Biogen and Eisai launch multiple initiatives to help patients with
Alzheimer’s disease access ADUHELM™
Following today’s U.S. Food and Drug Administration’s (FDA)
accelerated approval of ADUHELMTM (aducanumab-avwa) as the first
and only Alzheimer’s disease treatment to address a defining
pathology of the disease by reducing amyloid beta plaques in the
brain, Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary of
Eisai Co., Ltd., announced a range of programs intended to support
access for all qualified patients, including traditionally
underserved populations. These initiatives aim to help patients and
their families understand the disease, navigate the diagnostic
journey, secure culturally competent care and afford treatment.
“We feel a great sense of purpose and responsibility to turn the
hope of today’s FDA approval of ADUHELM into a reality for people
living with Alzheimer’s disease and their families,” said Alisha
Alaimo, President of Biogen U.S. “We are committed to access and
health equity as top priorities and will continue working with
multiple stakeholders with the goal of helping patients who may
benefit from treatment obtain care as quickly as possible.”
“ADUHELM is the first new treatment for Alzheimer’s disease to
be approved in the U.S. in nearly 20 years, bringing long-awaited
hope for patients and families living with this neurodegenerative
disease,” said Ivan Cheung, Chairman of Eisai Inc. and President,
Neurology Business Group, Eisai Co., Ltd. “It is critically
important for Eisai and Biogen to not only establish these access
programs but to champion their reach, especially in underserved
patient communities.”
Patient Services Now Available
Personal Biogen Support Service Coordinators are now available
to patients and their families to provide one-on-one support. The
service coordinators can answer questions about Alzheimer’s disease
and ADUHELM treatment, assess financial assistance options for
eligible patients, and locate healthcare providers and infusion
sites, among other topics. Biogen Support Service Coordinators can
be reached at 1-833-425-9360.
Biogen and Eisai have also established a program with
Labcorp and Mayo Clinic Laboratories to help physicians
and patients access cerebrospinal fluid (CSF) diagnostic laboratory
testing to aid in the diagnosis of Alzheimer’s disease.
Multiple Collaborations to Address Health
Equity
Biogen and Eisai are committed to addressing health equity for
underserved and underrepresented populations that are at higher
risk for Alzheimer’s disease. Black/African Americans and Latinx
people are disproportionally more likely to develop Alzheimer’s
disease as well as more likely to have missed diagnoses compared to
non-Hispanic white Americans. The ethnically diverse population of
U.S. veterans also faces increased risk for the disease as a result
of their service, including conditions such as post-traumatic
stress disorder, traumatic brain injury, and other factors.
With the Veterans Health Administration (VHA), Biogen is working
to finalize a multi-year agreement in order to support access for
veterans throughout the VHA system. The VHA is the largest
integrated health system in the U.S., with nine million enrolled
veterans, approximately 48 percent of which are over the age of
65.
Biogen has also entered into an initiative with CVS Health
focused on the importance of brain health, screening and disease
education. As part of this effort, cognitive screenings will be
available through CVS Health’s Project Health, a longstanding
health services program helping address care disparities for
uninsured and underinsured Americans, particularly in racially and
ethnically diverse communities. Patients or their caregivers will
be able to consult with onsite healthcare providers about their
personalized screening results. The program is scheduled to begin
in September in the following cities: Atlanta, Boston/Providence,
Charlotte, Charleston/Columbia, Chicago, Dallas/Fort Worth,
Detroit, Houston, Jackson/Memphis, Los Angeles, Miami, New York
City, Philadelphia, and Washington DC.
“We all recognize that the optimal delivery of healthcare
requires multiple stakeholders working together,” said Sree
Chaguturu, M.D., Chief Medical Officer, CVS Caremark. “We are
committed to addressing systemic health disparities in our country,
and this novel initiative is an example of how we can use our
enterprise assets and capabilities to make a real
difference.”
In addition, Biogen is working with The National Association of
Free and Charitable Clinics (NAFC), a nationwide network of 1,400
clinics that focuses on ensuring the medically underserved have
access to affordable quality healthcare. Together, the
organizations intend to develop a program that supports brain
health and culturally competent Alzheimer’s disease education for
patients and healthcare providers within the NAFC member clinic
network.
“Brain health is a vital part of overall health and wellbeing,
but so many people across the United States don’t have the
information or access they need to prevent them from falling
through the cracks of the healthcare system,” said Nicole
Lamoureux, President and Chief Executive Officer of the National
Association of Free and Charitable Clinics. “As a trusted source
for vulnerable communities nationwide, we are proud to work with
Biogen to support NAFC’s clinics with Alzheimer’s disease education
and resources.”
Cost, Coverage, Co-Pay Assistance and Value-Based
Contract with Cigna
Currently, Alzheimer’s disease represents a significant economic
burden for patients, caregivers and society, with more than 11
million Americans providing an estimated 15.3 billion hours of
unpaid care in 2020. The annual cost of care for Alzheimer’s
disease and other dementias in the U.S. is over $600 billion and
lifetime care for someone with Alzheimer’s disease is estimated to
cost approximately $500,000 per patient, which is primarily borne
by patients’ families as an out-of-pocket expense.
Biogen has established the price of ADUHELM based on the overall
value this treatment is expected to bring to patients, caregivers,
and society, while reflecting key principles such as innovation,
access and sustainability. The wholesale acquisition cost (WAC) of
ADUHELM, which is an infusion once every four weeks, is $4,312 per
infusion for a patient of 74 kg–the average weight of a U.S.
patient with mild cognitive impairment (MCI) or mild dementia. The
yearly cost at the maintenance dose (10 mg/kg) would be $56,000.
The cost during the first year of treatment will be lower due to
the titration period. WAC is a list price and not the net price or
the price paid by patients with insurance. The out-of-pocket cost
for patients with insurance will vary depending on their
coverage.
Biogen and Eisai are committed to providing access to ADUHELM
for patients across a spectrum of financial situations. For
qualified, commercially insured ADUHELM patients, co-pay and
infusion cost assistance programs may reduce out-of-pocket costs to
as low as $0. Patients who are covered by Medicare through a
Medicare Advantage plan have a maximum annual out-of-pocket cap.
Most traditional fee-for-service Medicare enrollees also have
secondary coverage (e.g., Medicaid or a supplemental Medigap plan)
that limit out-of-pocket expenses. Medicaid patients have nominal
co-pays.
ADUHELM has been studied in patients with early stages of
Alzheimer’s disease - MCI and mild dementia - with confirmed
presence of amyloid pathology. Biogen and Eisai estimate that
approximately one to two million people in the U.S. who have been
clinically diagnosed with MCI or mild dementia suspected to be due
to Alzheimer’s disease would have confirmed amyloid beta pathology
if tested.
The companies have been working closely with payers to prepare
them for the launch of ADUHELM and support patient access. In that
regard, Biogen and Cigna Corporation, a global health service
company, intend to enter into a value-based contract to ensure that
there is a streamlined path to access treatment for patients
consistent with the population in which ADUHELM was studied. The
parties will also be tracking performance towards certain outcome
metrics for patients.
“Alzheimer’s disease imposes a tremendous burden on patients,
caregivers and society as a whole,” said Dr. Steve Miller,
Executive Vice President and Chief Clinical Officer at Cigna.
“Given the known infrastructure challenges in the U.S., we are
working to ensure that the patients who will benefit most from this
new treatment have a clear path to access it.”
Biogen and Eisai have committed to not increasing the price of
ADUHELM for the next four years.
For patients facing difficulty affording ADUHELM, financial
assistance programs are available. For more information, please
contact Biogen Support Services at 1-833-425-9360.
INDICATION and IMPORTANT SAFETY INFORMATION
INDICATION ADUHELM is a prescription medicine
used to treat people with Alzheimer’s disease.
IMPORTANT SAFETY INFORMATION What is
the most important information a patient should know about
ADUHELM? ADUHELM can cause serious side effects
including: Amyloid Related Imaging Abnormalities or
“ARIA”. ARIA is a common side effect that does not
usually cause any symptoms but can be serious. It is most
commonly seen as temporary swelling in areas of the brain that
usually resolves over time. Some people may also have small spots
of bleeding in or on the surface of the brain with the swelling.
Although most people with swelling in areas of the brain do not
have symptoms, some people may have symptoms such as: headache,
confusion, dizziness, vision changes, and nausea. The patient’s
healthcare provider will do magnetic resonance imaging (MRI) scans
before and during treatment with ADUHELM to check for ARIA.
Patients should call their healthcare provider or go to the
nearest hospital emergency room right away if they have any of the
symptoms listed above. Before receiving ADUHELM,
patients should tell their healthcare provider about all of their
medical conditions, including if: they are pregnant or
plan to become pregnant or are breastfeeding or plan to breastfeed.
It is not known if ADUHELM will harm their unborn baby or if
aducanumab-avwa (the active ingredient in ADUHELM) passes into
breast milk.
What are the possible side effects of ADUHELM? ADUHELM
can cause serious side effects, including: See above “What is the
most important information a patient should know about
ADUHELM?”
Serious allergic reactions. Swelling of the
face, lips, mouth, or tongue and hives have happened during an
ADUHELM infusion. Patients should tell their healthcare provider if
they have any of the symptoms of a serious allergic reaction during
or after an ADUHELM infusion.
The most common side effects of ADUHELM include: swelling in
areas of the brain, with or without small spots of bleeding in or
on the surface of the brain (ARIA); headache and fall. Patients
should call their healthcare provider for medical advice about side
effects. Patients may report side effects to FDA at
1-800-FDA-1088.
Please see full Prescribing
Information, including Medication
Guide.
About ADUHELM (aducanumab-avwa)
ADUHELM (aducanumab-avwa), a human monoclonal antibody, is the
first and only Alzheimer’s disease treatment to address a defining
pathology of the disease by reducing amyloid beta plaques in the
brain. ADUHELM is indicated for the treatment of Alzheimer’s
disease. This indication is granted under accelerated approval
based on reduction in amyloid beta plaques in patients treated
with ADUHELM. Continued approval for this indication may be
contingent upon verification of clinical benefit in
confirmatory trial(s).
Biogen licensed ADUHELM from Neurimmune in 2007 under a
collaborative development and license agreement. Since October
2017, Biogen and Eisai have collaborated on the development and
commercialization of ADUHELM globally.
Full Prescribing Information is available here and at
www.ADUHELM.com.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurological condition that
impairs thinking, memory and independence, leading to premature
death. The disease is a growing global health crisis, affecting
those living with the disease and their families. According to the
World Health Organization (WHO), more than 30 million people
worldwide live with Alzheimer’s disease, and the number will grow
in the years ahead, outpacing the healthcare resources needed to
manage it and costing billions of dollars.
Alzheimer’s disease is characterized by changes in the brain,
including the abnormal accumulation of toxic amyloid beta plaques,
which begins approximately 20 years before patients exhibit
symptoms of the disease. Mild cognitive impairment due to
Alzheimer’s disease is one of the earliest symptomatic stages of
the disease when symptoms start to be more visible and can be
detected and diagnosed.
For more information about Alzheimer’s disease, visit
www.ItsTimeWeKnow.com.
About Biogen
At Biogen, our mission is clear: we are pioneers in
neuroscience. Biogen discovers, develops, and delivers worldwide
innovative therapies for people living with serious neurological
and neurodegenerative diseases as well as related therapeutic
adjacencies. One of the world’s first global biotechnology
companies, Biogen was founded in 1978 by Charles Weissmann, Heinz
Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert
and Phillip Sharp. Today Biogen has the leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, commercializes
biosimilars of advanced biologics, and is focused on advancing
research programs in multiple sclerosis and neuroimmunology,
Alzheimer’s disease and dementia, neuromuscular disorders, movement
disorders, ophthalmology, neuropsychiatry, immunology, acute
neurology, and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our
first thoughts to patients and their families, and helping to
increase the benefits health care provides. As the U.S.
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to discover and develop innovative therapies to
help address unmet medical needs. Eisai is a fully integrated
pharmaceutical business that operates in two global business
groups: oncology and neurology (dementia-related diseases and
neurodegenerative diseases). Our U.S. headquarters, commercial and
clinical development organizations are located in New Jersey; our
discovery labs are in Massachusetts and Pennsylvania; and our
global demand chain organization resides in Maryland and North
Carolina. To learn more about Eisai Inc., please visit us at
www.eisai.com/US and follow us on Twitter and LinkedIn.
Biogen Safe Harbor
This news release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, the potential
clinical effects of ADUHELM; the potential benefits, safety and
efficacy of ADUHELM; Biogen’s strategy and plans; potential of, and
expectations for, Biogen’s commercial business and pipeline
programs, including ADUHELM; planning and timing for the commercial
launch of, and access to, ADUHELM; anticipated manufacturing,
distribution, and supply of ADUHELM; the treatment of Alzheimer’s
disease; the anticipated benefits and potential of Biogen’s
collaboration arrangements with Eisai; the potential of Biogen’s
commercial business and pipeline programs, including ADUHELM; and
risks and uncertainties associated with drug development and
commercialization. These statements may be identified by words such
as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “intend,” “may,” “plan,” “possible,” “potential,”
“will,” “would” and other words and terms of similar meaning. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. Results in early stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements
or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including, without limitation, uncertainty of
success in the development and commercialization of ADUHELM; risks
relating to the launch of ADUHELM, including preparedness of
healthcare providers to treat patients, the ability to obtain and
maintain adequate reimbursement for ADUHELM, and other unexpected
difficulties or hurdles; unexpected concerns that may arise from
additional data or analysis obtained during clinical trials; the
occurrence of adverse safety events, restrictions on use, or
product liability claims; regulatory authorities may require
additional information or further studies, or may fail or refuse to
approve or may delay approval of Biogen’s drug candidates,
including ADUHELM; risks of unexpected costs or delays; the risk of
other unexpected hurdles; risks relating to investment in our
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risks associated with current and potential future healthcare
reforms; risks relating to the distribution and sale by third
parties of counterfeit or unfit versions of our products; and the
direct and indirect impacts of the ongoing COVID-19 pandemic on our
business, results of operations and financial condition. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from Biogen’s expectations in any
forward-looking statement. Investors should consider this
cautionary statement as well as the risk factors identified in
Biogen’s most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
###
MEDIA CONTACT:Biogen Inc.Anna Robinson+1-781-464-3260
public.affairs@biogen.comINVESTOR CONTACT:Biogen Inc.Mike
Hencke+1-781-464-2442IR@biogen.com |
MEDIA CONTACT:Eisai Inc. (U.S. Media)Public Relations
DepartmentTEL: +1-201-753-1945Eisai Co., Ltd. (Media outside the
U.S.)Public Relations DepartmentTEL: +81-(0)3-3817-5120INVESTOR
CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81-(0)3-3817-5327 |
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