Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Enbrel 2003-A SGM P2022a
Drug
ENBREL(etanercept)
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications 1. Moderately to severely active rheumatoid arthritis (RA) 2. Moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 2 years and older 3. Active psoriatic arthritis (PsA) 4. Active ankylosing spondylitis (AS) 5. Chronic moderate to severe plaque psoriasis (PsO) in patients aged 4 years or older who are candidates for systemic therapy or phototherapy 6. Juvenile psoriatic arthritis in patients aged 2 years and older (JPsA)
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Rheumatoid arthritis (RA) 1. For initial requests: i. 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. ii. 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). 2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
B. Articular juvenile idiopathic arthritis (JIA) 1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. 2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.
C. Psoriatic arthritis (PsA), ankylosing spondylitis (AS), non- radiographic axial spondyloarthritis (nr-axSpA), reactive arthritis, and hidradenitis suppurativa 1. Initial requests: 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. 2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.
D. Plaque psoriasis (PsO) 1. Initial requests: i. Chart notes or medical record documentation of affected area(s) and body surface area (BSA) affected (if applicable). ii. 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. 2. Continuation requests: Chart notes or medical record documentation of decreased body surface area (BSA) affected and/or improvement in signs and symptoms.
E. Graft versus host disease and immunotherapy-related inflammatory arthritis (initial requests only): 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.
F. Behcet’s disease (initial requests only): Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with one of the following:
A. Rheumatoid arthritis, articular juvenile idiopathic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, reactive arthritis, and Behcet’s disease: rheumatologist B. Psoriatic arthritis and hidradenitis suppurativa: rheumatologist or dermatologist C. Plaque psoriasis: dermatologist D. Graft versus host disease: oncologist or hematologist E. Stevens-Johnson syndrome or toxic epidermal necrolysis: oncologist, hematologist, or dermatologist F. Immunotherapy-related inflammatory arthritis: oncologist, hematologist, or rheumatologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Rheumatoid arthritis (RA) 1. Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active rheumatoid arthritis.
2. Authorization of 12 months may be granted for adult members for treatment of moderately to severely active RA when all of the following criteria are met: i. Member meets either of the following criteria: a. Member has been tested for either of the following biomarkers and the test was positive: 1. Rheumatoid factor (RF) 2. Anti-cyclic citrullinated peptide (anti-CCP) b. Member has been tested for ALL of the following biomarkers: 1. RF 2. Anti-CCP 3. C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR) ii. Member meets either of the following criteria: a. Member has experienced an inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (i.e., titrated to at least 15 mg/week). b. Member has an intolerance or contraindication to methotrexate (see Appendix A).
B. Articular juvenile idiopathic arthritis (JIA) 1. Authorization of 12 months may be granted for members 2 years of age and older who have previously received a biologic or targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active articular juvenile idiopathic arthritis.
2. Authorization of 12 months may be granted for members 2 years of age and older for the treatment of moderately to severely active articular juvenile idiopathic arthritis when any of the following criteria is met: i. Member has had an inadequate response to methotrexate or another conventional synthetic drug (e.g., leflunomide, sulfasalazine, hydroxychloroquine) administered at an adequate dose and duration. ii. Member has had an inadequate response to a trial of scheduled non-steroidal anti-inflammatory drugs (NSAIDs) and/or intra-articular glucocorticoids (e.g., triamcinolone hexacetonide) and one of the following risk factors for poor outcome: a. Involvement of ankle, wrist, hip, sacroiliac joint, and/or temporomandibular joint (TMJ) b. Presence of erosive disease or enthesitis c. Delay in diagnosis d. Elevated levels of inflammation markers e. Symmetric disease iii. Member has risk factors for disease severity and potentially a more refractory disease course (see Appendix B) and member also meets one of the following: a. High-risk joints are involved (e.g., cervical spine, wrist, or hip). b. High disease activity. c. Is judged to be at high risk for disabling joint disease.
C. Psoriatic arthritis (PsA) 1. Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active psoriatic arthritis.
2. Authorization of 12 months may be granted for members 2 years of age or older for treatment of active psoriatic arthritis when either of the following criteria is met: i. Member has mild to moderate disease and meets one of the following criteria: a. Member has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at an adequate dose and duration. b. Member has an intolerance or contraindication to methotrexate or leflunomide (see Appendix A), or another conventional synthetic drug (e.g., sulfasalazine). c. Member has enthesitis or predominantly axial disease. ii. Member has severe disease.
D. Ankylosing spondylitis (AS) and non-radiographicaxial spondyloarthritis (nr-axSpA) 1. Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for active ankylosing spondylitis or active non- radiographic axial spondyloarthritis.
2. Authorization of 12 months may be granted for adult members for treatment of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis when any of the following criteria is met: i. Member has experienced an inadequate response to at least two non-steroidal anti-inflammatory drugs (NSAIDs). ii. Member has an intolerance or contraindication to two or more NSAIDs.
E. Plaque psoriasis (PsO) 1. Authorization of 12 months may be granted for members 4 years of age or older who have previously a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for the treatment of moderate to severe plaque psoriasis.
2. Authorization of 12 months may be granted for treatment of moderate to severe plaque psoriasis in members 4 years of age or older when any of the following criteria is met: i. Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected. ii. At least 10% of the body surface area (BSA) is affected. iii. At least 3% of body surface area (BSA) is affected and the member meets any of the following criteria: a. Member has had an inadequate response or intolerance to either phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin. b. Member has a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, and acitretin (see Appendix C).
F. Reactive arthritis 1. Authorization of 12 months may be granted for members who have previously received a biologic indicated for reactive arthritis.
2. Authorization of 12 months may be granted for treatment of reactive arthritis when any of the following criteria is met: i. Member has experienced an inadequate response to at least a 3-month trial of one of the following despite adequate dosing or maximally tolerated dose: a. Sulfasalazine (i.e., titrated to 1000 mg twice daily) b. Methotrexate (i.e., titrated to at least 15 mg/week) ii. Member has an intolerance or contraindication to methotrexate (see Appendix A) and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
G. Hidradenitis suppurativa 1. Authorization of 12 months may be granted for members who have previously received a biologic indicated for the treatment of severe, refractory hidradenitis suppurativa.
2. Authorization of 12 months may be granted for treatment of severe, refractory hidradenitis suppurativa when either of the following is met: i. Member has experienced an inadequate response to an oral antibiotic for at least 90 days. ii. Member has an intolerance or contraindication to oral antibiotics.
H. Graft versus host disease Authorization of 12 months may be granted for treatment of graft versus host disease when either of the following criteria is met: 1. Member has experienced an inadequate response to systemic corticosteroids. 2. Member has an intolerance or contraindication to corticosteroids.
I. Behcet’s disease 1. Authorization of 12 months may be granted for members who have previously received Otezla or a biologic indicated for the treatment of Behcet’s disease.
2. Authorization of 12 months may be granted for the treatment of Behcet’s disease when the member has had an inadequate response to at least one nonbiologic medication for Behcet’s disease (e.g., apremilast, colchicine, systemic glucocorticoids, azathioprine).
J. Immune checkpoint inhibitor toxicity
1. Authorization of 1 month may be granted for treatment of immune checkpoint inhibitor toxicity when the member has Stevens-Johnson syndrome or toxic epidermal necrolysis.
2. Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor toxicity when the member has severe immunotherapy-related inflammatory arthritis and has experienced an inadequate response, intolerance, or contraindication to corticosteroids.
V. CONTINUATION OF THERAPY
A. Rheumatoid arthritis (RA) 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.
B. Articular juvenile idiopathic arthritis (JIA) Authorization of 12 months may be granted for all members 2 years of age and older (including new members) who are using the requested medication for moderately to severely active articular juvenile idiopathic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline: 1. Number of joints with active arthritis (e.g., swelling, pain, limitation of motion) 2. Number of joints with limitation of movement 3. Functional ability
C. Psoriatic arthritis (PsA) Authorization of 12 months may be granted for all members 2 years of age or older (including new members) who are using the requested medication for psoriatic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline: 1. Number of swollen joints 2. Number of tender joints 3. Dactylitis 4. Enthesitis 5. Axial disease 6. Skin and/or nail involvement
D. Ankylosing spondylitis (AS) and non-radiographicaxial spondylarthritis (nr-axSpA) Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis and who achieve or maintain a positive clinical response with the requested medication as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline: 1. Functional status 2. Total spinal pain 3. Inflammation (e.g., morning stiffness)
E. Plaque psoriasis (PsO) Authorization of 12 months may be granted for all members 4 years of age or older (including new members) who are using the requested medication for moderate to severe plaque psoriasis and who achieve or maintain positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when any of the following is met: 1. Reduction in body surface area (BSA) affected from baseline 2. Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)
F. Reactive arthritis Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for reactive arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition (e.g., tender joint count, swollen joint count, or pain).
G. Hidradenitis suppurativa Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for severe, refractory hidradenitis suppurativa and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when any of the following is met: 1. Reduction in abscess and inflammatory nodule count from baseline 2. Reduced formation of new sinus tracts and scarring 3. Decrease in frequency of inflammatory lesions from baseline 4. Reduction in pain from baseline 5. Reduction in suppuration from baseline 6. Improvement in frequency of relapses from baseline 7. Improvement in quality of life from baseline 8. Improvement on a disease severity assessment tool from baseline
H. Graft versus host disease and immune checkpoint inhibitor toxicity All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
I. All other indications Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for an indication outlined in Section IV and who achieve or maintain positive clinical response with the requested medication as evidenced by low disease activity or improvement in signs and symptoms of the condition.
VI. OTHER
For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* 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. 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.
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug.
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. Dose optimization with 50 mg product formulations should be used when possible. Exceptions for higher quantities of 25 mg vials will be allowed when the member has a latex allergy or is following FDA-approved weight-based dosing.
VIII. APPENDICES
Appendix A: Examples of Contraindications to Methotrexate or Leflunomide 1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease 2. Breastfeeding 3. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) 4. Elevated liver transaminases 5. History of intolerance or adverse event 6. Hypersensitivity 7. Interstitial pneumonitis or clinically significant pulmonary fibrosis 8. Myelodysplasia 9. Pregnancy or currently planning pregnancy 10. Renal impairment 11. Significant drug interaction
Appendix C: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine, or Acitretin 1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease 2. Breastfeeding 3. Drug interaction 4. Cannot be used due to risk of treatment-related toxicity 5. Pregnancy or currently planning pregnancy 6. Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
Place of Service:
Outpatient
The above policy is based on the following references:
Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; October 2023.
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Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behcet’s syndrome. Ann Rheum Dis. 2018;77:808-818.
Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726.
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The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 9, 2022.
Menter, A, Cordero, KM, Davis, DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.
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.
Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
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Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81(1):91-101.
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Azulfidine [package insert]. New York, NY: Pfizer; August 2021.
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.
