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
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.
- Complete an individual Patient Authorization for each patient including the patient signature. Individual patient authorization is not required if BAA is on file.
- 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.
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) .
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.
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:
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:
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 patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARV agents.
The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class ARV (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single arm, Phase 2 trial in ARV treatment-experienced pediatric subjects 6 years to less than 18 years of age.
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
- Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance
- In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs
- The use of other active ARV agents with INTELENCE® is associated with an increased likelihood of treatment response
- The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients
Warnings & Precautions
Severe Skin and Hypersensitivity Reactions:
- Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme
- 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
In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE® compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE®. In clinical trials of patients on INTELENCE®, the incidence of rash was higher in women compared to men. Rash occurred most commonly during the first 6 weeks of therapy. In the PIANO study of children ages 6 to ≤17 years of age, rash was seen more commonly than in adults and occurred in 15% (≥Grade 2) of pediatric subjects
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
- 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
- Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) 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
Use in Specific Populations
- 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
- Pregnancy Category B: INTELENCE® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women
- 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
- INTELENCE® should not be coadministered with the following ARVs: fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), PIs administered without low-dose ritonavir, and other NNRTIs
- INTELENCE® should only be used with dolutegravir when coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. INTELENCE® should not be coadministered with dolutegravir in the absence of a boosted PI. INTELENCE® significantly reduces plasma concentrations of dolutegravir
- INTELENCE® should not be coadministered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing PI/ritonavir), or products containing St. John’s wort (Hypericum perforatum)
- Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE® as it may alter the therapeutic effect or adverse reaction profile of INTELENCE® or the coadministered drug(s)
This is not a complete list of potential drug interactions.
Please see full Prescribing Information for more details.