Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Humira and Biosimilars 2008-A SGM P2022d
Drug
HUMIRA(adalimumab)
ABRILADA(adalimumab-afzb)
AMJEVITA(adalimumab-atto)
CYLTEZO(adalimumab-adbm)
HADLIMA(adalimumab-bwwd)
HULIO(adalimumab-fkjp)
HYRIMOZ(adalimumab-adaz)
IDACIO(adalimumab-aacf)
YUFLYMA(adalimumab-aaty)
YUSIMRY(adalimumab-aqvh)
adalimumab-adaz
adalimumab-fkjp
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. Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). 2. Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older. 3. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PsA). 4. Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 5. The treatment of moderately to severely active Crohn’s disease (CD) in adult and pediatric patients 6 years of age and older. 6. The treatment of moderately to severely active ulcerative colitis (UC) in adults and pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of Humira has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. 7. The treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. 8. The treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 9. The treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
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. 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. 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. Ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriatic arthritis (PsA), hidradenitis suppurativa, and uveitis (non-infectious intermediate, posterior and panuveitis) 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. Crohn’s disease (CD) Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
E. Ulcerative colitis (UC) Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
F. 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.
G. Behcet’s disease and immunotherapy-related inflammatory arthritis (initial requests only): Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
H. Pyoderma gangrenosum (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.
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, and Behcet’s disease: rheumatologist B. Psoriatic arthritis and hidradenitis suppurativa: rheumatologist or dermatologist C. Crohn’s disease and ulcerative colitis: gastroenterologist D. Plaque psoriasis and pyoderma gangrenosum: dermatologist E. Uveitis: ophthalmologist or rheumatologist 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 are 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 or 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 or older for 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 the 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 adult members 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 adult members 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 either 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. Crohn’s disease (CD) Authorization of 12 months may be granted for members 6 years of age or older for treatment of moderately to severely active CD.
F. Ulcerative colitis (UC) Authorization of 12 months may be granted for members 5 years of age or older for treatment of moderately to severely active ulcerative colitis.
G. Plaque psoriasis (PsO) 1. Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for treatment of moderate to severe plaque psoriasis.
2. Authorization of 12 months may be granted for adult members for treatment of moderate to severe plaque psoriasis 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 body surface area (BSA) is affected. iii. At least 3% of body surface area (BSA) is affected and the member meets either 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 A).
H. Hidradenitis suppurativa 1. Authorization of 12 months may be granted for members 12 years of age or older who have previously received a biologic indicated for treatment of moderate to severe hidradenitis suppurativa.
2. Authorization of 12 months may be granted for member 12 years of age or older for treatment of moderate to severe 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.
I. Uveitis (non-infectious intermediate, posterior and panuveitis) 1. Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic indicated for non-infectious intermediate, posterior, and panuveitis.
2. Authorization of 12 months may be granted for members 2 years of age or older for treatment of non-infectious intermediate, posterior and panuveitis when either of the following is met: i. Member has experienced an inadequate response to corticosteroids or immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate). ii. Member has an intolerance or contraindication to corticosteroids and immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate).
J. 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 non-biologic medication for Behcet’s disease (e.g., apremilast, colchicine, systemic glucocorticoids, azathioprine).
K. Pyoderma gangrenosum 1. Authorization of 12 months may be granted for members who have previously received a biologic indicated for treatment of pyoderma gangrenosum.
2. Authorization of 12 months may be granted for treatment of pyoderma gangrenosum when either of the following is met: i. Member has experienced an inadequate response to corticosteroids or immunosuppressive therapy (e.g., cyclosporine or mycophenolate mofetil). ii. Member has an intolerance or contraindication to corticosteroids and immunosuppressive therapy (e.g., cyclosporine, mycophenolate mofetil).
L. Immunotherapy-related inflammatory arthritis Authorization of 12 months may be granted for treatment of severe/refractory immunotherapy-related inflammatory arthritis that is not responding to corticosteroids and anti- inflammatory agents.
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 or 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 adult members (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-radiographic axial spondyloarthritis (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 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. Crohn’s disease (CD) 1. Authorization of 12 months may be granted for all members 6 years of age or older (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all members 6 years of age or older (including new members) who are using the requested medication for moderately to severely active Crohn’s disease 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: i. Abdominal pain or tenderness ii. Diarrhea iii. Body weight iv. Abdominal mass v. Hematocrit vi. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound vii. Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)
F. Ulcerative colitis (UC) 1. Authorization of 12 months may be granted for all members 5 years of age and older (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all members 5 years of age and older (including new members) who are using the requested medication for moderately to severely active ulcerative colitis 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: i. Stool frequency ii. Rectal bleeding iii. Urgency of defecation iv. C-reactive protein (CRP) v. Fecal calprotectin (FC) vi. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound vii. Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of Severity [UCEIS], Mayo score)
G. Plaque psoriasis (PsO) Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderate to severe plaque psoriasis 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 either 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)
H. Hidradenitis suppurativa Authorization of 12 months may be granted for all members 12 years of age and older (including new members) who are using the requested medication for moderate to severe 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
I. Uveitis (non-infectious intermediate, posterior and panuveitis) 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 non-infectious intermediate, posterior, and panuveitis 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 the patient meets any of the following: 1. Reduced frequency of disease flares compared to baseline 2. Stability or improvement in anterior chamber (AC) cell grade compared to baseline 3. Stability or improvement in vitreous haze (VH) grade compared to baseline 4. Stability or improvement in visual acuity compared to baseline 5. Reduction in glucocorticoid requirements from baseline 6. No new active inflammatory chorioretinal and/or inflammatory retinal vascular lesions relative to baseline
J. Immunotherapy-related inflammatory arthritis All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
K. 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 a positive clinical response 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. For rheumatoid arthritis, member must initiate treatment with every other week dosing.
VIII. APPENDICES
Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine, Acitretin, 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
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Hulio [package insert]. Morgantown, WV: Mylan Specialty L.P.; March 2023.
Hyrimoz [package insert]. Princeton, NJ: Sandoz Inc.; April 2023.
Idacio [package insert]. Lake Zurich, IL: Fresenius Kabi USA, LLC, December 2022.
Yuflyma [package insert]. Jersey City, NJ: Celltrion USA, Inc.; May 2023.
Yusimry [package insert]. Redwood City, CA: Coherus BioSciences, Inc.; March 2023.
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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.
