| West Virginia Oncology Society |
Who:
On February 16, 2010 the U.S. FDA approved a risk evaluation and mitigation strategy (REMS) that
will affect all hospitals and medical practices using erythropoiesis-stimulating agents (ESAs).
What:
The medications included in the program are Aranesp®, Epogen® and Procrit®. FDA required
Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating
that use of ESAs can increase the risk of tumor growth and shorten survival in patients with
cancer. Studies conducted in patients with cancer and in patients with renal failure also show that
use of ESAs can increase the risk of myocardial infarction, CHF, stroke and thrombotic events.
Richard Pazdur, director of FDA's Office of Oncology Drug Products said "these risks are unique to
oncology patients and are not observed when ESAs are used for other labeled indications, such as
treatment of anemia in patients with kidney disease".i
Requirements:
When:
Providers will have until February 16, 2011 to be in full compliance. Once the program is fully
implemented, only facilities and practitioners that are in full compliance will be able to order ESAs
for use in patients with cancer.
Why:
FDA is requiring aREMS to ensure the safe use of ESAs because studies show that ESAs can
increase the risk of tumor growth and shorten survival in patients with cancer who use these
products. Studies also show that ESAs can increase the risk of heart attack, HF, stroke or blood
clots in patients who use these drugs for other conditions.
______________________________________________________________________
1-Traynor, Kate American Society of Health-System Pharmacists, February 16, 2010
2-American Society of Clinical Oncology (ASCO) Research Policy, February 16, 2010
On February 16, 2010 the U.S. FDA approved a risk evaluation and mitigation strategy (REMS) that
will affect all hospitals and medical practices using erythropoiesis-stimulating agents (ESAs).
What:
The medications included in the program are Aranesp®, Epogen® and Procrit®. FDA required
Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating
that use of ESAs can increase the risk of tumor growth and shorten survival in patients with
cancer. Studies conducted in patients with cancer and in patients with renal failure also show that
use of ESAs can increase the risk of myocardial infarction, CHF, stroke and thrombotic events.
Richard Pazdur, director of FDA's Office of Oncology Drug Products said "these risks are unique to
oncology patients and are not observed when ESAs are used for other labeled indications, such as
treatment of anemia in patients with kidney disease".i
Requirements:
- 1. A Medication Guide explaining the risks and benefits of ESAs must be provided to all
patients receiving ESAs at the start of and throughout therapy.
2. Amgen, in collaboration with Ortho Biotech (markets Epogen®), was required to develop
the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the
Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to
patients with cancer.
3. Amgen will ensure that only those hospitals and healthcare professionals who have
enrolled and completed training in the program will prescribe and dispense ESAs to
patients with cancer. Amgen is required to oversee and monitor compliance with the
program.
4. Requirements for healthcare professionals who prescribes ESAs in patients with cancer:
- a. Complete a training module that covers the use of ESAs for patients with cancers.
Completion of training module is required for enrollment in the ESA APPRISE Oncology
program. (The enrollment form is attached, training takes approximately 15 minutes)
b. Obtain a signed patient/healthcare professional acknowledgement form prior to
initiating a new course of ESA therapy. The acknowledgement form attests that the
healthcare professional and patient have discussed the risks with using an ESA. The
same consent form will be used for all cancer patients. (Form is attached) The
consent form must be faxed to the ESA APPRISE program for tracking. The form is
triplicate; patient takes one copy, one copy in patient's record, and one copy in a
central file onsite for compliance auditing.
c. Re-enroll in the ESA APPRISE Oncology program every 3 years.
d. Healthcare professionals not enrolled in the ESA APPRISE Oncology program cannot
prescribe ESAs for use in patients with cancer.
e. As part of the enrollment in the ESA APPRISE Oncology program, healthcare
professionals must attest to understanding the following:
- i. ESAs shortened overall survival and/or increased the risk of tumor
progression or recurrence in clinical studies in patients with breast, NSCLC,
head and neck, lymphoid and cervical cancer.
ii. Must be enrolled in ESA APPRISE Oncology program to prescribe ESAs for use
in patients with cancer.
iii. To decrease the risks of ESAs, the lowest dose of ESAs to avoid red blood
cell transfusion should be used.
iv. Aranesp is indicated for the treatment of anemia due to concomitantly
administered chemotherapy based on studies that have shown a reduction in
the need for RBC transfusions in patients with metastatic, non-myeloid
malignancies receiving chemotherapy.
v. Epogen/Procrit is indicated for treatment of anemia due to the effect of
concomitantly administered chemotherapy based on studies that have shown a
reduction in the need for RBC transfusion in patients with metastatic, non-
myeloid malignancies receiving chemotherapy for a minimum of 2 months.
vi. ESAs are not indicated for use in patients receiving hormonal agents,
therapeutic biologic products or radiotherapy unless receiving concomitant
myelosuppressive chemotherapy.
vii. ESAs are not indicated for patients receiving myelosuppresive therapy when
the anticipated outcome is cure.
viii. ESA use has not been demonstrated in controlled trials to improve
symptoms of anemia, QOL, fatigue, or patient well-being.
ix. ESAs should be discontinued following completion of a chemotherapy course
of treatment.
When:
Providers will have until February 16, 2011 to be in full compliance. Once the program is fully
implemented, only facilities and practitioners that are in full compliance will be able to order ESAs
for use in patients with cancer.
Why:
FDA is requiring aREMS to ensure the safe use of ESAs because studies show that ESAs can
increase the risk of tumor growth and shorten survival in patients with cancer who use these
products. Studies also show that ESAs can increase the risk of heart attack, HF, stroke or blood
clots in patients who use these drugs for other conditions.
______________________________________________________________________
1-Traynor, Kate American Society of Health-System Pharmacists, February 16, 2010
2-American Society of Clinical Oncology (ASCO) Research Policy, February 16, 2010
What's New. . . . .
| Risk Evaluation and Mitigation Strategy (REMS) By Pam McDevitt |