Subject: Sotyktu 5600-A SGM P2024

Drug

SOTYKTU  (deucravacitinib)

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 adult patients with moderate to severe plaque psoriasis (PsO) 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., 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 either 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.


  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. Sotyktu [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; September 2022.
2. Armstrong, AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J AM Acad Dermatol. 2023;88(1):29-39. doi:10.1016/j.jaad.2022.07.002.
3. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program for Evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51.
4. Menter, A, Gelfand, JM, Connor, C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-86.
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. 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.
7. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on January 4, 2024 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.

 

 

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