BIOGEN INC. We are committed to responding to questions from the Alzheimer's disease community and providing more details about our plans.
About ADUHELM treatment and the confirmatory trial
ADUHELM is indicated for the treatment of Alzheimer's disease. 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).
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. ADUHELM can cause serious allergic reactions. The most common side effects include ARIA, headache and fall.
We are working with urgency and putting resources and plans in place towards the goal of completing the confirmatory trial ahead of the nine-year timeframe, with a focus on high quality data. We are advancing the design of the protocol and plan to engage with regulators, investigators and other stakeholders including CMS (
About the Patient Population
In
We do not have data on the more advanced Alzheimer's patients and our engagement with health professionals will be focused on patients in the early symptomatic stage of the disease.
Based on the entry criteria of the clinical trials conducted with ADUHELM, we estimate the appropriate patient population for ADUHELM to be approximately 1-2 million. These are patients who have been clinically diagnosed with mild cognitive impairment or mild dementia suspected to be due to Alzheimer's disease who would have confirmed amyloid beta pathology, if tested.
It is important to note that we do not expect all of these patients will be treated with ADUHELM, for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway and limited capacity of specialists, who we believe will be the primary prescribers of ADUHELM. As a result of these factors, we anticipate that patient uptake will be gradual over a number of years.
About the price of ADUHELM, impact on healthcare budget and patient access
We have determined the launch price of ADUHELM based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. In the event that our fundamental assumptions on population size and rate of adoption are significantly different than expected, we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability.
We have been engaging directly with public and private payers and health systems to ensure coverage policies support access for appropriate patients. For example, we have already announced our intention to enter into innovative access agreements with
We are committed to engaging with CMS on innovative price and access agreements, including but not limited to, volume-based agreements that would help support continued sustainability of Medicare budgets.
As part of our commitment to budget sustainability, Biogen will not be increasing the price of ADUHELM in the first four years following launch.
We are committed to providing access to ADUHELM for patients across a spectrum of financial situations. We operate within the existing health insurance and legal system that limits the company's ability to subsidize out of pocket expenses for Medicare patients while generally allowing such assistance for commercially insured patients.
We estimate that 40% of patients will have an out-of-pocket exposure of approximately
We believe a further 50% of patients will have a cap on out-of-pocket expenses, either because they are covered through a Medicare Advantage plan with a Maximum Out-of-Pocket (MOOP) or because they have a form of secondary coverage (e.g., employee retiree coverage).
We also acknowledge that an estimated 10% of patients, those who do not have supplemental Medicare coverage, will potentially have an out-of-pocket exposure of 20% of the costs. For patients facing difficulty affording ADUHELM, financial assistance programs are available that may help eligible patients. For more information, please contact
We stand ready to work with payers, including CMS, to create innovative agreements which could lower patient co-payment shares or out-of-pocket expense for patients treated with ADUHELM. We believe in the need to reform patient insurance benefit structures to reflect innovation.
About Health Equity
Biogen and
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.
To start, we have signed agreements with
We will continue to prioritize health equity in our programs moving forward including collecting more data from underserved and underrepresented populations.
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.
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.
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
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
At
Biogen Safe Harbor
This statement contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: Biogen's strategy and plans; potential of, and expectations for, Biogen's commercial business, including ADUHELM; the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; access to and reimbursement for ADUHELM; the treatment of Alzheimer's disease; the anticipated benefits and potential of our collaboration arrangements with
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: 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; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including ADUHELM; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; actual timing and content of submissions to and decisions made by the regulatory authorities regarding ADUHELM; the occurrence of adverse safety events, restrictions on use or product liability claims; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; third party collaboration risks; risks associated with current and potential future healthcare reforms; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition and any other risks and uncertainties that are described in other reports Biogen has filed with the
Contact:
Tel: +1-781-464-3260
Email: public.affairs@biogen.com
(C) 2021 Electronic News Publishing, source
