Helping Patients Afford ERLEADA®

Helping Patients Afford ERLEADA®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking ERLEADA®. You may download the Affordability Options for ERLEADA® resource for your patients to help them learn about cost support options.

Support for Patients Using Commercial or Private Insurance to Pay for Medication

Janssen CarePath Savings Program for ERLEADA® can help eligible patients receive instant savings on their out-of-pocket medication costs for ERLEADA®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Your eligible patients will pay $0 per month with a $15,000 maximum program benefit per calendar year or one-year supply, whichever comes first. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. See full eligibility requirements.

Two ways to help get your patients started:

In the Janssen CarePath Provider Portal, you can enroll your eligible patients in the Janssen CarePath Savings Program, print a card, review your patients' available benefits, view patient transactions, and receive timely alerts and program updates. You can also request and review benefits investigations, and request prior authorization or appeals support.

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If you only want to check your patients' eligibility and enroll them in the Janssen CarePath Savings Program for ERLEADA®, click here for the Express Enrollment Site. There is a "Print a Card" feature to provide the patient with a Savings Program card. Your patients will not have a Janssen CarePath account and will not be able to view and manage their Savings Program benefits.

Patients can also create their own Janssen CarePath Account where they can enroll in the Janssen CarePath Savings Program, learn about their insurance coverage for ERLEADA®, and sign up for personalized treatment reminders. Encourage your patient to sign up today at MyJanssenCarePath.com.

If your patient's pharmacy is unable to process their Savings Program card, your patient can complete, sign and return the rebate form, with the required proof of purchase, to receive a rebate check from the Janssen CarePath Savings Program. Click here to get the rebate form for your patient. Your patient can also request a rebate online in their Janssen CarePath Account.

Support for Patients Using Government-Funded Healthcare Programs or Patients Without Health Coverage

Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:

  • State-Sponsored Programs
  • Medicare Savings Program
  • Medicare Part D Extra Help—Low-Income Subsidy
  • Independent Foundations*

Call Janssen CarePath at 877-CarePath (877-227-3728) or visit JanssenPrescriptionAssistance.com for more information on affordability programs that may be available.

*Independent co-pay assistance foundations have their own rules for eligibility. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation.

Health Plan Open Enrollment Brochure for Your Patients

Even if patients keep the same health plan, benefits can change. The information in the Open Enrollment brochure can help patients review their health plan coverage and make changes if needed so they can stay on treatment in the new benefit period.

Other Resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday-Friday, 9:00 AM to 6:00 PM ET) or visit the foundation website at JJPAF.org.

Indication

ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with:

  • Metastatic castration-sensitive prostate cancer (mCSPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
Important Safety Information For ERLEADA®

WARNINGS AND PRECAUTIONS

Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA® and 3% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA® and 2% of patients treated with placebo. Across the SPARTAN and TITAN studies, 6 patients (0.5%) treated with ERLEADA® and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with current evidence of unstable angina, myocardial infarction, or congestive heart failure within 6 months of randomization were excluded from the SPARTAN and TITAN studies.

Ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA®. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA® for Grade 3 and 4 events.

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA® and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA® and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA® compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA® with increased frequency in the elderly. Evaluate patients for fall risk.

Seizure — In 2 randomized studies (SPARTAN and TITAN), 5 patients (0.4%) treated with ERLEADA® and 1 patient treated with placebo (0.1%) 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.

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA® have not been established in females. Based on its mechanism of action, ERLEADA® can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA®[see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS

Adverse Reactions — The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA®-treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

  • Hematology — In the TITAN study: white blood cell decreased ERLEADA® 27% (0.4%), placebo 19% (0.6%). In the SPARTAN study: 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 — In the TITAN study: hypertriglyceridemia ERLEADA® 17% (3%), placebo 12% (2%). In the SPARTAN study: 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 — In 2 randomized studies, rash was most commonly described as macular or maculopapular. Adverse reactions of rash were 26% with ERLEADA® vs 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA® treatment (6%) vs placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA®.

Hypothyroidism — In 2 randomized studies, 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 at the first scheduled assessment. 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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