Subject: Bimzelx 6220-A SGM P2023

Drug

BIMZELX  (bimekizumab-bkzx)

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 Indication
          Treatment of moderate to severe plaque psoriasis (PsO) in adult
          patients who are candidates for systemic therapy or
          phototherapy.

          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.  Initial requests:
               1.  Chart notes or medical record documentation of affected
                    area(s) and body surface area (BSA) affected (if
                    applicable).
               2.  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.
          B.  Continuation requests: Chart notes or medical record
               documentation of decreased body surface area (BSA)
               affected and/or improvement in signs and symptoms.


  III.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a
          dermatologist.


   IV.  CRITERIA FOR INITIAL APPROVAL

          Plaque psoriasis (PsO)
          A.  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 treatment
               of moderate to severe plaque psoriasis.

          B.  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:
               1.  Crucial body areas (e.g., hands, feet, face, neck, scalp,
                    genitals/groin, intertriginous areas) are affected.
               2.  At least 10% of body surface area (BSA) is affected.
               3.  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).


     V.  CONTINUATION OF THERAPY

          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:
          A.  Reduction in body surface area (BSA) affected from baseline
          B.  Improvement in signs and symptoms from baseline (e.g.,
               itching, redness, flaking, scaling, burning, cracking, pain)


   VI.  OTHER

          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.

          Member cannot use the requested medication concomitantly
          with any other biologic drug or targeted synthetic drug for the
          same indication.


 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, or Acitretin
          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. Bimzelx [package insert]. Smyrna, GA: UCB, Inc.; October 2023.
2. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial [published correction appears in Lancet. 2021 Mar 27;397(10280):1182]. 2021;397(10273):475-486
3. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328.
4. 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.
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 November 1, 2023 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
7. 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.
8. 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. doi:10.1016/j.jaad.2020.02.044.
9. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498.

 

 

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.

December 31, 2023