Subject: Skyrizi 3047-A SGM P2022b

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 in adults
               who are candidates for systemic therapy or phototherapy
          B.  Active psoriatic arthritis in adults
          C.  Moderately to severely active Crohn’s disease 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)
                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.

 
  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 the body surface area (BSA) is affected
                iii.    At least 3% of body surface area (BSA) is affected and
                        the member meets any 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 A).

           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
                                  B), 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)
                1.  Authorization of 12 months may be granted for adult
                     members who have previously received a biologic
                     indicated for the treatment of moderately to severely
                     active Crohn’s disease.

                2.  Authorization of 12 months may be granted for adult
                     members for the treatment of moderately to severely
                     active CD when the member has had an inadequate
                     response, intolerance, or contraindication to at least one
                     conventional therapy option (see Appendix C).

 
      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 positive clinical
                response as evidenced by low disease activity or
                improvement in signs and symptoms of the condition when
                any 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 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.    Endoscopic appearance of the mucosa
                     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.  APPENDICES
           Appendix A: Examples of Clinical Reasons to Avoid
           Pharmacologic Treatment with Methotrexate,
           Cyclosporine, or Acitretin
           1.  Clinical diagnosis of alcohol use disorder, alcoholic liver
                disease or other chronic liver disease
           2.  Breastfeeding
           3.  Drug interaction
           4.  Cannot be used due to risk of treatment-related toxicity
           5.  Pregnancy or currently planning pregnancy
           6.  Significant comorbidity prohibits use of systemic agents
                (e.g., liver or kidney disease, blood dyscrasias, uncontrolled
                hypertension)

           Appendix B: Examples of Contraindications to
           Methotrexate or Leflunomide 
           1.    Clinical diagnosis of alcohol use disorder, alcoholic liver
                  disease or other chronic liver disease
           2.    Breastfeeding
           3.    Blood dyscrasias (e.g., thrombocytopenia, leukopenia,
                  significant anemia)
           4.    Elevated liver transaminases
           5.    History of intolerance or adverse event
           6.    Hypersensitivity
           7.    Interstitial pneumonitis or clinically significant pulmonary
                  fibrosis
           8.    Myelodysplasia
           9.    Pregnancy or currently planning pregnancy
           10.  Renal impairment
           11.  Significant drug interaction

           Appendix C: Examples of Conventional Therapy Options
           for CD
          1.  Mild to moderate disease – induction of remission:
               a.  Oral budesonide
               b.  Alternatives: metronidazole, ciprofloxacin, rifaximin
          2.  Mild to moderate disease – maintenance of remission:
               a.  Azathioprine, mercaptopurine
               b.  Alternatives: oral budesonide, methotrexate
                    intramuscular (IM) or subcutaneous (SC), sulfasalazine
          3.  Moderate to severe disease – induction of remission:
               a.  Prednisone, methylprednisolone intravenous (IV)
               b.  Alternatives: methotrexate IM or SC
          4.  Moderate to severe disease – maintenance of remission:
               a.  Azathioprine, mercaptopurine
               b.  Alternative: methotrexate IM or SC
               c.  Perianal and fistulizing disease – induction of remission:
                   Metronidazole ± ciprofloxacin, tacrolimus
          5.  Perianal and fistulizing disease – maintenance of remission:
               a.  Azathioprine, mercaptopurine
               b.  Alternative: methotrexate IM or SC

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Skyrizi [package insert]. North Chicago, IL: AbbVie Inc.; June 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 June 28, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.

2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

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.

March 28, 2023