HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
I-87-011
Topic:
Oxaliplatin (Eloxatin)
Section:
Injections
Effective Date:
January 6, 2020
Issued Date:
January 6, 2020
Last Revision Date:
December 2019
Annual Review:
December 2019
 
 

Oxaliplatin (Eloxatin®) for injection is an organoplatinum complex used as an antineoplastic agent. In the human body, oxaliplatin (Eloxatin) metabolizes to form active oxaliplatin derivatives that help create deoxyribonucleic acid (DNA) crosslinks with resulting inhibition of DNA replication, transcription, and cell-cycle nonspecific cytotoxicity.

Policy Position

Delaware Mandate:

Effective September 1, 2017, 18 Delaware Code §§3338B and 3555B, require that no individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation or health maintenance organization that directly or indirectly covers the treatment of cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of such drug or drugs; provided, however that the use of such drug or drugs is consistent with best practices for the treatment of stage 4 advanced, metastatic cancer or, in the case of other cancers, the use of the drug is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature for the treatment of the cancer, or in the case of targeted therapy, the target at issue.

FDA Indications

The use of oxaliplatin (Eloxatin) may be considered medically necessary when used in combination with infusional 5-fluorouracil /leucovorin for ANY of the following conditions:

  • Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor; or
  • Treatment of advanced colorectal cancer.

 

The use of oxaliplatin (Eloxatin) for all other indications not listed in this policy is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of oxaliplatin (Eloxatin) for any indications other than those listed in this medical policy.

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National Comprehensive Cancer Network (NCCN) Recommendations

Oxaliplatin (Eloxatin) may be considered medically necessary for the category 1, 2A, or 2B NCCN recommendation for ANY of the following conditions:

  • Anal Carcinoma - Anal Carcinoma, Squamous cell carcinoma; or
  • B-Cell Lymphomas - AIDS-Related B-Cell Lymphomas, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma (grade 1-2), Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphomas, Mantle Cell Lymphoma, or Post-Transplant Lymphoproliferative Disorders; or
  • Bladder Cancer - Non-Urothelial and Urothelial with Variant Histology, Pure adenocarcinoma including urachal; or
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; or
  • Colon Cancer - Adenocarcinoma; or
  • Esophageal and Esophagogastric Junction Cancers - Adenocarcinoma, Squamous cell carcinoma; or
  • Gastric Cancer - Adenocarcinoma; or
  • Hepatobiliary Cancers - Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, or Extrahepatic Cholangiocarcinoma – Adenocarcinoma; or
  • Neuroendocrine and Adrenal Tumors - Neuroendocrine Tumors of the Gastrointestinal Tract, Lung and Thymus (Carcinoid Tumors), Neuroendocrine Tumors of the Pancreas, or Poorly Differentiated (High Grade)/Large or Small Cell; or
  • Occult Primary - Squamous cell carcinoma, Adenocarcinoma or carcinoma not otherwise specified; or
  • Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer - Mucinous Carcinoma, Mucinous; or
  • Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer - Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer, Carcinosarcoma, Clear cell, Endometrioid, Mucinous, Serous; or
  • Pancreatic Adenocarcinoma; or
  • Primary Cutaneous Lymphomas - Mycosis Fungoides/Sezary Syndrome or Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders; or
  • Rectal Cancer Adenocarcinoma; or
  • Small Bowel Adenocarcinoma; or
  • T-Cell Lymphomas - Adult T-Cell Leukemia/Lymphoma, Extranodal NK/T-Cell Lymphoma (nasal type), Hepatosplenic Gamma-Delta T-Cell Lymphoma, or Peripheral T-Cell Lymphomas; or
  • Testicular Cancer - Testicular Cancer, Nonseminoma, Pure Seminoma.

 

The use of oxaliplatin (Eloxatin) for all other indications not listed in this policy is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of oxaliplatin (Eloxatin) for any indications other than those listed in this medical policy.

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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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Covered Diagnosis Code B20 covered when billed with ANY ONE of the following diagnosis codes

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Place of Service: Outpatient

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

The administration of oxaliplatin (Eloxatin) 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



Links





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.