Ipilimumab (Yervoy) (ARCHIVED)

Policy ID: I-34-019

Section: Injections

Effective Date: June 01, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Policy ID: I-34-019

Section: Injections

Effective Date: June 01, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

Ipilimumab (Yervoy) may be considered medically necessary in individuals 12 years of age or older for ANY of the following indications:

Colorectal Cancer

As treatment in combination with nivolumab 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; or

Esophageal Cancer

As first line treatment in combination with nivolumab for adult individuals with unresectable advanced or metastatic esophageal squamous cell carcinoma; or

Hepatocellular Carcinoma

As treatment of individuals who have been previously treated with sorafenib, in combination with nivolumab; or

Malignant Pleural Mesothelioma

As first-line treatment in combination with nivolumab for individuals 18 years of age and older with unresectable malignant pleural mesothelioma; or

Melanoma

As treatment for individuals with unresectable or metastatic disease; or
As adjuvant treatment for individuals with cutaneous melanoma with pathologic involvement of regional lymphoma nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy; or
As treatment in combination with nivolumab for individuals with unresectable or metastatic melanoma; or

Non-Small Cell Lung Cancer (NSCLC)

As first-line treatment in combination with nivolumab for individuals 18 years of age and older with metastatic disease expressing PD-L1 (1% or greater) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; or
Treatment of individuals 18 years of age and older with metastatic or recurrent disease with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and two (2) cycles of platinum-doublet chemotherapy; or

Renal Cell Carcinoma

As therapy in combination with nivolumab for the treatment of advanced disease in individuals with intermediate or poor-risk, previously untreated advanced renal cell carcinoma; or

Compendia Sources

Ipilimumab (Yervoy) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of ipilimumab (Yervoy) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9228

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C00.0

C00.1

C00.2

C00.3

C00.4

C00.5

C00.6

C00.8

C00.9

C01

C02.0

C02.1

C02.2

C02.3

C02.4

C02.8

C02.9

C03.0

C03.1

C03.9

C04.0

C04.1

C04.8

C04.9

C05.0

C05.1

C05.8

C05.9

C06.0

C06.2

C06.80

C06.89

C06.9

C09.0

C09.1

C09.8

C09.9

C10.0

C10.1

C10.2

C10.3

C10.4

C10.8

C10.9

C12

C13.0

C13.1

C13.2

C13.8

C13.9

C14.0

C14.2

C14.8

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.3

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.0

C21.1

C21.8

C22.0

C22.1

C22.8

C22.9

C23

C24.0

C24.1

C25.0

C25.1

C25.2

C25.3

C25.7

C25.8

C25.9

C31.0

C31.1

C32.0

C32.1

C32.2

C32.3

C32.8

C32.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C38.4

C40.00

C40.01

C40.02

C40.10

C40.11

C40.12

C40.20

C40.21

C40.22

C40.30

C40.31

C40.32

C40.80

C40.81

C40.82

C40.90

C40.91

C40.92

C41.0

C41.1

C41.3

C41.4

C41.9

C43.0

C43.10

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C44.00

C44.02

C44.09

C45.0

C45.1

C45.2

C45.7

C45.9

C46.0

C46.1

C46.2

C46.3

C46.4

C46.50

C46.51

C46.52

C46.7

C46.9

C47.0

C47.10

C47.11

C47.12

C47.20

C47.21

C47.22

C47.3

C47.6

C47.8

C47.9

C49.0

C49.10

C49.11

C49.12

C49.20

C49.21

C49.22

C49.3

C49.6

C49.9

C4A.0

C4A.10

C4A.111

C4A.112

C4A.121

C4A.122

C4A.20

C4A.21

C4A.22

C4A.30

C4A.31

C4A.39

C4A.4

C4A.51

C4A.52

C4A.59

C4A.60

C4A.61

C4A.62

C4A.70

C4A.71

C4A.72

C4A.8

C4A.9

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C69.30

C69.31

C69.32

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C69.90

C69.91

C69.92

C72.0

C72.1

C76.0

C77.0

C78.00

C78.01

C78.02

C78.6

C78.7

C79.31

C7A.1

C7A.8

C7B.1

C7B.8

D37.01

D37.02

D37.05

D37.09

D37.1

D37.8

D37.9

D38.0

D38.5

D38.6

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019 Adopt policy

Internal Medical Policy Committee 1-22-2020

Changed to pre-certification policy,
Updated criteria

Internal Medical Policy Committee 11-19-2020 NCCN recommendations

Updated FDA indications, and
Updated NCCN recommendations.

Internal Medical Policy Committee 11-23-2021

Updated FDA indications and NCCN recommendations

Internal Medical Policy Committee 11-29-2022 Annual review, no clinical content change

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Added esophageal cancer criteria
Removed NCCN Recommendations
Added Compendia sources statement 'Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Updated diagnosis code list
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Updated diagnosis code list

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

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.

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