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Home » Healthcare Professionals » Patient Assistance and Support

Patient Assistance Program

Patient Assistance and Support

Patient Assistance Program

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, private, nonprofit organization that assists patients who do not have financial resources or prescription drug coverage to obtain free prescription products that are donated by Johnson & Johnson operating companies. These companies have a long-standing commitment to helping patients to access medicines. Janssen Therapeutics donates medicines to JJPAF.

To learn more about the JJPAF patient assistance programs or to apply for assistance, please visit the JJPAF Web site at jjpaf.org, or call and speak to one of our patient assistance program specialists at 1-800-652-6227.

Patient Savings Program

This program is for people with prescription coverage who pay high out-of-pocket costs for INTELENCE (etravirine). The Patient Savings Program (PSP) is a simple and easy way to lower costs for up to 1 year.

Patients should refer to the Q&A below for eligibility rules and regulations to determine whether they qualify. For more information, call 1-866-961-7169.

Janssen Therapeutics' Patient Savings Program (the “Program”) may request and obtain information from you to enroll you in the Program. People who work for the Program administrator may see your information, but they may use it only to help you get assistance with the cost of your drugs and to run the Program. Every effort will be made to keep your information private, but if it is accidentally given out, federal privacy laws will not protect it. You can withdraw from the Program at any time by calling 1-866-961-7169, but it will not change any actions taken before you withdrew from the Program.

Patient Savings Program Application Form

Patient Savings Application Form

Patient Savings Program Q&A

Patient Savings Program Q&A

 

Additional Information

The Janssen TherapeuticsLine, 1-866-836-0014, is a convenient, toll-free hotline to answer questions from patients and healthcare providers. It is available Monday through Friday from 9 AM to 8 PM, Eastern Standard Time.  You can also reach us by fax at 1-866-836-0567.  The Janssen TherapeuticsLine provides reimbursement information including: benefit verification; prior authorization requirements; appeal process and procedures; alternate sources of payment; and additional information about patient assistance.

Insurance Benefit Verification Form

Insurance Benefit Verification Form

 

When calling about a patient-specific reimbursement issue, please have the following information available:

  • Patient’s full name, date of birth, address, telephone, and Social Security number
  • Name and telephone number of insurance plan(s), policy number(s), and name of subscriber
  • Physician’s name, address, and telephone number
  • Patient’s financial information if calling on behalf of an uninsured patient, including total gross income, household size, and value of assets

This information is provided for informational purposes only and represents no statement, promise, or guarantee by Janssen Therapeutics concerning levels of reimbursement, payment, or charge. We strongly suggest that you consult your payer organization about local reimbursement policies.

 

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Indication

INTELENCE, in combination with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs.

This indication 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, protease inhibitor [PI]) treatment-experienced adults.

The following points should be considered when initiating therapy with INTELENCE:

  • Treatment history and, when available, resistance testing, should guide the use of INTELENCE
  • The use of other active ARVs with INTELENCE is associated with an increased likelihood of treatment response
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N(t)RTIs
  • The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naïve adult patients

Important Safety Information

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 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. Rash occurred most commonly during the first 6 weeks of therapy

    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, 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 antiretroviral (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

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

Adverse Reactions

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

Drug Interactions

  • INTELENCE should not be coadministered with the following ARVs: atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without low-dose ritonavir, and other NNRTIs
  • INTELENCE should not be coadministered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/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 the full Prescribing Information in PDF format for more details.

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© Janssen Therapeutics, Division of Janssen Products, LP 2011. All rights reserved.

Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy. This site is published by Janssen Therapeutics, Division of Janssen Products, LP, which is solely responsible for its contents.

The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

This information is intended for the use of our customers, patients, and healthcare professionals in the United States only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States.

INTELENCE is a registered trademark of Tibotec Pharmaceuticals.

This site was last updated on: 02/29/12 at 10:42 am GMT.

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