INTELENCE® Patient Insurance Coverage

Verifying Patient Insurance Coverage

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 INTELENCE®, 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 INTELENCE® for your patient or submit it to support the medical necessity of treatment with INTELENCE® 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 INTELENCE®.

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 Statement

INTELENCE® (etravirine), in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced adults and pediatric patients ages 2 years and older.

Important Safety Information For INTELENCE®

WARNINGS & PRECAUTIONS

  • Severe Skin and Hypersensitivity Reactions:
    • Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. In clinical trials, these include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.
    • Stevens-Johnson syndrome was reported in 1.1% (2/177) of pediatric patients less than 18 years of age receiving INTELENCE® in combination with other HIV-1 ARV agents in an observational study.
    • Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

    Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema).

    • Monitor clinical status including liver transaminases, and initiate appropriate therapy.
    • Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction.
  • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
    • The concomitant use of INTELENCE® and other drugs may result in potentially significant drug interactions, some of which may lead to the loss of therapeutic effect of INTELENCE® and possible development of resistance or possible clinically significant adverse reactions from greater exposures of INTELENCE® or concomitant drugs.
    • Consult the full Prescribing Information for potential drug interactions prior to and during INTELENCE® therapy; review concomitant medications during INTELENCE® therapy.
  • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. Autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.

ADVERSE REACTIONS

  • The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in adult patients taking INTELENCE® and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%). The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea.

DRUG INTERACTIONS

  • Consult the full Prescribing Information for INTELENCE® for more information on significant drug interactions, including clinical comments.
  • Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P‑glycoprotein (P-gp). Therefore, co‑administration of INTELENCE® and drugs that are substrates of CYP3A, CYP2C9 and CYP2C19 or are transported by P-gp may alter the therapeutic effect or adverse reaction profile of the co‑administered drug(s).

USE IN SPECIFIC POPULATIONS

  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. Patients should not breastfeed if they are receiving INTELENCE®.
  • Hepatic Impairment: INTELENCE® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE® have not been evaluated in these patients.
  • Pediatric Use: In clinical trials, the safety, pharmacokinetics, and efficacy were comparable to that observed in adults except for rash (greater than or equal to Grade 2) which was observed more frequently in pediatric subjects. Postmarketing reports of Stevens-Johnson syndrome in pediatric patients receiving INTELENCE® have been reported (see Warnings & Precautions).

Please see full Prescribing Information for INTELENCE®.

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