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Ustekinumab (Stelara®) IV

Section: Injections
Effective Date: April 01, 2020

Description

Ustekinumab (Stelara®) is a human monoclonal antibody. It is directed against interleukin 12 and interleukin-23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.

The intravenous formulation which is FDA-approved for Crohn's disease and Ulcerative Colitis is covered under the medical benefit; please refer to pharmacy policies for coverage of the subcutaneous formulation.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Ustekinumab (Stelara) Intravenous (IV)

Ustekinumab (Stelara) as a single IV infusion dose may be considered medically necessary when an individual meets ANY ONE of the following indications:

  • Crohn’s Disease (CD)
    • The individual is 18 years of age or older with moderately to severely active CD; and
    • The individual is currently pregnant; or
    • The individual has had an inadequate response or experienced intolerance to ONE conventional agent (e.g., 6-mercaptopurine, azathoiprine, corticosteroids [e.g. prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in treatment of CD for at least 3 months; or
    • The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL conventional agents used in the treatment of CD; or
    • The individual has had an inadequate response or experienced intolerance to another biologic agent indicated for CD; or
  • Ulcerative Colitis (UC)
    • The individual is 18 years of age or older with moderately to severely active UC; and
    • The individual is currently pregnant; or
    • The individual has had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3 months; or
    • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of UC;or
    • The individual has had an inadequate response or experienced intolerance to another biologic agent indicated for UC.

The use of ustekinumab (Stelara) for any other indication or in combination with any other biologic disease-modifying antirheumatic drug (DMARD) (e.g. adalimumab, golimumab, infliximab, certolizumab, tofacitinub, etc.) is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support its use for any other indication or in combination with any other biologic DMARD.

Procedure Codes

J3358

The subcutaneous formulation is a pharmacy benefit. Please refer to pharmacy policies for coverage information.

Procedure Codes

J3357

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J3358

K50.00 K50.011 K50.012 K50.013 K50.014 K50.018 K50.019
K50.10 K50.111 K50.112 K50.113 K50.114 K50.118 K50.119
K50.80 K50.811 K50.812 K50.813 K50.814 K50.818 K50.819
K51.00 K51.011 K51.012 K51.013 K51.014 K51.018 K51.019
K51.20 K51.211 K51.212 K51.213 K51.214 K51.218 K51.219
K51.30 K51.311 K51.312 K51.313 K51.314 K51.318 K51.319
K51.40 K51.411 K51.412 K51.413 K51.414 K51.418 K51.419
K51.50 K51.511 K51.512 K51.513 K51.514 K51.518 K51.519
K51.80 K51.811 K51.812 K51.813 K51.814 K51.818 K51.819
K51.90 K51.911 K51.912 K51.913 K51.914 K51.918 K51.919

Professional Statements and Societal Positions Guidelines

NA

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