Commercial Payer Information

Commercial Payer Information

Payers create their own policies with regard to product coverage. Since information varies by payer, it is important to contact the payer directly or consult its Web site to obtain product-specific coverage information.

Commercial payers each have their own forms and requirements for requesting prior authorization of a prescription drug. Below are links to payer Web sites where you may obtain more information on pharmacy policies and the approval process, including direct links to drug prior authorization forms and links to formularies. It is important to contact the payer directly or consult its Web site to obtain product-specific information.

California, Colorado and Oregon require that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules regarding the PA process. The rules are effective based on the type of health plan for each state. Click on the PDF below for more information:

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Payer Prior Authorization (PA)* Policy* Formulary*
Aetna Precertification Request Clinical Policy Bulletin
Searchable Coverage Criteria
Pharmacy Clinical Policy Bulletin
Formulary
Anthem Blue Cross Prior Authorization/Clinical Criteria
Prior Authorization Form
Medical Policy Formulary
Anthem Blue Cross Blue Shield Approval Criteria Medical Policy Formulary
Blue Cross and Blue Shield of Alabama Drug Coverage Guidelines
Prior Authorization Form
Medical Policy Specialty Drug List
Formulary
Blue Cross of Idaho Pharmacy Prior Authorization Request
Commercial Prior Authorization Request
Specialty Drugs Medical Policy Formulary
Blue Cross Blue Shield of Michigan Prior Authorization & Step Therapy Guidelines Medical Policy Formulary
Capital BlueCross Prior Authorization List
Preauthorization Request
Medical Policy Formulary
Fallon Health Prior Authorization Approval Criteria Formulary
Highmark Blue Cross Blue Shield West Virginia Medication Request Form Pharmacy Policy Bulletin Formulary
Highmark Blue Cross Blue Shield (formerly Blue Cross of Northeastern Pennsylvania) Prior Authorization Form Pharmacy Utilization Management Criteria Formulary
Independence Blue Cross Prior Authorization Form   Specialty Drug List
Medica Drug Policies Utilization Management Policy Formulary
Regence BlueCross BlueShield of Utah Pharmacy Prior Authorization Medication Policy Manual Formulary

* Linked documents shown are only a sample of the payer's available documents and are not representative of all documents available for payer plans.

Alabama

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Alabama   2, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Alaska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Arizona

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Health Net Formulary dependent Specialty   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Arkansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Arkansas Blue Cross and Blue Shield Yes 3, Specialty   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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California

California requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in California regarding the PA process. The rules are effective October 1, 2014 or January 1, 2015, depending on the type of health plan. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in California

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross California Yes Specialty Yes For more information
Blue Shield of California Formulary dependent 4, Specialty Yes  
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Kaiser Permanente   Specialty    
UnitedHealthcare Yes 2 Yes For more information

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Colorado

Colorado requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in Colorado regarding the PA process. The rules are effective January 1, 2015. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in Colorado

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Colorado Yes 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Connecticut

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Connecticut Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
ConnectiCare Yes 3 Yes  
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Delaware

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Highmark Blue Cross Blue Shield Delaware Yes 3 Yes  
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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District of Columbia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Florida

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Florida, Inc. (Florida Blue) Yes 2, 4 Yes For more information
Capital Health Plan of Florida Yes Specialty    
Cigna Yes 3   For more information
Coventry Health Care of Florida Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Georgia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Georgia Yes 3, 4 Yes  
Cigna Yes 3   For more information
Coventry Health Care of Georgia Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Hawaii

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Kaiser Permanente   3, 4    
UnitedHealthcare Yes 2 Yes For more information

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Idaho

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross of Idaho Yes 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Illinois

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Illinois   Specialty Yes For more information
Cigna Yes 3   For more information
Coventry Health Care of Illinois Yes 4, Specialty, Preferred Yes For more information
Health Alliance Medical Plans Yes Medical, Specialty    
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Indiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Indiana Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Iowa

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Coventry Health Care of Iowa Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information
Wellmark Blue Cross and Blue Shield of Iowa Yes Medical, Specialty Yes For more information

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Kansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Kansas Yes Specialty Yes For more information
Cigna Yes 3   For more information
Coventry Health Care of Kansas Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Kentucky

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Kentucky Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Louisiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Coventry Health Care of Louisiana Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Maine

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield of Maine Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Maryland

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
CareFirst BlueCross BlueShield Yes 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Massachusetts

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Fallon Health Yes      
Harvard Pilgrim Health Care, Inc. Yes Medical   For more information
Humana Yes Specialty, Group A Yes For more information
Tufts Health Plan Yes 4 Yes  
UnitedHealthcare Yes 2 Yes For more information

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Michigan

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Michigan Yes 3, 5 Yes For more information
Cigna Yes 3   For more information
Health Alliance Plan of Michigan Yes Medical, Specialty   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Minnesota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Minnesota   2, Specialty, Preferred Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Medica Yes Specialty Yes  
UnitedHealthcare Yes 2 Yes For more information

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Mississippi

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Missouri

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Missouri Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Coventry Health Care of Missouri Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Montana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Montana   Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Nebraska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Nebraska Yes Specialty Yes For more information
Cigna Yes 3   For more information
Coventry Health Care of Nebraska Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Nevada

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Nevada Yes 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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New Hampshire

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield of New Hampshire Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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New Jersey

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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New Mexico

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of New Mexico   Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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New York

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Empire BlueCross BlueShield of New York Yes 3 Yes For more information
Excellus BlueCross BlueShield Yes 2   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information
Univera Healthcare Yes 2, Brand   For more information

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North Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of North Carolina Yes 3, Specialty Yes For more information
Cigna Yes 3   For more information
Coventry Health Care of the Carolinas Yes 4, Specialty, Preferred Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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North Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of North Dakota Yes Specialty   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Ohio

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Ohio Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Medical Mutual of Ohio Yes Brand   For more information
UnitedHealthcare Yes 2 Yes For more information

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Oklahoma

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Oklahoma Yes Specialty Yes For more information
Cigna Yes 3   For more information
CommunityCare Yes 4 Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Oregon

Oregon requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in Oregon regarding the PA process. The rules are effective July 1, 2015. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in Oregon

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Kaiser Permanente   Brand    
Providence Health & Services   Specialty Yes For more information
Regence BlueCross BlueShield of Oregon Yes Brand   For more information
UnitedHealthcare Yes 2 Yes For more information

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Pennsylvania

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross of Northeastern Pennsylvania Yes Medical   For more information
Cigna Yes 3   For more information
HealthAmerica, Coventry Health Care of Pennsylvania Yes 4, Specialty, Preferred Yes For more information
Highmark Blue Cross Blue Shield Yes 3 Yes For more information
Humana Yes Specialty, Group A Yes For more information
Independence Blue Cross Yes Medical   For more information
UnitedHealthcare Yes 2 Yes For more information

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Rhode Island

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross & Blue Shield of Rhode Island Yes Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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South Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
BlueCross BlueShield of South Carolina Yes 4, Specialty   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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South Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information
Wellmark Blue Cross and Blue Shield of South Dakota Yes Medical, Specialty Yes For more information

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Tennessee

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Texas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
BlueCross BlueShield of Texas   Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Scott & White Health Plan Yes 2    
UnitedHealthcare Yes 2 Yes For more information

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Utah

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Altius, Coventry Health Care Yes 4, Specialty, Preferred Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Regence BlueCross BlueShield of Utah Yes 2, Preferred, Medical Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Vermont

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross and Blue Shield of Vermont Yes Brand    
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross and Blue Shield Virginia Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
Southern Health, Coventry Health Care of Virginia Yes 4, Specialty, Preferred Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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Washington

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Group Health Cooperative Yes 3 Yes For more information
Health Net Yes Specialty   For more information
Humana Yes Specialty, Group A Yes For more information
Kaiser Permanente   Brand    
Premera Blue Cross Yes 3, 4   For more information
UnitedHealthcare Yes 2 Yes For more information

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West Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Cigna Yes 3   For more information
Highmark Blue Cross Blue Shield West Virginia Yes 3 Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information
West Virginia Public Employees Insurance Agency (PEIA) Yes Specialty    

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Wisconsin

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Anthem Blue Cross Blue Shield Wisconsin Yes 3, 4, Specialty Yes For more information
Cigna Yes 3   For more information
Dean Health Plan, Inc. Yes Medical Yes For more information
Gundersen Health Plan Yes 4 Yes For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information
Unity Health Plans Insurance Corporation Yes Medical, Specialty Yes For more information

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Wyoming

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Aetna Yes 2, 4   For more information
Blue Cross Blue Shield of Wyoming Yes Specialty Yes For more information
Cigna Yes 3   For more information
Humana Yes Specialty, Group A Yes For more information
UnitedHealthcare Yes 2 Yes For more information

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The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

Indications

STELARA® (ustekinumab) is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).

STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who:

  • have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or
  • failed or were intolerant to treatment with one or more TNF blockers.

For plaque psoriasis and psoriatic arthritis:

STELARA®, available as 45 mg and 90 mg, is a subcutaneous injection intended for use under the guidance and supervision of a physician with patients who will be closely monitored and have regular follow-up. Patients may self-inject with STELARA® after physician approval and proper training. Patients should be instructed to follow the directions provided in the Medication Guide.1

For Crohn’s disease:

STELARA® for intravenous infusion is available as a 130 mg/26mL (5 mg/mL) single-dose vial. It must be diluted, prepared, and infused by a healthcare professional for Crohn’s disease.

STELARA®, available as 90 mg, is a subcutaneous injection intended for use under the guidance and supervision of a physician with patients who will be closely monitored and have regular follow-up. Patients may self-inject with STELARA® after physician approval and proper training. Patients should be instructed to follow the directions provided in the Medication Guide.1

Important Safety Information For STELARA®

Infections

STELARA® (ustekinumab) may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections, some requiring hospitalization, were reported. In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and Listeria meningitis.

Treatment with STELARA® 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 initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA®. Closely monitor patients receiving STELARA® for signs and symptoms of active TB during and after treatment.

Malignancies

STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA® in clinical studies. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

Hypersensitivity Reactions

STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or excipients. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. No cases of RPLS were observed in clinical studies of Crohn’s disease. If RPLS is suspected, administer appropriate treatment and discontinue STELARA®. RPLS is a neurological disorder, which is not caused by an infection or demyelination. RPLS can present with headache, seizures, confusion, and visual disturbances. RPLS has been associated with fatal outcomes.

Immunizations

Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations recommended by current guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA®. Exercise caution when administering live vaccines to household contacts of STELARA® patients, as shedding and subsequent transmission to STELARA® patients may occur. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.

Concomitant Therapies

The safety of STELARA® in combination with other immunosuppressive agents or phototherapy was not evaluated in clinical studies of psoriasis. Ultraviolet-induced skin cancers developed earlier and more frequently in mice. In psoriasis studies, the relevance of findings in mouse models for malignancy risk in humans is unknown. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease studies, concomitant use of 6-mercaptopurine, azathioprine, methotrexate and corticosteroids did not appear to influence the overall safety or efficacy of STELARA®.

Allergen Immunotherapy

STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Most Common Adverse Reactions

The most common adverse reactions (≥3% and higher than that with placebo) in psoriasis clinical trials for STELARA® 45 mg, STELARA® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. In psoriatic arthritis (PsA) studies, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA® when compared with placebo (3% vs 1% for both). In Crohn’s disease induction studies, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%).

Please see full Prescribing Information and Medication Guide for STELARA®. Provide the Medication Guide to your patients and encourage discussion.

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