00003-2327-XX Yervoy 50 MG/10ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE))
00003-2328-XX Yervoy 200 MG/40ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE))
Ipilimumab (Yervoy®) is a recombinant human monoclonal antibody and an IgG1 kappa immunoglobulin. It binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a negative regulator of T-cell activation, and blocks interaction with its ligands CD80/CD86. Ipilimumab’s mechanism of action is likely through T-cell mediated anti-tumor immune responses. Ipilimumab has been proven to be effective in crossing the blood brain barrier.
Ipilimumab is considered medically necessary for the treatment for the following if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Central nervous system cancer
Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dMMR) Colorectal Cancer
Renal Cell Carcinoma (RCC)
Small Cell Lung Cancer (SCLC)
Ipilimumab for the treatment of other conditions/diseases is considered investigational.
Ipilimumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older, unless otherwise indicated;
Diagnosis of ANY ONE of the following:
Diagnosis of central nervous system cancer if ALL of the following:
Individual must have brain metastases from melanoma
Ipilimumab must have been active against the primary melanoma tumor and ANY ONE of the following:
Used as initial therapy in combination with nivolumab
Used for recurrent disease as a single agent or in combination with nivolumab
Diagnosis of melanoma with ANY ONE of the following:
Disease is unresectable or metastatic and ANY ONE of the following:
Used as a single agent in individuals 12 years of age or older
Used in combination with nivolumab
Used as adjuvant treatment and used as a single agent if ANY ONE of the following:
Individual has cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm and has undergone complete resection including total lymphadenectomy
Following complete lymph node dissection and/or complete resection of nodal recurrence
Used as a single agent or in combination with nivolumab for unresectable or metastatic Uveal Melanoma
Diagnosis of Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dMMR) Colorectal Cancer with ALL of the following:
Individual is 12 years of age or older
Used in combination with nivolumab
Disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
Individual has metastatic disease that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Diagnosis of Renal Cell Carcinoma (RCC) with ANY ONE of the following:
Used as initial therapy in combination with nivolumab and individual has advanced or metastatic disease with intermediate or poor risk
Used as subsequent therapy in combination with nivolumab and ALL of the following:
Individual has relapsed or surgically unresectable stage IV disease
Used for predominant clear cell histology
Diagnosis of small cell lung cancer (SCLC) with ALL of the following:
Used as subsequent therapy in combination with nivolumab
Performance status (ECOG) score is 0-2 and ANY ONE of the following:
Used for primary progressive disease
Used for relapse within 6 months of initial therapy following a complete or partial response or stable disease
Ipilimumab considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: immune-mediated reactions (e.g. enterocolitis, hepatitis, dermatitis, neuropathies, endocrinopathies like hypopituitarism, hypothyroidism, hypogonadism, or adrenal insufficiency, and ocular disease, etc)
Diagnosis of ANY ONE of the following:
CNS metastases from melanoma if ANY ONE of the following:
Initial renewal: Individual’s disease is clinically stable at week 24
Subsequent renewals: Tumor response/absence of recurrence
Melanoma (metastatic or unresectable disease) and Individual has completed initial induction (completion of 4 cycles within a 16 week period) and ANY ONE of the following:
Used as re-induction therapy in individuals who experienced disease control, but subsequently disease progression/relapse > 3 months after treatment discontinuation
Used as subsequent therapy in combination with nivolumab in individuals who experienced disease relapse and/or progression within 3 months after initial monotherapy with ipilimumab
Melanoma Maintenance therapy (adjuvant treatment) if ALL of the following:
Tumor response/absence of recurrence
Length of therapy has not exceeded 3 years
Small Cell Lung Cancer (SCLC)/Renal Cell Carcinoma (RCC)/Colorectal Cancer (CRC) - Coverage may NOT be renewed
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Melanoma - unresectable or metastatic||
3 mg/kg every 3 weeks for a total of 4 doses*all treatment must be administered within 16 weeks of the first dose
|Melanoma – adjuvant treatment||
10 mg/kg every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years
|CNS metastases from melanoma||
· Single Agent:
· Initial: 10 mg/kg every 3 weeks for 4 doses
· Subsequent: 10 mg/kg every 12 weeks
· Combination Therapy (with nivolumab):
· Initial: Ipilimumab 3 mg/kg and Nivolumab 1mg/kg, every 3 weeks for 4 doses
Subsequent: Nivolumab 3 mg/kg every 2 weeks until disease progression or intolerance
|Small Cell Lung Cancer (SCLC)||
3 mg/kg every 3 weeks for a total of 4 doses (given in combination with nivolumab followed by nivolumab monotherapy)*all treatment must be administered within 16 weeks of the first dose
Renal Cell Carcinoma (RCC) and Colorectal Cancer (CRC)
|1 mg/kg every 3 weeks for a total of 4 doses (given in combination with nivolumab followed by nivolumab monotherapy)|
LENGTH OF AUTHORIZATION
Small Cell Lung Cancer (SCLC)/Renal Cell
(unresectable or metastatic)/Colorectal
Coverage will be provided for 12 weeks (may be extended to 16 weeks if 4 doses were not administered within the 12 week time frame) and may not be renewed (unless the patient meets the provisions for metastatic or unresectable melanoma re-induction).
Melanoma (maintenance adjuvant therapy)
Coverage for adjuvant treatment will be provided for six months and may be renewed for up to 3 years of therapy total
CNS metastases from Melanoma
Coverage will be provided for 12 weeks initially (may be extended to 16 weeks if 4 doses were not administered within the 12 week time frame). Coverage may be renewed in 6 month intervals thereafter.
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
Lexi-Comp Online. (2018). AHFS DI. Ipilimumab. Retrieved October 11, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, April). Ipilimumab. Retrieved October 11, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Ipilimumab. Retrieved October 11, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. Yervoy® (ipilimumab). Retrieved October 11, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s073lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/11/2011
MOST RECENT REVIEW DATE: 3/2/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 1 mg