Modelling A.I. in Economics

Medicare to Cover Alzheimer's Drugs, Giving Hope to Patients

Under the new policy, Medicare will cover Alzheimer's drugs that have received traditional approval from the FDA. Currently, only two Alzheimer's drugs — Biogen's Aduhelm and Eisai's Leqembi — have accelerated approval from the FDA.

Accelerated approval is granted to drugs that show a promising effect on a surrogate endpoint, such as slowing the decline in amyloid plaques in the brain. However, accelerated approval requires companies to conduct additional studies to prove that the drug actually improves clinical outcomes, such as slowing cognitive decline or preventing dementia.

Biogen and Eisai are both conducting confirmatory studies of their Alzheimer's drugs, but those studies are not expected to be completed until 2025. In the meantime, Medicare's new policy will allow patients to access the drugs under certain conditions.

To be eligible for coverage, patients must have mild cognitive impairment or early dementia caused by Alzheimer's disease. They must also be enrolled in a registry that collects data on how the drugs work in the real world.

The registry requirement is intended to help Medicare monitor the safety and effectiveness of the drugs. It is also a way for Medicare to ensure that patients are getting the best possible care.

The Alzheimer's Association, which has been lobbying for Medicare to expand coverage of Alzheimer's drugs, praised the new policy.

"This is a major step forward for people living with Alzheimer's disease and their families," said Harry Johns, CEO of the Alzheimer's Association. "It will ensure that people who need these drugs can get them."

Biogen and Eisai are likely to benefit from Medicare's new policy. Both companies are developing additional Alzheimer's drugs that are in late-stage development. If those drugs are approved by the FDA, they could also be covered by Medicare under the new policy.

The Alzheimer's disease market is expected to grow significantly in the coming years. The number of people living with Alzheimer's disease is expected to double by 2050, and the cost of treating the disease is expected to reach $1 trillion annually.

Medicare's new policy is a positive development for patients and drugmakers alike. It will help ensure that patients have access to the latest Alzheimer's drugs, and it will help drugmakers recoup the high cost of developing those drugs.

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