BlueCross BlueShield of Tennessee Medical Policy Manual
Ipilimumab (Yervoy®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Yervoy is indicated as a single agent or in combination with nivolumab for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older.
Yervoy is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Yervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
Yervoy, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Yervoy, in combination with nivolumab, is indicated for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Yervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
Yervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
All other indications are considered experimental/investigational and not medically necessary.
Submission of the following information is necessary to initiate the prior authorization review:
Authorization of 6 months may be granted for treatment of cutaneous melanoma in any of the following settings:
Authorization of 6 months may be granted as a single agent or in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of uveal melanoma for unresectable or metastatic disease.
Authorization of 6 months may be granted as a single agent or in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of CNS brain metastases in members with melanoma.
Authorization of 6 months may be granted for treatment of recurrent, advanced or metastatic non-small cell lung cancer if there are no EGFR exon 19 deletions or exon 21 L858R mutations or ALK rearrangements (unless testing is not feasible due to insufficient tissue) and the requested medication will be used in a regimen containing nivolumab.
Authorization of 6 months may be granted for treatment of renal cell carcinoma in combination with nivolumab (for 4 doses, followed by single agent nivolumab) for relapsed, advanced, or stage IV disease with clear cell histology.
Authorization of 6 months may be granted for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) or polymerase epsilon/delta (POLE/POLD1) tumors when used in combination with nivolumab (for 4 doses followed by nivolumab as a single agent).
Authorization of 6 months may be granted in combination with nivolumab for treatment of pleural or peritoneal mesothelioma, including pericardial mesothelioma and tunica vaginalis testis mesothelioma.
Authorization of 6 months may be granted in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of hepatocellular carcinoma.
Authorization of 6 months may be granted in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of advanced or metastatic small bowel adenocarcinoma for microsatellite-instability high (MSI-H), or mismatch repair deficient (dMMR) or polymerase epsilon/delta (POLE/POLD1) tumors.
Authorization of 6 months may be granted in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of progressive, unresectable, or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ampullary adenocarcinoma.
L. Gastric Cancer
M. Kaposi Sarcoma
Authorization of 6 months may be granted in combination with nivolumab for subsequent treatment of relapsed/refractory classic Kaposi Sarcoma.
Authorization of 6 months may be granted in combination with nivolumab for unresectable or metastatic disease when all of the following are met:
1. Disease has tumor mutation burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] tumors
2. Disease has progressed following prior treatment and has no satisfactory alternative treatment options
O. Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Authorization of 6 months may be granted as subsequent treatment in combination with nivolumab for unresectable or resected gross residual (R2) disease, or metastatic disease that is tumor mutation burden-high (TMB-H).
Authorization of 6 months may be granted in combination with nivolumab for treatment of extremity/body wall sarcomas, head/neck sarcomas and retroperitoneal/intra-abdominal sarcomas, rhabdomyosarcoma and angiosarcoma.
Authorization of 6 months may be granted as a single agent or in combination with nivolumab (for 4 doses followed by nivolumab as a single agent) for treatment of unresectable, recurrent, or stage IV Merkel cell carcinoma.
Authorization of 6 months may be granted (up to 3 years) for continued treatment in members requesting reauthorization for adjuvant melanoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Authorization of 6 months may be granted (up to 4 doses maximum, if member has not already received 4 doses) for continued treatment in members requesting reauthorization for cutaneous melanoma, renal cell carcinoma, colorectal cancer, and hepatocellular cancer when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Authorization of 6 months may be granted (up to 24 months total) for continued treatment in members requesting reauthorization for non-small cell lung cancer, esophageal cancer, or pleural mesothelioma, including pericardial mesothelioma and tunica vaginalis testis mesothelioma subtypes, when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for all other indications listed in Section III when treatment guidelines do not specify a limited number of total doses (see above) and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Yervoy (Ipilimumab) |
Ampullary Adenocarcinoma, Colorectal Cancer or Appendiceal Adenocarcinoma, Renal Cell Carcinoma, Small Bowel Adenocarcinoma |
Route of Administration: Intravenous 1mg/kg every 3 weeks for 4 doses |
|
Yervoy (Ipilimumab) |
Biliary Tract Cancer: Gallbladder Cancer, Cholangiocarcinoma, Bone Cancer, Kaposi Sarcoma, Mesothelioma (Pleural, Peritoneal, Pericardial, or Tunica Vaginalis Testis), Non-Small Cell Lung Cancer |
Route of Administration: Intravenous 1mg/kg every 6 weeks |
|
Yervoy (Ipilimumab) |
Central Nervous System (CNS) Cancer - Brain Metastases |
Route of Administration: Intravenous 3mg/kg every 3 weeks for 4 doses
Initial: 10mg/kg every 3 weeks for 4 doses Maintenance: 10mg/kg every 12 weeks beginning with week 24 |
|
Yervoy (Ipilimumab) |
Esophageal Squamous Cell Carcinoma |
Route of Administration: Intravenous ≥18 Years 1mg/kg every 6 weeks |
|
Yervoy (Ipilimumab) |
Gastric Cancer |
Route of Administration: Intravenous 3mg/kg every 3 weeks for 4 doses |
|
Yervoy (Ipilimumab) |
Hepatocellular Carcinoma, Melanoma |
Route of Administration: Intravenous 3mg/kg every 3 weeks for 4 doses |
|
Yervoy (Ipilimumab) |
Melanoma Cutaneous, Adjuvant |
Route of Administration: Intravenous Initial: 10mg/kg every 3 weeks for 4 doses Maintenance: 10mg/kg every 12 weeks |
|
Yervoy (Ipilimumab) |
Merkel Cell Carcinoma |
Route of Administration: Intravenous |
|
Yervoy (Ipilimumab) |
Soft Tissue Sarcoma: Angiosarcoma, Extremity/Body Wall Sarcoma, Head/Neck Sarcoma, Retroperitoneal/Intra-Abdominal Sarcoma, Rhabdomyosarcoma |
Route of Administration: Intravenous 1mg/kg every 6 weeks |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 9/11/2011
MOST RECENT REVIEW DATE: 12/3/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.