BlueCross BlueShield of Tennessee Medical Policy Manual

Olaratumab

NDC CODE(S)

00002-8926-XX - Lartruvo 500 mg/50 mL single-dose vial (Eli 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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION – 6 month initial approval
Soft tissue sarcoma 15 mg/kg IV on Days 1 and 8 of a 21-day cycle,  with doxorubicin for the first 8 cycles

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).

SOURCE

U. S. Food and Drug Administration. (2016, October). Center for Drug Evaluation and Research. Lartruvo (olaratumab) injection, for intravenous use. Retrieved January 23, 2017 from http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process.

ORIGINAL EFFECTIVE DATE:  3/10/2017

MOST RECENT REVIEW DATE:  3/10/2017

ID_MRxEx

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.

Pharmaceutical Decision Support Tree

Olaratumab (Lartruvo ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Is the individual 18 years of age or older?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of soft tissue sarcoma (STS) which is not amenable to curative treatment with radiotherapy or surgery?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria olaratumab

  1. Is the disease a histologic subtype for which anthracycline-containing treatment regimen is appropriate?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will administration be in combination with doxorubicin for the first 8 cycles of treatment?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a maximum of 4000 mg per 21 days per dose and over time for a dosage of 15 mg/kg on days 1 and 8 of each 21-day cycle for a six month period?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in question 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity from the agent, including nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, headache, lymphopenia, neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT, hypokalemia, and hypophosphatemia?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.