DUDE ACCESS SERVICES
STRONG COVERAGE AND SUPPORT OPTIONS FOR YOU AND YOUR PATIENTS
Experience NUBEQA now with a range of services available to help your patients access therapy
1-month free trial*
Patients new to NUBEQA are eligible for up to 1 month of free treatment.
Enroll patients by downloading and completing the Patient Service Request Form or calling the number below.
$0 co-pay†
Commercially insured patients may qualify for $0 co-pay.
Patients can determine whether they qualify by calling the number below or visiting NUBEQAcopayprogram.com.
Other support
Reimbursement, access, and other types of support are available.
DUDE Access ServicesTM will connect you to representatives who can help with benefits verification, prior authorization assistance, and appeal support.
To provide these savings to your patients and benefit from the advantages of DUDE Access Services, complete and fax the Patient Service Request Form or call:
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A PATIENT SERVICE
REQUEST FORM
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*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 DUDE Access Services at 1-833-337-DUDE (1-833-337-3833) or download the Patient Service Request Form above.
†Restrictions may apply. For full terms and conditions, please call DUDE Access Services at 1-833-337-DUDE (1-833-337-3833). 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.
RESOURCES
RESOURCES AVAILABLE TO HELP YOU CONNECT PATIENTS WITH NUBEQA
Patient Brochure (English)
A patient-friendly explanation of what NUBEQA is, how it works, and its efficacy, safety, and more.
Patient Brochure (Spanish)
A patient-friendly explanation of what NUBEQA is, how it works, and its efficacy, safety, and more.
Resources for you and your practice
Patient Service Request Form
Download and complete this form to request support from DUDE Access Services, which includes enrolling new patients into the NUBEQA Free Trial Program.
Sample Letter of Medical Necessity
A sample letter as a guide for specific patient clinical information when requesting coverage for NUBEQA.
Prior Authorization Tips
Helpful tips when collecting patients' clinical information and submitting a prior authorization request.
NUBEQA Specialty Pharmacy Network
A list of specialty pharmacies that partner with Bayer to provide reliable prescription delivery and a higher level of coordinated care.
NUBEQA Free Trial Patient Information Guide
An overview of the NUBEQA Free Trial Program for your patients who are prescribed NUBEQA.
Pill Size and Dosing Card
Learn more about pill size and recommended dosage for NUBEQA.
Appeal Checklist and Sample Letter
An overview of actions to take if a payer denies coverage for NUBEQA; includes a sample letter.
ARAMIS Pivotal Phase III Trial Publication*
The results from the first analysis, published in 2019 in The New England Journal of Medicine.
ARAMIS Final Analysis Publication*
Read the results, published in 2020 in The New England Journal of Medicine.
*Bayer, the manufacturer of darolutamide, is providing you with the published articles. These peer-reviewed articles contain data, conclusions, and recommendations that may not be consistent with the FDA-approved labeling. Darolutamide is only approved for the indication specified in the Prescribing Information. Before prescribing the product, please read the enclosed full Prescribing Information.
This study was supported by Bayer HealthCare and Orion Pharma. Authors’ affiliations can be found in the full text of the article. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. There are authors of this journal article who have declared financial interest or reported compensation from Bayer.
Visit openpaymentsdata.cms.gov for specific financial disclosures. Additional significant safety risks not listed in the NEJM Fizazi 2019 & 2020 reprint are included in the Prescribing Information. For more information, please call 888-84-BAYER (22937) or submit a product information request.
CONTACT A BAYER REPRESENTATIVE
CONTACT A BAYER REPRESENTATIVE
To stay informed on everything NUBEQA, 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 an e-mail, we’re happy to help.
Sales
Consultants
Provide information about the safety and efficacy of NUBEQA, who it’s for, and how to help patients gain access.
Medical
Support
Offers access to Clinical Nurse Educators who provide patient education and support to nurses in your practice who care for patients on NUBEQA, and Medical Science Liaisons who 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.
INDICATION
NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
IMPORTANT SAFETY INFORMATION
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
Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.
Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).
Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).
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.
For important risk and use information about 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.
