Benefit Investigation Support

Benefit Investigation Support

Access to the Information You May Need

Janssen CarePath provides benefits information that may help your patients get the Janssen treatment you may be considering for them. Contact us directly and get started today.

  • Information on payer policies and coverage for Janssen products
  • Investigation of patient eligibility and coverage:
    • Patient-specific benefits
    • Requirements for prior authorization process
  • Benefits summary for physicians, staff, and patients
  • Prior authorization support and status monitoring
  • Information on the appeals process for administrative denials

Janssen CarePath Provider Portal

Verifying your patients' benefits is easy with the Provider Portal. The new Janssen CarePath Provider Portal gives you 24-hour online access to request and review benefits investigations, provide prior authorization support and status monitoring, request exceptions and appeals research, and enroll patients in the Janssen CarePath Savings Program.

To get started

  1. Complete a Business Associate Agreement (BAA) for your practice one time only. The completed BAA allows you to request verification of patient benefits without requiring individual patient authorization.
    OR
  2. Complete an individual Patient Authorization for each patient including the patient signature. Individual patient authorization is not required if BAA is on file.

We cannot accept any information without an executed BAA or Patient Authorization on file.

If you have a BAA or Patient Authorization on file with us, please Sign Up for the Provider Portal at JanssenCarePathPortal.com.

Registered or returning Provider Portal users, Log In here.

Benefits Investigation Form

If you prefer, you can complete the benefit investigation form and submit it to us via fax. Download the benefit investigation form (BIF) here.

Patients can also create their own Janssen CarePath Account where they can learn about their insurance coverage for ZYTIGA®, enroll in the Janssen CarePath Savings Program, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.

Letter of Medical Necessity

Submit a letter of medical necessity with either the initial claim to support the medical necessity of treatment with ZYTIGA® for your patient or submit it to support the medical necessity of treatment with ZYTIGA® when requesting reconsideration of a denied claim.

Access the Provider Portal to customize a Letter of Medical Necessity for your patient. Log In or Sign Up here.

Or click here for a sample format letter for ZYTIGA®.

Exceptions & Appeals Process

Each payer follows a different process for filing exceptions and appeals. If you are looking for general information to start the process, Janssen CarePath can help. Please call a Care Coordinator at 877-CarePath (877-227-3728). It is important to contact the payer directly or consult its Web site to obtain product-specific information.

Here's a helpful guide to share with your patients:

How to Request an Exception or Appeal a Decision From Your Prescription Drug Plan

Prior Authorization Information

Some health plans in select states must use their state's Uniform Prior Authorization Request Form.

Click here to see if your state is included:

Uniform Prior Authorization Information for Select States

Indication

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Important Safety Information For ZYTIGA®

Contraindications - ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

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. Use caution and monitor 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. Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three 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.

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.

Adverse Reactions - The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT 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, exercise caution and 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 - Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

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