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.
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:
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.
The subcutaneous formulation is a pharmacy benefit. Please refer to pharmacy policies for coverage information.
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.
Covered Diagnosis Codes for Procedure Code J3358