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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-73

Original Effective Date: 03/15/17

Reviewed: 02/08/17

Revised: 04/01/17

Subject: Olaratumab (Lartruvo®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Approximately 12,310 individuals are predicted to be diagnosed with soft tissue sarcoma (STS) in 2016 and 4,990 are expected to die from the disease. A receptor tyrosine kinase, platelet-derived growth factor receptor alpha (PDGFR-α), has been detected on some tumor cells, including sarcomas. This receptor has a role in signaling cancer cell proliferation, metastasis, and maintenance of the tumor. Olaratumab is a human IgG1 antibody that binds PDGFR-α to provide antitumor activity through disruption of the receptor signaling pathway.

Olaratumab (Lartruvo™) was approved by the US Food and Drug Administration (FDA) in October 2016, in combination with doxorubicin, for the treatment of STS which is not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype appropriate for an anthracycline-containing regimen. Approval is contingent upon confirmation of clinical benefit as part of the accelerated approval process.

Olaratumab was evaluated in an open-label, randomized trial of 133 patients with metastatic STS. Patients were required to have STS not amenable to curative treatment with surgery or radiotherapy, and a histologic type of sarcoma for which an anthracycline-containing regimen was appropriate, but had not been administered. Patients received either the combination of olaratumab plus doxorubicin or doxorubicin as a single agent. Olaratumab was administered at 15 mg/kg as an intravenous (IV) infusion on days 1 and 8 of each 21-day cycle and all patients received doxorubicin 75 mg/m2 as an IV infusion on day 1 of each 21-day cycle for maximum of eight cycles. Patients were permitted to receive dexrazoxane prior to doxorubicin on cycles 5 to 8.

An improvement in overall survival (OS) was demonstrated with the combination of olaratumab plus doxorubicin compared to those receiving doxorubicin alone (Median OS of 26.5 months compared to 14.7 months, HR=0.52 [95% CI: 0.34, 0.79]). The median progression-free survival was numerically improved with combination therapy at 8.2 months compared to 4.4 months with single agent doxorubicin. The overall response rate was 18% in the combination arm and 8% with single agent use. Common adverse effects of treatment with olaratumab included gastrointestinal effects (nausea, vomiting, diarrhea, mucositis, abdominal pain), hematologic effects (lymphopenia, neutropenia, thrombocytopenia), fatigue, musculoskeletal pain, alopecia, decreased appetite, neuropathy, headache and infusion-related reactions.  

The National Comprehensive Cancer Network (NCCN) guidelines for STS support the use of olaratumab for angiosarcoma, rhabdomyosarcoma, and STS of the extremity, superficial trunk, head, neck, retroperitoneal, and intraabdominal area.

POSITION STATEMENT:

I. Initiation of olaratumab (Lartruvo®) meets the definition of medical necessity when used for an indication in Table 1, all indication specific criteria are met, and the dose does not exceed 15 mg/kg on Day 1 and 8 of a 21 day cycle:

Table 1

Indication

Specific criteria

Soft tissue sarcoma (STS):

Angiosarcoma

Extremity/trunk/head/neck

Retroperitoneal/intra-abdominal

Rhabdomyosarcoma

Olaratumab is used in combination with doxorubicin for ONE of the following:

1. Angiosarcoma

2. STS of the extremity, trunk, head, or neck and ONE of the following:

a. Unresectable disease

b. Recurrent disease

c. Stage IV or Metastatic disease

d. Resectable, stage II or III disease with adverse functional outcomes

3. STS of the retroperitoneal/intra-abdominal area and ONE of the following:

a. Unresectable disease

b. Recurrent disease

c. Progressive disease

d. Metastatic disease

4. Pleomorphic rhabdomyosarcoma

Approval duration: 6 months

II. Continuation of olaratumab (Lartruvo®) meets the definition of medical necessity for the indications in Table 1 when the following criteria are met:

A. The member’s disease has not progressed while receiving therapy with olaratumab

B. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

C. The dose does not exceed 15 mg/kg on Day 1 and 8 of a 21 day cycle

Approval duration: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Olaratumab is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

The recommended dose of olaratumab is 15 mg/kg administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. For the first 8 cycles, olaratumab is administered with doxorubicin. Premedicate with diphenhydramine (25 to 50 mg intravenously) and dexamethasone (10 to 20 mg intravenously) prior to olaratumab on Day 1 of cycle 1.

Dose Adjustments

Infusion-Related Reactions

• Permanently discontinue for Grade 3 or 4 infusion-related reactions

• Interrupt infusion for Grade 1 or 2 infusion-related reactions (IRR). After resolution, resume infusion at 50% of the initial infusion rate.

Neutropenia

• For neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week, discontinue administration until the absolute neutrophil count is 1,000 /microliter or greater and then permanently reduce the dose to 12 mg/kg.

The pharmacokinetics of olaratumab in patients with severe renal or severe hepatic impairment is unknown.

Drug Availability

500 mg/50 mL (10 mg/mL) solution in a single-dose vial

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Infusion-Related Reactions: Monitor for signs and symptoms during and following infusion. Discontinue for Grade 3 or 4 infusion-related reactions

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment and for 3 months after the last dose.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9485

Injection, olaratumab, 10 mg (hospital outpatient use ONLY)

J9999

Not otherwise classified, antineoplastic drugs

ICD-10 Diagnoses Codes That Support Medical Necessity

C48.0 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C49.0 – C49.9

Malignant neoplasm of other connective and soft tissue

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the guideline creation.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

Table 1: Common Terminology Criteria for Adverse Events v4.0 (CTCAE)

Grade

Description

1

Mild; asymptomatic or mild symptoms; clinical diagnostic observations only; intervention not indicated

2

Moderate; minimal, local or noninvasive intervention indicated; limited age-appropriate instrumental activities of daily living

3

Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living

4

Life-threatening consequences; urgent intervention indicated

5

Death related to adverse event

REFERENCES:

  1. AHFS drug information 2017 [monograph on the Internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2017 [cited 2017 Jan 18].
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2017. URL www.clinicalpharmacilogy-ip.com Accessed 1/18/17.
  3. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 1/18/17.
  4. National Cancer Institute. Common Terminology Criteria for Adverse Events. Available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed 1/18/17.
  5. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 1/18/17.
  6. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Soft Tissue Sarcoma, v.1.2017 [cited 2017 Jan 25]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  7. Lartruvo (olaratumab) [package insert]. Eli Lilly and Company. Wayne (NJ): October 2016.
  8. U.S. Food and Drug Administration Website. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526087.htm Accessed 1/24/17.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on0 2/08/2017.

GUIDELINE UPDATE INFORMATION:

03/15/17

New Medical Coverage Guideline.

04/01/17

Revision to guideline consisting of adding HCPCS code C9485.

Date Printed: August 18, 2017: 10:27 AM