Biogen Announces Reduced Price for ADUHELM® to Improve Access for
Patients with Early Alzheimer’s Disease
Biogen Inc. (Nasdaq: BIIB) today announced that, effective January
1, 2022, it will reduce the wholesale acquisition cost (WAC) of
ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use
in the United States by approximately 50%. For a patient of average
weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg)
will be $28,200.
“Over the past several months, we have listened to the feedback
of our stakeholders, and we are now taking important actions to
improve patient access to ADUHELM,” said Michel Vounatsos, Chief
Executive Officer at Biogen. “Too many patients are not being
offered the choice of ADUHELM due to financial considerations and
are thus progressing beyond the point of benefitting from the first
treatment to address an underlying pathology of Alzheimer’s
disease. We recognize that this challenge must be addressed in a
way that is perceived to be sustainable for the U.S. healthcare
system.”
Biogen is taking this action with the goal of lowering
out-of-pocket expenses for patients and reducing the potential
financial implications for the U.S. healthcare system. ADUHELM’s
reduced price takes into consideration the questions raised about
this first class of therapies, the potential eligible population
and revised pharmaco-economic assumptions. Biogen believes with
insurance coverage, and access to diagnostics and specialized
centers, approximately 50,000 patients may initiate treatment with
ADUHELM in 2022.
Mr. Vounatsos added, “It is a critical time for the Alzheimer’s
disease community as the Centers for Medicare and Medicaid Services
(CMS) is considering the possibility of coverage of not only
ADUHELM, but also this entire new class of Alzheimer’s disease
therapies. We hope our actions today will facilitate patient access
to these innovative Alzheimer’s treatments.”
The reduced price is part of the Company’s ongoing commitment to
further inform treatment choice. Biogen recently presented new
p-tau181 biomarker data at the Clinical Trials on Alzheimer’s
Disease conference (CTAD) and announced its plan to complete the
Phase 4 confirmatory post marketing study of ADUHELM in an
accelerated timeline of four years. ADUHELM’s accelerated approval
by the U.S. Food and Drug Administration has served as a catalyst
for significant investment and additional research and innovation
for Alzheimer’s disease.
Biogen also announced that it will implement a series of
cost-reduction measures in 2022 to better align its costs with its
revenue base, which is expected to be impacted by the continued
entry of generics in multiple sclerosis, as well as the delayed
uptake of ADUHELM. The cost-reduction measures are estimated to
yield approximately $500 million in annualized savings, a
significant portion of which will be realized in 2022. A portion of
these savings will be offset by investments in Biogen’s pipeline
and strategic initiatives. Further details will be finalized in the
coming weeks and will be communicated in the first quarter of
2022.
Mr. Vounatsos said, “These are difficult decisions necessary to
sustain our mission to develop medicines for the most devastating
neurological diseases. We must bring our cost base in-line so we
can continue to invest in future innovation and growth, retain and
compete for outstanding talent, and provide acceptable returns to
our shareholders.”
About ADUHELM®
(aducanumab-avwa) 100 mg/mL injection for intravenous
useADUHELM is indicated for the treatment of Alzheimer’s
disease. Treatment with ADUHELM should be initiated in patients
with mild cognitive impairment or mild dementia stage of disease,
the population in which treatment was initiated in clinical trials.
There are no safety or effectiveness data on initiating treatment
at earlier or later stages of the disease than were studied. This
indication is approved under accelerated approval based on
reduction in amyloid beta plaques observed in patients treated with
ADUHELM. Continued approval for this indication may be contingent
upon verification of clinical benefit in confirmatory trial(s).
Aducanumab-avwa is a monoclonal antibody directed against
amyloid beta. The accumulation of amyloid beta plaques in the brain
is a defining pathophysiological feature of Alzheimer’s disease.
The accelerated approval of ADUHELM has been granted based on data
from clinical trials showing the effect of ADUHELM on reducing
amyloid beta plaques, a surrogate biomarker that is reasonably
likely to predict clinical benefit, in this case a reduction in
clinical decline.
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.
Although most people 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. ADUHELM can also cause serious allergic
reactions. The most common side effects of ADUHELM include:
swelling in areas of the brain, with or without small spots of
bleeding in the brain or on the surface of the brain (ARIA);
headache; and fall. Patients should call their healthcare provider
for medical advice about side effects.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating
on the global co-development and co-promotion of aducanumab.
Please click here for full Prescribing Information, including
Medication Guide, for ADUHELM.
Cost, Coverage and Co-Pay AssistanceThe WAC of
ADUHELM, which is an infusion once every four weeks, will be
$2,171.40 per infusion for a patient of 74 kg – the average weight
of a U.S. patient with mild cognitive impairment (MCI) or mild
dementia. A 170 mg vial will be $479.40 and a 300 mg vial will be
$846.00. The yearly cost at the maintenance dose (10 mg/kg) would
be $28,200. The cost during the first year of treatment will be
$20,500 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.
For patients facing difficulty affording ADUHELM, financial
assistance programs are available. For more information, please
contact Biogen Support Services at 1-833-425-9360.
About Alzheimer’s Disease 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 hours1 of unpaid care
in 2020. The annual cost of care for Alzheimer’s disease and other
dementias in the U.S. is over $600 billion1 and lifetime care for
someone with Alzheimer’s disease is estimated to cost approximately
$500,000 per patient2, which is primarily borne by patients’
families as an out-of-pocket expense. It is important to note that
in the U.S., nursing home costs per patient are approximately
$100,0001 per year.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological 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, Sir 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, and is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
investors on its website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen on social
media
– Twitter, LinkedIn, Facebook, YouTube.
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, about the potential clinical effects
of ADUHELM; the potential benefits, safety and efficacy of ADUHELM;
the treatment of Alzheimer’s disease; the anticipated benefits and
potential of Biogen’s collaboration arrangements with Eisai;
clinical development programs, clinical trials and data readouts
and presentations; 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 unexpected concerns
that may arise from additional data, analysis or results obtained
during clinical trials; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
hurdles; failure to protect and enforce Biogen’s data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks associated with
current and potential future healthcare reforms; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
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.
References:
- Alzheimer’s Association. 2021 Alzheimer’s disease facts and
figures.
- Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz
KM. Societal and family lifetime cost of dementia: implications for
policy. J Am Geriatr Soc. 2017.
MEDIA CONTACT:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:BiogenMike Hencke+1 781 464
2442IR@biogen.com |
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024