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| 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:
- Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or all immunosuppressants are contraindicated; or
- The individual received a single induction dose of Stelara IV and achieved clinical response or remission.
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:
- The individual has had an inadequate response or experienced intolerance with at least two (2) Immuno suppressants or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker; or
- The individual has had an inadequate response or experienced intolerance with at least one TNF blocker, or all TNF blockers are contraindicated (due to demyelinating disease or heart failure).
* 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.
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:
- Treatment with at least one (1) or more non-biologic DMARD was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated.
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:
- Treatment with systemic therapy (e.g., methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated; or
- Treatment with phototherapy (e.g., psoralen plus ultraviolet A [PUVA], ultraviolet B [UVB]) was ineffective or not tolerated.
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.
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| 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.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
01/2018, Coverage Criteria Revised for Ustekinumab (Stelara®)
03/2018, Coverage Criteria Revised for Ustekinumab (Stelara)
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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.
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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:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
- Written information in other formats (large print, audio, accessible electronic formats, other formats)
- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
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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