Amgen to Provide New Evidence as Part of a Formal Reconsideration of CMS' National Coverage Determination on ESAs
Revised Class Labeling and Data on Increased Transfusions are Part
of the Growing New Evidence to Revise the Policy
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Nov. 8, 2007--Amgen
(NASDAQ:AMGN) today announced its intention to submit new evidence to
the Centers for Medicare and Medicaid Services (CMS) to support a
reconsideration of the agency's National Coverage Determination (NCD)
on Erythropoiesis Stimulating Agents (ESAs). The Company plans to file
its request shortly.
The oncology community, Amgen, and CMS have worked collaboratively
to arrive at consensus-based, patient-centric provisions for most
aspects of the NCD. However, the Company shares the serious concerns
voiced by physicians and their patients that the hemoglobin ceiling of
10 grams per deciliter (g/dL) should be reconsidered. This restriction
prevents oncologists from effectively managing chemotherapy-induced
anemia with ESAs, subjects Medicare beneficiaries to an untested
treatment regimen that is not based on scientific evidence, and
requires Medicare patients to undergo otherwise avoidable red blood
Upon reconsideration, a revised policy should be implemented,
allowing physicians to follow evidence-based clinical practice
guidelines developed by experts in oncology and hematology and to
exercise discretion to use their best clinical judgment to treat
individual patients based on their unique medical needs. After
consultation with leading scientific and clinical experts, practicing
physicians, and with patients, Amgen intends to base its formal
request for reconsideration on the growing body of new evidence that
supports the need for a change in the hemoglobin ceiling of 10 g/dL,
to enable oncologists to manage patients within the range of 10-12
g/dL recognized to represent the safe and effective use of ESAs. The
body of new evidence includes the following:
- On Oct. 22, the American Society of Hematology and the
American Society of Clinical Oncology revised their
evidenced-based clinical practice guidelines to reflect a
target range of 10 g/dL to 12 g/dL, following a rigorous and
evidence-based review by cancer experts. Again, this treatment
range recommended by the leading clinical authorities in the
United States stands in contrast to the NCD provision that
denies coverage for ESAs above a hemoglobin level of 10 g/dL.
- On Nov. 8, Amgen announced that it has updated the Aranesp(R)
(darbepoetin alfa) and EPOGEN(R)/PROCRIT (Epoetin alfa)
package inserts in collaboration with the U.S. Food and Drug
Administration (FDA). The new package inserts strengthen the
warnings about ESA risks and confirms that physicians should
use the lowest dose that avoids transfusions. Importantly, the
label provides for a physician's discretion to use ESAs to
achieve a hemoglobin level not to exceed the upper safety
limit of 12 g/dL in patients. This approach stands in contrast
to the NCD provision that denies coverage for ESAs above a
hemoglobin level of 10 g/dL.
- On Oct. 29, the European Agency for the Evaluation of
Medicinal Products (EMEA) issued a press release about
upcoming changes to product information for ESAs stipulating a
uniform target hemoglobin range for all ESAs of 10 g/dL to 12
g/dL with a warning not to exceed a concentration of 12 g/dL.
The treatment range approved by the EMEA also stands in
contrast to the NCD provision that denies coverage for ESAs
above a hemoglobin level of 10 g/dL.
- Major U.S. health plans announced that they will continue to
base their coverage policies on evidence-based clinical
practice guidelines and not adopt the NCD. In this regard, the
NCD has created an unprecedented two-tiered healthcare system
based solely on insurance status: one for patients covered by
Medicare and another for those with private healthcare
-On Nov. 4, the German Hodgkins Study Group (GHSG) presented
interim results from an independent investigator-sponsored
study. This is one of the largest randomized trials of ESAs in
patients with Hodgkin's Lymphoma. The interim data show no
significant difference between Epoetin alfa and placebo on
overall survival and serious adverse events. Additionally,
there were significantly less RBC transfusions in the Epoetin
alfa group compared to placebo.
- On Sept. 26, Amgen submitted new data presented at the
European Cancer Conference (ECCO). This analysis suggests that
achieving target hemoglobin levels through the use of red
blood cell transfusions may be associated with less favorable
- In its reconsideration request Amgen will provide new evidence
describing a trend towards increased transfusion utilization
among patients over age 65 who have received chemotherapy in
- On Oct. 22, Amgen announced that it has developed a
comprehensive pharmacovigilence program designed to address
outstanding questions about ESA safety in both investigational
and labeled settings.
- Amgen has implemented a robust risk management plan to ensure
that providers and patients are made aware of important new
data related to ESA safety including communication with
physicians via Dear Health Care Provider letters, and direct
communications to patients via upcoming Medication Guides.
"Amgen is committed to the highest standard of patient safety and
encourages CMS to revise its NCD based on the growing body of
compelling new evidence," said Roger M. Perlmutter, M.D., Ph.D.,
Amgen's executive vice president of Research and Development.
Perlmutter added, "Important revisions in the NCD are needed, so
physicians can deliver cancer care using their best clinical judgment
with the goal of providing the best possible care to Medicare
beneficiaries suffering from cancer."
In the Company's reconsideration request, Amgen intends to request
a narrow revision in the policy designed to allow physicians to treat
patients between a hemoglobin range of 10 to 12 g/dL when such
treatments have been certified as medically appropriate and in a
manner consistent with the new FDA-approved product labeling and the
recently revised evidence-based clinical practice guidelines.
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.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in our Form 10-K for the year ended Dec.
31, 2006, and in our periodic reports on Form 10-Q and Form 8-K. Amgen
is providing this information as of the date of this news release and
does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information,
future events or otherwise.
No forward-looking statement can be guaranteed and actual results
may differ materially from those we project. The Company's results may
be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments (domestic or foreign) involving current and
future products, sales growth of recently launched products,
competition from other products (domestic or foreign) and difficulties
or delays in manufacturing our products. In addition, sales of our
products are affected by reimbursement policies imposed by third-party
payors, including governments, private insurance plans and managed
care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward
managed care and health care cost containment as well as U.S.
legislation affecting pharmaceutical pricing and reimbursement.
Government and others' regulations and reimbursement policies may
affect the development, usage and pricing of our products.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
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side effects or manufacturing problems with our products after they
are on the market. Our business may be impacted by government
investigations, litigation and product liability claims. Further,
while we routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
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on third parties for a significant portion of our manufacturing
capacity for the supply of certain of our current and future products
and limits on supply may constrain sales of certain of our current
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well as for the discovery and development of new products. Discovery
or identification of new product candidates cannot be guaranteed and
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CONTACT: Amgen, Thousand Oaks
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)