00002-8926-XX - Lartruvo 500 MG/50 ML SOLN (LILLY)
00002-7190-XX - Lartruvo 190 MG/19ML SOLN (LILLY)
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.
Olaratumab for the treatment of soft tissue sarcoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Olaratumab for the treatment of other conditions/diseases is considered investigational.
Olaratumab is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of soft tissue sarcoma (STS)
combination with doxorubicin when an anthracycline containing
regimen is appropriate and
used disease is not amenable
to curative radiotherapy or surgery for ANY
ONE of the following histologic sub-types of disease:
Retro-peritoneal/Intra-Abdominal Sarcoma for ANY ONE of the following:
Primary treatment as chemotherapy or chemoradiation for attempted downstaging of unresectable, recurrent, or metastatic disease
Used as palliative therapy for unresectable or progressive disease.
Extremity/Superficial Trunk/Head-Neck Sarcoma and ALL of the following:
Will not be used as neoadjuvant or adjuvant therapy for Stages II-III disease
Used for ANY ONE of the following:
Primary treatment as chemotherapy or chemoradiation for stage II-III resectable disease with adverse functional outcomes
Chemotherapy following regional node dissection
Disease is recurrent or metastatic
Uterine Sarcoma and individual does not have Stage I disease for ANY ONE of the following:
May be considered following total hysterectomy with or without bilateral salpingo-oophorectomy (TH ± BSO) for stage II-III disease
Disease is not suitable for primary surgery;
Disease is recurrent or metastatic.
Olaratumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent, including severe infusion-related reactions, severe neutropenia, etc.
|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.
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, 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
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=10 mg