Subject: Bimzelx 6220-A SGM P2023a

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 [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.

          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 May 10, 2024 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.

June 30, 2024