Zytiga. Zytiga (abiraterone acetate) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Zytiga Page: 1of 5 Last Review Date: March 13, 2014 Zytiga Description Zytiga (abiraterone acetate) Background Zytiga is indicated in combination with prednisone to treat men with late-stage (metastatic) castration-resistant prostate cancer. In prostate cancer, testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone s effects. In castration-resistant prostate cancer, the prostate cancer cells continue to grow even with low levels of testosterone (1). Zytiga targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing (2). Regulatory Status FDA-approved indication: Zytiga is a CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (3). Zytiga may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Zytiga should be used with caution in patients with a history of cardiovascular disease. Before treatment is initiated, hypertension should be controlled and hypokalemia corrected. Blood pressure, serum

2 Subject: Zytiga Page: 2 of 5 potassium, and symptoms of fluid retention should be monitored at least monthly. Adrenal cortical insufficiency may occur with the use of Zytiga (3). Adrenal insufficiency has occurred during Zytiga treatment. Caution should be used and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress (3). Zytiga may cause hepatotoxicity. Increases in liver enzymes have led to drug interruption, dose modification and/or discontinuation. Serum transaminases (ALT and AST) and bilirubin levels should be measured prior to initiation of therapy, every two weeks for the first three months of treatment, and monthly thereafter. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring. If at any time, AST or ALT rise above five times the upper limit of normal (ULN), or the bilirubin rises above three times the ULN, Zytiga treatment should be interrupted and liver function closely monitored (3). Zytiga carries a pregnancy category X warning and is not indicated for use in women. Maternal use of an androgen receptor inhibitor could affect development of the fetus. If the patient has a partner who is pregnant or plans to become pregnant, a condom and another form of birth control must be used during and for 3 months after treatment (3). The safety and effectiveness of Zytiga have not been established in pediatric patients (3). Related policies Jevtana, Provenge, Xtandi Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Zytiga may be considered medically necessary in male patients 18 years of age or older with a confirmed diagnosis of metastatic castration-resistant prostate cancer when used in combination with prednisone. Zytiga is considered investigational in patients that are less than 18 years of age or without confirm diagnosis of metastatic castration-resistant prostate cancer.

3 Subject: Zytiga Page: 3 of 5 Prior-Approval Requirements Age Gender 18 years of age and older Male Diagnosis Patients must have of the following: Metastatic castration-resistant prostate cancer AND 1. Using in combination with prednisone Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 12 months Prior Approval Renewal Limits Duration 12 months Rationale Summary

4 Subject: Zytiga Page: 4 of 5 Zytiga is a CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Zytiga may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Zytiga may cause adrenal insufficiency and hepatotoxicity. Zytiga carries a pregnancy category X warning and is not indicated for use in women. The safety and effectiveness of Zytiga have not been established in pediatric patients (3). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Zytiga while maintaining optimal therapeutic outcomes. References 1. FDA Website. Food and Drug Administration News Release. FDA expands Zytiga s use for late-stage prostate cancer. December 10, FDA Website. Food and Drug Administration News Release. FDA approves Zytiga for latestage prostate cancer. April 28, Zytiga [package insert]. Horsham, Pa: Janssen Biotech, Inc; September Policy History Date October 2012 December 2012 March 2014 Action/Reason New addition to PA New FDA indication to be used before treatment with chemotherapy. Deleted requirement for prior treatment with docetaxel. Annual editorial review and update Annual editorial review and reference update Keywords This policy was approved by the FEP Pharmacy Medical Policy Committee on March 13, 2014 and is effective April 1, Signature on File

5 Subject: Zytiga Page: 5 of 5 Deborah M. Smith, MD, MPH

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