Alzheimer's Breakthrough: FDA Approves New Biogen Drug

Diane Lilli
Posted

There is some strong hope brewing for Alzheimer's patients today. The FDA approved Biogen Inc's (BIIB.O)  drug for Alzheimer's for patients suffering from this tragic disease.

Aduhelm is now going to be the only go-to drug that can offer some hope for patients, especially in the early stages of the disease.  Though it is not a cure, it is considered the only drug on the market that can slow the decline of a patient's devastating symptoms.

 Biogen's newly approved drug is the first in history to slow the decline in Alzheimer's patients, and not just attempt to treat symptoms of the devastating disease.

Aduhelm is a monoclonal antibody. This drug impacts brain proteins that in Alzheimer's patients create a damaging plaque that impacts brain function, including thinking and memory.  symptoms.

However, it is not a cure. And, there is also some controversy in regard to the new drug.  

Biogen conducted two trials of Aduhelm, and in 2019 reported a low chance of it working. However, due to some data not being included in one of the trials, the company reported they had success in that trial.  The FDA used their "accelerated approval" process for the drug since patients had zero options for any help treating Alzheimer's.

Here is the full press release with important information from Biogen.

Click here to read a letter from the CEO of Biogen.

Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access ADUHELM™
JUNE 7, 2021  INVESTOR RELATIONS
 

Programs now available to support patients and families with their treatment journey

Collaborations with Veterans Health Administration, CVS Health and NAFC focused on health disparities in underserved communities

Value-based agreements in progress with Cigna and other payers

CAMBRIDGE, Mass. and WOODCLIFF LAKE, N.J., June 07, 2021 (GLOBE NEWSWIRE) -- 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.

Because the FDA did use this "accelerated approval" process, the agency did not adhere to their typical standards of proof of success as compared to other drug approvals.

However, the FDA is often criticized for taking many years to approve drugs other countries already successfully use for numerous serious diseases and other conditions. 

Numerous researchers are calling. this new drug the biggest breakthrough of the century. 

The small study plus one of the larger Biogen studies yielded positive results, meaning it did slow down the decline of memory, thinking, and brain function due to Alzheimer’s.

It is. expected that 600 new sites will be open in the next few months, and that insurance will cover this drug.

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