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| Medical Policy: | I-124-003 |
| Topic: | Azacitidine (Vidaza®) |
| Section: | Injections |
| Effective Date: | July 30, 2018 |
| Issue Date: | July 30, 2018 |
| Last Reviewed: | April 2018 |
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. |
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 circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Intravenous or subcutaneous use of azacitidine (Vidaza) may be considered medically necessary for ANY ONE of the following indications:
Myelofibrosis
- When used as treatment for ANY ONE of the following indications:
- Myelofibrosis (MF)- accelerated phase; or
- MF-blast phase/acute myeloid leukemia; or
Acute Myeloid Leukemia (AML):
- When used as a single agent in individuals age 60 years and older for ANY ONE of the following indications:
- Lower-intensity induction therapy when not a candidate for intensive remission induction therapy or declines intensive therapy (preferred*); or
- Lower-intensity induction therapy for intensive remission induction therapy with unfavorable cytogenetic/molecular markers/antecedent hematologic disorder/therapy-related AML; or
- Post-remission maintenance therapy following complete response to previous intensive therapy; or
- Post-remission therapy following response to previous lower intensity therapy, or
- Therapy for relapsed or refractory disease in individuals for ANY ONE of the following indications:
- As a component of repeating the initial successful induction regimen if late relapse ≥12 months; or
- As a single agent in less aggressive therapy; or
- In combination with sorafenib (Nexavar) (FLT3-ITD mutation positive), or
Myelodysplastic Syndromes (MDS):
- When used for treatment of individuals for ANY ONE of the following French-American-British MDS subtypes:
- Refractory anemia; or
- Refractory anemia with ringed sideroblasts (if accompanied by neutropenia, thrombocytopenia, or requiring transfusions); or
- Refractory anemia with excess blasts; or
- Refractory anemia with excess blasts in transformation; or
- Chronic myelomonocytic leukemia, or
- When used for the treatment of lower risk disease associated with ANY ONE of the following indications:
- Symptomatic anemia without del(5q), with or without other cytogenetic abnormalities with serum erythropoietin levels greater than 500 mU/mL, and a low probability of response to immunosuppressive therapy; or
- Clinically relevant thrombocytopenia, neutropenia, or increased marrow blasts; or
- Clinically relevant thrombocytopenia, neutropenia, or increased marrow blasts, following disease progression or no response to immunosuppressive therapy or clinical trial, or
- When used for the treatment of lower risk disease associated with symptomatic anemia for ANY ONE of the following indications:
- With del(5q), with or without one (1) other cytogenetic abnormalities (except those involving chromosome seven (7)), and serum erythropoietin levels greater than 500 mU/mL with no response or intolerance to lenalidomide (Revlimid) and low probability of response to immunosuppressive therapy; or
- Without del(5q), with or without other cytogenetic abnormalities, and serum erythropoietin levels less than or equal to 500 mU/mL with no response to hematopoietic cytokines alone, followed by and no response to hematopoietic cytokines in combination with lenalidomide (Revlimid), followed by and no response or intolerance to immunosuppressive therapy; or
- Without del(5q), with or without other cytogenetic abnormalities, with serum erythropoietin less than or equal to 500 mU/mL, with no response to hematopoietic cytokines alone, followed by no response to hematopoietic cytokines in combination with lenalidomide (Revlimid), and poor probability of response to immunosuppressive therapy, or
- Treatment of higher risk disease in ANY ONE of the following indications:
- In non-transplant candidates (preferred*); or
- In transplant candidates with a donor stem cell source available, followed by hematopoietic stem cell transplant; or
- In transplant candidates without donor stem cell source available or as bridge to transplant while awaiting donor availability (preferred*); or
- Following no response or relapse after hematopoietic stem cell transplant.
Azacitidine (Vidaza) is considered experimental/investigational for all other indications. Peer reviewed literature does not support the use of azacitidine (Vidaza) for any indications other than those listed on this medical policy.
Dosage recommendations per the FDA label. *Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines Note: Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very Low, Low, Intermediate). Higher risk defined as IPSS-R (Intermediate, High, Very High), IPSS (Intermediate-2, High), WPSS (High, Very High). |
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
02/2016, Revised Policy Guidelines For Azacitidine (Vidaza)
05/2018, Coverage Guidelines Revised for Azacitidine (Vidaza)
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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.
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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
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- Qualified interpreters
- Information written in other languages
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.
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