Clinical UM Guideline

 

Subject: Azacitidine (Vidaza®)
Guideline #:  CG-DRUG-48 Publish Date:    06/06/2018
Status: Reviewed Last Review Date:    05/03/2018

Description

This document addresses azacitidine (Vidaza, Celgene Corporation, Summit, NJ), a nucleoside metabolic inhibitor used for the treatment of myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) under specific conditions.

Clinical Indications

Medically Necessary:

Azacitidine is considered medically necessary for the following conditions:

  1. Myelodysplastic syndrome (MDS); or
  2. Acute myelogenous leukemia (AML) if the following criteria are met:
    1. Used as a single agent for individuals 60 years of age and older or individuals who cannot tolerate more aggressive regimens; or
    2. Used in combination with sorafenib for relapsed or refractory AML with FLT3-ITD mutations; or
    3. AML arising from MDS.

Not Medically Necessary:

Azacitidine (Vidaza) is considered not medically necessary if the above criteria are not met.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

 

J9025

Injection, azacitidine, 1 mg [Vidaza]

 

 

ICD-10 Diagnosis

 

C92.00-C92.02

Acute myeloblastic leukemia

C92.40-C92.42

Acute promyelocytic leukemia

C92.50-C92.52

Acute myelomonocytic leukemia

C92.60-C92.62

Acute myeloid leukemia with 11q23-abnormality

C92.A0-C92.A2

Acute myeloid leukemia with multilineage dysplasia

C93.10-C93.12

Chronic myelomonocytic leukemia

D46.0

Refractory anemia without ring sideroblasts, so stated

D46.1

Refractory anemia with ring sideroblasts (RARS)

D46.20-D46.22

Refractory anemia with excess of blasts (RAEB)

D46.A

Refractory cytopenia with multilineage dysplasia

D46.B

Refractory cytopenia with multilineage dysplasia and ring sideroblasts (RCMD RS)

D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

D46.4

Refractory anemia, unspecified

D46.Z

Other myelodysplastic syndromes

D46.9

Myelodysplastic syndrome, unspecified

Discussion/General Information

On May 19, 2004, Azacitidine (Vidaza) received FDA approval for the treatment of the following French American British (FAB) myelodysplastic syndrome (MDS) subtypes:

The safety and efficacy of azacitidine were demonstrated in one multi-center, randomized trial consisting of 191 subjects with all five FAB subtypes of MDS, and in two multi-center single-arm azacitidine trials consisting of 120 subjects. Silverman and colleagues (2002) reported on the randomized trial in which treatment consisted of either subcutaneous azacitidine plus supportive care (n=99) or supportive care alone (n=92). Subjects in the supportive care arm were free to cross over to the azacitidine arm if their symptoms worsened during the trial. Azacitidine was administered by subcutaneous injection at 75 mg/m2 daily for 7 days every 4 weeks. The dose was increased to 100 mg/m2 if there were no beneficial effects after two treatment cycles. Responses occurred in 60% of subjects on the azacitidine arm (7% complete response, 16% partial response, 37% improved) compared with 5% on the supportive care arm (P<0.001). Median time to leukemic transformation or death was 21 months for azacitidine versus 13 months for supportive care (P=0.007). Transformation to AML occurred as the first event in 15% of those in the azacitidine arm and in 38% receiving supportive care (P=0.001). Eliminating the confounding effect of early cross-over to azacitidine, a 6-month analysis showed median survival of an additional 18 months for azacitidine and 11 months for supportive care (P=0.03). Similar response rates were observed in the two single arm studies (as reported by the FDA approval summary). During response, subjects became independent of red cell or platelet transfusions. Median duration of response was at least 9 months. An additional 19% of those treated with azacitidine had less than partial responses with most becoming transfusion independent. Common adverse events attributed to azacitidine were hematologic, gastrointestinal, local injection site, and constitutional. No deaths were attributed to azacitidine in these studies.

A quality-of-life assessment was performed by Kornblith and colleagues (2002) on the 191 subjects from the Silverman trial. Quality of life measures were assessed by telephone interviews at baseline and days 50, 106, and 182.The authors found significant advantages in physical function, symptoms, and psychological state for those in the azacitidine treatment group. Significant differences between the two groups in quality of life were maintained even after controlling for the number of red blood cell (RBC) transfusions. The authors concluded that improved quality of life for subjects treated with azacitidine along with significantly greater treatment response and delayed time to transformation to AML or death compared with those on supportive care (P < 0.001) establishes azacitidine as an important treatment option for MDS.

Since the initial clinical trials of azacitidine for MDS, new classification systems, such as World Health Organization (WHO) diagnostic criteria and the International Prognostic Scoring System and response criteria guidelines have been developed and revised. In 2006, Silverman and colleagues analyzed previous trials of azacitidine treatment for MDS and reported results using newer classification systems. The authors noted that overall, complete remissions occurred in 10-17% of subjects treated with azacitidine, partial remissions were rare, and 23%-36% of subjects demonstrated hematologic improvement (HI). Using WHO criteria, 103 subjects had AML at baseline and 35%-48% had responses of HI or better. Of the 27 subjects with AML randomly assigned to azacitidine, the median survival time was 19.3 months as compared to the 25 subjects assigned to the observation groups who had a median survival time of 12.9 months.

Azacitidine has been used in the treatment of previously untreated AML in elderly individuals not eligible to receive standard induction therapy with an anthracycline-cytarabine regimen, and also in the treatment of elderly with relapsed or refractory AML (AHFS, 2011). A retrospective review by Sudan and colleagues (2006) included 12 subjects with bone marrow blast counts up to 29% (mean age of 66 years [range, 44–80]), that had been previously assigned by the FAB classification as having refractory anemia with excess blasts in transformation (RAEB-t). Under the newer WHO classification, these individuals met criteria for AML. An additional 8 subjects (mean age of 71 years [range, 58–79]) with more than 29% blasts in the marrow were deemed to be poor candidates for standard induction therapy. All individuals were treated with azacitidine for 7 consecutive days via subcutaneous injection. This cycle was repeated every 28 days for as long as therapy was tolerated and a response was maintained. The overall response rate was 60% (12/20): complete response (CR; n= 4; 20%); partial response (PR; n=5; 25%); hematologic improvement (HI; n=3; 15%). The median survival of responders was 15+ months compared with 2.5 months for non-responders. During treatment, responders had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The most common adverse event was infection.

A phase III randomized controlled trial (Fenaux, 2009) demonstrated prolonged overall survival (OS) of subjects with higher-risk MDS syndromes treated with azacitidine compared with conventional care regimens (CCR). A total of 358 persons were randomized to receive azacitidine (n=179) or CCR (n=179). Approximately one-third of these individuals could be classified as having AML under WHO criteria. After a median follow-up of 20.1 months, median OS was 24.5 months for the azacitidine group versus 15 months for the CCR group. The 2 year overall survival rates were 50.8% and 26.2%, respectively. The most common grade 3-4 adverse events were peripheral cytopenias.

In 2010, Fenaux and colleagues performed further analysis of 113 elderly subjects (median age of 70 years) from their primary study who met WHO criteria for AML. These individuals had been randomized to azacitidine (n=55) or CCR (n=58). A total of 86% were deemed “unfit” to receive intensive chemotherapy. After a median follow-up period of 20.1 months, median OS for those treated with azacitidine was 24.5 months as compared to 16 months for those treated with CCR considered unfit for intensive chemotherapy. The 2 year OS rates were 50% and 16%, respectively. The most common grade 3 or 4 hematologic adverse events were thrombocytopenia, neutropenia and anemia.

Dombret and colleagues (2015) performed a multi-center, randomized, open-label, phase III trial that evaluated azacitidine safety and efficacy versus CCR in 488 individuals 65 years or older with newly diagnosed AML with greater than 30% bone marrow blasts. Prior to randomization, a CCR consisting of standard induction chemotherapy, low-dose ara-c, or supportive care only was preselected for each person. Participants were then assigned 1:1 to azacitidine (n=241) or CCR (n=247). Median OS was increased with azacitidine versus CCR: 10.4 months (95% confidence interval [CI], 8.0-12.7 months) vs 6.5 months (95% CI, 5.0-8.6months), respectively. Survival rates at 1 year with azacitidine and CCR were 46.5% and 34.2%, respectively. A prespecified analysis of subjects who received AML treatment after discontinuing study drug showed median OS with azacitidine versus CCR was 12.1 months (95% CI, 9.2-14.2 months) versus 6.9 months (95% CI, 5.1-9.6 months). Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features. Adverse events were consistent with the established safety profile of azacitidine. The authors concluded that study results were encouraging and suggested that azacitidine may provide an additional treatment option for elderly individuals with newly diagnosed AML.

In 2017, Chou and colleagues studied the safety and efficacy of azacitidine in Taiwanese subjects with high risk MDS in a multicenter, open-label, single arm, phase IV study. The primary endpoint was hematologic response and hematologic improvement (HI). Subjects received azacitidine 75 mg/m2/day for 7 days/28-day cycle for up to 6 cycles, and had baseline and cycle 6 marrow assessments. Out of 44 initially enrolled, 25 subjects (57%) completed the study. The authors found that 22 subjects (50%) achieved HI. Some limitations to this study include small sample size and 25% of subjects not evaluated for hematologic response (primary endpoint) due to no post-baseline bone marrow assessment.

Du and colleagues (2017) evaluated the safety, efficacy, and pharmacokinetics of azacitidine in Chinese subjects with high risk MDS in a multicenter, single-arm, open-label phase II study. The authors’ primary outcome was response rate, which included complete remission, partial remission, and stable disease. A total of 72 subjects enrolled in the study and 39 subjects (54%) completed more than 6 treatment cycles. Results showed an overall response rate of 96% with complete remission being 1%, partial remission being 0%, and stable disease being 94%. The authors conclude that azacitidine provides clinical benefit to Chinese subjects with high risk MDS.

A meta-analysis was performed by Komrokji and colleagues (2017) to evaluate azacitidine in subjects with RBC transfusion-dependent low risk MDS. The endpoints for the meta-analysis were RBC transfusion independence (TI) and Clinical Benefit (RBC-TI, erythroid response, and complete or partial remission). The search for publications between 2000 and 2015 yielded data for 233 subjects from 6 clinical studies and 1 registry study. The authors found that 90.3% of subjects had non-deletion (5q) low risk MDS. In addition, “pooled estimates from random-effects models of RBC-TI and Clinical Benefit were 38.9% and 81.1%, respectively; for the ESA-refractory subgroup, they were 40.5% and 77.3%; and for patients with isolated anemia, they were 41.9% and 82.5%” (Komrokji, 2017). Study limitations noted by the authors include an imbalance in subject numbers due to the majority of subject data coming from the registry study and some subject demographic characteristics and pretreatment data were not available.

Ram and colleagues (2017) studied treatment with azacitidine in elderly and infirm subjects with AML with either induction refractory or relapse disease. This retrospective study aimed to assess progression-free and overall survival in 34 subjects. The assessment showed “at 12 and 18 months after the first course of azacitidine, 33 and 10% of the patients were progression-free, respectively. Incidences of overall survival at 12 and 24 months were 54.5 and 16%, respectively” (Ram, 2017). Retrospective design and small sample size are noted as study limitations. The authors conclude that prospective studies are needed to validate the results.

The NCCN Drugs and Biologics compendium (2018) addresses the use of azacitidine (2A recommendations) for AML, including single agent use for low intensity therapy in individuals 60 years of age and older as induction therapy or post remission therapy, and for use as therapy for relapsed or refractory disease in individuals who cannot tolerate more aggressive regimens as a single agent; or in combination with sorafenib (FLT3-ITD mutation positive). Additionally, the NCCN Drugs and Biologics compendium (2018) addresses using azacitidine for treatment of lower and higher risk MDS under specific circumstances.

Contraindications, Warnings, Precautions and Adverse Events (Vidaza Prescribing Information, 2016)

Contraindications:

Warnings and Precautions:

Adverse Reactions:
Most common adverse reactions (>30%) by SC route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia.

Definitions

French American British (FAB) myelodysplastic syndrome subtypes: A classification of myelodysplastic syndrome subtypes based on bone marrow appearance and blood cell counts. The FAB system consists of 5 subtypes of MDS:

International Prognostic Scoring System (IPSS)a,b:

Survival and AML evolution

 

Score value

Prognostic variable

0

0.5

1.0

1.5

2.0

Marrow blasts (%)c

< 5

5-10

---

11-20

21-30

Karyotyped

Good

Intermediate

Poor

 

 

Cytopeniae

0/1

2/3

 

 

 

 

IPSS Risk category

Overall Risk Score

Low

0

INT-1

0.5-1.0

INT-2

1.5-2.0

High

≥2.5

a Greenberg P, Cox C, LeBeau M, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997; 89:2079-2088.
b Greenberg P, Cox C, LeBeau M, et al. Erratum. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1998; 91:1100.
c Patients with 20-30 % blasts may be considered as MDS or AML.
d Cytogenetics: Good = normal, -Y alone, del(5q) alone, del(20q) alone; Poor = complex (³ 3 abnormalities) or chromosome 7 anomalies; Intermediate = other abnormalities. [This excludes karyotypes t(8;21), inv16, and t(15;17), which are considered to be AML not MDS.]
e Cytopenias: neutrophil count <1,800/mcL, platelets < 100,000/mcL, Hb < 10g/dL

 

International Prognostic Scoring System-Revised (IPSS-R) F

 

Score value

Prognostic variable

0

0.5

1.0

1.5

2

3

4

Cytogenetics

Very good

n/a

Good

n/a

Intermediate

Poor

Very poor

Bone marrow blasts %

≤ 2

n/a

> 2% to < 5%

n/a

5-10

>10

n/a

Hemoglobin

≥ 10

n/a

8 to < 10

< 8

n/a

n/a

n/a

Platelets

≥ 100

50 to < 100

< 50

n/a

n/a

n/a

n/a

ANC

≥ 0.8

< 0.8

n/a

n/a

n/a

n/a

n/a

ANC – Absolute neutrophil count
n/a – not applicable

IPSS-R Risk category

Overall Risk
Score

Very low

≤ 1.5

Low

> 1.5 to 3

Intermediate

> 3.0 to 4.5

High

> 4.5 to 6

Very high

> 6

f Greenberg P, Heinz T, Schanz J, et al. Revised International Prognostic Scoring System for Myelodysplastic Syndromes. Blood. 2012;120: 2454-2465.
Myelodysplastic syndrome (MDS): A condition that occurs when the blood-forming cells in the bone marrow are damaged.

World Health Organization (WHO) Classification Systems:

WHO 2016 Classification for MDS (NCCN, 2018)

Subtype

Blood

Bone marrow

MDS with single lineage dysplasia (MDS-SLD)

Single or bicytopenia

Dysplasia in greater than or equal to 10% of one cell line, less than 5% blasts

MDS with ring sideroblasts (MDS-RS)

Anemia, no blasts

Greater than or equal to 15% of erythroid precursors with ring sideroblasts, or greater than or equal to 5% ring sideroblasts if SF3B1 mutation present.

MDS with multilineage dysplasia (MDS-MLD)

Cytopenia(s), less than 1 x 109 /L monocytes

Dysplasia in greater than or equal to 10% of cells in greater than or equal to 2 hematopoietic lineages, ± 15% ring sideroblasts, less than 5% blasts

MDS with excess blasts–1 (MDS-EB-1)

Cytopenia(s), less than or equal to 2-4% blasts, less than 1 x 109 /L monocytes

Unilineage or multilineage dysplasia, 5% to 9% blasts, no Auer rods

MDS with excess blasts–2 (MDS-EB-2)

Cytopenia(s) 5-19% blasts, less than 1 x 109 /L monocytes

Unilineage or multilineage dysplasia, 10% to 19% blasts, ± Auer rods

MDS, unclassifiable (MDS-U)

Cytopenias, ±1% blasts on at least 2 occasions

Unilineage dysplasia or no dysplasia but characteristic MDS cytogenetics, less than 5% blasts

MDS associated with isolated del(5q)

Anemia, platelets normal or increased

Unilineage erythroid dysplasia, isolated del 5(q), less than 5% blasts

Refractory cytopenia of childhood

Cytopenias, less than 2% blasts

Dysplasia in 1-3 lineages, less than 5% blasts

MDS with excess blasts in transformation (MDS-EB-T)

Cytopenias, 5%-19% blasts

Multilineage dysplasia, 20%-29% blasts, ± Auer rods

WHO Classification Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) (NCCN, 2018)

Subtype

Blood

Bone Marrow

Chronic myelomonocytic leukemia (CMML)-0

Greater than 1 x 109 /L monocytes, less than 2% blasts

Dysplasia in greater than or equal to 1 hematopoietic line, less than 5% blasts

Chronic myelomonocytic leukemia (CMML)-1

Greater than 1 x 109 /L monocytes, 2-4% blasts

Dysplasia in greater than or equal to 1 hematopoietic line, 5-9% blasts

CMML-2

Greater than 1 x 109 /L monocytes, 5-19% blasts or Auer rods

Dysplasia in greater than or equal to 1 hematopoietic line, 10-19% blasts or Auer rods

Atypical chronic myeloid leukemia (CML), BCR-ABL 1 negative

WBC greater than 13 x 109 /L, neutrophil precursors greater than 10%, less than 20% blasts, dysgranulopoiesis

Hypercellular, less than 20% blasts

Chronic neutrophilic leukemia (CNL)

 

WBC greater than or equal to 25,000 with PMN/bands greater than or equal to 80%, no dysplasia

Mature myeloid hyperplasia, less than 5% blasts, no dysplasia

Juvenile myelomonocytic leukemia (JMML)

Greater than 1 x 109 /L monocytes, less than 20% blasts

Greater than 1 x 109 /L monocytes, less than 20% blasts

MDS/MPN, unclassifiable (overlap syndrome)

Dysplasia + myeloproliferative features, no prior MDS or MPN

Dysplasia + myeloproliferative features

MDS/MPN with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)

Dysplasia + myeloproliferative features, platelets greater than or equal to 450 x 109/L, greater than or equal to 15% ring sideroblasts

Dysplasia + myeloproliferative features

WHO-Based Prognostic Scoring System (WPSS) (NCCN, 2018)g:

Variable

Variable scores

0

1

2

3

WHO category

RCUD, RARS, MDS with isolated deletion (5q)

RCMD

RAEB-1

RAEB-2

Karyotype

Good

Intermediate

Poor

n/a

Severe anemia (hemoglobin < 9 g/dl in males or < 8g/dl in females)

Absent

Present

n/a

n/a

 

WPSS Risk

Sum of individual variable scores

Median survival (y) from diagnosis

Median time (y) to AML progression from diagnosis

Very low

0

11.6

Not recorded

Low

1

9.3

14.7

Intermediate

2

5.7

7.8

High

3-4

1.8

1.8

Very high

5-6

1.1

1.0

g Malcovati L, Della Porta MG, Strupp C, et al. Impact of the degree of anemia on the outcome of patients with myelodysplastic syndrome and its integration into the WHO classification-based Prognostic Scoring System (WPSS). Haematologica. 2011; 96(10):1433-1440.

References

Peer Reviewed Publications:

  1. Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016; 127(20):2391-2405.
  2. Chou WC, Yeh SP, Hsiao LT, et al. Efficacy, safety, and pharmacokinetics of subcutaneous azacitidine in Taiwanese patients with higher-risk myelodysplastic syndromes. Asia Pac J Clin Oncol. 2017; 13(5): [Epub]. Available at: https://onlinelibrary.wiley.com/doi/abs/10.1111/ajco.12659. Accessed on April 9, 2018.
  3. Dombret H, Seymour JF, Butrym A, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015; 126(3):291-299.
  4. Du X, Lai YY, Xiao Z, et al. Efficacy, safety and pharmacokinetics of subcutaneous azacitidine in Chinese patients with higher risk myelodysplastic syndromes: Results from a multicenter, single-arm, open-label phase 2 study. Asia Pac J Clin Oncol. 2017 Dec 28; [Epub ahead of print] Available at: https://onlinelibrary.wiley.com/doi/abs/10.1111/ajco.12835. Accessed on April 9, 2018.
  5. Fenaux P, Mufti GJ, Hellström-Lindberg E, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010; 28(4):562-569.
  6. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009; 10(3):223-232.
  7. Greenberg P, Cox C, LeBeau M, et al. Erratum. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1998; 91:1100.
  8. Greenberg P, Cox C, LeBeau M, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997; 89:2079-2088.
  9. Greenberg P, Heinz T, Schanz J, et al. Revised International Prognostic Scoring System for Myelodysplastic Syndromes. Blood. 2012; 20: 2454-2465.
  10. Komrokji R, Swern AS, Grinblatt D, et al. Azacitidine in lower-risk myelodysplastic syndromes: a meta-analysis of data from prospective studies. Oncologist. 2018; 23(2):159-170.
  11. Kornblith AB, Herndon JE 2nd, Silverman LR, et al. Impact of azacytidine on the quality of life of patients with myelodysplastic syndrome treated in a randomized phase III trial: a Cancer and Leukemia Group B study. J Clin Oncol. 2002; 20(10):2441-2452.
  12. Malcovati L, Della Porta MG, Strupp C, et al. Impact of the degree of anemia on the outcome of patients with myelodysplastic syndrome and its integration into the WHO classification-based Prognostic Scoring System (WPSS). Haematologica. 2011; 96(10):1433-1440.
  13. Ram R, Gatt M, Merkel D, et al. Second line azacitidine for elderly or infirmed patients with acute myeloid leukemia (AML) not eligible for allogeneic hematopoietic cell transplantation-a retrospective national multicenter study. Ann Hematol. 2017; 96(4):575-579.
  14. Silverman LR, Demakos EP, Peterson BL, et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002; 20(10):2429-2440.
  15. Silverman LR, McKenzie DR, Peterson BL, et al; Cancer and Leukemia Group B. Further analysis of trials with azacitidine in patients with myelodysplastic syndrome: studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol. 2006; 24(24):3895-3903.
  16. Sudan N, Rossetti JM, Shadduck RK, et al. Treatment of acute myelogenous leukemia with outpatient azacitidine. Cancer. 2006; 107(8):1839-1843.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Azacitidine Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised May 11, 2011. Accessed on April 3, 2018.
  2. Azacitidine (systemic). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated August 10, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 7, 2018.
  3. Kaminskas E, Farrell A, Abraham S, et al; FDA. Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes. Clin Cancer Res. 2005; 11(10):3604-3608.
  4. National Comprehensive Cancer Network®. NCCN Drugs & Biologic Compendium™ (electronic version). For additional information visit the NCCN website: http://www.nccn.org. Accessed on April 3, 2018.
  5. NCCN Clinical Practice Guidelines in Oncology™. © 2018 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on April 7, 2018.
    • Acute Myeloid Leukemia (V1.2018). Revised February 7, 2018.
    • Myelodysplastic Syndromes (V2.2018). Revised February 15, 2018.
  6. Vidaza® [Product Information]. Summit, NJ. Celgene Corporation. August 2016. Available at: http://www.vidaza.com/pi.pdf. Accessed on April 7, 2018.
Websites for Additional Information
  1. National Cancer Institute. Available at: http://www.cancer.gov/. Accessed on April 7, 2018.
    • Acute Myeloid Leukemia Treatment (PDQ). Updated February 7, 2018.
    • Myelodysplastic Syndromes Treatment (PDQ). Updated April 2, 2015.
Index

Aza C

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Reviewed

05/03/2018

Medical Policy & Technology Assessment Committee (MPTAC) review.

Reviewed

05/02/2018

Hematology/Oncology Subcommittee review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated formatting in the Clinical Indications section. Description, Discussion, References, and Websites sections updated.

Reviewed

05/04/2017

MPTAC review.

Reviewed

05/03/2017

Hematology/Oncology Subcommittee review. Description, Discussion, Definitions and References sections updated.

New

05/05/2016

MPTAC review.

New

05/04/2016

Hematology/Oncology Subcommittee review. Initial document development.