Prior Authorization, Exceptions, & Appeals
Prior Authorization, Exceptions, & Appeals
There are 3 primary categories of requests:
- Prior authorizations
- Coverage determinations (including exception requests)
Click here for a brochure that has been developed to help healthcare providers understand the information that payers may require for coverage of medically necessary drug therapies.
Janssen Link provides Janssen subcutaneous products to eligible patients whose commercial insurance delays (>5 business days) or denies treatment. Click here for more information.
Letter of Medical Necessity
Below is a Letter of Medical Necessity template that you can use to create your letter documenting the medical necessity for treatment with TREMFYA® for your patient. You may submit the letter to the payer either with the initial claim or when requesting reconsideration of a denied claim.
Letter of Medical Necessity (editable)
Letter of Exception
An exception request is a specific type of coverage determination that asks a payer to reconsider an adverse tiering or formulary decision. Below is a Letter of Exception template you can use to create your own letter to request an exception for TREMFYA®.
Letter of Exception (editable)
Letter of Appeal
Below is a Letter of Appeal template:
Letter of Appeal (editable)
A standardized, or "uniform," prior authorization (PA) form may be required in certain states to submit PA requests to a health plan for review, along with the necessary clinical documentation. These standard forms can be used across payers and health benefit managers.
- Standardized PA Forms are only applicable to prescription drug benefits; they are not applicable to medical services or procedures.
- Standardized PA Forms are typically not applicable to self-funded employer-sponsored health plans, Medicare Part D plans, and Medicaid fee-for-service plans.
Please visit the Know Your State Interactive Tool to learn what is required for your state.
Additional information on the PA process at major payers is shown below. Please see table below, use the Janssen CarePath Provider Portal, or contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining PA forms.
The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement, payment, or charge. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Please refer to the applicable plan's website, or contact the plan for more information about coverage or any restrictions or prerequisites that may apply. We strongly recommend you consult the payer organization for its reimbursement policies.
Click on the payer link to be taken to the payer's website.
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.
WARNINGS AND PRECAUTIONS
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.
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.
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®.
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.