BlueCross BlueShield of Tennessee Medical Policy Manual

Ipilimumab

NDC CODE(S)

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))

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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
Malignant Pleural Mesothelioma (MPM)

Nivolumab 3 mg/kg every 2 weeks, followed by ipilimumab 1mg/kg every 6

weeks, until disease progression or unacceptable toxicity

LENGTH OF AUTHORIZATION

Small Cell Lung Cancer (SCLC) and unresectable or metastatic Melanoma

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.

Malignant Pleural Mesothelioma (MPM)

Coverage for treatment will be provided for six months and may be renewed.

Click here to view DOSAGE LIMITS

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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validates the use of ipilimumab for the treatment of conditions or diseases.

SOURCES

Lexi-Comp Online. (2017). AHFS DI. Ipilimumab. Retrieved October 04, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Ipilimumab. Retrieved October 04, 2017 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Ipilimumab. Retrieved December 29, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017,December). Center for Drug Evaluation and Research. Yervoy® (ipilimumab). Retrieved December 29, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/11/2011

MOST RECENT REVIEW DATE:  1/9/2018

ID_MRx

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.

 

 



DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

MAXIMUM UNITS/DOSE

Unresectable or metastatic Melanoma

 

350 billable units per 21 days x 4 doses

Adjuvant treatment of Melanoma

1150 billable units per 21 days x 4 doses;

then 1150 billable units per 84 days

CNS metastases from Melanoma

 

Initial authorization: 1150 billable units per 21 days x 4 doses

Subsequent authorizations: 1150 billable units per 84 days

Small Cell Lung Cancer (SCLC)

350 billable units per 21 days x 4 doses

Malignant Pleural Mesothelioma (MPM)

150 billable units per 42 days