TOKYO, Dec 21, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that, effective January 1, 2022, Biogen 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, Biogen has listened to the feedback of our stakeholders. 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. Biogen recognizes that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system and Biogen is now taking important actions to improve patient access to ADUHELM.
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 in 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.
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 that mainly have Abeta removing effects. We hope the 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.
In addition, the reduced price will have a minor impact on the consolidated result forecasts for the period ended March 31, 2022. There are no changes to the consolidated financial forecast announced on November 1, 2021.
About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use
ADUHELM 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.
Cost, Coverage and Co-Pay Assistance
The 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.
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Source: Eisai
Copyright 2021 JCN Newswire . All rights reserved.
Over the past several months, Biogen has listened to the feedback of our stakeholders. 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. Biogen recognizes that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system and Biogen is now taking important actions to improve patient access to ADUHELM.
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 in 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.
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 that mainly have Abeta removing effects. We hope the 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.
In addition, the reduced price will have a minor impact on the consolidated result forecasts for the period ended March 31, 2022. There are no changes to the consolidated financial forecast announced on November 1, 2021.
About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use
ADUHELM 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.
Cost, Coverage and Co-Pay Assistance
The 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.
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Source: Eisai
Copyright 2021 JCN Newswire . All rights reserved.
