Description 
LARTRUVO^™ is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody 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.  

Policy

1. Lartruvo (olaratumab) is MEDICALLY NECESSARY for the following FDA-approved indication when ALL of the following criteria are met:
   • Members who have soft tissue sarcoma (STS) with histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery and to be used in combination with doxorubicin AND
     • Member is over the age of 18 AND
     • Member has an ECOG performance score of 0 – 2
2. When Lartruvo (olaratumab) is considered MEDICALLY NECESSARY, initial therapy will be approved for a period of 6 months at the following FDA-approved dose:
   • 15 mg/kg as an intravenous infusion on days 1 and 8 of each 21-day cycle
   • First 8 cycles, Lartruvo should be administered with doxorubicin
3. Continuation of Lartruvo (olaratumab) will be approved annually at the FDA-approved dose of 15 mg/kg as an intravenous infusion on days 1 and 8 of each 21-day cycle if none of the following occurs:
   • Unacceptable toxicity;
   • Grade 3 or 4 infusion related reactions; OR
   • Disease progression
4. Lartruvo (olaratumab) is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY  for all other indications.

BlueCross BlueShield of South Carolina recognizes uses and indications of injectable oncology medications (including chemotherapy/systemic therapy, therapeutic radiopharmaceuticals, and selected supportive therapies) to be medically necessary if they are listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence + Consensus of 1, 2A and 2B. Treatments listed with a Category of Evidence and Consensus of 3 are considered unproven and not medically necessary.

Definitions
ECOG Performance Status: A scale used to determine the individual's level of functioning. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score, which is based on the following scale:

• 0 = Fully active, able to carry on all pre-disease performance without restriction
• 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light housework, office work
• 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
• 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
• 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair
• 5 = Dead

Metastatic: The spread of cancer from one part of the body to another. A metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

Monoclonal antibody: A laboratory-produced substance that can locate and bind to specific cells wherever they are in the body. Monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins, or radioactive material directly to their target cell.

Overall survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that individuals diagnosed with the disease remain alive.

Progression-free survival (PFS): The length of time during and after treatment that an individual lives but does not get worse (usually measured by the size of a tumor or amount of cancer in the body).

References

1. Chiorean EG, Sweeney C, Youssoufian H, et al. A phase I study of olaratumab, an anti-platelet-derived growth factor receptor alpha (PDGFRα) monoclonal antibody, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014;73(3):595-604.
2. Doi T, Ma Y, Dontabhaktuni A, et al. Phase I study of olaratumab in Japanese patients with advanced solid tumors. Cancer Sci. 2014;105(7):862-869.
3. Sheng JY, Movva S. Systemic therapy for advanced soft tissue sarcoma. Surg Clin North Am. 2016;96(5):1141-1156.
4. Martin-Broto J, Hindi N. Targeted treatments of sarcomas and connective tumors beside gastrointestinal stromal tumor. Curr Opin Oncol. 2016;28(4):338-344.
5. 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(10043):488-497.
6. U.S. Food and Drug Administration (FDA). FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma. Silver Spring, MD: FDA; October 19, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm525878.htm. Accessed October 20, 2016.
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8. Eli Lilly and Company. Lartruvo (olaratumab) injection, for intravenous use. Prescribing Information. LAR-0001-USPI-20161019. Indianapolis, IN: Lilly; revised October 2016. 
9. Chiorean EG, Sweeney C, Youssoufian H, et al. A phase I study of olaratumab, an anti-platelet-derived growth factor receptor alpha (PDGFRα) monoclonal antibody, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014; 73(3):595-604.
10. Doi T, Ma Y, Dontabhaktuni A, et al. Phase I study of olaratumab in Japanese patients with advanced solid tumors. Cancer Sci. 2014; 105(7):862-869.
11. Sheng JY, Movva S. Systemic therapy for advanced soft tissue sarcoma. Surg Clin North Am. 2016; 96(5):1141-1156.
12. 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(10043):488-497.
13. Lartruvo [Product Information], Indianapolis, IN. Eli Lilly and Co., February 2017. Available at: http://pi.lilly.com/us/lartruvo-uspi.pdf. Accessed on April 4, 2017.
14. National Comprehensive Cancer Network^® . NCCN Drugs & Biologic Compendium™ (electronic version). For additional information visit the NCCN website: http://www.nccn.org. Accessed on April 4, 2017.
15. National Comprehensive Cancer Network^® NCCN Clinical Practice Guidelines in Oncology^™ . For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on April 4, 2017.
16. Soft Tissue Sarcoma (V.2.2017). Revised February 8, 2017.
17. National Institute of Health. A randomized, double-blind, placebo-controlled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcoma. Clinical trials.gov Identifier: NCT02451943. Last updated on November 22, 2016. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02451943?term=NCT02451943&rank=1 . Accessed on April 4 , 2017.
18. Olaratumab. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated November 11, 2016. Available at: http://www.micromedexsolutions.com. Accessed on April 4, 2017.
19. Olaratumab Monograph. Lexicomp^® Online, American Hospital Formulary Service^® (AHFS^® ) Online, Hudson, Ohio. Lexi-Comp., Inc. November 7, 2016. Accessed on April 4, 2017.
20. Lartruvo (olaratumab) [Prescribing Information]. Eli Lilly Company. November 2016.
21. Sarcoma: Adult Soft tissue Sarcoma. American Cancer Society. November 2016. Available at: http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-soft-tissue-sarcoma
22. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology, soft tissue sarcoma (version 2). 2016.
23. Tap WD, Jones RL, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomized phase 2 trial. Lancet. 2016;388(10043):488-97.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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