Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-37-014
Topic: Ustekinumab (Stelara®)
Section: Injections
Effective Date: May 28, 2018
Issue Date: May 28, 2018
Last Reviewed: February 2018

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.  

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

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

Crohn’s Disease

Ustekinumab (Stelara) subcutaneous (SC) may be considered medically necessary to treat moderately to severely active Crohn’s disease (CD) in adult individuals (18 years of age or older) when ANY ONE of the following are met:

Ustekinumab (Stelara) (IV) may be considered medically necessary to treat moderately to severely active Crohn’s disease (CD) in adult individuals (18 years of age or older) when ANY ONE of the following criteria are met:  

* Evaluate individuals for (tuberculin skin test) prior to initiating treatment. Treatment of latent infection should be started prior to ustekinumab (Stelara®) therapy.

The use of ustekinumab (Stelara) for any other indication or in combination with any other biologic disease-modifying antirheumatic drug (DMARD) (e.g. Humira, Remicade, Cimzia, etc.) is considered experimental/investigational, and therefore, non-covered because its effectiveness for these indications has not been established.  

Ustekinumab (Stelara) is a single intravenous infusion dose for Crohn’s disease.

Procedure Codes
J3357, J3358


Psoriatic Arthritis

Ustekinumab (Stelara) subcutaneous (SC) may be considered medically necessary in adult individuals (18 years or older) with active psoriatic arthritis alone or in combination with methotrexate when the following criterion is met:

Plaque Psoriasis

Ustekinumab (Stelara) subcutaneous (SC) may be considered medically necessary for the treatment of moderate to severe plaque psoriasis in adult individuals (18 years or older) when ANY ONE of the following criteria are met:

The use of ustekinumab (Stelara) for any other indication is considered experimental/investigational, and therefore, non-covered because its effectiveness for these indications has not been established.


NOTE:  Dosage recommendations per the FDA label.

  • The individual should be under the supervision of a dermatologist for severe plaque psoriasis or active psoriatic arthritis.
  • Ustekinumab (Stelara) should not be used in combination with biologic agents (i.e., Enbrel, Remicade, Humira, or Kineret).


Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Ustekinumab (Stelara®) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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