HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-124-009
Topic:
Azacitidine (Vidaza)
Section:
Injections
Effective Date:
May 6, 2024
Issued Date:
May 6, 2024
Last Revision Date:
March 2024
Annual Review:
March 2024
 
 

Azacitidine (Vidaza®) is a pyrimidine nucleoside used as an antineoplastic agent. The drug disrupts the chemistry of DNA and causes cellular death in rapidly dividing cells, including cancer cells that no longer respond to normal growth control mechanism.

Policy Position

Azacitidine (Vidaza) may be considered medically necessary for ANY of the following:

Myelodysplastic Syndromes (MDS):

  • When used as treatment for ANY of the following French-American-British (FAB) myelodysplastic syndrome subtypes:
    • Refractory anemia (RA); or
    • RA with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions); and
      • Individual also meets ONE of the following:
        • Requires packed RBC transfusions; or
        • Platelet counts less than or equal to 50 x 109 /L; or
        • Requires platelet transfusions; or
        • Neutropenic (ANC less than 1 x 109/L) with infections requiring treatment with antibiotics; or
    • RA with excess blasts (RAEB);or
    • RA with excess blasts in transformation (RAEB-T); or
    • Chronic myelomonocytic leukemia (CMMoL); or

Juvenile Myelomonocytic Leukemia (JMML):

  • Individuals one (1) month to less than 18 years of age with newly diagnosed JMML; and
  • Confirmed diagnosis in peripheral blood and bone marrow with ONE of the following:
    • Somatic mutation in PTPN11; or
    • Somatic mutation in KRAS; or
    •  Somatic mutation in NRAS and HbF % greater than 5 times normal value for age; or
    • Clinical diagnosis of neurofibromatosis Type 1; and
    • No CNS involvement; or

Compendia Sources

  • Azacitidine (Vidaza) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations

The use of azacitidine (Vidaza) not meeting the criteria as indicated in this policy is considered not medically necessary.

J9025

 

 

 

 

 

 


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. 

Related Policies

Refer to Pharmacy Policy J-0771, Venclexta (venetoclax), for additional information.

Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.


Covered Diagnosis Codes for J9025

 

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C86.4

C86.5

C92.00

C92.01

C92.02

C92.20

C92.22

C92.50

C92.51

C92.52

C92.60

C92.61

C92.62

C92.A0

C92.A1

C92.A2

C93.00

C93.01

C93.02

C93.10

C93.11

C93.12

C93.30

C93.31

C93.32

C94.00

C94.01

C94.02

C94.20

C94.21

C94.22

C94.40

C94.41

C94.42

C94.6

D46.0

D46.1

D46.20

D46.21

D46.22

D46.4

D46.9

D46.A

D46.B

D46.C

D46.Z

D47.1

D47.3

D47.4

D75.81

 

 

 


Place of Service: Outpatient

The administration of azacitidine (Vidaza) 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.