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| Medical Policy: | I-34-011 |
| Topic: | Ipilimumab (Yervoy) |
| Section: | Injections |
| Effective Date: | July 2, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | February 2018 |
Ipilimumab (Yervoy®) is a recombinant, human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4) and blocks the interaction of CTLA-4 with its ligands CD80/CD86. Blockade of CTLA-4 augments T cell activation and proliferation, resulting in an increase in antitumor responsiveness and allowing the body's immune system to recognize, target, and attack cells in tumors. |
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. |
Ipilimumab (Yervoy) may be considered medically necessary in individuals 12 years of age or older when ANY ONE of the following indications is met:
Central Nervous System Cancers - Limited (one to three) Metastatic Lesions
- As a single-agent treatment for brain metastases if active against primary tumor (melanoma) for recurrent disease; or
- In combination with nivolumab (Opdivo®) for brain metastases if active against primary tumor (melanoma); or
Central Nervous System Cancers - Multiple (greater than three) Metastatic Lesions
- As a single-agent treatment if active against primary tumor (melanoma) for brain metastases in individuals with recurrent stable systemic disease; or
- In combination with nivolumab (Opdivo) for brain metastases if active against primary tumor (melanoma); or
Melanoma
- Adjuvant treatment as a high-dose single agent;
- For stage III sentinel lymph node positive metastasis greater than one mm following a complete lymph node dissection; or
- For stage III disease with clinically positive node(s) following wide excision of primary tumor and a complete therapeutic lymph node dissection; or
- Following complete lymph node dissection and/or complete resection of nodal recurrence; or
- Therapy for metastatic or unresectable disease when;
- In combination with nivolumab (Opdivo) as first-line therapy; or
- As a single agent or in combination with nivolumab (Opdivo) as second-line or subsequent therapy for disease progression for individuals with performance status 0-2 if not previously used (however, for individuals who progress on single-agent checkpoint immunotherapy, nivolumab (Opdivo )/ipilimumab (Yervoy) combination therapy is a reasonable treatment option); or
- As a single agent or in combination with nivolumab (Opdivo) after maximum clinical benefit from BRAF targeted therapy for individuals with performance status 0-2; or
- As a single agent or in combination with nivolumab (Opdivo) as re-induction therapy for individuals with performance status 0-2 who experience disease control and have no residual toxicity, but subsequently experience disease progression/relapse greater than three (3) months after treatment discontinuation; or
Uveal Melanoma
- Therapy for metastatic or unresectable disease
- As single agent therapy; or
- In combination with nivolumab (Opdivo); or
Small Cell Lung Cancer (SCLC)
- Subsequent systemic therapy for individuals with performance status 0-2 in combination with nivolumab (Opdivo) for
- Relapse within six (6) months following complete or partial response or stable disease with initial treatment; or
- Primary progressive disease; or
Malignant Pleural Mesothelioma
- Subsequent therapy in combination with nivolumab (Opdivo).
The use of ipilimumab (Yervoy) for any other indication is considered experimental/investigational. Scientific evidence does not support the use of ipilimumab (Yervoy) for any other indication.
NOTE: Dosage recommendations per the FDA label. Refer to medical policy I-120 for information on nivolumab (Opdivo)/ipilimumab (Yervoy) combination therapy. |
| Place of Service: Outpatient |
The administration of Ipilimumab (Yervoy) 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
03/2017, Criteria Revised for Ipilimumab (Yervoy®)
04/2018, Coverage Guidelines Revised for Ipilimumab (Yervoy®)
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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)
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- 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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