In 2022, 6.5 million Americans over the age of 65 were living with Alzheimer’s disease. Those numbers are expected to increase to nearly 13 million by 2050. Alzheimer’s is the most expensive disease in America, costing more than both cancer and heart disease. It’s a devastating diagnosis that takes a huge financial and emotional toll on individuals, their families, and caregivers.
Recently, researchers have made huge advancements in their understanding of Alzheimer’s and in developing new treatments. Although there is still no cure, the drugs available help slow the progression of the disease and provide some hope to those diagnosed with the disease.
A New Class of Drugs
New therapies target amyloid plaque buildup in the brain – a key characteristic of Alzheimer’s. They are designed to help people with mild cognitive impairment in the early stages of the disease. There is optimism that, at last, there are medications that can make a meaningful difference.
However, the optimism of potential treatment has been countered with real concern over the risks and side effects of the drugs. Whereas some Alzheimer’s advocates are pushing to get new drugs onto the market, other experts feel it’s necessary to collect more clinical data before drugs are approved for widespread use.
FDA Approval Process
It can take many years for the Food and Drug Administration (FDA) to study a new drug to learn about its effectiveness and possible side effects. The FDA’s accelerated approval process makes drugs available much sooner. This fast-track approval is only available for drugs that treat serious conditions and fill an unmet medical need – in other words, when there are no other treatments available.
The three drugs under FDA review are:
ADUHELM – Received accelerated approval from the FDA in 2021. It is only approved for use in clinical trials.
LEQEMBI – Received accelerated approval from the FDA in January this year. It is currently undergoing the FDA’s standard approval process. A decision is expected by early July.
DONANEMAB – The FDA rejected the company’s application for accelerated approval in January. The company plans to submit for full FDA approval later this year.
CMS recently issued a statement explaining how it plans to cover these drugs. Drugs that receive accelerated FDA approval are currently only available to patients participating in eligible clinical trials. Once the above drugs have full FDA approval, they will be covered for patients enrolled in Medicare Part B, provided the patient meets certain criteria: the patient must be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s and have a qualified physician participating in a registry. These registries collect information on how the drugs work in the real world, as opposed to in clinical trials. Physicians will be required to submit evidence through a CMS facilitated portal that will track the safety and efficacy of the drugs.
CMS is under pressure from advocacy groups and pharmaceutical companies to reverse its decision. The groups feel that registries create unnecessary barriers and will delay full access to the drugs. CMS continues to express concerns that it needs more time and data to properly evaluate the drugs.
What Will the Drugs Cost?
All these drugs come with high price tags. ADUHELM is estimated to cost $28,200 a year per patient. LEQEMBI will cost $26,500 a year. With millions of seniors already diagnosed with Alzheimer’s, the medications will cost billions of dollars.
The drugs are administered by intravenous infusion. Once they are fully approved by the FDA, Medicare will cover them under Part B. Medicare will pay 80% and the Medicare beneficiary will pay 20%. Those with Medicare supplement plans may have additional coverage to help pay their 20% share.
The costs of the drugs could impact Part B premiums in the future. In 2022, in anticipation of covering the costs of ADUHELM, Part B premiums were increased by 15%. Medicare’s later decision to limit coverage of the drug resulted in a 3% decline in the 2023 premium.
New Drugs Offer Hope
Although there are still many questions surrounding these drugs, researchers believe we have entered a new era in Alzheimer’s treatment. There is optimism that this is an important step toward a potential cure.
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