STELARA® and Medicare

STELARA® and Medicare

Overview of Medicare

Medicare is a federal program that provides health insurance coverage to the following types of people:

  • Individuals over age 65 with a work history
  • Individuals with certain disabilities who have been disabled for at least 2 years
  • Individuals diagnosed with end-stage renal disease (ESRD)

While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. The patient may have to pay a monthly premium for Medicare and then pay a co-insurance and a deductible for many services.

The 4 Parts of Medicare

Medicare is divided into 4 parts: A, B, C, and D. Part A covers facility care such as hospitals, and Part B covers physician and other outpatient services. Part C, which is known as the Medicare Advantage program, allows private managed care plans to administer a patient's Medicare benefits.

Medicare Part D offers prescription drug coverage to anyone enrolled in Medicare Parts A or B. Table 1 provides additional detail regarding the 4 parts of the Medicare program.

Table 1.The 4 Parts of Medicare

Part A

Typically known as the hospital benefit, Part A provides coverage for services such as hospitalizations, hospice care, skilled nursing facility stays, and home health services.

Part B

Part B benefits provide reimbursement for physician services, clinical laboratory services, hospital outpatient services, prescription drugs administered "incident to" a physician's services, durable medical equipment, and some home health services.

Part C

Also known as Medicare Advantage, this benefit provides Medicare Part A, B, and often Part D coverage through managed care plans.

Part D

Prescription drug coverage for medicines that are usually self-administered or taken orally.

To learn more about the different parts of Medicare, you can call the Medicare program at 1-800-MEDICARE (1-800-633-4227) or visit Medicare.gov

Our Medicare Resource Guide provides important information for your patients to consider as they are selecting their insurance coverage.

Medicare Part D Payers

Payer Prior Authorization (PA)* Policy* Formulary*
Aetna Coverage Determination Form
Prior Authorization Criteria
Prior Authorization Form
Clinical Policy Bulletin Formulary
Anthem Blue Cross Blue Shield Coverage Determination Form Medical Policy Formulary
Blue Cross of Idaho Prior Authorization Criteria
Coverage Determination Form
Specialty Drugs Medical Policy Formulary
Blue Cross Blue Shield of Michigan Drug-Specific Criteria Specialty Drug Pharmacy Enrollment Form Formulary
Capital BlueCross Coverage Determination Form
Prior Authorization Criteria
Medical Policy Formulary
Fallon Health Coverage Determination Form
Pharmacy Prior Authorization
Prior Authorization Approval Criteria Formulary
Geisinger Health Plan Coverage Determination Form
Prior Authorization Requirements
Clinical Benefit Policy List of Covered Drugs
Hawaii Medical Service Association Coverage Determination Form Drug Policy Formulary
HealthPartners Coverage Determination Form
Prior Authorization Requirements
Coverage Criteria Formulary
Highmark Blue Cross Blue Shield West Virginia Medication Request Form Pharmacy Policy Formulary
Highmark Blue Cross Blue Shield (formerly Blue Cross of Northeastern Pennsylvania) Prior Authorization Criteria (Note: Scroll to specific region.) Pharmacy Criteria Formulary
Independence Blue Cross Coverage Determination Form
Specialty Drug Medical Benefit
Medical Policy Formulary
Medica Prior Authorization Request Drug Coverage Policies
Utilization Management
Formulary
Regence BlueCross BlueShield of Utah Medical Prior Authorization List 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

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross and Blue Shield of Alabama Yes 5, Specialty   For more information

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Alaska

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Arizona

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Health Net Yes 5   For more information
Humana Yes   Yes For more information

R6

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Arkansas

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Arkansas Blue Cross and Blue Shield Yes 5   For more information

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California

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Shield of California Yes 6    
Health Net Yes 5   For more information
Kaiser Permanente Yes 5, Specialty    

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Colorado

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Kaiser Permanente Yes 5, Specialty    

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Connecticut

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Delaware

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Highmark Blue Cross Blue Shield Delaware Yes Specialty Yes  

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District of Columbia DC

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Florida

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross and Blue Shield of Florida, Inc./Florida Blue Yes 5   For more information
Humana Yes   Yes For more information
SantaFe HealthCare, Inc./AvMed Health Plans Yes 5 Yes For more information

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Georgia

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Kaiser Permanente Yes 5, Specialty    

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Hawaii

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Hawaii Medical Service Association (HMSA) Yes 5    
Kaiser Permanente Yes 5, Specialty    

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Idaho

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Blue Cross of Idaho Yes 5   For more information

R5

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Illinois

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross and Blue Shield of Illinois Yes 5   For more information

R6

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Indiana

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Iowa

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Kansas

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Kentucky

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Louisiana

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Maine

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Maryland

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Massachusetts

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Fallon Health Yes 3    
Tufts Health Plan Yes 2    

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Michigan

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Blue Cross Blue Shield of Michigan Yes 5   For more information
HealthPlus of Michigan Yes 5   For more information

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Minnesota

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Medica Yes 5 Yes  

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Mississippi

Contact Janssen CarePath

 

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Missouri

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Montana

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Nebraska

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Nevada

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New Hampshire

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New Jersey

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New Mexico

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Blue Cross and Blue Shield of New Mexico Yes 5, Specialty   For more information

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New York

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Excellus BlueCross BlueShield Yes 5   For more information
Univera Healthcare Yes 5   For more information

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North Carolina

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross and Blue Shield of North Carolina Yes 5   For more information

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North Dakota

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Ohio

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Humana Yes   Yes For more information

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Oklahoma

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Blue Cross and Blue Shield of Oklahoma Yes 5   For more information
CommunityCare Yes 5   For more information

R7

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Oregon

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Kaiser Permanente Yes 5, Specialty    
Regence BlueCross BlueShield of Oregon Yes 5 Yes For more information

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Pennsylvania

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross of Northeastern Pennsylvania Yes 5, Specialty Yes For more information
Highmark Blue Cross Blue Shield Yes 5, Specialty Yes For more information
Independence Blue Cross Yes 4 Yes For more information

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Rhode Island

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South Carolina

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
BlueCross BlueShield of South Carolina Yes 5, Specialty   For more information

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South Dakota

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Tennessee

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Texas

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
BlueCross BlueShield of Texas Yes 5, Specialty   For more information

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Utah

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Regence BlueCross BlueShield of Utah Yes 5 Yes For more information

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Vermont

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Virginia

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Washington

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Group Health Cooperative Yes 5 Yes For more information
Health Net Yes 5   For more information
Kaiser Permanente Yes 5    

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West Virginia

Payer Prior Authorization Tier Quantity Limits Exception & Appeals
Highmark Blue Cross Blue Shield West Virginia Yes Specialty Yes For more information
West Virginia Public Employees Insurance Agency (PEIA) Yes 4, Specialty Yes  

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Wisconsin

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Wyoming

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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.

060385-160920