Subject: Rinvoq 3173-A SGM P2023a
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.
G. Treatment of adult patients with moderately to severely
active Crohn’s disease 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), and non-radiographic axial
spondyloarthritis (nr-axSpA)
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.
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)
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.
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, and non-
radiographic axial spondyloarthritis: 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 adult
members for treatment of active psoriatic arthritis 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, Otezla) indicated for active psoriatic arthritis.
C. Atopic dermatitis
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:
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 meets one of the following:
i. Member has had an inadequate treatment response
with one of the following in the past year:
a. A medium potency to super-high potency topical
corticosteroid (see Appendix)
b. A topical calcineurin inhibitor
ii. 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).
3. Member has had an inadequate response to treatment
with a systemic drug product (e.g., oral cyclosporine,
azathioprine, methotrexate, mycophenolate mofetil) or a
biologic (e.g., Dupixent, Adbry) 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-radiographic axial
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.
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. Psoriatic arthritis
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
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 when the member has achieved or maintained 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-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 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)
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)
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, 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
|
Potency
|
Drug
|
Dosage form
|
Strength
|
|
I. Super-
high
potency
(group 1)
|
Augmented betamethasone
dipropionate
|
Ointment, Lotion, Gel
|
0.05%
|
|
Clobetasol propionate
|
Cream, Gel, Ointment,
Solution, Cream
(emollient), Lotion,
Shampoo, Foam, Spray
|
0.05%
|
|
Fluocinonide
|
Cream
|
0.1%
|
|
Flurandrenolide
|
Tape
|
4 mcg/cm2
|
|
Halobetasol propionate
|
Cream, Lotion, Ointment,
Foam
|
0.05%
|
|
II. High
potency
(group 2)
|
Amcinonide
|
Ointment
|
0.1%
|
|
Augmented betamethasone
dipropionate
|
Cream
|
0.05%
|
|
Betamethasone dipropionate
|
Ointment
|
0.05%
|
|
Clobetasol propionate
|
Cream
|
0.025%
|
|
Desoximetasone
|
Cream, Ointment, Spray
|
0.25%
|
|
Gel
|
0.05%
|
|
Diflorasone diacetate
|
Ointment, Cream
(emollient)
|
0.05%
|
|
Fluocinonide
|
Cream, Ointment, Gel,
Solution
|
0.05%
|
|
Halcinonide
|
Cream, Ointment
|
0.1%
|
|
Halobetasol propionate
|
Lotion
|
0.01%
|
|
Potency
|
Drug
|
Dosage form
|
Strength
|
|
III. High
potency
(group 3)
|
Amcinonide
|
Cream, Lotion
|
0.1%
|
|
Betamethasone dipropionate
|
Cream, hydrophilic
emollient
|
0.05%
|
|
Betamethasone valerate
|
Ointment
|
0.1%
|
|
Foam
|
0.12%
|
|
Desoximetasone
|
Cream, Ointment
|
0.05%
|
|
Diflorasone diacetate
|
Cream
|
0.05%
|
|
Fluocinonide
|
Cream, aqueous emollient
|
0.05%
|
|
Fluticasone propionate
|
Ointment
|
0.005%
|
|
Mometasone furoate
|
Ointment
|
0.1%
|
|
Triamcinolone acetonide
|
Cream, Ointment
|
0.5%
|
|
IV. Medium
potency
(group 4)
|
Betamethasone dipropionate
|
Spray
|
0.05%
|
|
Clocortolone pivalate
|
Cream
|
0.1%
|
|
Fluocinolone acetonide
|
Ointment
|
0.025%
|
|
Flurandrenolide
|
Ointment
|
0.05%
|
| |
|
|
Hydrocortisone valerate
|
Ointment
|
0.2%
|
|
Mometasone furoate
|
Cream, Lotion, Solution
|
0.1%
|
|
Triamcinolone acetonide
|
Cream
|
0.1%
|
|
Ointment
|
0.05% and
0.1%
|
|
Aerosol Spray
|
0.2 mg per
2-second
spray
|
|
V. Lower-
mid
potency
(group 5)
|
Betamethasone dipropionate
|
Lotion
|
0.05%
|
|
Betamethasone valerate
|
Cream
|
0.1%
|
|
Desonide
|
Ointment, Gel
|
0.05%
|
|
Fluocinolone acetonide
|
Cream
|
0.025%
|
|
Flurandrenolide
|
Cream, Lotion
|
0.05%
|
|
Fluticasone propionate
|
Cream, Lotion
|
0.05%
|
|
Hydrocortisone butyrate
|
Cream, Lotion, Ointment,
Solution
|
0.1%
|
|
Hydrocortisone probutate
|
Cream
|
0.1%
|
|
Hydrocortisone valerate
|
Cream
|
0.2%
|
|
Prednicarbate
|
Cream (emollient),
Ointment
|
0.1%
|
|
Triamcinolone acetonide
|
Lotion
|
0.1%
|
|
Ointment
|
0.025%
|
|
VI. Low potency (group 6)
|
Alclometasone dipropionate
|
Cream, Ointment
|
0.05%
|
|
Betamethasone valerate
|
Lotion
|
0.1%
|
|
Desonide
|
Cream, Lotion, Foam
|
0.05%
|
|
Fluocinolone acetonide
|
Cream, Solution,
Shampoo, Oil
|
0.01%
|
|
Triamcinolone acetonide
|
Cream, lotion
|
0.025%
|
|
VII. Least
potent
(group 7)
|
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.; May 2023.
- 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.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 15, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.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;70:338-351.
- Eichenfield LF, Tom WL, Berger TG, 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;71:116-132.
- 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.
- 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; December 1, 2021. Accessed November 7, 2022.
- 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.
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.
July 26, 2023
