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.

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

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

Some health plans in select states must use their state's Uniform Prior Authorization request form. Please contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining prior authorization forms.

Click here to see if your state is included:

Uniform Prior Authorization Information for Select States

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 information 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 Web site, 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.

Janssen CarePath does not endorse and is not responsible for the content on any of the Web sites listed below, or the services provided by these organizations. Clicking on any of the links below will take you to a Web site to which our Privacy Policy does not apply. We encourage you to read the Privacy Policy of every Web site you visit.

Commercial Payer Information

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 List
Health Care Professional Forms: Specialty Pharmacy Precertification
Prior Authorization Form
Anthem Blue Cross Blue Shield
Anthem Blue Cross of California
Anthem Blue Cross Blue Shield of Colorado
Anthem Blue Cross and Blue Shield of Georgia
Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Request Form
Colorado Prescription Drug Prior Authorization Request Form
Georgia Prescription Drug Prior Authorization Information
Blue Cross and Blue Shield of Alabama Drug Coverage Guidelines (Search by drug name)
Specialty Pharmacy Prior Authorization Form
Physician-Administered Drug Policies and Forms (Acceptance required to view)
General Prescription Drug Coverage Authorization Request Form
Blue Cross and Blue Shield of Florida/Florida Blue Prior Authorization Program Information
Medical Pharmacy Prior Authorization Lists and Utilization Management
Medication Guides (Check for prior authorization requirements)
Member Prescription Drug Prior Authorization Forms
Online Prescription Drug Prior Authorization Form
Specialty Pharmacy Request Form
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Specialty Drug Request Form
Preauthorization Request Physician Fax Form
Blue Cross Blue Shield of Massachusetts Medication Guides
Quantity Limit Request Form
Specialty Pharmacy Request Form
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 drug list for medication requirements)
Pharmacy Utilization Management
Minnesota Uniform Form for Prescription Drug Prior Authorization
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)
Preauthorization Request
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
Preauthorization Request Physician Fax Form
BlueCross BlueShield of Tennessee Pharmacy Resources & Forms
Specialty Medications Program
Prior Authorization Process for Provider-Administered Specialty Medications
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs: Request Forms
Physician-Administered Drug Policies and Forms
Preauthorization Request Physician Fax Form
CareFirst BlueCross BlueShield Pharmacy Forms
Pharmacy Prior Authorization
Prior Authorization/Step Therapy Forms
Cigna Pharmacy Resources
Pharmacy Prior Authorization Forms (Select drug)
Medication Prior Authorization Form
CVS Caremark Prior Authorization Information
Clinical Prior Authorization Criteria Request Form
Specialty Pharmacy Services, Information and Forms
Prior Authorization Request Form
EmblemHealth Pharmacy Resources and Forms
Injectable and Specialty Drugs: Prior Approval Requirement
Prior Authorization/Precertification Portal
Harvard Pilgrim Health Care, Inc. Medication Prior Authorization Program
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
Highmark (formerly Blue Cross of Northeastern Pennsylvania) Provider Rx Prior Authorization Form
Drug Utilization Management Criteria
Horizon Blue Cross Blue Shield of New Jersey Pharmacy Guidelines
Prior Authorization/Medical Necessity Determination Medicine List
Online Prior Authorization Form
Humana Medical and Pharmacy Coverage Policies
For Prescribers: Specialty Pharmacy Medications
Pharmacy Prior Authorizations
Online Pharmacy Prior Authorization Portal (Members)
Medical Precertification Request Form
Independence Blue Cross Prior Authorization: Pharmacy Benefit
Specialty Medical Benefit Drugs
Kaiser Permanente (Kaiser Foundation Health Plan, Inc.)
Washington Kaiser Permanente (formerly Group Health Cooperative - GHC members)
Formulary and Formulary Exceptions Form (Select Region)
Pharmacy Forms (GHC members)
Injectable Drugs Requiring Prior Authorization (GHC members)
Non-Medicare Injectable Drugs Requiring Prior Authorization List (GHC 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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Indication

ERLEADA™ (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Important Safety Information For ERLEADA

CONTRAINDICATIONS

Pregnancy — ERLEADA™ (apalutamide) can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Falls and Fractures In a randomized study (SPARTAN), falls and fractures occurred in 16% and 12% of patients treated with ERLEADA™ compared to 9% and 7% treated with placebo, respectively. Falls were not associated with loss of consciousness or seizure. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents.

Seizure —  In a randomized study (SPARTAN), 2 patients (0.2%) treated with ERLEADA™ experienced a seizure. Permanently discontinue ERLEADA™ in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA™. Advise patients of the risk of developing a seizure while receiving ERLEADA™ and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

ADVERSE REACTIONS

Adverse Reactions —  The most common adverse reactions (≥10%) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema.

Laboratory Abnormalities — All Grades (Grade 3-4)

  • Hematology —  anemia ERLEADA™ 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA™ 41% (2%), placebo 21% (2%)
  • Chemistry — hypercholesterolemia ERLEADA™ 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA™ 70% (2%), placebo 59% (1%); hypertriglyceridemia ERLEADA™ 67% (2%), placebo 49% (0.8%); hyperkalemia ERLEADA™ 32% (2%), placebo 22% (0.5%)

Rash — Rash was most commonly described as macular or maculo-papular. Adverse reactions  were 24% with ERLEADA™ versus 6% with placebo. Grade 3 rashes (defined as covering > 30% body surface area [BSA]) were reported with ERLEADA™ treatment (5%) versus placebo (0.3%).

The onset of rash occurred at a median of 82 days. Rash resolved in 81% of patients within a median of 60 days (range: 2 to 709 days) from onset of rash. Four percent of patients treated with ERLEADA™ received systemic corticosteroids. Rash recurred in approximately half of patients who were re-challenged with ERLEADA™.

Hypothyroidism was reported for 8% of patients treated with ERLEADA™ and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA™ and 7% of patients treated with placebo. The median onset was day 113. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA™ — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA™ dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA™ on Other Drugs — ERLEADA™ is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA™ with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA™ with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA™ and evaluate for loss of activity.

P-gp, BCRP or OATP1B1 substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA™ with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP or OATP1B1 must be co-administered with ERLEADA™ and evaluate for loss of activity if medication is continued.

Please see the full Prescribing Information for ERLEADA™.

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