Medicaid Fee-for-Service

Medicaid Fee-for-Service

Medicaid Fee-for-Service is a state-specific program. Coverage for ZYTIGA® may depend on the indication as well as other factors. As this information varies by state, it is important to contact the state agency directly or consult its Web site to obtain product-specific coverage and other information.

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

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Blank Entry: Not found in the public domain
Brand: A patented drug listed in PDL or supporting documents
Covered: Drug is listed in PDL or supporting documents
Preferred: Refers to the coverage level of a drug

State Preferred Drug List (PDL)* Status Prior Authorization Required
Alabama Covered  
Alaska   Yes
Arizona Covered Yes
Arkansas   Yes
California Covered Yes
Colorado   Yes
Connecticut Preferred  
Delaware Covered Yes
District of Columbia   Yes
Florida   Yes
Georgia Preferred Yes
Hawaii Covered  
Idaho   Yes
Illinois Covered  
Indiana   Yes
Iowa Brand Yes
Kansas   Yes
Kentucky Preferred  
Louisiana   Yes
Maine See payer for details Yes
Maryland Covered  
Massachusetts Brand Yes
Michigan Covered  
Minnesota Covered Yes
Mississippi   Yes
Missouri Covered Yes
Montana   Yes
Nebraska See payer for details Yes
Nevada   Yes
New Hampshire Covered  
New Jersey Covered  
New Mexico    
New York    
North Carolina   Yes
North Dakota Covered  
Ohio Covered  
Oklahoma Covered Yes
Oregon See payer for details Yes
Pennsylvania Preferred Yes
Rhode Island   Yes
South Carolina Covered Yes
South Dakota   Yes
Tennessee Preferred  
Texas Covered  
Utah   Yes
Vermont Covered Yes
Virginia Covered Yes
Washington   Yes
West Virginia Covered Yes
Wisconsin Covered  
Wyoming   Yes

* The title for each state's Medicaid Fee-for-Service drug list may vary (eg, Prescription Drug List, Contract Drug List)

R9

Indication

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients

  • with metastatic castration-resistant prostate cancer (mCRPC)
  • with metastatic high-risk castration-sensitive prostate cancer (CSPC) 
Important Safety Information For ZYTIGA®

Contraindications - ZYTIGA® (abiraterone acetate) can cause fetal harm and potential loss of pregnancy.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess -  ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment.

Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. The safety of ZYTIGA® in patients with left ventricular ejection fraction <50% or New York Heart Association (NYHA) Class III or IV heart failure (in COU-AA-301) or NYHA Class II to IV heart failure (in COU-AA-302 and LATITUDE) has not been established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14)].

Adrenocortical Insufficiency (AI) - AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity - In postmarketing experience, there have been ZYTIGA®-associated severe hepatic toxicities, including fulminant hepatitis, acute liver failure and deaths. Measure serum transaminases alanine aminotransferase (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA® dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. 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, interrupt ZYTIGA® treatment and closely monitor liver function. Re-treatment with ZYTIGA® at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [See Dosage and Administration (2.4)].

Permanently discontinue ZYTIGA® for patients who develop a concurrent elevation of ALT greater than 3X ULN and total bilirubin greater than 2X ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

The safety of ZYTIGA® re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Adverse Reactions - The most common adverse reactions (≥10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory tract infection, cough, and headache.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia and hypokalemia.

Drug Interactions - Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA® treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA® dosing frequency only during the co-administration period [see Dosage and Administration (2.3)]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, consider a dose reduction of the CYP2D6 substrate drug. In a CYP2C8 drug interaction trial in healthy subjects, the AUC of pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a single dose of ZYTIGA®. Patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA®.

Use in Specific Populations

  • Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception.
  • Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please read the full Prescribing Information and Patient Information for ZYTIGA®.

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