira that including patients that were between ages 4-17 who were receiving MTX with placebo or Humira in the withdrawal period. Those patients who received Humira had significantly lower disease flares compared to placebo, both without MTX (43% vs 71%) and with MTX (37% vs. 65%). 4 For Orencia, patients were 6-17 years of age and was compared to placebo. During the withdrawal phase, Orencia-treated patients significantly fewer disease compared to placebo-treated patients (20% vs. 53%). 6 Ankylosing spondylitis (AS) is chronic inflammation of the hip and pelvic joints that includes the spine (axial AS). Patients with AS experience symptoms of fatigue, back pain, and stiffness in the
Actemra Cimzia Enbrel Humira Kineret Orencia Remicade Rituxan Simponi Ilaris Xeljanz CLINICAL POLICY Page: 14 of 18 spine leading to stooped posture. In addition, AS can also progress to affecting the peripheral joints in the arms and legs (peripheral AS) 22. NSAIDs and COX-2 inhibitors are used as first-line agents used for axial AS to reduce pain and decreasing inflammation. Sulfasalazine is the only DMARD that is effective for AS patients with peripheral arthritis. TNF blockers are the only biologics approved for AS that has shown to reduce the inflammatory activity of spinal disease. The efficacy of Enbrel for the treatment of active AS was conducted in patients who were administered with the drug twice a week for 6 months. The primary measure was a 20% improvement in the Assessment in Ankylosing Spondylitis (ASAS) response criteria compared to placebo for a 6-month treatment. At 6 months, ASAS 20 response was achieved for Enbrel and placebo (60% vs. 27%). 3 A similar trial was conducted with Remicade versus placebo. Patients taking Remicade achieved a 60% ASAS 20 response compared an 18% of patients taking placebo. 7 Furthermore; similar trials were also used for Humira, Cimzia, and Simponi. Patients taking Humira achieved a 58% ASAS 20 response compared to 21% patients taking placebo. 4 Patients taking Cimzia achieved a 68-70% response compared to 37% patients taking placebo. 2 Patients taking Simponi achieved 56% response compared to 23% patients taking placebo. 9 Safety The algorithms (Figures 1a-1c) provide details on how each safety concern is addressed. For a summary by medication, refer to Table 2. Table 2. Safety Concerns with DMARDs for Rheumatoid Arthritis 1-10 Safety Concern Active infection X X X X X X X X X X X Active or latent TB X X X X X X X X X Concomitant use with biologics X X X X X X X X X X Concomitant use with potent immunosuppressants X HBV reactivation X X X X X X X X Severe infusion reactions X X Malignancy X X X X X X Heart failure worsening or new onset* X X X X X Severe mucocutaneous reactions X PML X Tumor Lysis Syndrome X
Actemra Cimzia Enbrel Humira Kineret Orencia Remicade Rituxan Simponi Ilaris Xeljanz CLINICAL POLICY Page: 15 of 18 Safety Concern Pulmonary toxicity/copd exacerbations X X CNS demyelinating disorders (new onset or exacerbation) X X X X X X X Hematologic abnormalities (eg, cytopenias) X X X X X X X X X Elevated lipids & LFTs X X Serious allergic reactions/anaphylaxis X X X X X X X X X Autoantibody formation/lupus-like syndrome X X X X X Gastrointestinal perforations X X X Hepatic impairment use not recommended X X * Remicade doses > 5 mg/kg are contraindicated in patients with moderate to severe heart failure. Actemra is associated with neutropenia and thrombocytopenia; Xeljanz is associated with lymphopenia, neutropenia, and anemia. Refer to prescribing information for laboratory monitoring and dose adjustment recommendations. Actemra is not recommended in patients with active hepatic disease or hepatic impairment; Xeljanz is not recommended in patients with severe hepatic impairment. Appendices Appendix A: Abbreviation Key CAPS: cryopyrin-associated periodic syndrome CNS: central nervous system CSA: cyclosporin DMARD disease-modifying anti-rheumatic drug HBV: hepatitis B virus IBD: inflammatory bowel disease ITP: immune thrombocytopenic purpura IV: intravenous LFT: liver function test LTBI: latent tuberculosis infection MTX: methotrexate NSAID: non-steroidal anti-inflammatory drug PML: progressive multifocal leukoencephalopathy TB: tuberculosis TNF: tumor necrosis factor SJIA: systemic juvenile idiopathic arthritis PJIA: polyarticular juvenile idiopathic arthritis AS: ankylosing spondylitis RPLS: reversible posterior leukoencephalopathy syndrome
Page: 16 of 18 Appendix B: Diagnosis of moderately to severely active rheumatoid arthritis Elevation of erythrocyte sedimentation rate (ESR) and/or serum c-reactive protein (CRP) concentration Positive rheumatoid factor and/or anti-cyclic citrullinated peptide (CCP) Radiography showing evidence of rheumatoid arthritis, including osteopenia and/or joint space narrowing and/or bony erosions and/or loss of cartilage Functional limitation based on the Health Assessment Questionnaire Disability Index (HAQ-DI) Appendix C: Maximum dose requirements For Enbrel, the prescribed maintenance dose may not exceed 50 mg per week For Humira, the prescribed maintenance dose may not exceed 40 mg every other week; if not taking methotrexate, may not exceed 40 mg every week For Simponi, the prescribed dose may not exceed 50 mg monthly Appendix D: Examples of tumor necrosis factor (TNF) inhibitors Cimzia (certolizumab pegol) Enbrel (etanercept) Humira (adalimumab) Remicade (infliximab) Simponi (golimumab) Appendix E: Examples of NSAIDs and COX-2 Inhibitors NSAIDs Diclofenac Indomethacin Diflunisal Ketoprofen Etodolac Meloxicam Flurbiprofen Nabumetone Ibuprofen Naproxen COX-2 inhibitors: Celecoxib Oxaprozin Piroxicam Salsalate Sulindac Appendix F: Other nonbiologic DMARDs Hydroxychloroquine CSA Sulfasalazine Gold Cyclophosphamide Azathioprine Appendix G: Age Requirements of Medications Actemra: for patients with SJIA & PJIA who are 2 years of age or older
Page: 17 of 18 Enbrel: for patients with PJIA who are 2 years of age or older Ilaris: for patients with SJIA who are 2 years of age or older Humira: for patients with PJIA who are 4 years of age or older Orencia: for patients with PJIA who are 6 years of age or older Appendix H: Permanently Discontinued Therapy for the Following Conditions with Rituxan Diagnosis of PML Rise in serum creatinine or oligouria Severe infection Hepatitis B virus reactivation Severe mucocutaneous reactions Life-threatening cardiac arrhythmias Bibliography 1. Actemra [package insert]. South San Francisco, CA: Genentech, Inc.; October 2013. 2. Cimzia [package insert]. Smyrna, GA: UCB, Inc.; October 2013. 3. Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; vember 2013. 4. Humira [package insert]. rth Chicago, IL: Abbott Laboratories; May 2014. 5. Kineret [package insert]. Stockholm, Sweden: Biovitrum AB (publ); December 2012. 6. Orencia [package insert]. Princeton, NJ: Bristol-Meyers Squibb Company; December 2013. 7. Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc.; vember 2013. 8. Rituxan [package insert]. South San Francisco, CA: Genentech, Inc.; September 2013. 9. Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc.; January 2014. 10. Xeljanz [package insert]. New York, NY: Pfizer, Inc.; May 2014. 11. Centers for Disease Control and Prevention. Rheumatoid arthritis. http://www.cdc.gov/arthritis/basics/rheumatoid.htm. Accessed July 16, 2014. 12. Scott DL, Wolfe F, Huizinga TWJ. Rheumatoid arthritis. Lancet. 2010;376:1094-1108. 13. Singh JA, Furst DE, Bharat A, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. 14. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014; 73:492-509. 15. van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367(6):508-519. 16. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495-507. 17. Fox D. Kinase inhibition a new approach to the treatment of rheumatoid arthritis. N Engl J Med. 2012;367(6):565-567. 18. Ilaris [package insert]. East Hanover, NJ: vartis Pharmaceuticals Corporation; May 2013.
Page: 18 of 18 19. Ringold, S, Weiss PF, et al. 2013 Update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis. Arthritis Care Res. 2013; 65 (10): 2499-2512. 20. Braun J, van den berg R, et al. 2010 Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Am Rheu Dis. 2011: 70; 896-904. 21. American College of Rheumatology. www.rheumatology.org. Accessed on July 16, 2014. Revision Log Date clinical changes. 09/12 Questions rearranged so that patients who have previously received biologic therapy will bypass safety questions related to TB and HBV Combined all reauthorization algorithms into one. Added Xeljanz 07/13 Removed ITP and safety question regarding prior reactions from Rituxan safety 07/13 algorithm Renamed policy to Arthritis Treatments since it covers more than Rheumatoid 07/13 Arthritis Added drugs: Ilaris for SJIA 07/14 Updated background information: JIA, AS Updated safety concerns: Ilaris Added efficacy data for RA, JIA, and AS Added appendices G & H Figure 2a and Figure 2b algorithm joined Figure 2: added Actemra for PJIA, Ilaris for SJIA & patient age requirement Figure 3: Cimzia added for AS Figure 4: Added question requiring Simponi be administered with MTX Figure 5: PsA algorithm removed and to be added to Psoriasis Centene policy Figure 6: now Figure 5, added requiring Remicade be administered with MTX Figure 7: now Figure 6, added Appendix H to algorithm 2014 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation.