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-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.

          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-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 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

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%
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:

1. Rinvoq [package insert]. North Chicago, IL; AbbVie, Inc.; April 2024.
2. 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.     
3. 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.
4. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 6, 2023 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
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 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, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.
12. 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.
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, 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.
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. Topical Corticosteroids. Drug Facts and Comparisons.  Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; September 1, 2023.  Accessed November 2, 2023.
18. 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.
19. 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.
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.

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 30, 2024