THOUSAND OAKS, Calif.,
March 19, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced new data from two
studies that showed that for appropriate patients (on-label) in the
U.S., the majority of prescription claims for PCSK9 inhibitors,
such as Repatha® (evolocumab), were initially
rejected. Additionally, one of the studies showed no major
differences in patient characteristics across those approved and
denied, suggesting a utilization management process that is not
driven by any observable clinical criteria. The studies were
presented at the American College of Cardiology 66th
Annual Scientific Session (ACC.17).
"While it is important to ensure that PCSK9 inhibitors are used
in appropriate cases, our data suggest that the current approval
process is lengthy and highly variable by payer. High initial
rejection and slow approval rates may be preventing patients who
could truly benefit from getting these drugs," said Ann Marie Navar, M.D., Ph.D., assistant
professor of medicine at the Duke Clinical Research Institute and
lead study investigator. "This study highlights the need to better
investigate the impact of policies around drug access on the
utilization of novel therapies, including pricing, payments and
reimbursement, and the approval process."
In a retrospective study presented today as Featured Clinical
Research, researchers evaluating 45,029 new PCSK9 inhibitor
prescription claims found an average of 79.2 percent were initially
rejected across commercial and Medicare plans, and of those, 52.8
percent were ultimately rejected. Additionally, 34.7 percent of
prescriptions were abandoned (unfilled) by the patient. Rejection
rates varied by prescribing provider and payer
(p<0.0001). Of prescription claims submitted to
commercial payers, 71.2 percent were ultimately rejected. Among
prescription claims submitted to government payers, 40.0 percent
were ultimately rejected. This analysis did not specifically look
at the patient characteristics of those denied and approved.
(Abstract 415-08)
"Individuals with familial hypercholesterolemia are by
definition at high risk for heart attacks in the prime of their
lives. PCSK9 inhibitors were developed and approved with FH
patients in mind and yet, too often, they are being denied
appropriate therapy for their genetic condition," said Katherine Wilemon, founder and chief executive
officer of The FH Foundation. "All stakeholders in the health care
arena need to live up to their responsibility to get the right
treatments to the right patients."
Results of a second retrospective study of 44,234 new PCSK9
inhibitor prescription claims showed 83 percent of PCSK9 inhibitor
prescription claims were initially rejected, and of those, 57
percent were ultimately rejected. Final rejection rates were higher
in commercially insured patients (69.5 percent) compared to
Medicare patients (42.3 percent). When comparing characteristics of
approved and denied patients, there were no major differences in
baseline statin use, statin intensity, ezetimibe use or history of
co-medication use, including antiplatelet therapy, a clinical
characteristic highly suggestive of atherosclerotic cardiovascular
disease (ASCVD). (Abstract 1258-435)
"The similarities in clinical profiles between accepted and
rejected patients suggest concerning inconsistencies in the
approval-rejection process," said Seth
Baum, M.D., president of the American Society for Preventive
Cardiology and lead study investigator. "These results deepen
concerns that without meaningful improvement in the burdensome
processes and complex access issues, many of our high-risk ASCVD
and FH patients with uncontrolled LDL cholesterol levels will
continue to be denied or delayed access to a PCSK9 inhibitor, an
important and approved treatment option."
In the U.S., there are approximately 11 million people with
ASCVD and/or familial hypercholesterolemia (FH) who have
uncontrolled levels of low-density lipoprotein cholesterol (LDL-C)
over 70 mg/dL, despite treatment with statins or other
cholesterol-lowering therapies.1,2
Estimates based on these access restrictions and real world data
suggest at least 100,000 heart attacks and strokes could have been
avoided last year in the U.S. alone if all of the appropriate
high-risk patients were actually treated with
Repatha.3,4
Amgen is committed to providing personalized support services
for patients and providers in the U.S. through its
RepathaReady™ program. RepathaReady is a
comprehensive suite of services to help patients and providers,
including a Repatha co-pay card for eligible commercial patients,
insurance coverage support and injection training.
Amgen also provides patient assistance for its medicines
marketed in the U.S. in a variety of ways, including free medicines
through The Amgen Safety Net Foundation for qualifying individuals
with no or limited drug coverage.
Payer policies that restrict the ability of appropriate patients
to access medicines are not limited to PCSK9 inhibitors. Other
organizations have recently highlighted concerns with payer
utilization management practices, including the American College of
Cardiology and the American Medical Association along with a
coalition of 16 other organizations.
About
Repatha® (evolocumab)
Repatha® (evolocumab)
is a human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and
inhibits circulating PCSK9 from binding to the low-density
lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR
degradation and permitting LDLR to recycle back to the liver cell
surface. By inhibiting the binding of PCSK9 to LDLR, Repatha
increases the number of LDLRs available to clear LDL from the
blood, thereby lowering LDL-C levels.5
Repatha is approved in more than 40 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the European Union. Applications in other countries
are pending.
U.S. Repatha Indication
Repatha® is
indicated as an adjunct to diet and:
- Maximally tolerated statin therapy for treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of low-density lipoprotein cholesterol
(LDL-C)
- Other LDL-lowering therapies (e.g., statins, ezetimibe, LDL
apheresis) in patients with homozygous familial
hypercholesterolemia (HoFH) who require additional lowering of
LDL-C
The effect of Repatha® on cardiovascular
morbidity and mortality has not been determined.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with HoFH who are
younger than 13 years old.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with primary
hyperlipidemia or HeFH.
Important U.S. Safety
Information
Contraindication:
Repatha® is contraindicated in patients with a
history of a serious hypersensitivity reaction to
Repatha®.
Allergic reactions: Hypersensitivity reactions
(e.g., rash, urticaria) have been reported in patients treated with
Repatha®, including some that led to discontinuation of
therapy. If signs or symptoms of serious allergic reactions occur,
discontinue treatment with Repatha®, treat according to
the standard of care, and monitor until signs and symptoms
resolve.
Adverse reactions: The most common adverse reactions
(>5% of Repatha®-treated patients and more common
than placebo) were: nasopharyngitis, upper respiratory tract
infection, influenza, back pain, and injection site reactions.
In a 52-week trial, adverse reactions led to discontinuation of
treatment in 2.2% of Repatha®-treated patients and 1% of
placebo-treated patients. The most common adverse reaction that led
to Repatha® treatment discontinuation and occurred
at a rate greater than placebo was myalgia (0.3% versus 0% for
Repatha® and placebo, respectively).
Adverse reactions from a pool of the 52-week trial and seven
12-week trials:
Local injection site reactions occurred in 3.2% and 3.0% of
Repatha®-treated and placebo-treated patients,
respectively. The most common injection site reactions were
erythema, pain, and bruising. The proportions of patients who
discontinued treatment due to local injection site reactions in
Repatha®-treated patients and placebo-treated patients
were 0.1% and 0%, respectively.
Allergic reactions occurred in 5.1% and 4.7% of
Repatha®-treated and placebo-treated patients,
respectively. The most common allergic reactions were rash (1.0%
versus 0.5% for Repatha® and placebo,
respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus
0.2%), and urticaria (0.4% versus 0.1%).
Neurocognitive events were reported in less than or equal to
0.2% in Repatha®-treated and placebo-treated
patients.
In a pool of placebo- and active-controlled trials, as well as
open-label extension studies that followed them, a total of 1,988
patients treated with Repatha® had at least one
LDL-C value <25 mg/dL. Changes to background lipid-altering
therapy were not made in response to low LDL-C values, and
Repatha® dosing was not modified or interrupted on
this basis. Although adverse consequences of very low LDL-C were
not identified in these trials, the long-term effects of very low
levels of LDL-C induced by Repatha® are
unknown.
Musculoskeletal adverse reactions were reported in 14.3% of
Repatha®-treated patients and 12.8% of placebo-treated
patients. The most common adverse reactions that occurred at a rate
greater than placebo were back pain (3.2% versus 2.9% for
Repatha® and placebo, respectively), arthralgia
(2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Homozygous Familial Hypercholesterolemia (HoFH): In
49 patients with homozygous familial hypercholesterolemia studied
in a 12-week, double-blind, randomized, placebo-controlled trial,
33 patients received 420 mg of
Repatha® subcutaneously once monthly. The adverse
reactions that occurred in at least 2 (6.1%)
Repatha®-treated patients and more frequently than in
placebo-treated patients, included upper respiratory tract
infection (9.1% versus 6.3%), influenza (9.1% versus 0%),
gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus
0%).
Immunogenicity: Repatha® is a human
monoclonal antibody. As with all therapeutic proteins, there is a
potential for immunogenicity with Repatha®.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
or 844-REPATHA (844-737-2842) regarding
Repatha® availability or find more information,
including full Prescribing Information,
at www.amgen.com and www.Repatha.com.
About Amgen in the Cardiovascular Therapeutic
Area
Building on more than three decades of experience in
developing biotechnology medicines for patients with serious
illnesses, Amgen is dedicated to addressing important
scientific questions to advance care and improve the lives of
patients with cardiovascular disease, the leading cause of
morbidity and mortality
worldwide.6 Amgen's research into
cardiovascular disease, and potential treatment options, is part of
a growing competency at Amgen that utilizes human
genetics to identify and validate certain drug targets. Through its
own research and development efforts, as well as
partnerships, Amgen is building a robust cardiovascular
portfolio consisting of several approved and investigational
molecules in an effort to address a number of today's important
unmet patient needs, such as high cholesterol and heart
failure.
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by
using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human
biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, 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. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, 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 healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, 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. In addition, our business may be impacted by the adoption
of new tax legislation or exposure to additional tax liabilities.
If we fail to meet the compliance obligations in the corporate
integrity agreement between us and the U.S. government, we could
become subject to significant sanctions. Further, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors, or we
may fail to prevail in present and future intellectual property
litigation. We perform a substantial amount of our commercial
manufacturing activities at a few key facilities and also depend on
third parties for a portion of our manufacturing activities, and
limits on supply may constrain sales of certain of our current
products and product candidate development. In addition, we compete
with other companies with respect to many of our marketed products
as well as for the discovery and development of new products.
Discovery or identification of new product candidates cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate will be successful and become a commercial product.
Further, some raw materials, medical devices and component parts
for our products are supplied by sole third-party suppliers.
Certain of our distributors, customers and payers have substantial
purchasing leverage in their dealings with us. The discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to acquire other
companies or products and to integrate the operations of companies
we have acquired may not be successful. We may not be able to
access the capital and credit markets on terms that are favorable
to us, or at all. We are increasingly dependent on information
technology systems, infrastructure and data security. Our stock
price is volatile and may be affected by a number of events. Our
business performance could affect or limit the ability of our Board
of Directors to declare a dividend or our ability to pay a dividend
or repurchase our common stock.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
- Amgen Data on File.
- Centers for Disease Control and Prevention. Vital signs:
prevalence, treatment, and control of high levels of low-density
lipoprotein cholesterol. United
States, 1999–2002 and 2005–2008. MMWR.
2011;60(4):109–14.
- Value of Improved Lipid Control in Patients at High Risk for
Adverse Cardiac Events. Am J Manag Care. 2016;22(6):e199-e207.
- Amgen Data on File.
- Repatha® U.S. Prescribing Information. Amgen.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed February 2017.
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SOURCE Amgen