Coverage Policy Manual
Policy #: 2000030
Category: Pharmacy
Initiated: July 1999
Last Review: June 2018
  Chemotherapy for Malignancy

Description: Chemotherapy is the treatment of a disease process with pharmaceutical drugs.  Malignancies may be treated with different classes of chemotherapeutic agents including antineoplastics, hormones, and immunomodulating agents.

Policy/
Coverage:
Effective 3/15/2011
 
Cancer chemotherapeutic agents meet primary coverage criteria for effectiveness and are covered for their FDA approved labeling.   
 
Coverage for the off-label use of cancer chemotherapeutic agents is allowed if:
    • The drug has been recognized as safe and effective for off-label use for a specific type of cancer recommended in The American Hospital Formulary Service Drug Information (AHFS), The National Comprehensive Cancer Network (NCCN) Drugs and Biologic Compendium (category 1, 2A or 2B) or The Elsevier Gold Standard’s Clinical Pharmacology unless one of the compendia recommends against the off-label coverage; OR
    • The drug has been recognized as safe and effective for the specific type of cancer as documented in two articles from journals listed below and that information is not contraindicated by clear and convincing evidence in a third article from medical literature.  Articles from supplements for these journals are not considered.  
 
Articles from the following journals are considered:
    • American Journal of Medicine
    • Annals of Internal Medicine;
    • The Journal of the American Medical Association;
    • Journal of Clinical Oncology;
    • Blood;
    • Journal of the National Cancer Institute;
    • The New England Journal of Medicine;
    • British Journal of Cancer;
    • British Journal of Hematology;
    • Drugs;
    • European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology);
    • Lancet; or
    • Leukemia.
  
Chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, does not meet Primary Coverage Criteria for effectiveness.
 
For contracts without Primary Coverage Criteria the use of chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
 
Effective prior to 3/15/2011
Cancer chemotherapeutic agents meet primary coverage criteria for effectiveness and are covered for their FDA approved labeling.   
 
Coverage for the off-label use of cancer chemotherapeutic agents is allowed if:
    • The drug has been recognized as safe and effective for off-label use for a specific type of cancer recommended in The American Hospital Formulary Service Drug Information (AHFS), The National Comprehensive Cancer Network (NCCN) Drugs and Biologic Compendium or The Elsevier Gold Standard’s Clinical Pharmacology unless one of the compendia recommends against the off-label coverage;
    • The drug has been recognized as safe and effective for the specific type of cancer as documented in two articles from journals listed below and that information is not contraindicated by clear and convincing evidence in a third article from medical literature.  Articles from supplements for these journals are not considered.  
 
An off-label use identified by a compendium as medically accepted if the indication is Category 1 or 2A in the NCCN compendium.  
 
Articles from the following journals are considered:
    • American Journal of Medicine
    • Annals of Internal Medicine;
    • The Journal of the American Medical Association;
    • Journal of Clinical Oncology;
    • Blood;
    • Journal of the National Cancer Institute;
    • The New England Journal of Medicine;
    • British Journal of Cancer;
    • British Journal of Hematology;
    • Drugs;
    • European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology);
    • Lancet; or
    • Leukemia.
  
Chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, does not meet Primary Coverage Criteria for effectiveness.
 
For contracts without Primary Coverage Criteria the use of chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Coverage statement effective Jul 20, 2010- March 14, 2011
 Cancer chemotherapeutic agents meet primary coverage criteria for effectiveness and are covered for their FDA approved labeling.   
 
Coverage for the off-label use of cancer chemotherapeutic agents is allowed if:
    • The drug has been recognized as safe and effective by the FDA, and has been recommended for a specific off-label use by the AHFS, Clinical Pharmacology Online, or NCCN drug compendia (unless one of the compendia recommends against the same use); Or  
    • If not reviewed by any of the 3 compendia, the drug has been recommended for a specific off-label use by two articles from journals listed below and that information is not contraindicated by clear and convincing evidence in a third article from medical literature.  Articles from supplements for these journals are not considered.   
 
Articles from the following journals are considered:
        • American Journal of Medicine
        • Annals of Internal Medicine;
        • The Journal of the American Medical Association;
        • Journal of Clinical Oncology;
        • Blood;
        • Journal of the National Cancer Institute;
        • The New England Journal of Medicine;
        • British Journal of Cancer;
        • British Journal of Hematology;
        • Drugs;
        • European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology);
        • Lancet; or
        • Leukemia.
  
Chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, does not meet Primary Coverage Criteria for effectiveness.
 
For contracts without Primary Coverage Criteria the use of chemotherapy for indications not listed as labeled, or is not consistent with off-label determinations as described above, is considered investigational.  Investigational services are  exclusions in the member certificate of coverage.
 

Rationale:
This policy is mandated by Act 270, originally passed in 1999 and revised by the Arkansas legislature in 2009.
  

References: Arkansas State Law; Act 466; 1999.

Clarification of Standards for Coverage of Cancer Medications. Act 270, Section 1, A.C.A. 23-79-147(b)(1).


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.