Subject: Rinvoq SGM 3173-A P2026a

Drug

RINVOQ  (upadacitinib)

Policy:

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 Indications¹

·        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

·        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

·        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

·        Adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of Rinvoq.

·        Adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers

·        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

·        Adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of Rinvoq.

·        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

·        Adults with giant cell arteritis (GCA)

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and polyarticular juvenile idiopathic arthritis (pJIA)

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.

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Giant cell arteritis (GCA)

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Atopic dermatitis

Initial requests

·        Chart notes or medical record documentation showing affected area(s) and body surface area.

·        Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Ulcerative colitis (UC) and Crohn’s disease (CD)

Initial requests

Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy (where applicable).

Continuation requests

Chart notes or medical record documentation supporting positive clinical response to therapy or remission.

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

·        Rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis: rheumatologist

·        Psoriatic arthritis: rheumatologist or dermatologist

·        Atopic dermatitis: dermatologist or allergist/immunologist

·        Ulcerative colitis and Crohn’s disease: gastroenterologist

Coverage Criteria

Rheumatoid arthritis (RA)^1-3,5,6

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active rheumatoid arthritis (RA) when the member has had an inadequate response, intolerance, or has a contraindication to at least one TNF inhibitor.

Psoriatic arthritis (PsA)^1,7,14,16

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, intolerance, or has a contraindication to at least one TNF inhibitor.

Atopic dermatitis^{1,8-9,17,21,24-25}

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:

§  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.

§  Member meets either of the following:

·        Member has had an inadequate treatment response with one of the following:

§  A medium potency to super-high potency topical corticosteroid (see Appendix)

§  A topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)

§  A topical Janus kinase (JAK) inhibitor (e.g., Opzelura)

§  A topical phosphodiesterase-4 (PDE-4) inhibitor (e.g., Eucrisa, Zoryve)

§  A topical aryl hydrocarbon receptor agonist (e.g., Vtama)

·        The use of medium potency to super-high potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, topical PDE-4 inhibitor, and topical aryl hydrocarbon receptor agonist are not advisable for the member (e.g., due to contraindications, prior intolerances).

§  Member has had an inadequate response, intolerance, or contraindication to treatment with other systemic drug products, including biologics, indicated for the treatment of atopic dermatitis in the past 12 months.

Ulcerative colitis (UC)¹

Authorization of 12 months may be granted for treatment of moderately to severely active UC when the member has had an inadequate response or intolerance to at least one TNF inhibitor. If TNF inhibitors are clinically inadvisable, the member should have received at least one approved systemic therapy prior to use of the requested medication.

Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^1,13,15

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 had an inadequate response, intolerance, or has a contraindication to at least one TNF inhibitor.

Crohn’s disease (CD)¹

Authorization of 12 months may be granted for treatment of moderately to severely active CD when the member has had an inadequate response or intolerance to at least one TNF inhibitor. If TNF inhibitors are clinically inadvisable, the member should have received at least one approved systemic therapy prior to use of the requested medication.

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, intolerance, or has a contraindication to at least one TNF inhibitor.

Giant cell arteritis (GCA)¹

Authorization of 12 months may be granted for adult members for treatment of giant cell arteritis when the member’s diagnosis was confirmed by either of the following:

·        Temporal artery biopsy or cross-sectional imaging

·        Acute-phase reactant elevation (i.e., high erythrocyte sedimentation rate [ESR] and/or high serum C-reactive protein [CRP])

Continuation of Therapy

Rheumatoid arthritis (RA)^1,3,5,6

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.

Psoriatic arthritis^1,7,16

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:

·        Number of swollen joints

·        Number of tender joints

·        Dactylitis

·        Enthesitis

·        Axial disease

·        Skin and/or nail involvement

·        Functional status

·        C-reactive protein (CRP)

Atopic dermatitis^1,8

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).

Ulcerative colitis (UC)^1,10-12

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission.

Authorization of 12 months may be granted for all 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:

·        Stool frequency

·        Rectal bleeding

·        Urgency of defecation

·        C-reactive protein (CRP)

·        Fecal calprotectin (FC)

·        Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound

·        Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of Severity [UCEIS], Mayo score)

Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^1,13,15

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:

·        Functional status

·        Total spinal pain

·        Inflammation (e.g., morning stiffness)

·        Swollen joints

·        Tender joints

·        C-reactive protein (CRP)

Crohn’s disease (CD)^1,18,19

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.

Authorization of 12 months may be granted for all 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:

·        Abdominal pain or tenderness

·        Diarrhea

·        Body weight

·        Abdominal mass

·        Hematocrit

·        Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound

·        Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)

Polyarticular juvenile idiopathic arthritis (pJIA)^1,20

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:

·        Number of joints with active arthritis (e.g., swelling, pain, limitation of motion)

·        Number of joints with limitation of movement

·        Functional ability

Giant cell arteritis (GCA)^1,23

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for GCA 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:

·        Headaches

·        Scalp tenderness

·        Tenderness and/or thickening of superficial temporal arteries

·        Constitutional symptoms (e.g., weight loss, fever, fatigue, night sweats)

·        Jaw and/or tongue claudication

·        Acute visual symptoms (e.g., amaurosis fugax, acute visual loss, diplopia)

·        Symptoms of polymyalgia rheumatica (e.g., shoulder and/or hip girdle pain)

·        Limb claudication

·        Acute-phase reactants (i.e., erythrocyte sedimentation rate [ESR] or serum C-reactive protein [CRP])

Other^1,4

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 12 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.

Dosage and Administration

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Appendix

Table. Relative Potency of Select Topical Corticosteroid Products¹⁷

Potency	Drug	Dosage form	Strength
I. Super-high potency (group 1)	Augmented betamethasone dipropionate	Ointment, Lotion, Gel	0.05%
I. Super-high potency (group 1)	Clobetasol propionate	Cream, Gel, Ointment, Solution, Cream (emollient), Lotion, Shampoo, Foam Aerosol, Spray Aerosol, Solution (scalp)	0.05%
I. Super-high potency (group 1)	Fluocinonide	Cream	0.1%
I. Super-high potency (group 1)	Flurandrenolide	Tape	4 mcg/cm2
I. Super-high potency (group 1)	Halobetasol propionate	Cream, Lotion, Ointment, Foam	0.05%
II. High potency (group 2)	Amcinonide	Ointment	0.1%
II. High potency (group 2)	Augmented betamethasone dipropionate	Cream	0.05%
II. High potency (group 2)	Betamethasone dipropionate	Ointment	0.05%
II. High potency (group 2)	Clobetasol propionate	Cream	0.025%
II. High potency (group 2)	Desoximetasone	Cream, Ointment, Spray	0.25%
II. High potency (group 2)	Desoximetasone	Gel	0.05%
II. High potency (group 2)	Diflorasone diacetate	Ointment, Cream (emollient)	0.05%
II. High potency (group 2)	Fluocinonide	Cream, Ointment, Gel, Solution	0.05%
II. High potency (group 2)	Halcinonide	Cream, Ointment, Solution	0.1%
II. High potency (group 2)	Halobetasol propionate	Lotion	0.01%
III. High potency (group 3)	Amcinonide	Cream	0.1%
III. High potency (group 3)	Betamethasone dipropionate	Cream	0.05%
III. High potency (group 3)	Betamethasone valerate	Ointment	0.1%
III. High potency (group 3)	Betamethasone valerate	Foam	0.12%
III. High potency (group 3)	Desoximetasone	Cream, Ointment	0.05%
III. High potency (group 3)	Diflorasone diacetate	Cream	0.05%
III. High potency (group 3)	Fluocinonide	Cream (aqueous emollient)	0.05%
III. High potency (group 3)	Fluticasone propionate	Ointment	0.005%
III. High potency (group 3)	Mometasone furoate	Ointment	0.1%
III. High potency (group 3)	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium potency (group 4)	Betamethasone dipropionate	Spray	0.05%
IV. Medium potency (group 4)	Clocortolone pivalate	Cream	0.1%
IV. Medium potency (group 4)	Fluocinolone acetonide	Ointment	0.025%
IV. Medium potency (group 4)	Flurandrenolide	Ointment	0.05%
IV. Medium potency (group 4)	Fluticasone propionate	Cream	0.05%
IV. Medium potency (group 4)	Hydrocortisone valerate	Ointment	0.2%
IV. Medium potency (group 4)	Mometasone furoate	Cream, Lotion, Solution	0.1%
IV. Medium potency (group 4)	Triamcinolone acetonide	Cream, Paste (mouth/throat), Ointment	0.1%
IV. Medium potency (group 4)	Triamcinolone acetonide	Ointment	0.05%
IV. Medium potency (group 4)	Triamcinolone acetonide	Aerosol Spray	0.2 mg per 2-second spray
V. Lower-mid potency (group 5)	Betamethasone dipropionate	Lotion	0.05%
V. Lower-mid potency (group 5)	Betamethasone valerate	Cream	0.1%
V. Lower-mid potency (group 5)	Desonide	Ointment, Gel	0.05%
V. Lower-mid potency (group 5)	Fluocinolone acetonide	Cream	0.025%
V. Lower-mid potency (group 5)	Flurandrenolide	Cream, Lotion	0.05%
V. Lower-mid potency (group 5)	Fluticasone propionate	Lotion	0.05%
V. Lower-mid potency (group 5)	Hydrocortisone butyrate	Cream, Lotion, Ointment, Solution	0.1%
V. Lower-mid potency (group 5)	Hydrocortisone probutate	Cream	0.1%
V. Lower-mid potency (group 5)	Hydrocortisone valerate	Cream	0.2%
V. Lower-mid potency (group 5)	Prednicarbate	Cream (emollient), Ointment	0.1%
V. Lower-mid potency (group 5)	Triamcinolone acetonide	Lotion	0.1%
V. Lower-mid potency (group 5)	Triamcinolone acetonide	Ointment	0.025%
VI. Low potency (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
VI. Low potency (group 6)	Betamethasone valerate	Lotion	0.1%
VI. Low potency (group 6)	Desonide	Cream, Lotion, Foam	0.05%
VI. Low potency (group 6)	Fluocinolone acetonide	Cream, Solution, Shampoo, Oil	0.01%
VI. Low potency (group 6)	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal to 2%)	Cream, Ointment, Lotion, Solution	2.5%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal to 2%)	Cream, Gel, Lotion	2%
VII. Least potent (group 7)	Hydrocortisone (base, less than 2%)	Cream, Ointment, Liquid, Lotion, Solution	1%
VII. Least potent (group 7)	Hydrocortisone (base, less than 2%)	Cream, Ointment	0.5%
VII. Least potent (group 7)	Hydrocortisone acetate	Cream	2.5%
VII. Least potent (group 7)	Hydrocortisone acetate	Lotion	2%
VII. Least potent (group 7)	Hydrocortisone acetate	Cream, Ointment	1%

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Rinvoq [package insert]. North Chicago, IL; AbbVie, Inc.; October 2025.

2.     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.

3.     Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82:3-18.

4.     Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 7, 2025 from https://www.cdc.gov/tb/testing/index.html.

5.     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.

6.     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.

7.     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.

8.     Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.

9.     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.

10.  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.

11.    Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline Update: Ulcerative Colitis in Adults. Am J Gastroenterol. 2025;120(6):1187-1224.

12.   Singh S, Loftus EV Jr, Limketkai BN, et al. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2024;167(7):1307-1343.

13.   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.

14.   Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706-719. Published 2024 May 15. doi:10.1136/ard-2024-225531.

15.   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.

16.   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.

17.   Comparison of Representative Topical Corticosteroid Preparations (Classified According to the United States System). Drug Facts and Comparisons. Facts and Comparisons. UpToDate Inc. https://fco.factsandcomparisons.com. Accessed November 7, 2025.

18.   Lichtenstein GR, Loftus EV, Afzali A, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2025;120(6):1225-1264.

19.   Scott FI, Ananthakrishnan AN, Click B, et al. AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease. Gastroenterology. 2025;169(7):1397-1448.

20. 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.

21.   Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. J Am Acad Dermatol. 2024 Feb;90(2):e43-e56.

22.  Blockmans D, Penn SK, Setty AR, et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. Published online April 2, 2025. doi:10.1056/NEJMoa2413449.

23.  Hellmich B, Agueda A, Monti S, et al. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020;79(1):19-30.

24.  Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025;93(3):745.e1-745.e7.

25.  Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71:1218-1233.

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.

June 14, 2026