Amgen Cites Evidence that Majority of EPOGEN(R) Use Has Been
Appropriate Over Time and Shares New Data Showing More Conservative
Dosing in Response to Updated CMS Policy and Product Labeling
Company Says Data Shows No Compelling Rationale for Congress to
Mandate Untested Changes to Payment System
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 26, 2007--Amgen
(NASDAQ:AMGN) today submitted testimony for the record of the House
Ways & Means Subcommittee on Health hearing on "Ensuring Kidney
Patients Receive Safe and Appropriate Anemia Management Care."
Amgen cited data in its testimony showing that the majority of
EPOGEN(R) (Epoetin alfa) use in dialysis has been and continues to be
appropriate. When examined over time, 83 percent of patient hemoglobin
excursions above 12 g/dL fall below 12 g/dL within three months.
Amgen also highlighted new analyses of U.S. dialysis data showing
that physicians are using EPOGEN even more conservatively since the
Centers for Medicare & Medicaid Services (CMS) announced the
Erythropoietin Monitoring Policy (EMP) in November 2005 and the U.S.
Food and Drug Administration (FDA) made changes to the product
labeling for Erythropoiesis Stimulating Agents (ESAs), including
EPOGEN, in March 2007.
"Amgen is committed to the highest standards of patient safety.
The well-being of patients is Amgen´s top priority as is the
appropriate use of all of our products," said Joshua Ofman, M.D.,
M.S.H.S., vice president of Global Coverage and Reimbursement at
Amgen. "Based on the best available scientific evidence and
utilization data, there does not appear to be a compelling policy or
clinical rationale to immediately make fundamental, untested changes
to the dialysis payment system."
Current Utilization Data
The new analyses cited in Amgen´s testimony are based on dialysis
data collected through April 2007, representing approximately 80
percent of all U.S. dialysis patients. This data indicates:
-- The percentage of patients with hemoglobin levels between
11-12 g/dL is increasing (from 26.3 percent in January 2007 to
27.7 percent in April 2007).
-- The percentage of patients with hemoglobin levels greater than
13 g/dL is declining (from 26 percent in January 2007 to 23.6
percent in April 2007).
-- Physicians are decreasing EPOGEN doses more frequently in
response to elevated hemoglobin levels. (In April 2007, 81
percent of hemoglobin excursions above 13 g/dL were followed
by a physician reducing ESA dose within 30 days, compared to
72 percent in November 2005 when the EMP was announced. In
April 2007, 49 percent of hemoglobin excursions between 12
g/dL and 13 g/dL were followed by a physician reducing ESA
dose within 30 days, compared to 37 percent in January 2007).
"When considering the impact of current reimbursement policies and
revised product labeling on patient care it´s important to look at
data collected after current changes were made and communicated to the
community," explained Robert Brenner, M.D., executive director,
Nephrology Medical Affairs at Amgen. "Although these policies have
only been in effect for a short period of time, we´re seeing early
indication that changes in clinical practice patterns are underway.
The full impact has not yet been determined."
Patient Risks, Financial Costs of Underutilization
Citing documented risks to patients and potential increased
healthcare costs associated with dialysis patient hemoglobin levels
below 11 g/dL, Amgen cautioned Congress against changing Medicare ESA
payment policy using untested mechanisms that could have the harmful
consequence of negatively impacting the quality of care for Medicare
beneficiaries receiving dialysis.
Hemoglobin levels less than 11 g/dL are associated with increased
hospitalization, mortality and healthcare expenditures. CMS has an
established Clinical Performance Measure (CPM) for all dialysis
clinics that evaluates the percentage of patients with hemoglobin
levels above 11 g/dL, and publishes this data on its web site for
patients and providers to monitor clinical performance.
Amgen´s testimony notes that Medicare per unit expenditures for
EPOGEN have decreased over time, from $10 per 1,000 units in 1994-2004
to $9.10 per 1,000 units in July 2007. Since the reimbursement method
for EPOGEN switched to average sales price (ASP) +6 percent in 2006,
per unit Medicare payments for EPOGEN have decreased by almost 7
Amgen addressed concerns about rising total CMS expenditures for
EPOGEN. The testimony notes that increased overall expenditures are a
consequence of steady growth in the dialysis patient population,
meaningful improvement in meeting CMS´ quality standards on dialysis
patient health, and an increasingly sicker dialysis population with
higher EPOGEN requirements.
Science-Based, Patient-Focused Reimbursement Policy
"Amgen believes that any changes considered to the dialysis
payment system should have a strong policy or clinical rationale,
promote access and quality of patient care, and be financially viable
for dialysis providers, patients and taxpayers," explained Ofman.
One potential change to reimbursement involves a new payment
system that would bundle government payment for dialysis services with
separately billable dialysis drugs. According to Amgen´s testimony,
bundled payment systems create powerful financial incentives to save
money by underutilizing and withholding needed medical services.
Bundling methodologies should be balanced with a robust and clinically
valid risk-adjustment system, as well as an agreed-upon set of quality
safeguards, or they may result in the under-treatment of vulnerable
Amgen points to the potential for serious unintended consequences
to specific dialysis populations, in particular those patients who are
treated by smaller, independent dialysis facilities, including in
rural areas and centers located in underserved urban areas. Amgen
cites these potential consequences of a fully bundled system in urging
Congress to wait for the results of a demonstration project to test a
bundled system in dialysis, as currently mandated by the Medicare
Prescription Drug, Modernization, and Improvement Act (MMA).
Appropriate Anemia Management
Before the advent of EPOGEN, physicians had few options for
treating anemia in dialysis patients and had to rely on blood
transfusions. Unfortunately, chronically administered blood
transfusions put patients at risk for complications such as
blood-borne infections and antibody responses that limit the chances
for a successful kidney transplant.
On March 9, 2007, the FDA and Amgen announced that a black box
safety warning was being added to all ESA labels, including new
guidance for dosing and administration. The updated label states
physicians should use the lowest dose of EPOGEN that will gradually
increase the hemoglobin concentration to the lowest level sufficient
to avoid the need for red blood cell transfusions and not to exceed 12
According to Amgen´s testimony, the nephrology community consensus
is that a hemoglobin target range of 11 to 12 g/dL minimizes risk and
maximizes benefit in dialysis patients, but due to the severity of
additional disease burden and inherent natural hemoglobin variability,
dialysis patients are very difficult to consistently maintain within
this relatively narrow hemoglobin range.
The testimony also underscores that when used as directed by the
FDA-approved package insert, EPOGEN has been shown to be safe and
effective in multiple clinical trials, and has over a decade and half
of safety monitoring in real-world use in almost 1.4 million dialysis
patients for a total exposure of approximately 3.8 million
U.S. Dialysis Patient Population
The U.S. Renal Data System reports that prevalent dialysis
patients have more than doubled since 1988. About one-third of U.S.
dialysis patients are African-American and one in seven is Hispanic.
Dialysis patients typically carry a heavy burden of other medical
conditions, including high blood pressure, diabetes, heart disease and
Some members of Congress have raised questions about differences
in ESA utilization between the United States and Europe. Amgen´s
testimony states that the differences in ESA dose across world regions
can be explained in part by differences in patient co-morbidities,
race and dialysis vascular access type, as well as hemoglobin
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people´s lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
CONTACT: Amgen, Washington, D.C.
Kelley Davenport, 202-585-9637 (media)
Amgen, Thousand Oaks
Dan Whelan, 805-447-5995 (media)
Arvind Sood, 805-447-1060 (investors)