Prior Auth Protocol

FDA Approved Indications:

For treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

Health Net Approved Indications and Usage Guidelines:

Myelodysplastic syndromes

Diagnosis of MDS

AND

For patients with 5q cytogenetic abnormality, failure or clinically significant adverse effects to Revlimid^R

AND

Failure or clinically significant adverse effects to Procrit^R, Epogen^R or Aranesp^Rin patients with symptomatic anemia whose serum erythropoietin is not more than 500 mU/mL

Acute myelogenous leukemia

Diagnosis of untreated acute myelogenous leukemia (AML) in elderly patients (greater than 60 years old) who are not considered eligible to receive conventional induction therapy, as defined by a poor performance status or evidence of a clinically important comorbidity.

OR

Relapse of refractory disease in patients who cannot tolerate more aggressive regimens

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Chronic myelogenous leukemia is listed as an off-label indication in Clinical Pharmacology for Vidaza.
The NCCN guideline for MDS recommends the use of Vidaza or Dacogen for initial active therapy for all subtypes of MDS with the exception of patients with 5q cytogenic abnormality or patients with serum erythropoetin levels not more than 500 mU/mL; these patients should be treated with Revlimid or an erythropoietic agent such as Procrit, respectively.
International Prognostic Scoring System (IPSS) has been developed to predict the prognosis with more accuracy. Intermediate-risk patients have scores 1.5-2.0 (intermediate-2), and High-risk patients have an IPSS score of greater than 2.5.
Vidaza use for untreated acute myelogenous leukemia (AML) in elderly patients (>60 years old) who are not considered eligible to receive conventional induction therapy has an AHFS Grade of Recommendation of reasonable (accepted), an NCCN Category rating of 2A for induction therapy, and is listed as an off-label indication in Clinical Pharmacology.
Vidaza use for relapse or refractory acute myelogenous leukemia (AML) in patients who cannot tolerate more aggressive regimens has an NCCN Category rating of 2A and is listed as an off-label indication in Clinical Pharmacology.
RAEB-T now reclassified as Acute Myelogenous Leukemia (AML) with multilineage dysplasia in World Health Organization (WHO) system.
Contraindicated in patients with advanced malignant hepatic tumors.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Procrit^R/ Epogen^R (epoetin alfa)*	40,000 - 60,000 Units SC 1-3 times weekly based on laboratory results	Target hemoglobin up to 12 g/dL
Aranesp^R (darbepoetin alfa)*	150-300 mcg SC weekly	Target hemoglobin up to 12 g/dL
decitabine (Dacogen^TM)*	Option 1: 15 mg/m² IV infusion over 3 hrs repeated Q 8hrs for 3 days. Repeat cycle every 6 weeks. May require premedication with standard anti-emetic therapy. Option 2: 20 mg/m² IV infusion over 1 hr repeated QD for 5 days. Repeat cycle every 4 weeks. May require premedication with standard anti-emetic therapy. Doses may be adjusted or delayed based on hematology lab values Untreated AML in elderly patients: 20 mg/m² IV infused over 1 hour QD for 5 days. Repeat cycle every 4 weeks.	135 mg/m²/cycle IV
Revlimid^R(lenalidomide)*	10 mg PO QD; dosing is modified based upon clinical and laboratory findings	10 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Vidaza^TM	MDS 75 mg/m² SC or IV infusion QD for 7 days. Repeat cycle every 4 weeks. May be increased to 100 mg/m²(after 2 treatment cycles). May require premedication for nausea and vomiting. Doses may be adjusted or delayed based on hematology lab values, renal function, or serum electrolytes. Untreated AML in elderly patients 75 mg/m² SC QD for 7 days. Repeat cycle every 4 weeks.	4 cycles initially Treatment may be continued as long as patient continues to benefit

Product Availability:

Vidaza: 100 mg single dose vial

References:

1. Vidaza [Prescribing Information] Summit, NJ: Celgene Corporation; January 2014.

2. Azacitidine. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 25, 2015.

3. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. June 25, 2015.

4. Clinical Pharmacology Website. Available at http://www.clinicalpharmacology-ip.com. Accessed June 25, 2015.

5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 25, 2015.

6. National Comprehensive Cancer Network. Myelodysplastic Syndromes Version 1.2016. Available at http://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed June 25, 2015.

7. National Comprehensive Cancer Network. Acute Myeloid Leukemia Version 1.2015. Available at http://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed June 25, 2015.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending