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Prior Authorization, Exceptions, & Appeals

Prior Authorization, Exceptions, & Appeals

There are 3 primary categories of requests:

  • Prior authorizations
  • Coverage determinations (including exception requests)
  • Appeals

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)

Prior Authorization

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.

Payer Prior Authorization Information
Aetna Formularies & Pharmacy Clinical Policy Bulletins
Provider Precertification Lists
Health Care Professional Forms: Specialty Pharmacy Medication Request
Prior Authorization Form
Anthem Blue Cross Blue Shield Prescription Prior Authorization
California Prescription Prior Authorization
California Prescription Drug Prior Authorization Request Form
Georgia Prescription Prior Authorization
Blue Cross and Blue Shield of Alabama Prescription Coverage Guidelines (Search by product name)
Provider-Administered Drug Policies and Forms
General Prescription Drug Coverage Authorization Request Form
Blue Cross and Blue Shield of Florida/Florida Blue Prior Authorization Program Information (Search by product name)
Medical Pharmacy Prior Authorization Lists and Utilization Management
Physician and Provider Forms
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Specialty Drug Request Form
Prior Authorization Request Form
Blue Cross Blue Shield of Massachusetts Prior Authorization - Pharmacy
Online Prior Authorization Requests
Blue Cross Blue Shield of Michigan Provider Prior Authorization for Medical Drugs
Prior Authorization and Step Therapy Coverage Criteria
Medication Prior Authorization Request
Blue Cross and Blue Shield of Minnesota Prescription Drugs (Search by product name)
Pharmacy Utilization Management
Tools & Resources for Health Care Providers: Electronic Prior Authorization
Blue Cross and Blue Shield of Montana Prior Authorization and Step Therapy Programs
Provider Forms and Documents
Prior Authorization Request Form
Online Prior Authorization Form
Blue Cross and Blue Shield of New Mexico Prior Authorization and Step Therapy Programs
Prior Authorization Forms (Select pharmacy tab)
Prior Authorization Request Form
Online Prior Authorization Form
Blue Cross and Blue Shield of North Carolina Prior Review and Limitations
Prior Authorization Facsimile Form
Online Prior Authorization Requests
Blue Cross and Blue Shield of Oklahoma Prior Authorization and Step Therapy Programs: Request Forms
Prior Authorization Request Form
Online Prior Authorization Form
BlueCross BlueShield of Tennessee Pharmacy Resources & Forms
Prior Authorization Process for Provider-Administered Specialty Medications
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs: Request Forms
Prior Authorization Criteria and Forms for Drugs
Prior Authorization Request Form
Online Prior Authorization Form
CareFirst BlueCross BlueShield Pharmacy Forms
Pharmacy Prior Authorization
Prior Authorization Inquiries and Appeals
Online Prior Authorization Form
Cigna Provider Resources
Pharmacy Resources: Prior Authorization Forms
Medication Prior Authorization Form
CVS Caremark Electronic Prior Authorization Information
Clinical Prior Authorization Criteria Request Form
Prior Authorization for Professionally Administered Drugs
EmblemHealth Pharmacy Resources and Forms
Injectables and Specialty Pharmacy Program and Form
Prior Authorizations/Coverage Determinations
Harvard Pilgrim Health Care, Inc. Medication Request Forms and Clinical Coverage Criteria
Medical Drugs Prior Authorization
Massachusetts Standard Form for Medication Prior Authorization Requests
Health Net Pharmacy and Prior Authorization Forms
Prior Authorization Forms for Specific Drugs
Highmark Blue Cross Blue Shield Prescription Drug Medication Request Form
Provider Resources for Prior Authorization Submissions
Horizon Blue Cross Blue Shield of New Jersey Pharmacy Guidelines
Prior Authorization/Medical Necessity Determination Medicine List
Online Prior Authorization Form
Prior Authorization/Medical Necessity Determination Fax Form
Humana Medical and Pharmacy Coverage Policies
Prescribing Specialty Drugs
Pharmacy Prior Authorizations
Online Pharmacy Prior Authorization Portal (Members)
Independence Blue Cross Prior Authorization: Pharmacy Benefit
Specialty Medical Benefit Drugs (Search by product name)
Prior Authorization Forms
Kaiser Permanente (Kaiser Foundation Health Plan, Inc.)
Kaiser Permanente Washington 		Formulary and Formulary Exceptions Form (Select Region)
Injectable Drugs Requiring Prior Authorization (WA members)
Non-Medicare Injectable Drugs Requiring Prior Authorization List (WA members)
Premera Blue Cross Drugs Requiring Approval
Pharmacy Services Prior Authorization Request Form
Wellmark Blue Cross and Blue Shield Provider Drug Information
Provider Prior Authorization

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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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