Subject: Taltz 2013-A SGM P2023

Drug

TALTZ  (ixekizumab)

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.  Moderate to severe plaque psoriasis (PsO) in patients 6 years
               of age and older who are candidates for systemic therapy or
               phototherapy
          B.  Adult patients with active psoriatic arthritis (PsA)
          C.  Adult patients with active ankylosing spondylitis (AS)
          D.  Adult patients with active non-radiographic axial
               spondyloarthritis (nr-axSpA) with objective signs of 
               inflammation

          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.  Ankylosing spondylitis (AS), axial spondyloarthritis (axSpA),
               and 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.

 
  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.  Ankylosing spondylitis and axial spondyloarthritis:
               rheumatologist

 
   IV.  CRITERIA FOR INITIAL APPROVAL

          A.  Plaque psoriasis (PsO)
               1.  Authorization of 12 months may be granted for members
                    6 years of age or older 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 members
                    6 years of age or older for the treatment of moderate to
                    severe plaque psoriasis when any of the following criteria
                    is met:
                    a.  Crucial body areas (e.g., hands, feet, face, neck,
                         scalp, genitals/groin, intertriginous areas) are
                         affected.
                    b.  At least 10% of body surface area (BSA) is affected.
                    c.  At least 3% of body surface area (BSA) is affected and
                         the member meets any of the following criteria:
                         i.     Member has had an inadequate response or
                                intolerance to either phototherapy (e.g., UVB,
                                PUVA) or pharmacologic treatment with
                                methotrexate, cyclosporine, or acitretin.
                         ii.    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.  Ankylosing spondylitis (AS) and axial spondyloarthritis
               (axSpA)
               1.  Authorization of 12 months may be granted for adult
                    members who have previously received a biologic or
                    targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
                    for active ankylosing spondylitis or active axial
                    spondyloarthritis.

               2.  Authorization of 12 months may be granted for adult
                    members for treatment of active ankylosing spondylitis
                    or active axial spondyloarthritis when any of the following
                    criteria is met:
                    i.     Member has had an inadequate response to at least
                           two non-steroidal anti-inflammatory drugs (NSAIDs).
                    ii.    Member has an intolerance or contraindication to two
                           or more NSAIDs.

     V.  CONTINUATION OF THERAPY

          A.  Plaque psoriasis (PsO)
               Authorization of 12 months may be granted for all members
               6 years of age or older (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.  Ankylosing spondylitis (AS) and axial spondyloarthritis
               (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 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)

   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. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; September 2022.
2. 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.
3. 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;61:451-485.
4. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. 2015;386(9993):541-51.
5. 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.
6. McInnes IB,Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386(9999):1137-46.
7. 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.
8. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on January 11, 2023 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
9. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896–904.
10. 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):1285-1299.
11. 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.
12. 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.
13. 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.
14. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82:19-34.

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 11, 2023