Janssen CarePath

Savings Program

Janssen CarePath Provider Portal

Benefits investigations & prior authorizations
Enroll eligible patients in Savings Program
View Savings Program transactions

Janssen Link

Supports eligible, commercially insured patients until they receive coverage for their prescribed treatment

Janssen Link enables eligible patients to receive TREMFYA^® at no cost until they receive coverage or until the end of the current program year if the following program requirements are met.

Janssen Link Program Requirements

Patient has been prescribed TREMFYA^® for an on-label, FDA-approved indication
Patient has commercial insurance that has delayed (>5 business days) or denied their treatment
Patient does not use any state or federal government-funded healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration
Patient cannot submit the value of the free product as a claim for payment to any third-party payer
Patient is not eligible if the prior authorization is denied due to missing information on coverage determination form, use for a non-FDA-approved indication or invalid clinical rationale
Patient must contact Janssen CarePath if the patient switches from commercial health insurance coverage to a government-funded healthcare program at any point during the program year

Prescriber must complete and submit an electronic enrollment in the Provider Portal or electronic submission through i-Assist (dermatology only), or fax the Prescription Information and Enrollment Form to Janssen CarePath to enroll patient in Janssen Link
- Janssen CarePath cannot accept any information without an executed Business Associate Agreement or Patient Authorization on file. The patient authorization can be found on the Prescription Information and Enrollment Form. Or patient can create an account on MyJanssenCarePath.com and electronically sign a patient authorization there.
Prescriber agrees to not purchase the Janssen medication on behalf of Janssen Link patient participants, and not bill commercial payers for any part of the prescribed subcutaneous treatment
Prescriber completes and submits a form of coverage determination (ie, prior authorization or prior authorization with exception) to the commercial insurance
If coverage is denied, prescriber challenges the coverage denial with an exception, Letter of Medical Necessity, or appeal

How Janssen Link Works

Program covers the cost of therapy only - not associated administration cost
No portion of the value of the free product will count towards the patient's applicable out-of-pocket cost-sharing obligations
Program year runs March 1 - February 28
Janssen CarePath reserves the right to cancel or modify Janssen Link at any time

Getting started with Janssen Link

Prescribe TREMFYA^® for an FDA-approved indication

Complete a benefits investigation request in the Provider Portal at JanssenCarePathPortal.com

Download Prescription Enrollment Form (PEF)

Complete the form and fax to Janssen CarePath at 844-322-9402

Submit an electronic submission through i-Assist (dermatology only)

Participating prescribers authorize Janssen CarePath to:

Conduct a benefits investigation and confirm prior authorization requirements
Provide prior authorization form assistance and status monitoring, including the exceptions and appeals processes
Coordinate shipment of TREMFYA^® from the program Specialty Pharmacy to eligible patients at no charge until they have coverage or until the end of the current program year
Support the transition of patients to commercial product if a favorable coverage determination is made within 90 days of the PA submission
Conduct verification of insurance coverage annually for patients enrolled in the program and any time for patients who have coverage change throughout the program year to confirm eligibility criteria are met for continued participation

FAQs

Which of my patients are eligible for the Janssen Link program?

Eligible patients are those who have just been prescribed TREMFYA^® for an FDA-approved indication and who are commercially insured and whose insurance has delayed (>5 business days) or denied their treatment. Patients using any state or federal government-funded healthcare programs, such as Medicare, Medicaid, TRICARE, Department of Defense, and Veterans Administration, are excluded from participating.

Can I submit the TREMFYA^® Prescription Enrollment Form (PEF) through my usual Specialty Pharmacy Provider (SPP)?

No. The TREMFYA^® PEF needs to be submitted through Janssen CarePath for your patient to be eligible for Janssen Link.

Can my office participate in Janssen Link without an executed Business Associate Agreement (BAA)?

Yes. If you do not have an executed BAA on file, each of your patients will simply have to sign the Patient Authorization on the PEF to opt in to Janssen CarePath support services. Or you can invite each patient to create an account on MyJanssenCarePath.com and electronically sign a patient authorization there.

If you would prefer to complete a BAA, fill out the form available here.

How long will Janssen CarePath provide TREMFYA^® for my commercial patients enrolled in the Janssen Link program?

If insurance coverage is delayed >5 business days or denied, Janssen CarePath will provide TREMFYA^® at no cost through the program year. For example, if your patient enrolls in the program in May or June, he or she will be enrolled until the end of February if his or her commercial insurance continues to be delayed (>5 business days) or denied.

Applicants in November or December who are approved will be covered through the following year if insurance coverage continues to be delayed (>5 business days) or denied.

If, at the end of one year, insurance coverage has not been secured, patients can repeat the program process and re-enroll for another program year if they remain eligible and you and the patient choose to continue treatment.

Which of my patients are eligible for the Janssen Link program?

Can I submit the TREMFYA^® Prescription Enrollment Form (PEF) through my usual Specialty Pharmacy Provider (SPP)?

No. The TREMFYA^® PEF needs to be submitted through Janssen CarePath for your patient to be eligible for Janssen Link.

Can my office participate in Janssen Link without an executed Business Associate Agreement (BAA)?

If you would prefer to complete a BAA, fill out the form available here.

How long will Janssen CarePath provide TREMFYA^® for my commercial patients enrolled in the Janssen Link program?

Applicants in November or December who are approved will be covered through the following year if insurance coverage continues to be delayed (>5 business days) or denied.

Program Materials en Español

TREMFYA^® Prescription Enrollment Form – en Español para Puerto Rico

Full Prescribing Information and Medication Guide – en Español

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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