The intent of the criteria is to provide coverage for biologic drugs for adult members who have maximized the use of conventional synthetic drugs for the treatment of rheumatoid arthritis. This program applies to the following products that are FDA-approved for the treatment of rheumatoid arthritis (Abrilada, Actemra, adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Amjevita, Avsola, Cimzia, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, infliximab, Kevzara, Kineret, Orencia, Remicade, Renflexis, Simlandi, Simponi, Simponi Aria, Tofidence, Tyenne, Yuflyma, Yusimry). Coverage will be provided if all approval criteria are met and the member has no exclusions to the prescribed therapy.
II. DOCUMENTATION
The following information must be submitted: A. Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy. B. Laboratory results, chart notes, or medical record documentation of biomarker testing (i.e., rheumatoid factor [RF], anti-cyclic citrullinated peptide [anti-CCP], and C-reactive protein [CRP] and/or erythrocyte sedimentation rate [ESR]) (if applicable).
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a rheumatologist.
IV. CRITERIA FOR INITIAL APPROVAL
A. Authorization of 12 months may be granted when the member has previously received a biologic or targeted synthetic drug indicated for moderately to severely active rheumatoid arthritis (RA) within the past 120 days.
B. Authorization of 12 months may be granted when the member has not previously received a biologic or targeted synthetic drug indicated for RA when all of the following criteria are met:
1. Member meets either of the following: i. Member has been tested for either of the following biomarkers and the test was positive: a. Rheumatoid factor (RF) b. Anti-cyclic citrullinated peptide (anti-CCP)
ii. Member has been tested for ALL of the following biomarkers: a. RF b. Anti-CCP c. C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
2. Member meets ONE of the following:
i. Member has failed to achieve a low disease activity after a 3-month trial of methotrexate (MTX) monotherapy at a maximum titrated dose of at least 15 mg per week and meets any of the following conditions: a. Member has had a documented inadequate response to MTX in combination with at least one other conventional synthetic drug (i.e., hydroxychloroquine and/or sulfasalazine) after a 3-month trial at a maximum tolerated dose(s). b. Member has experienced a documented intolerable adverse event to hydroxychloroquine or sulfasalazine. c. Member has a documented contraindication to hydroxychloroquine (see Appendix) and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction). d. Member has moderate to high disease activity.
ii. Member was unable to tolerate a 3-month trial of MTX monotherapy at a maximum titrated dose of at least 15 mg per week and meets any of the following conditions: a. Member has had a documented inadequate response to MTX in combination with at least one other conventional synthetic drug (i.e., hydroxychloroquine and/or sulfasalazine) after a 3-month trial at a maximum tolerated dose(s). b. Member has stopped taking MTX and has had a documented inadequate response to another conventional synthetic drug (i.e., leflunomide, hydroxychloroquine, and/or sulfasalazine) alone or in combination after a 3-month trial at a maximum tolerated dose(s). c. Member has experienced a documented intolerable adverse event to hydroxychloroquine or sulfasalazine. d. Member has a documented contraindication to leflunomide, hydroxychloroquine (see Appendix), and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction). e. Member has moderate to high disease activity.
iii. Member has experienced a documented intolerable adverse event or has a documented contraindication to MTX (see Appendix), discontinues MTX, and meets any of the following conditions: a. Member has had a documented inadequate response to another conventional synthetic drug (i.e., leflunomide, hydroxychloroquine, and/or sulfasalazine) alone or in combination after a 3-month trial at a maximum tolerated dose(s). b. Member has experienced a documented intolerable adverse event to leflunomide, hydroxychloroquine, or sulfasalazine. c. Member has a documented contraindication to leflunomide, hydroxychloroquine (see Appendix), and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction). d. Member has moderate to high disease activity. iv. The requested product is Actemra, Tofidence, or Tyenne.
3. For Avsola, Inflectra, infliximab, Remicade, Renflexis, Simponi, and Simponi Aria requests, member is prescribed the requested medication in combination with methotrexate or leflunomide or has a clinical reason not to use methotrexate or leflunomide (see Appendix).
4. For Kineret requests, member has experienced an inadequate response to at least a 3-month trial of a biologic or a targeted synthetic drug (e.g., Rinvoq, Xeljanz) or has an intolerance to a biologic or targeted synthetic drug.
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active rheumatoid arthritis and who achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.
VI. OTHER
Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA])* within 6 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.
* If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
VIII. APPENDIX
Examples of clinical reasons to avoid pharmacologic treatment with methotrexate, hydroxychloroquine, or leflunomide 1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease 2. Drug interaction 3. Risk of treatment-related toxicity 4. Pregnancy or currently planning pregnancy 5. Breastfeeding 6. Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension) 7. Hypersensitivity 8. History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
DRUGDEX® System [Internet database]. Ann Arbor, MI: Truven Health Analytics. Updated periodically. Accessed August 10, 2023.
Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005;52:3381–90.
Graudal N, Jurgens G. Similar effects of disease-modifying antirheumatic drugs, glucocorticoids, and biologic agents on radiographic progression in rheumatoid arthritis: meta-analysis of 70 randomized placebo-controlled or drug-controlled studies, including 112 comparisons. Arthritis Rheum. 2010;62:2852–63.
Ma MH, Kingsley GH, Scott DL. A systematic comparison of combination DMARD therapy and tumour necrosis inhibitor therapy with methotrexate in patients with early rheumatoid arthritis. Rheumatology(Oxford). 2010;49:91–8.
Methotrexate tablets [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; August 2021.
Moreland LW, O’Dell JR, Paulus HE, et al. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the Treatment of Early Aggressive Rheumatoid Arthritis trial. Arthritis Rheum. 2012;64:2824–35.
O’Dell JR, Mikuls TR, Taylor TH, et al. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. 2013;369:307-18.
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1)1-26.
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;64:625-39.
Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699. doi:10.1136/annrheumdis-2019-216655.
Van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet. 2012;379(9827):1712–20.
Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.
Menter, A, Gelfand, JM, Connor, C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6): 1445-86.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
