Bayer’s Collaboration to Overcome Barriers to Treatment

Editor’s note: This information was provided by Bayer. The article was not verified or reported by U.S. Medicine.

Our military members are a valuable asset to the security of the nation. For putting their lives on the line, they deserve access to the best medical care available—both while in service and after they leave the military. But sometimes barriers to treatment can prevent them from accessing the care they need.

These barriers are often put in place for all the right reasons: Because we need controls to guarantee that the right product gets to the right patient at the right time and place. Unfortunately, for patients who are managing complex, chronic diseases and are at risk for experiencing post-traumatic stress disorder (PTSD) episodes, these controls can prevent them from receiving the treatment they need. In these situations, it is incumbent on all stakeholders in the health system to work together to ensure a patient receives the care they need and deserve in a timely way.

A recent example of this involved a Veteran from the Clement Zablocki Milwaukee VAMC. The Veteran was prescribed Xofigo® (radium Ra 223 dichloride), an injection used to treat patients with castration-resistant prostate cancer, symptomatic bone metastasis and no known visceral disease. The prescribing information notes that Xofigo should be received, used, and administered only by authorized persons in designated clinical settings and patients should have their blood counts monitored at baseline and prior to every dose of Xofigo.

These controls were put in place because the therapy requires precise handling. They were also established because of outcomes from the phase 3 ALSYMPCA trial, the pivotal trial that established Xofigo’s clinical effectiveness, 2% of those individuals experienced bone marrow failure, or ongoing pancytopenia, compared to no patients treated with placebo. As a result, two deaths were attributed to bone marrow failure.

At the time the Veteran was seen, Zablocki VAMC was not licensed to administer Xofigo. Following the passage of Care in the Community Network (CCN), which directly links VA facilities with community providers to ensure Veterans receive timely, high-quality care, the Veteran’s oncologist decided to refer the patient to a nearby licensed facility to treat their prostate cancer. But when the patient arrived at the CCN facility, an event triggered his PTSD. The patient walked out without receiving treatment. Upon returning to the VA, he told his physician he would not go back to the CCN facility at this time.

When the physician heard about the patient’s experience, Zablocki VAMC chief of pharmacy, Rick Purko, immediately contacted Bayer, the maker of Xofigo, to see what could be done to help this Veteran. Ultimately this would require contract execution, certification of the VAMC to receive and administer Xofigo, and training for staff—a process which normally takes up to three months.

The Chief of Medicine at Zablocki VAMC, Dr. Andreea Anton, coordinated with the local Radiation Oncology (Dr. Elizabeth Gore), Medical Oncology, and Nuclear Medicine teams to arrange a training for necessary staff and complete the budgeting process. Bayer worked with administrative staff to finalize the VA contract forms necessary to establish an appropriate budget for treatment. In parallel, Bayer activated a cross-functional team to train staff on the  handling, administering, and disposal of Xofigo. Training for the nuclear medicine and radiation oncology teams was paramount.

Working together, the VA was licensed, conducted staff training, certified their dose calibrator, and received a test dose within 60 days. To ensure all staff were adequately trained, follow-up trainings were coordinated for anyone who could not attend the initial training session.

In just two months, the Bayer and local VA team completed this multi-step process, knowing that a Veteran was awaiting treatment. For Bayer, patients always come first.  But this situation also highlighted another reality: While controls are necessary to guarantee the right product gets to the right patients at the right time and place, they should not become barriers which prevent Veterans from receiving the best potential medical care available.

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 Xofigotreated 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 × 10^9/L, the platelet count ≥100 × 10^9/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 10^9/L and the platelet count ≥50 × 10^9/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

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

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 additional risk and important use information, please see the Full Prescribing Information. You are encouraged to report side effects or quality complaints of the products to the FDA by visiting www.fda.gov/medwatch, or 1-800-FDA-1088

© 2021 Bayer. All rights reserved. BAYER, the Bayer Cross, and Xofigo are registered trademarks of Bayer.

MAC-XOF-US-0107-1      01/21