Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Rinvoq 3173-A SGM P2024b
Drug
RINVOQ(upadacitinib)
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.
FDA-Approved Indications Rinvoq is indicated for: A. Adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. B. Adults and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers. C. Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. D. Adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. E. Adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers. F. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. G. Adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. H. Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers.
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), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non- radiographic axial spondyloarthritis (nr-axSpA), and polyarticular juvenile idiopathic arthritis (pJIA) 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.
B. Atopic dermatitis 1. Initial requests: i. Chart notes or medical records showing affected area(s) and affected body surface area (where applicable). ii. Chart notes, medical record documentation, or claims history of prerequisite therapies, including response to therapy. If prerequisite therapies are not advisable, documentation of why therapies are not advisable for the member. 2. Continuation requests: Documentation (e.g., chart notes) supporting positive clinical response to therapy as evidenced by low disease activity or improvement in signs or symptoms of atopic dermatitis.
C. Ulcerative colitis (UC) 1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. 2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
D. Crohn’s disease (CD) 1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. 2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with one of the following: A. Rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and polyarticular juvenile idiopathic arthritis: rheumatologist B. Psoriatic arthritis: rheumatologist or dermatologist C. Atopic dermatitis: dermatologist or allergist/immunologist D. Ulcerative colitis and Crohn’s disease: gastroenterologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Rheumatoid arthritis (RA) 1. Authorization of 12 months may be granted for adult members for treatment of moderately to severely active rheumatoid arthritis (RA) when the member has experienced an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor.
2. Authorization of 12 months may be granted for adult members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Xeljanz, Olumiant) indicated for moderately to severely active RA.
B. Psoriatic arthritis (PsA) 1. Authorization of 12 months may be granted for members 2 years of age or older for treatment of active psoriatic arthritis when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Xeljanz, Otezla) indicated for active psoriatic arthritis.
C. Atopic dermatitis 1. Authorization of 4 months may be granted for members 12 years of age or older for treatment of moderate-to-severe atopic dermatitis when the member has experienced an inadequate response or intolerance to at least one biologic (e.g., Dupixent, Adbry) or a targeted synthetic drug (e.g., Cibinqo) in the past year.
2. Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 12 years of age or older when all of the following criteria are met: i. Affected body surface is greater than or equal to 10% body surface area OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected. ii. Member meets one of the following: a. Member has had an inadequate treatment response with one of the following in the past year: 1. A medium potency to super-high potency topical corticosteroid (see Appendix) 2. A topical calcineurin inhibitor b. The use of medium potency to super-high potency topical corticosteroid and topical calcineurin inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances). iii. Member has had an inadequate response to treatment with a systemic drug product (e.g., oral cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) indicated for the treatment of atopic dermatitis, or use of these therapies are not advisable for the member.
D. Ulcerative colitis (UC) 1. Authorization of 12 months may be granted for adult members for treatment of moderately to severely active UC when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for adult members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active ulcerative colitis.
E. Ankylosing spondylitis (AS) and non-radiographicaxial spondyloarthritis (nr-axSpA) 1. Authorization of 12 months may be granted for adult members for treatment of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis when the member has experienced an inadequate response or intolerance to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for adult members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Xeljanz) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis.
F. Crohn’s disease (CD) 1. Authorization of 12 months may be granted for adult members for treatment of moderately to severely active CD when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for adult members who have previously received a biologic (other than a TNF inhibitor) indicated for moderately to severely active Crohn’s disease.
G. Polyarticular juvenile idiopathic arthritis (pJIA) 1. Authorization of 12 months may be granted for members 2 years of age or older for treatment of active polyarticular juvenile idiopathic arthritis when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug indicated for active polyarticular juvenile idiopathic arthritis.
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 RA 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. Psoriatic arthritis Authorization of 12 months may be granted for 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 7. Functional status 8. C-reactive protein (CRP)
C. Atopic dermatitis Authorization of 12 months may be granted for members 12 years of age or older (including new members) who are using the requested medication for moderate-to-severe atopic dermatitis and who achieve or maintain a positive clinical response as evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).
D. Ulcerative colitis (UC) 1. 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 ulcerative colitis and who achieve or maintain remission.
2. 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 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)
E. Ankylosing spondylitis (AS) and non-radiographicaxial spondyloarthritis (nr-axSpA) Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for ankylosing spondylitis or 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) 4. Swollen joints 5. Tender joints 6. C-reactive protein (CRP)
F. Crohn’s disease (CD) 1. 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 Crohn’s disease and who achieve or maintain remission.
2. 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 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)
G. Polyarticular juvenile idiopathic arthritis (pJIA) Authorization of 12 months may be granted for members 2 years of age or older (including new members) who are using the requested medication for active polyarticular 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
VI. OTHER
For all indications: 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.
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug, targeted synthetic drug, or potent immunosuppressant such as azathioprine or cyclosporine.
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
Table. Relative potency of select topical corticosteroid products
Hydrocortisone (base, greater than or equal to 2%)
Cream, Ointment, Solution
2.5%
Lotion
2%
Hydrocortisone (base, less than 2%)
Cream, Ointment, Gel, Lotion, Spray, Solution
1%
Cream, Ointment
0.5%
Hydrocortisone acetate
Cream
2.5%
Lotion
2%
Cream
1%
Place of Service:
Outpatient
The above policy is based on the following references:
Rinvoq [package insert]. North Chicago, IL; AbbVie, Inc.; April 2024.
Singh JA,Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis2016;68(1)1-26.
Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
Aletaha D, Neogi T, Silman, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
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.
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.
Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
Sidbury R, Alikhan A, Bercovitch L, et. al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.
Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology 2020;158:1450.
Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. doi:10.1002/art.41042.
Gossec L, Baraliakos X, Kerschbaumer A. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;0:1-14.
Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.
Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; September 1, 2023. Accessed November 2, 2023.
Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
Feuerstein J, Ho E, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. 2021; 160:2496-2508.
Ringold S, Angeles-Han S, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res (Hoboken). 2019; 71(6):717-734.
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.
