Subject: Rinvoq 3173-A SGM P2021d
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. Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate
response or intolerance to one or more tumor necrosis factor (TNF) blockers
B. Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to
one or more TNF blockers
C. Treatment of 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. Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate
response or intolerance to one or more TNF blockers
E. Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance
to one or more TNF blockers
F. Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy
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: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
B. Psoriatic arthritis (PsA):
1. For initial requests: Chart notes, medical record documentation, or claims history supporting previous
medications tried, including response to therapy.
2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
C. Atopic dermatitis
1. For initial requests:
i. Chart notes or medical records showing affected areas and affected body surface area
ii. Chart notes, medical record documentation, or claims history of prerequisite therapies,
including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
2. For continuation requests: Documentation (e.g., chart notes) that the member has experienced
a positive clinical response to therapy as evidenced by low disease activity or improvement in signs
or symptoms of atopic dermatitis.
D. Ulcerative colitis (UC)
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 to therapy or remission.
E. Ankylosing spondylitis (AS) and axial spondyloarthritis
1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous
medications tried, including response to therapy (if applicable).
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.
III. CRITERIA FOR INITIAL APPROVAL
A. Moderately to severely active rheumatoid arthritis (RA)
1. Authorization of 12 months may be granted 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 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. Active psoriatic arthritis (PsA)
Authorization of 12 months may be granted for treatment of active psoriatic arthritis (PsA) when the
member has experienced an inadequate response or intolerance to at least one TNF inhibitor.
C. Moderate-to-severe atopic dermatitis
Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis
when all of the following criteria are met:
1. 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.
2. Member has had an inadequate response to treatment with a topical corticosteroid or topical
calcineurin inhibitor, or topical corticosteroids and topical calcineurin inhibitors are not advisable
for the member.
3. Member has had an inadequate response to treatment with other systemic drug products, including
biologics, or use of these therapies is not advisable for the member.
4. Member is 12 years of age or older.
D. Moderately to severely active 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, intolerance, or contraindication to at least one TNF inhibitor.
2. Authorization of 12 months may be granted for 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. Active ankylosing spondylitis (AS) and axial spondyloarthritis
1. Authorization of 12 months may be granted for treatment of active ankylosing spondylitis or active 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 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 axial spondyloarthritis.
IV. CONTINUATION OF THERAPY
A. Moderately to severely active rheumatoid arthritis (RA)
Authorization of 12 months may be granted for all 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. Active psoriatic arthritis
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for active 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. Skin and/or nail involvement
C. Moderate-to-severe atopic dermatitis
Authorization of 12 months may be granted for members 12 years of age or older 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. Moderately to severely active ulcerative colitis (UC)
1. 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.
2. 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:
i. Stool frequency
ii. Rectal bleeding
iii. Urgency of defecation
iv. C-reactive protein (CRP)
v. Fecal calprotectin (FC)
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index
of Severity [UCEIS], Mayo score)
E. Active ankylosing spondylitis (AS) and axial spondyloarthritis
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for active ankylosing spondylitis or active 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)
V. OTHER
For all indications: Member has had a documented negative 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 DMARDs or targeted synthetic DMARDs 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 drugs, targeted synthetic drugs, or potent immunosuppressants such as azathioprine or cyclosporine.
VI. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Place of Service:
Outpatient
The above policy is based on the following references:
- Rinvoq [package insert]. North Chicago, IL; AbbVie, Inc.; October 2022.
- Singh JA,Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis 2016;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.
- Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on November 15, 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
- 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;70:338-51.
- Eichenfield LF, Tom WL, et. al. Guidelines of care for the management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71:116-32.
- 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 Gastroentrol. 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.
- 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.
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.
December 15, 2022
