COVERAGE FOR XOFIGO

It is important for prescribing physicians to understand payor policies and requirements affecting patient access and product coverage, coding, and reimbursement. Conduct an insurance benefit verification for your patient prior to treatment with Xofigo to identify the necessary requirements.

    Medicare
    • Medicare coverage of Xofigo may be available to beneficiaries if reasonable and necessary
    • Options for supplemental insurance coverage for patients already enrolled in traditional Medicare include Medigap plans or a supplemental commercial insurance plan
    • A Medigap plan may cover a patient's 20% coinsurance remaining after Medicare pays 80%
    • Third-party financial assistance options may be available for eligible patients in need

     

    Find Medicare Administrative Contractor (MAC) updates in your state

      Medicaid
      • Medicaid coverage and reimbursement policies may vary state to state and depend on individual insurance plans and negotiated contracts with physicians and hospitals
      • State Medicaid agencies may require additional documentation to grant coverage or obtain prior authorization for Xofigo
      • Patient cost-share will vary based on the state Medicaid policies, but may require patients to pay a minimal copay or coinsurance for Xofigo
      • Third-party financial assistance options may be available for eligible patients in need
        Commercial payors
        • Commercial payors develop their own coverage and reimbursement policies and depend on individual insurance plans and negotiated contracts with physicians and hospitals
        • Contracted prices may be based on fee schedules, invoices, or other payment methodologies such as average selling prices
          • Sites should review their payor contracts to determine specific payment methodology
        • Commercial payors may also require additional documentation to grant coverage or obtain prior authorization for Xofigo
        • Patients may be responsible for a copay and deductible based on their individual insurance plan
        • Please consult local payors for specific claims-submission guidance
        • Financial assistance options are available for eligible patients in need 

         

        Learn about copay assistance with Xofigo

          Claims processing

          Providing documentation will support payors in processing a claim for Xofigo.

          • FDA approval letter for Xofigo
          • Patient medical history
          • Physician’s clinical notes on the patient’s condition
          • Invoice for Xofigo

           

          In the event the payor made an error in processing the claim, the administering provider’s office should contact the payor to discuss the processing issue in order to allow the patient access to Xofigo.

            Claims appeal

            When appealing a denied claim, payors may request additional documentation (if not submitted with the original claim), including:

            • Sample letter of appeal
            • Copy of the original claim
            • Copy of denial notification from payor
            • Xofigo Prescribing Information
            • FDA approval letter
            • Copy of invoice
            • Patient medical history, including clinical notes
            • Copy of referring physician’s order

            Helpful resources

            Alt text

            Xofigo® Access Services Patient Assistance Application PDF

            Register qualified uninsured and underinsured patients for the Patient Assistance Program
            Alt text

            Xofigo Access Services Enrollment Form for Providers PDF

            Request insurance benefit verification services for your patients or order Xofigo through Xofigo Access Services
            Alt text

            Xofigo Access Services Enrollment Form for VA/DoD PDF

            Order Xofigo for your Veterans Affairs (VA)/Department of Defense (DOD) patients through Xofigo Access Services

            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: 06/22

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