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Delay and Denial Support

TREMFYA withMe Delay and Denial Support

TREMFYA withMe offers eligible patients TREMFYA® at no cost until their commercial insurance covers the medication. See program requirements below.

Need Delay and Denial Support?

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Program Requirements

To be eligible, patient must have:

Janssen CarePath Patients
  1. a TREMFYA® prescription for an on-label, FDA-approved indication
  2. commercial insurance with biologics coverage
  3. a delay of more than 5 business days or a denial of treatment from their insurance

In addition, for patient to be eligible, Prescriber must submit:

Janssen CarePath HCP
  1. a program enrollment form*
  2. a coverage determination form (eg, prior authorization or prior authorization with exception) to the commercial insurance

If coverage is denied, Prescriber must also submit a Letter of Formulary Exception, Letter of Medical Necessity or appeal within 90 days of patient becoming eligible for patient to stay in the program.

Patient is not eligible if:

Janssen CarePath Patients
  1. patient uses any state- or federal government-funded healthcare program to cover medication costs. Examples of these programs are Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration
  2. prior authorization is denied due to missing information on coverage determination form, use for a non-FDA-approved indication or invalid clinical rationale

Patient is eligible until commercial insurance covers the medication. Program requires periodic verification of insurance coverage status to confirm continued eligibility.

Delay and Denial Support covers the cost of therapy only—not associated administration cost. Prescriber cannot bill commercial insurance plan for any part of the prescribed subcutaneous treatment. Patient cannot submit the value of the free product as a claim for payment to any health plan. Program good only in the United States and its territories. Void where prohibited, taxed, or limited by law. Program terms may change.

*A Patient Authorization and/or an executed Janssen CarePath Business Associate Agreement is required for enrollment in TREMFYA withMe Delay and Denial Support.

Participating prescribers authorize TREMFYA withMe to:

  1. conduct a benefits investigation and confirm prior authorization requirements
  2. provide prior authorization form assistance and status monitoring, including the exceptions and appeals processes
  3. refer eligible patients to Wegman Specialty Pharmacy for further program support and shipment of medication
  4. support the transition of patients to commercial product if medication is covered
  5. check insurance coverage status during the program
INDICATIONS

TREMFYA® (guselkumab) is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

TREMFYA® is indicated for the treatment of adults with active psoriatic arthritis.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy.

Infections
TREMFYA® may increase the risk of infection. Treatment with TREMFYA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.

Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA® until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA®. Initiate treatment of latent TB prior to administering TREMFYA®. Monitor patients for signs and symptoms of active TB during and after TREMFYA® treatment. Do not administer TREMFYA® to patients with active TB infection.

Immunizations
Prior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA®.

ADVERSE REACTIONS

Most common (≥1%) adverse reactions associated with TREMFYA® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

 

Please read the full Prescribing Information and Medication Guide for TREMFYA®. Provide the Medication Guide to your patients and encourage discussion.

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