NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 2A Recommenda­tion4,5*

The NCCN Guidelines® for Soft Tissue Sarcoma (STS) recommend olaratumab (LARTRUVO) in combination with doxorubicin for treatment of adult patients with STS.

The NCCN Guidelines for Uterine Neoplasms recommend olaratumab (LARTRUVO) in combination with doxorubicin as a systemic therapy option for the treatment of uterine sarcoma.

INDICATION
LARTRUVO 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.

This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

*Category 2A recommendation is based on lower-level evidence and there is uniform NCCN consensus that the intervention is appropriate.

Clinical trials are strongly recommended.

The clinical benefits of LARTRUVO for any one histologic subtype of STS have not been established.

The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Tap WD, Jones RL, Van Tine BA, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388:488-497. 2. Data on file. Lilly USA, LLC. LAR20161014a. 3. Data on file. Lilly USA, LLC. ONC20160229b. 4. Referenced with permission from The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 27, 2018. To view the most recent and complete version of the guidelines, go online to http://nccn.org. 5. Referenced with permission from The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed May 25, 2018. To view the most recent and complete version of the guidelines, go online to http://nccn.org.

Patient Brochure

Helpful information for patients to learn what they can expect from treatment with LARTRUVO.

Find easy-to-use forms and reimbursement information to help support your patient's treatment journey.

Lilly PatientOne is committed to helping eligible patients access support programs for Lilly Oncology products they are prescribed. We aim to address both financial and coverage issues for qualified uninsured, underinsured, and insured patients. Lilly PatientOne strives to offer resources, ranging from benefits investigations to financial assistance and appeals information, that provide reliable and individualized treatment support for eligible patients.

Co-pay Program

  • Lilly PatientOne Co-pay Program—patients pay no more than $25 per dose—to assist eligible patients with co-pay and coinsurance costs for prescribed Lilly Oncology products where available*
  • No income eligibility requirement
  • Provides an annual maximum patient benefit of $25,000

*This offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program.

Insurance Expertise

  • Billing and coding information
  • Payment methodologies and allowables
  • Payer policy information

Reimbursement Assistance

  • Eligibility determination
  • Benefits investigation
  • Prior authorization assistance
  • Denied claims appeals information

Lilly Cares Foundation

The Lilly Cares Foundation, Inc., a separate nonprofit organization, provides free Lilly medications to qualifying patients. For more information about Lilly Cares, please visit LillyCares.com or call 1-800-545-6962.

For more information about Lilly PatientOne, call 1-866-4PatOne (1-866-472-8663), Monday–Friday, 9 AM–7 PM ET, or visit LillyPatientOne.com.

Practice support

Lilly Oncology offers a suite of tools and resources to facilitate treatment with LARTRUVO and help you provide the best possible care for your patients.

LARTRUVO Billing and Coding Guide

Helpful billing and coding information for LARTRUVO.

LARTRUVO Distribution and Specification Guide

Helpful information on the specialty distributors and specialty pharmacy that Lilly has contracted to help provide LARTRUVO to customers.

CMS-1450 Sample Claim Form

This resource provides suggested guidance on how to populate the CMS-1450 claim form when submitting a claim for the administration of LARTRUVO in the outpatient hospital setting.

CMS-1500 Sample Claim Form

This resource provides suggested guidance on how to populate the CMS-1500 claim form when submitting a claim for the administration of LARTRUVO in the physician’s office.

Effective January 1, 2018, the following code can be used for administrative and billing purposes specific to LARTRUVO® (olaratumab): J9285, Injection, olaratumab, 10 mg for physician office use. This information is presented for information purposes only and is not intended to provide reimbursement or legal advice.

Indication and Important Safety Information
Indication

LARTRUVO 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.

This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO
Warnings and Precautions
Infusion-Related Reactions
  • Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade ≥3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N=485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.
Embryo-Fetal Toxicity
  • Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.
Most Common Adverse Reactions/Lab Abnormalities
  • The most commonly reported adverse reactions (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%).
  • The most common laboratory abnormalities (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%) and thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aPTT (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%).
Use in Specific Populations
  • Lactation: Because of the potential risk for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LARTRUVO and for at least 3 months following the last dose.

Please see full Prescribing Information for additional information about LARTRUVO.

OR HCP ISI 19OCT2016