• TREMFYA® (guselkumab)

    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.

     

    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
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • 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

Coding & Billing

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Coding & Billing

This overview outlines the key points you need to know about reimbursement for TREMFYA®, including:

  • Reimbursement support
  • Coding for TREMFYA®

Coverage policies may vary by insurer or even between plans offered by the same insurer.

Coding

National Drug Code (NDC)

10-digit NDC for Ordering 11-digit NDC for Billing Description
57894-640-01 57894-0640-01 100 mg prefilled syringe
Single-dose 100 mg prefilled syringe of guselkumab for injection
57894-640-11 57894-0640-11 100 mg One-Press patient-controlled injector
100 mg single-dose One-Press patient-controlled injector of guselkumab for injection

HCPCS Codes

Site of Care Payer Dates of Service: January 1, 2018 - December 31, 2018 Permanent National Code effective January 1, 2019
Physician Office Non-Medicare J3590 - Unclassified biologics J1628 - Injection, guselkumab, 1 mg
Medicare
HOPD Non-Medicare J3590 - Unclassified biologics J1628 - Injection, guselkumab, 1 mg
Medicare Effective January 1, 2018: C9029 - Injection, guselkumab, 1 mg

Collected in 10/21 and may change.

This information is not a promise of coverage or payment. It is not intended to give reimbursement advice or increase reimbursement by any payer. The fact that a treatment is assigned a code and payment rate does not promise that it will be covered. Codes are used to describe products, procedures, or services on insurance claims. Payers use these codes with other information to figure out if treatment will be covered, and how much will be paid if covered. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, reimbursement policies, restrictions, or requirements that may apply.

Please consult your local payer for specific coding policies or call Janssen CarePath for assistance at 877-CarePath (877-227-3728).

Reimbursement Support through Janssen CarePath
Janssen CarePath provides information and assistance regarding coding, coverage, and claims process related to TREMFYA®. In addition, we can also investigate specialty pharmacies that may be available to simplify product procurement and billing for healthcare providers.

If you have questions, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

Coding

National Drug Code (NDC)

10-digit NDC for Ordering 57894-640-01
11-digit NDC for Billing 57894-0640-01
Description 100 mg prefilled syringe
Single-dose 100 mg prefilled syringe of guselkumab for injection
10-digit NDC for Ordering 57894-640-11
11-digit NDC for Billing 57894-0640-11
Description 100 mg One-Press patient-controlled injector
100 mg single-dose One-Press patient-controlled injector of guselkumab for injection

HCPCS Codes

Site of Care Physician Office
Payer Non-Medicare
Medicare
Dates of Service: January 1, 2018 - December 31, 2018 J3590 - Unclassified biologics
Permanent National Code effective January 1, 2019 J1628 - Injection, guselkumab, 1 mg
Site of Care HOPD
Payer Non-Medicare
Dates of Service: January 1, 2018 - December 31, 2018 J3590 - Unclassified biologics
Permanent National Code effective January 1, 2019 J1628 - Injection, guselkumab, 1 mg
Site of Care HOPD
Payer Medicare
Dates of Service: January 1, 2018 - December 31, 2018 Effective January 1, 2018: C9029 - Injection, guselkumab, 1 mg
Permanent National Code effective January 1, 2019 J1628 - Injection, guselkumab, 1 mg

Collected in 10/21 and may change.

This information is not a promise of coverage or payment. It is not intended to give reimbursement advice or increase reimbursement by any payer. The fact that a treatment is assigned a code and payment rate does not promise that it will be covered. Codes are used to describe products, procedures, or services on insurance claims. Payers use these codes with other information to figure out if treatment will be covered, and how much will be paid if covered. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, reimbursement policies, restrictions, or requirements that may apply.

Please consult your local payer for specific coding policies or call Janssen CarePath for assistance at 877-CarePath (877-227-3728).

Reimbursement Support through Janssen CarePath
Janssen CarePath provides information and assistance regarding coding, coverage, and claims process related to TREMFYA®. In addition, we can also investigate specialty pharmacies that may be available to simplify product procurement and billing for healthcare providers.

If you have questions, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

Important Safety Information For

  • TREMFYA®

    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.

     

    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