ACCESS

COPAY ASSISTANCE WITH XOFIGO®

Xofigo $0 Copaya Savings Program

Your patient may be eligible for copay/coinsurance assistance if your patient has a private commercial plan that covers Xofigo. 

  • Out-of-pocket expenses up to $10,000 per dose for up to 6 doses may be covered through the $0 Copay Program

PLEASE NOTE: If your patient has public insurance (eg, Medicare or other government payors, such as the Department of Veterans Affairs and Department of Defense), your patient is not eligible.

HERE’S HOW TO APPLY:

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Confirm your patient is eligible. Eligibility criteria include:

  • Private commercial insurance
  • Residency in the United States, including the District of Columbia, Puerto Rico, Guam, or the US Virgin Islands
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Complete the Xofigo $0 Copay Reimbursement Form on your patient’s behalf.

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Ensure both the patient and physician sign and date the application.

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Send the application to Xofigo® Access Services via secure email in the portal. You can also fax the application to Xofigo Access Services at 1-855-963-4463. Remember to include the signed patient authorization. Contact Xofigo Access Services if you have any questions or to obtain more information. Both you and your patient will then receive an Explanation of Payment (EOP) and Explanation of Benefits (EOB), respectively, which show how much was reimbursed and how much your patient owes.

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Once approved, your patient will receive an approval letter with commercial copay/coinsurance identification information. Then, you or your patient will be reimbursed up to $10,000 per dose for up to 6 doses. You may also collect any remaining balance from your patient.

Copay assistance for patients with public insurance

  • Medicare beneficiaries and patients with other government insurance who need help paying for treatment with Xofigo are not eligible for copay assistance through the Xofigo Access Services commercial copay/coinsurance assistance program
  • If your patient needs assistance with cost-share requirements for Xofigo, they may be eligible for copay or coinsurance assistance through an independent copay/coinsurance assistance foundation
  • Xofigo Access Services Access Counselors can verify your patients’ coverage for Xofigo
  • If copay assistance needs are identified, an Access Counselor can provide information about any available foundation
  • The foundations determine your patient’s eligibility for copay or coinsurance assistance based on their own criteria

Comprehensive support right when you need it

Xofigo® access services logo

Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

For helpful resources, click here.

aPatients 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, e.g., copay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors 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. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Xofigo Access Services at any time, including but not limited to this commercial copay assistance program. Only patients not currently enrolled in the Xofigo Access Services are eligible; current participants may enroll upon their annual renewal date.

Community Practices

$0 Commercial Copaya Assistance Program

Your patient may be eligible for copay/coinsurance assistance if your patient has a private commercial plan that covers Xofigo.b Patients approved for assistance will not have to pay anything to access Xofigo.

PLEASE NOTE: If your patient has public insurance (eg, Medicare or other government payors, such as the Department of Veterans Affairs and Department of Defense), your patient is not eligible. Learn more

How to apply:

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  • Private commercial insurance
  • Residency in the United States, including the District of Columbia, Puerto Rico, Guam, or the US Virgin Islands
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  • Ensure both the patient and physician sign and date the application
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  • Fax the application, including the signed patient authorization, to Xofigo Access Services at 1-855-963-4463
  • Contact Xofigo Access Services if you have any questions or to obtain more information
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  • Once approved, your patient will receive an approval letter with a commercial copay/coinsurance identification (ID) card

Copay assistance for patients with public insurance

  • Medicare beneficiaries and patients with other government insurance who need help paying for treatment with Xofigo are not eligible for copay assistance through the Xofigo Access Services commercial copay/coinsurance assistance program

  • If your patient needs assistance with cost-share requirements for Xofigo, they may be eligible for copay or coinsurance assistance through an independent copay/coinsurance assistance foundation

  • Xofigo Access Services Access Counselors can verify your patients’ coverage for Xofigo. Use the Xofigo Access Services Provider Referral Form

  • If copay assistance needs are identified, an Access Counselor can provide information about any available foundation

  • The foundations determine your patient’s eligibility for copay or coinsurance assistance based on their own criteria

Comprehensive support right when you need it

Xofigo® access services

Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

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Community practices
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aPatients 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, e.g., copay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors 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. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Xofigo Access Services at any time, including but not limited to this commercial copay assistance program. Only patients not currently enrolled in the Xofigo Access Services are eligible; current participants may enroll upon their annual renewal date.

bThe Xofigo Commercial Copay Assistance identification card is not a credit or debit card, and no cash or ATM access is available. This card cannot be used in any other capacity outside of copay assistance for Xofigo.

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Copay assistance
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Indication

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information

Warnings and Precautions:

  • Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.             

    Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure
  • Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
  • Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued
  • Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established
  • Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo

Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

For important risk and use information about Xofigo, 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. For Bayer products, you can report these directly to Bayer by clicking here.

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Site Last Modified: 12/24

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