UPDATED: FDA Approves New Alzheimer’s Disease Drug

The FDA approval of Aduhelm on June 7, 2021, sparked both concern and confusion among stakeholders. There was skepticism that patients in all stages of Alzheimer’s disease could benefit from this new drug. The FDA has revised the labeled indication, effective July 8, 2021. The recommendation has been updated to treat early-stage Alzheimer’s patients.

“Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Despite an estimated 6 million in the U.S. with Alzheimer’s, Biogen (the manufacturer of Aduhelm) expects the drug to be used by one to two million with mild disease. The most significant impact is anticipated for Medicare, which covers the largest proportion of patients with Alzheimer’s.

What does this mean for plans?

As plan sponsors contemplate coverage of Aduhelm, it will be important to confirm Alzheimer’s disease as stated in the product labeling and consistent with the patient population that was studied.

Why is this update important?

The revised product labeling expects to minimize the potential for inappropriate use in patients with more advanced disease where the drug is unlikely to provide any benefit. The previous FDA approval had a great risk of providing false hope to patients, families, and caregivers.

Published June 9, 2021:

What this promising but controversial drug means for payers and plan sponsors

Tremendous buzz led up to the June 7, 2021 announcement that the U.S. Food and Drug Administration (FDA) approved aducanumab, Biogen’s drug for Alzheimer’s disease. Aducanumab, marketed as Aduhelm^TM, is the first drug for the disease-modifying treatment of this condition. It has been 17 years since the last breakthrough in Alzheimer’s disease treatment.

What do I need to know about this new drug?

• Aducanumab is the first Alzheimer’s disease treatment for slowing progression and treating cognitive impairment.
• The drug is administered by intravenous infusion four weeks apart, and the FDA approval did not specify duration limits.
• For patients and families affected by this horrible disease, this drug approval offers a ray of hope.
• For payers and plan sponsors, it carries an estimated price tag of $56,000 per patient per year, and a large population of patients could be candidates as the FDA did not limit its use to patients with early disease, which some anticipated.

What are the key takeaways and next steps?

• Stringent utilization management is necessary to ensure appropriate use.
• Out of the estimated 6.2 million people in the United States to have Alzheimer’s disease, eligibility for therapy could reach approximately 1.4 million.
• Medicare may limit access. The new drug will be covered under Part B, and Medicare Advantage plans can implement formulary management tools for Part B drugs.
• In advance of FDA approval, Biogen stated 600 sites nationwide were ready to administer the drug.

How does Aducanumab work?

• Aducanumab reduces the levels of beta-amyloid in the brain, the toxic protein which builds up and forms plaques in patients with Alzheimer’s disease.
• Experts believe these plaques play a critical role in developing this disease. How the reduction translates into clinical benefits for patients or slowing cognitive decline has been difficult to assess.
• In the positive results trial, patients given aducanumab declined 22 percent slower than those who received the placebo.
• Aducanumab did not reverse cognitive decline.
• Aducanumab’s mechanism of action targets an underlying cause of the disease rather than just the symptoms.

What are experts saying about this medical advancement?

The reviews are mixed. Many suggest this is a new era of hope for the Alzheimer’s disease community.

“This will give us a new biological foothold to build on,” said Stephen Salloway, Director of Neurology at Butler Hospital and professor at Brown University.

“It will take more advances, but it does appear from the science that people, especially at early stages, could be real beneficiaries and that the benefits accumulate over time,” said Harry Johns, President and Chief Executive of the Alzheimer’s Association.

On the other end of the spectrum, the Institute for Clinical and Economic Review (ICER) found aducanumab’s price does not align with clinical benefits. Given the risk of side effects and the uncertainty of benefit, ICER assigned a draft rating of “insufficient” to the strength of evidence on whether aducanumab provides a net health benefit for patients.

For additional information on the clinical and financial implications as the Alzheimer’s disease community adopts this new drug, contact your PSG contact or reach out to be connected to a pharmacy expert.

References

1. https://www.biopharmadive.com/news/biogen-aducanumab-alzheimers-fda-drug-review/600897/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20BioPharma%20Dive:%20Daily%20Dive%2005-29-2021&utm_term=BioPharma%20Dive%20Weekender
2. https://www.washingtonpost.com/health/2021/05/31/new-alzheimers-drug/
3. https://www.aarp.org/health/dementia/info-2020/approval-sought-for-aducanumab.html
4. https://www.optum.com/business/resources/library/alzheimers-treatment.html

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