![](https://www.worldpharmatoday.com/images/nBanners/Docuvera-728x90.jpeg")
Following today’s U.S. FDA accelerated approval of ADUHELMTM 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 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.”
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.
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.
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.
