||August 20, 2018
||August 20, 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 patients 12 years of age or older when ANY ONE of the following indications is met:
Limited Metastatic Melanoma Central Nervous System (CNS) 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
- In combination with nivolumab (Opdivo) for newly diagnosed brain metastases in select individuals with ANY ONE of the following:
- Newly diagnosed; or
- Stable systemic disease; or
- Reasonable systemic treatment options; or
Extensive Metastatic Melanoma CNS Lesions
- As a single-agent treatment if active against primary tumor (melanoma) for brain metastases in patients with recurrent stable systemic disease; or
- In combination with nivolumab (Opdivo) for brain metastases if active against primary tumor (melanoma); or
- Adjuvant treatment in individuals with cutaneous melanoma with pathologic involvement of regional lymph nodes of greater than one (1) mm who have undergone complete resection, including total lymphadenectomy;
- Adjuvant treatment as a high-dose single agent;
- For stage III sentinel lymph node positive metastasis greater than one (1) 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 or without 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 patients with performance status 0-2 if not previously used (however, for patients 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 patients with performance status 0-2; or
- As a single agent or in combination with nivolumab (Opdivo) as re-induction therapy for patients 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
- 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 patients 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);or
Renal Cell Carcinoma
- First-line treatment, in combination with nivolumab (Opdivo) for advanced disease in individuals with intermediate or poor risk; or
- Used in combination with nivolumab (Opdivo) for relapse or surgically unresectable stage IV clear cell disease for ANY of the following:
- As preferred first-line therapy for predominant clear cell histology; or
- As subsequent therapy for predominant clear cell histology.
- Treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab.
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|
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.
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.
- 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.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.