Soleo Health, an innovative leader and national provider of complex specialty pharmacy services, announced today it is urging Centers for Medicare & Medicaid Services (CMS), US Department of Health & Human Services to allow patient access to monoclonal antibodies directed against Amyloid for the treatment of Alzheimer’s Disease.
The Company’s position is in direct response to CMS’ Decision Memo CAG-00460N, which limits coverage of U.S. Food & Drug Administration (FDA)-approved monoclonal antibody treatment for Alzheimer’s Disease. The proposed National Coverage Determination (NCD) by CMS will unnecessarily limit patient access to important treatment advancements for this devastating disease.
Soleo Health also expressed its opposition to the proposed NCD’s requirement that designates CMS-approved clinical trials be limited to hospital-based outpatient facilities. This requirement creates additional, unnecessary barriers for patients who otherwise could obtain this important therapy. Providing broader access to care delivered in the home or at alternate infusion sites is critical for patients who qualify for this therapy.
Monoclonal antibody treatment for Alzheimer’s Disease has the potential to change the lives of millions of Americans. According to the National Institute on Aging, more than six million people in the U.S. live with Alzheimer’s Disease, about half of whom demonstrate mild symptoms – the target group for this class of drug. Additionally, in the U.S., deaths relating to Alzheimer’s Disease and dementia increased 16 percent during the COVID-19 pandemic. Lastly, in 2021 alone, healthcare and other expenses resulting from Alzheimer’s Disease and other dementias cost the nation $355 billion, as stated by the Alzheimer’s Association here.
“Patient access to innovative therapy treatments is critical to supporting our aging population, including the recent FDA-approved monoclonal antibody treatment for Alzheimer’s patients. We believe new therapeutics for those patients in need could prove extremely beneficial to their well-being and quality of life, while helping manage the overall impact of this devastating disease,” explained Soleo Health Chief Executive Officer Drew Walk.
About Soleo Health
Soleo Health is an innovative national provider of complex specialty pharmacy services administered in the home or alternate sites of care. Soleo Health’s interdisciplinary team comprises highly experienced pharmacists, registered nurses, reimbursement specialists and patient care ambassadors. The Company optimizes patient access solutions and delivers comprehensive services leading to quantifiable clinical and economic value, resulting in a positive patient experience.
Soleo Health operates 21 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states and is accredited by URAC, ACHC Specialty Pharmacy with Distinction in Rare Disease and Orphan Drugs and The Joint Commission.
Visit www.soleohealth.com or connect with Soleo Health on LinkedIn, Facebook and Twitter for more information.
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