Important Safety Information
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  • TREMFYA® (guselkumab)

    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.

    cp-82625v3

    INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION

Prescribing Information
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  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/TREMFYA-medication-guide.pdf

Prior Authorizations, Exceptions & Appeals

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Prior Authorizations, Exceptions & Appeals

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Prior Authorizations

In certain states, a standardized Prior Authorization (PA) form may be required for submission to a health plan along with clinical documentation. These standard forms can be used across payers.

  • Most standardized PA forms are only for prescription drugs, but some states allow them for other medical services.
  • Standardized PA forms may not be used by self-funded employer-sponsored health plans, Medicare Part D plans, and Medicaid fee-for-service plans.
TREMFYA® Letter of Medical Necessity
Letter of Medical Necessity
A template that you can fill out and submit to a patient’s health insurance provider. You may use it to explain why TREMFYA® is medically necessary for your patient.

Exceptions

An exception is a request made to a patient's insurance company. It asks them to release a restriction they have placed on the healthcare provider's recommended treatment. Restrictions can include medication not in the formulary, step therapy, quantity limit, or high tier. Usually, a healthcare provider is required to send a statement explaining the medical reason for the exception.

You can request information on the exceptions process for your patient in the Provider Portal.

TREMFYA® Letter of Exception
Letter of Exception
A template that you can fill out and submit to a patient’s health insurance provider asking them to cover a medication that is not on formulary.

Appeals

Appeals are actions taken by the patient or their healthcare provider. An appeal is used to challenge when the insurance company refuses to cover the patient's recommended treatment, or the level of coverage does not meet the patient’s expectations. The goal is to overturn the decision.

TREMFYA® Letter of Medical Necessity
Letter of Medical Necessity
A template that you can fill out and submit to a patient’s health insurance provider. You may use it to explain why TREMFYA® is medically necessary for your patient.
TREMFYA® Letter of Appeal
Letter of Appeal
A template to send to patients' insurance companies to help get patients on treatment.

Additional information on the PA process at major payers is shown below. Within the Provider Portal, we can give you payer-specific PA forms to complete online. You can also contact us at 844-4withMe (844-494-8463) for assistance in obtaining PA forms. Please see below for more details. [1]

Click on the payer links to be taken to the payer's website.

R8

[1] Collected in 11/21 and may change.

This information does not give advice or promise coverage or payment. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, restrictions, or requirements that may apply.

Important Safety Information For

  • TREMFYA®

    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.

    cp-82625v3

    INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION