BlueCross BlueShield of Tennessee Medical Policy Manual

Olaratumab

NDC CODE(S)

00002-8926-XX - Lartruvo 500 MG/50 ML SOLN (LILLY)

 

00002-7190-XX - Lartruvo 190 MG/19ML SOLN (LILLY)

DESCRIPTION

Olaratumab is a recombinant IgG1 monoclonal blocking antibody.  It specifically binds to human platelet-derived growth factor receptor alpha (PDGFR-α).  PDGFR-α is a receptor tyrosine expressed on cells of mesenchymal origin.  Signaling through this receptor plays a role in cell growth, chemotaxis and mesenchymal stem cell differentiation.  It has also been detected in some tumor and stromal cells, including sarcomas.  Olaratumab exhibits anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFR-α signaling pathway.      

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL 

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION – 6 month initial approval
Soft tissue sarcoma

15 mg/kg by intravenous infusion on Days 1 and 8 of  each 21-day cycle until disease progression or unacceptable toxicity.

Administer  with doxorubicin for the first 8 cycles

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

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).

SOURCES

Lexi-Comp Online. (2018, February). AHFS DI. Olaratumab. Retrieved December 5, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, June). Olaratumab. Retrieved December 5, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Olaratumab. Retrieved December 5, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, October). Center for Drug Evaluation and Research. Lartruvo (olaratumab) injection, for intravenous use. Retrieved December 5, 2018 from http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

ORIGINAL EFFECTIVE DATE: 3/10/2017

MOST RECENT REVIEW DATE:  4/2/2019

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     1 billable unit=10 mg   

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

Soft tissue sarcoma

1 billable unit=10 mg

400 billable units (4,000 mg) per 21 days