Aduhelm, a controversial new Alzheimer's drug, is causing concern. Critics, legislators, and advocates are concerned about the impact that the drug's $56,000-per-year price tag will have on Medicare. The federal insurance program covers approximately 6 million Americans with Alzheimers. It is available to anyone 65 years and older.The cost of Aduhlema intravenous doctor-administered drughas the potential of surpassing the money Medicare spends on all other doctor prescribed drugs.Aduhelm was approved by the Food and Drug Administration earlier in the month. This sparked intense and widespread criticism. Industry watchers and experts have called the decision dangerous and disgraceful, noting that Aduhelm's clinical trials did not prove that it is effective in treating Alzheimers. The criticism was only heightened by the fact that Biogen, Aduhelms' maker, raised the list price.Kaiser Family Foundation did an analysis this month and found that if only a quarter of 2 million Medicare beneficiaries used an Alzheimers treatment, or 500,000 beneficiaries, Medicare would spend an estimated $29Billion annually. Medicare spent $37Billion on all drugs administered by doctors in 2019.Stat released Monday a new analysis that pushed the numbers even further. According to Stat, Medicare could spend $334.5 billion annually if all Medicare-eligible seniors with Alzheimers took Aduhelm. Stat stated that $334.5 billion represents nearly half of the total budget for the Department of Defense or approximately 4 million Tesla Model Xs (for people who think in terms of Teslas). This staggering figure is also much higher than Medicare's combined spending on prescription drugs for doctors and retailers, which was about $220 billion in 2019.AdvertisementSevere concernsIt is impossible to predict how many people will take Aduhelm or how long they will stay on the treatment. However, the rising cost estimates are not impossible to predict. Aduhelm was approved by the FDA for use in Alzheimer's patients despite Biogen having only tested it in mild cases. Many patients are eager to test the drug, despite the insufficient efficacy data. Aduhelm is the first drug to be approved for Alzheimer's disease in almost two decades.Critics say that the drug only created false hope for patients and their families as well as weakening regulatory standards. A leading industry watchdog demanded that three FDA officials responsible for the decision to resign or be fired earlier this month. Three of the regulator's expert advisors resigned in protest. These advisors were members of an 11-member panel which overwhelmingly voted against approval in November last year.The drug is now under investigation by the legislature. Last week, Senators. Bill Cassidy M.D. (R-La. ), and Elizabeth Warren, D-Mass. A hearing was requested to address the new and difficult questions that Aduhelm's approval poses for Medicare. The House Committee on Oversight and Reform also announced on Friday that it will be opening an investigation into Aduhelms pricing and approval.We are concerned about the high price of Biogen's new Alzheimers drug Aduhelm, and the process that led it to approval, Reps. Carolyn Maloney (D.N.Y.) said in a joint statement.Biogen and FDA seem to have taken the criticisms in stride so far. Biogen CEO Michel Vounatsos stated that the pricing was justified in a conference call this month. Janet Woodcock, acting FDA Commissioner, said that she doesn't worry about the growing backlash.
