YOUR AREA, YOUR PATIENTS:
INSTANTLY ACCESS LOCAL COVERAGE INFORMATION FOR NUBEQA
NUBEQA: Market-leading coverage across Commercial and Medicare Part D plans
may allow you to focus more on treatment and less on your patients’ coverage1*
*Health plan coverage includes commercial and Medicare plans nationally, which is accurate as of April 2021 per DRG. Better: NUBEQA formulary access has preferred formulary coverage criteria or fewer restrictions and/or step edits than Erleada or Xtandi. On par: NUBEQA formulary access is the same as Erleada or Xtandi. Formulary status does not imply a comparison of efficacy, safety or dosing. Restrictions may apply. Please confirm PA requirements by calling your patient's insurance provider. Erleada is a registered trademark of Janssen Biotech, Inc. Xtandi is a registered trademark of Astellas Pharma US Inc.
CHOOSE NUBEQA FOR BEST-IN-CLASS COVERAGE
Access Services by BayerTM offers savings and support options to make it easier for patients to start and stay on NUBEQA
$0 CO-PAY*
Commercially insured patients may qualify for $0 co-pay.
- Annual auto-enrollment that helps avoid gaps in therapy
- No income requirement
To enroll, call 1-800-288-8374 or visit NUBEQAcopayprogram.com.
1-MONTH
FREE TRIAL†
Patients new to NUBEQA are eligible for 1 month of free treatment.
Enroll patients here or simply call 1-800-288-8374.
ENHANCED
SUPPORT
Reimbursement, access, and other types of support are available.
Access Services by Bayer will connect you to representatives who can help with benefits verification, prior authorization assistance, and appeal support.
- Electronic Benefit Verification (eBV)
- Electronic Prior Authorization (ePA): PA requests can be submitted and approved in minutes
- Online patient enrollment
- Electronic signatures for prescribers and patients
- Real-time patient updates for portal prescribers
- Electronic Benefit Verification (eBV)
- Electronic Prior Authorization (ePA): PA requests can be submitted and approved in minutes
- Online patient enrollment
- Electronic signatures for prescribers and patients
- Real-time patient updates for portal prescribers
To provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call
Celebrating over a year of achieving on-par or better health-plan coverage
vs other second-generation androgen receptor inhibitors
Celebrating over a year of achieving on-par or better health-plan coverage
vs other second-generation androgen receptor inhibitors
Health plan coverage includes commercial and Medicare plans nationally, which is accurate as of April 2021 per DRG. Better: NUBEQA formulary access has preferred formulary coverage criteria or fewer restrictions and/or step edits than Erleada or Xtandi. On par: NUBEQA formulary access is the same as Erleada or Xtandi. Formulary status does not imply a comparison of efficacy, safety or dosing. Restrictions may apply. Please confirm PA requirements by calling your patient's insurance provider. Erleada is a registered trademark of Janssen Biotech, Inc.
To provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call:
blue line
blue line
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Access Services by Bayer
is ready to help.
Enroll now
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TESTETo provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call:
blue line
blue line
Access Services by Bayer
is ready to help.
Enroll now
blue line
*The NUBEQA Free Trial Program provides 1 month’s supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions and to enroll patients, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com.
†Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.
THE NUBEQA
30-DAY FREE
SAMPLE PROGRAM
offers you several opportunities
- Address patient concerns
- Monitor for PSA reduction
- Start the journey to survival
- Observe tolerability
- Verify benefits and process prior authorizations
THE NUBEQA FREE SAMPLE PROGRAM
WILL GIVE YOU THE OPPORTUNITY TO
- Start your patients on NUBEQA right in your office
- Provide your patients with a 30-day supply of NUBEQA at no cost
ORDERING A SAMPLE IS SIMPLE
- Your sales representative will process your sample request
- Your order will be shipped within 24 to 48 hours
Terms and conditions apply.
*Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As
a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.
†The NUBEQA Free Trial Program provides 1 month's supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com. to enroll patients online and view full terms and conditions.
Terms and conditions apply.
*Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.
†The NUBEQA Free Trial Program provides 1 month's supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions and to enroll patients, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com.
PSA=prostate-specific antigen.
CONTACT A BAYER REPRESENTATIVE
Questions? Get answers when you contact a Bayer representative
A team of Bayer representatives is available to answer any questions you might have about NUBEQA. Whether it takes place over an in-person visit, a phone call, or e-mail, we’re happy to help.
Questions? Get answers when you contact a Bayer representative
A team of Bayer representatives is available to answer any questions you might have about NUBEQA. Whether it takes place over an in-person visit, a phone call, or email, we’re happy to help.
Sales Consultants
and Clinical
Nurse Educators
Sales consultants provide information about the safety and efficacy of NUBEQA, who it’s for, and how to help patients gain access. Clinical nurse educators provide patient education and support to nurses in your practice who care for patients on NUBEQA.
Medical Science
Liaisons
These professionals are available for information and consultation about NUBEQA.
Field
Reimbursement
Managers
Work to reduce reimbursement barriers, educate staff, and serve as Bayer representatives for Medicare Administration Contractor policy and claims professionals.
Sales Consultants and Clinical Nurse Educators
Sales consultants provide information about the safety and efficacy of NUBEQA, who it’s for, and how to help patients gain access. Clinical nurse educators provide patient education and support to nurses in your practice who care for patients on NUBEQA.
Medical Science Liaisons
These professionals are available for information and consultation about NUBEQA.
Field Reimbursement Managers
Work to reduce reimbursement barriers, educate staff, and serve as Bayer Representatives for Medicare Administration Contractor policy and claims professionals.
Indications
NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
Important Safety Information
Warnings & Precautions
Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 2.9% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.
Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.
Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.
Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity, and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.
In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.
Drug Interactions
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.
Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.
Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.
NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.
Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.
Please see the full Prescribing Information.
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
Reference:
- Data on file. Bayer HealthCare Pharmaceuticals, Inc.; Whippany, NJ.
Reference: 1. Data on file. Bayer HealthCare Pharmaceuticals, Inc.; Whippany, NJ.
