Amgen and Centocor Ortho Biotech Products Launch ESA APPRISE Program for Safe Use of Erythropoiesis-Stimulating Agents

Strategic Insights -

The US Food and Drug Administration (FDA) has approved a Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp, EPOGEN, and PROCRIT. As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. The ESA APPRISE Oncology Program will be launched on March 24, 2010, to ensure continued access to ESAs for healthcare providers who prescribe or dispense ESAs to patients with cancer.

Key Takeaways:

  • The FDA has approved a REMS for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence in patients with certain types of cancer.
  • The ESA APPRISE Oncology Program will require healthcare providers to train and enroll in the program, provide a Medication Guide to patients, and document a discussion about the risks of ESAs before initiating treatment.
  • The goal of the ESA REMS is to support informed decisions between patients and healthcare providers considering treatment with Aranesp, EPOGEN, or PROCRIT, and to mitigate the risk of decreased survival and/or poorer tumor outcomes.
  • The ESA APPRISE Oncology Program will be launched on March 24, 2010, and will require healthcare providers to train and enroll in the program, provide a Medication Guide to patients, and document a discussion about the risks of ESAs before initiating treatment.
  • Amgen and Centocor Ortho Biotech Products will distribute a Dear Healthcare Provider letter introducing the program, providing the rationale, program objectives, training and enrollment requirements, and consequences for non-enrollment.
  • The program will be accessible through a website and hotline, and healthcare providers will be able to train and enroll in the program by contacting their local field representative or accessing the website.

Statistics:

  • The REMS will require healthcare providers to enroll in and comply with the ESA APPRISE Oncology Program to prescribe or dispense Aranesp, EPOGEN, or PROCRIT to patients with cancer.
  • The program will be launched on March 24, 2010, and will require healthcare providers to train and enroll in the program.
  • The Medication Guide will be provided to all patients receiving ESAs, and healthcare providers must document a discussion about the risks of ESAs before initiating treatment.
  • Amgen and Centocor Ortho Biotech Products will distribute a Dear Healthcare Provider letter introducing the program, providing the rationale, program objectives, training and enrollment requirements, and consequences for non-enrollment.

Sources:

  • "Companies To Launch ESA APPRISE Program On March 24, 2010 For Patients With Cancer Medication Guide Available For All Indications" (PR Newswire-FirstCall, Feb. 16 /PRNewswire-FirstCall/)
  • Amgen Forward-Looking Statements (Amgen, Feb. 16, 2010)
  • Amgen Therapeutics Have Changed the Practice of Medicine (Amgen, 1980)
  • "Erythropoiesis-Stimulating Agents (ESAs) for the Treatment of Anemia in Patients with Chronic Renal Failure (CRF)" (Amgen, 2010)
  • "Information about the complete ESA APPRISE Oncology Program" (Amgen, 2010)
  • "Full prescribing information and medication guides" (Amgen, 2010)