Ustekinumab (Stelara®) IV

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 13, 2020
Last Reviewed: May 19, 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 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)

  • The individual is 18 years of age or older with moderately to severely active CD; and
    • ONE of the following:
      • The individual is currently pregnant; or
      • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
      • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
      • The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months or
      • The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD or
      • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of CD; and
    • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
    • The individual will NOT be using ustekinumab (Stelara) with another biologic immunomodulator agent.

Ulcerative Colitis (UC)

  • The individual is 18 years of age or older with moderately to severely active UC; and
    • ONE of the following:
      • The individual is currently pregnant
      • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
      • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
      • The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, metronidazole, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months; or
      • The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC; or
      • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of UC; and
    • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
    • The individual will NOT be using ustekinumab (Stelara) with another biologic immunomodulator agent.

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.

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

Not Applicable

ND Committee Review

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

Links

Disclaimer

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.