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UNITED STATES – April 15: Chiquita Brooks-LaSure appears before the Senate Finance Committee… [+] during her confirmation hearing for the position of Administrator of the Centers for Medicare & Medicaid Services. (Image courtesy of Caroline Brehman/CQ-Roll Call, Inc/Getty Images)
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The Food and Medicine Administration (FDA) approved a controversial new drug to treat Alzheimer’s disease earlier this month. Despite the fact that the FDA approved the medicine for sale, Medicare is not obligated to pay for it. The Centers for Medicare & Medicaid Services (CMS) started a process Monday to see if Medicare will adopt a national coverage policy for Biogen’s Aduhelm (aducanumab), as well as other Alzheimer’s medications. According to incoming CMS administrator Chiquita Brooks-LaSure, this procedure, known as a National Coverage Determination (NCD), will take around nine months. It will result in national advice on whether and under what conditions Medicare will cover the medicine. Until then, payment choices will be made by contractors in the agency’s 12 areas, which might result in turmoil.
Assuming that Medicare will cover the costs
Because Biogen wants to sell the medicine for $56,000 per year, this is a critical decision for patients, the firm, and Medicare’s financial stability. Alzheimer’s disease affects around 6 million people in the United States. Medicare expenses might approach $50 billion per year if only 1 million people are prescribed the medicine. Patients would be responsible for 20% plus the cost of required testing and imaging that Medicare does not cover, even if Medicare decides to pay.
Few Americans could afford to pay $56,000 per year out of pocket, so Biogen appears to have fixed the price based on the premise that Medicare will cover it. A realistic price, according to an independent analysis, would be between $3,000 and $8,400.
Medicare is required by law to examine if the drug is “reasonable and necessary for the diagnosis or treatment of sickness or injury.” CMS will make its judgment based on “an review of the clinical evidence, such as published clinical research, professional society guidelines, and public comments,” according to the agency.
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CMS’s choices
Consumers, physicians, and others will have two chances to comment on the proposed finding, the first before the draft guidance is released in about six months and the second before CMS takes a final decision, according to CMS.
CMS will select from a variety of choices. Among them are the following: It could cover the costs of any Medicare recipient. It may refuse to pay at all if there is insufficient evidence of clinical benefit. It might only pay for those who are most likely to benefit from the medicine. Alternatively, it may pay only as long as there is evidence that a patient is improving, but stop if the drug looks to be no longer beneficial.
Given the immense political pressure that drug firms and some Alzheimer’s advocacy groups will exert on CMS, it appears doubtful that the agency will refuse coverage. Given the drug’s high cost and lack of evidence that it helps people with advanced disease, it appears that open-ended approval is likewise doubtful.
While the FDA initially did not place any restrictions on who might be prescribed the medicine, it later decided to need a label stating that it is just for patients with early-stage disease.
The FDA’s contentious approval
The FDA’s decision to approve Aduhelm was one of the most contentious in recent memory. The medicine appeared to reduce the amount of amyloid beta material identified in the brains of Alzheimer’s patients in two uncompleted trials. The trials, however, found no clear evidence that breaking down this substance benefits patients clinically.
After the FDA rejected the panel’s unanimous recommendation that the medicine not be approved without more testing, three members of the research panel quit. Many practicing physicians have expressed worry about the approval, which places the onus on them to counsel patients on whether or not to take the medicine. The FDA’s decision is currently being looked into both internally and by a congressional committee.
Aduhelm could have a positive effect “on a surrogate endpoint that is reasonably expected to predict a therapeutic benefit to patients,” according to the FDA. In other words, the FDA believes the medicine has the potential to lower a chemical that may be a cause of Alzheimer’s disease. However, even if it works, it is not certain that it will assist patients.
The ball is now in CMS’s court because that is the standard Medicare must use. The CMS decision will be one of the most far-reaching in recent history, given the drug’s price and potential market./nRead More

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