THOUSAND OAKS, Calif.,
Oct. 24, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that effective
Dec. 31, 2019, Repatha®
(evolocumab), an innovative treatment for patients with high
cholesterol and cardiovascular disease proven to reduce heart
attacks and strokes, will be distributed exclusively at the 60%
lower list price of $5,850 per year
and will no longer be available at its original list price.
"One year ago, Amgen announced a commitment to improve patient
affordability, particularly for Medicare patients, in order to
ensure that every patient who needs Repatha, gets Repatha. The
discontinuation of the original list price option is a critical
step in delivering on this commitment," said Murdo Gordon, executive vice president of Global
Commercial Operations at Amgen.
Amgen introduced the lower list priced option of Repatha in
October 2018 to reduce out-of-pocket
costs, especially for Medicare patients. To minimize disruption in
the supply chain and allow time for payers and pharmacy benefit
managers (PBMs) to modify existing contracts, Amgen continued to
offer the original list price option of Repatha. Through
contracting, Amgen continues to offer all PBMs and health plans
equivalent or better net pricing on the lower list price option of
Repatha.
"We have seen significant improvements in access and
affordability, but not all Medicare patients are benefitting from
these improvements because some Medicare Part D plans have not
transitioned to the lower list price option of Repatha. Almost half
of all Medicare patients who are prescribed Repatha will have an
affordable co-pay of less than $50 in
2020, but that means that the other half will still face
affordability challenges that need to be addressed. We are
discontinuing the original list price option so that payers and
Medicare Part D health plans have clarity and can do their part:
cover the lower list price option of Repatha to help every patient
prescribed Repatha fill their prescription at an affordable, low
fixed dollar co-pay," continued Gordon.
A recent observational study sponsored by the Familial
Hypercholesterolemia (FH) Foundation published in Circulation:
Cardiovascular Quality and Outcomes showed that patients who
were unable to get their prescribed PCSK9 inhibitor experienced
more cardiovascular (CV) events than patients who received their
prescription. Furthermore, women, minorities and individuals with
low incomes were more likely to have rejected or unfilled
prescriptions.
"Heart disease is a leading public health issue in the U.S. When
individuals with established heart disease and FH face obstacles to
getting their prescribed lipid-lowering medications, it has
devastating effects on their health. We are pleased that
Amgen is taking this additional step to remove barriers that stand
in the way of patients getting the care they need," said
Katherine A. Wilemon, founder and
chief executive officer of the FH Foundation.
Amgen will work with payers, wholesalers and pharmacies to phase
out supply of the original list price national drug codes (NDCs)
through the remainder of 2019 and to return any remaining inventory
of the discontinued NDCs in 2020.
Burden of Cardiovascular Disease
Cardiovascular
disease (CVD) remains one of the most pressing public health issues
in the U.S., with someone in the country experiencing a heart
attack every 40 seconds.1 LDL-Cholesterol, also known as
bad cholesterol, is one of the most important modifiable risk
factors for having a heart attack.2,3 About seven out of
10 adults in the U.S. with CVD have elevated LDL-C, despite optimal
lipid-lowering treatment.4 Additionally, 43% of patients
who have had a CV event, such as heart attack, will have at least
one new event within two years.5,6 Professional
guidelines around the world, including the American Heart
Association , the American College of Cardiology and the
European Society of Cardiology call for more intensive reduction of
LDL-C.7,8 The guidelines confirm the lower the LDL-C
value, the lower the risk of future CV events for patients with
CVD, and recommend intensive lipid-lowering treatment for very
high-risk patients.
About Repatha® (evolocumab)
Repatha 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.
Repatha is approved in more than 60 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.
Important U.S. Product Information
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9)
inhibitor antibody indicated:
- to reduce the risk of myocardial infarction, stroke, and
coronary revascularization in adults with established
cardiovascular disease.
- as an adjunct to diet, alone or in combination with other
lipid-lowering therapies (e.g., statins, ezetimibe), for treatment
of adults with primary hyperlipidemia (including heterozygous
familial hypercholesterolemia [HeFH]) to reduce low-density
lipoprotein cholesterol (LDL-C).
- as an adjunct to diet and 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 safety and effectiveness of Repatha have not been
established in pediatric patients with HoFH who are younger than 13
years old or 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. Serious hypersensitivity reactions including angioedema
have occurred in patients treated with Repatha.
Allergic reactions: Hypersensitivity reactions (e.g.
angioedema, 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 patients treated with Repatha and occurring more
frequently than placebo) were: nasopharyngitis, upper respiratory
tract infection, influenza, back pain, and injection site
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.
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%).
The most common adverse reactions in the Cardiovascular Outcomes
Trial (>5% of patients treated with Repatha and occurring more
frequently than placebo) were: diabetes mellitus (8.8% Repatha,
8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and
upper respiratory tract infection (5.1% Repatha, 4.8%
placebo).
Among the 16,676 patients without diabetes mellitus at baseline,
the incidence of new-onset diabetes mellitus during the trial was
8.1% in patients assigned to Repatha compared with 7.7% in those
assigned to placebo.
Homozygous Familial Hypercholesterolemia (HoFH): The
adverse reactions that occurred in at least two patients treated
with Repatha and more frequently than placebo were: upper
respiratory tract infection, influenza, gastroenteritis, and
nasopharyngitis.
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. 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 biologics manufacturing 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 the world's largest
independent biotechnology company, 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 any statements on the
outcome, benefits and synergies of the acquisition of
Otezla® (apremilast), including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion, as well as
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 current reports on 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, including our devices, 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,
including in Puerto Rico, 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. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. 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 or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product 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. A
breakdown, cyberattack or information security breach could
compromise the confidentiality, integrity and availability of our
systems and our data. 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. We may not be able to access the capital and credit markets
on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-447-0974
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Benjamin EJ, et al. Circulation. 2017;135:e146-e603.
- Goldstein JL, et al. Arterioscler Thromb Vasc Biol.
2009;29(4):431-438.
- Yusuf S, et al. Lancet. 2004;364:937-952.
- Data on File, Amgen; 2018.
- Data on File, Amgen; 2018.
- Punekar R, Fox KM, Richhariya A, et al. Burden of first and
recurrent cardiovascular events among patients with hyperlipidemia.
Clin Cardiol. 2015;38:483-491.
- Mach F, et al. European Heart Journal. 2019;ehz455.
- Grundy SM, et al. JACC. 2018; 1-80.
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