HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-148-005
Topic:
Ramucirumab (Cyramza®)
Section:
Injections
Effective Date:
May 31, 2021
Issued Date:
May 31, 2021
Last Revision Date:
May 2021
Annual Review:
April 2021
 
 

Ramucirumab (Cyramza®) is a recombinant human IgG1 monoclonal antibody that blocks the binding of vascular endothelial growth factor (VEGF) receptor 2 to VEGFR ligands (VEGF-A, VEGF-C, and VEGF-D). By attaching itself to the VEGF receptor 2 of cancer cells, ramucirumab (Cyramza) is able to prevent the receptor from being activated, thus inhibiting proliferation and migration of the cells, and inhibiting angiogenesis.

Policy Position

Ramucirumab (Cyramza) may be considered medically necessary for ANY of the following indications:

Food and Drug Administration (FDA) Indications

Colorectal Cancer

  • In combination with irinotecan, folinic acid, and fluorouracil (FOLFIRI) for the treatment of individuals with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine; or

Gastric Cancer

  • As a single agent or in combination with paclitaxel for individuals with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy; or

Hepatocellular Carcinoma

  • As single agent therapy for the treatment of individuals with HCC who have an alpha fetoprotein (AFP) of 400 ng/mL or greater and have been treated with sorafenib; or

Lung Cancer, Non-Small Cell (NSCLC)

  • In combination with erlotinib, for first-line treatment of metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations; or
  • In combination with docetaxel as treatment of individuals with metastatic NSCLC with disease progression on or after platinum-based therapy:
    • Individuals with EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab (Cyramza); or

National Comprehensive Cancer Network (NCCN) Recommendations

Colon Cancer

  • As subsequent therapy for progression of unresectable advanced or metastatic disease in combination with irinotecan or with FOLFIRI regimen in individuals not previously treated with irinotecan-based therapy; or
  • As adjuvant treatment in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy; or
  • As primary treatment for unresectable metachronous metastases and previous adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) within the past 12 months as ANY of the following:
    • In combination with irinotecan; or
    • In combination with FOLFIRI; or

Esophageal and Esophagogastric Junction Cancers

  • As palliative therapy for individuals who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic adenocarcinoma and Karnofsky performance score of 60% or greater or ECOG performance score (PS) 0-2 as second-line or subsequent therapy as ANY of the following:
    • In combination with paclitaxel; or
    • As a single agent; or
    • In combination with irinotecan with or without flourouracil; or

Gastric Cancer

  • As palliative therapy for locoregional disease in individuals who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease and Karnofsky performance score of 60% or greater or performance score 0-2 as second-line or subsequent therapy as ANY of the following:
    • In combination with paclitaxel; or
    • As a single agent; or
    • In combination with irinotecan with or without flourouracil; or

Hepatocellular Carcinoma

  • As single agent subsequent treatment for progressive disease in individuals with AFP 400 ng/mL or higher in ANY of the following:
    • Have unresectable disease and are not a transplant candidate; or
    • Are inoperable by performance status or comorbidity, or have local disease or local disease with minimal extrahepatic disease only; or
    • Have metastatic disease or extensive liver tumor burden; or

Lung Cancer, Non-Small Cell (NSCLC)

  • As subsequent therapy in combination with docetaxel (if not already given) for recurrent, advanced, or metastatic disease in individuals with performance status 0-2; or
  • As first line therapy in combination with erlotinib for sensitizing EGFR mutation-positive recurrent, advanced, or metastatic disease; or
  • As continuation of therapy following disease progression on combination of erlotinib and ramucirumab for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited metastases; or

Rectal Cancer

  • As primary treatment for individuals with unresectable metachronous metastases and previously adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months for ANY of the following:
    • In combination with irinotecan; or
    • In combination with FOLFIRI; or
  • As subsequent therapy for progression of advanced or metastatic disease in combination with irinotecan or with FOLFIRI in individuals not previously treated with irinotecan-based therapy; or
  • As adjuvant treatment in combination with FOLFIRI or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy.

Ramucirumab (Cyramza) is considered experimental/investigational for all other indications. Scientific evidence does not support the use of ramucirumab (Cyramza) for any other indications not listed above.

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NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

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Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of ramucirumab (Cyramza) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.