Subject: Skyrizi 3047-A SGM P2023

Drug

SKYRIZI  (risankizumab-rzaa)

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
          A.  Treatment of moderate-to-severe plaque
               psoriasis (PsO) in adults who are candidates
               for systemic therapy or phototherapy
          B.  Treatment of active psoriatic arthritis (PsA) in
               adults
          C.  Treatment of moderately to severely active
               Crohn’s disease (CD) in adults

          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.  Plaque psoriasis (PsO)
               1.  Initial requests:
                    i.     Chart notes or medical record
                           documentation of affected area(s) and
                           body surface area (BSA) affected (if
                           applicable).
                    ii.    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 of decreased
                    body surface area (BSA) affected and/or
                    improvement in signs and symptoms.

          B.  Psoriatic arthritis (PsA)
               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.

          C.  Crohn’s disease (CD)
               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.  Plaque psoriasis: dermatologist
          B.  Psoriatic arthritis: rheumatologist or
               dermatologist
          C.  Crohn’s disease: gastroenterologist


   IV.  CRITERIA FOR INITIAL APPROVAL

          A.  Plaque psoriasis (PsO)
               1.  Authorization of 12 months may be granted
                    for adult members who have previously
                    received a biologic or targeted synthetic
                    drug (e.g., Sotyktu, Otezla) indicated for
                    the treatment of moderate to severe plaque
                    psoriasis.

 
               2.  Authorization of 12 months may be granted
                    for adult members for treatment of
                    moderate to severe plaque psoriasis when
                    any of the following criteria is met:
                    i.     Crucial body areas (e.g., hands, feet,
                           face, neck, scalp, genitals/groin,
                           intertriginous areas) are affected.
                    ii.    At least 10% of body surface area
                          (BSA) is affected.
                    iii.   At least 3% of body surface area (BSA)
                           is affected and the member meets
                           either of the following criteria:
                           a.  Member has had an inadequate
                                response or intolerance to either
                                phototherapy (e.g., UVB, PUVA) or
                                pharmacologic treatment with
                                methotrexate, cyclosporine, or
                                acitretin.
                           b.  Member has a clinical reason to
                                avoid pharmacologic treatment
                                with methotrexate, cyclosporine,
                                and acitretin (see Appendix).

          B.  Psoriatic arthritis (PsA)
               1.  Authorization of 12 months may be granted
                    for adult members who have previously
                    received a biologic or targeted synthetic
                    drug (e.g., Rinvoq, Otezla) indicated for
                    active psoriatic arthritis.

               2.  Authorization of 12 months may be granted
                    for adult members for treatment of active
                    psoriatic arthritis when either of the
                    following criteria is met:
                    i.     Member has mild to moderate disease
                           and meets one of the following
                           criteria:
                           a.  Member has had an inadequate
                                response to methotrexate,
                                leflunomide, or another
                                conventional synthetic drug (e.g.,
                                sulfasalazine) administered at an
                                adequate dose and duration.
                           b.  Member has an intolerance or
                                contraindication to methotrexate or
                                leflunomide (see Appendix), or
                                another conventional synthetic
                                drug (e.g., sulfasalazine).
                            c.  Member has enthesitis or
                                 predominantly axial disease.
                     ii.    Member has severe disease.

          C.  Crohn’s disease (CD)
               Authorization of 12 months may be granted for
               adult members for the treatment of
               moderately to severely active Crohn’s disease.


    V.  CONTINUATION OF THERAPY

          A.  Plaque psoriasis (PsO)
               Authorization of 12 months may be granted for
               all adult members (including new members)
               who are using the requested medication for
               moderate to severe plaque psoriasis 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 either of the following is met:
               1.  Reduction in body surface area (BSA)
                    affected from baseline
               2.  Improvement in signs and symptoms from
                    baseline (e.g., itching, redness, flaking,
                    scaling, burning, cracking, pain)

          B.  Psoriatic arthritis (PsA)
               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.  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 or targeted synthetic drug.


 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

          Examples of Clinical Reasons to Avoid
          Pharmacologic Treatment with Methotrexate,
          Cyclosporine, Acitretin, or Leflunomide
          1.  Clinical diagnosis of alcohol use disorder,
               alcoholic liver disease or other chronic liver
               disease
          2.  Drug interaction
          3.  Risk of treatment-related toxicity
          4.  Pregnancy or currently planning pregnancy
          5.  Breastfeeding
          6.  Significant comorbidity prohibits use of
               systemic agents (e.g., liver or kidney disease,
               blood dyscrasias, uncontrolled hypertension)
          7.  Hypersensitivity
          8.  History of intolerance or adverse event

Place of Service:

Outpatient

The above policy is based on the following references:

1. Skyrizi [package insert]. North Chicago, IL: AbbVie Inc.; December 2022.
2. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61(3):451-485.
3. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
4. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661.
5. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
6. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on January 11, 2023 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
   
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 Rheum. 2018;71:5-32.
8. Gossec L,Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
9. D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. 2022;399(10340):2015-2030.
10. 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.
11. 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.
12. Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486.

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.

August 13, 2023