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 IV (Stelara) Intravenous
Ustekinumab (Stelara) as a single IV infusion dose may be considered medically necessary when an individual meets the following criteria:
Crohn’s Disease (CD)
Ulcerative Colitis (UC)
If approved, ustekinumab IV (Stelara) will be allowed as a single intravenous infusion.
The use of ustekinumab IV (Stelara) for any other indication 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
Original Effective Date: July 1, 2018
Internal Medical Policy Committee 11-14-2019 Added Ulcerative Colitis indication to policy, updated diagnosis and references
Internal Medical Policy Committee 3-16-2020 Updated criteria to mirror pharmacy policy, added statement that subcutaneous formulation is a pharmacy benefit
Internal Medical Policy Committee 5-19-2020 Updated language to match other biologic immunomodulator medical policies
Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.