This summer, Aduhelm became the first Alzheimer’s medication to receive FDA approval in nearly 20 years. However, it was met with controversy from across the healthcare industry and beyond.
Here is what you need to know:
- What is Aduhelm? Aduhelm (aducanumab-avwa) is a drug developed by pharmaceutical manufacturers Biogen and Eisai to treat Alzheimer’s Disease. It is purported to be the first medication to substantially reduce amyloid-beta plaques, which are present in abnormal levels and appear to disrupt brain cell function in people with Alzheimer’s Disease.The drug is not a cure and does not reverse the disease’s progression, but it did appear in clinical trials to slow the rate of cognitive decline.
- Why is Aduhelm controversial? On June 7, Aduhelm received accelerated approval from the FDA – despite an earlier vote from an FDA advisory committee that found there was not enough evidence to support the drug’s clinical efficacy.The accelerated approval was based on findings from clinical trials that showed a reduction in beta-amyloid plaques. While this is believed to be associated with a clinical benefit, that was not confirmed in the trials, and additional studies are needed.Three advisory committee members resigned in response to the approval decision, raising serious questions in the industry and the media about Aduhelm.The drug’s high price tag – estimated at $56,000 per patient per year – has also been met with criticism.
- What happened once Aduhelm received approval? The FDA has called for an independent investigation into the drug’s approval process. The agency has also narrowed the recommended window of eligible recipients from all Alzheimer’s patients to only those with milder forms of the disease.Additionally, as a condition of the accelerated approval, Biogen continues to conduct studies to determine the clinical benefit associated with Aduhelm. If the trial results do not demonstrate a clinical benefit for patients with Alzheimer’s, the FDA can pull Aduhelm from the market.
- What does the industry say? Health plans and others have questioned Aduhelm because of the lack of clinical evidence and its implications for payer budgets. This is especially true for Medicare, which has the highest percentage of Alzheimer’s patients in the US.Many healthcare providers are still deciding if and how to prescribe this therapy, particularly given its potentially dangerous side effects, such as swelling and bleeding in the brain. Additionally, the Centers for Medicare & Medicaid Services (CMS) is considering implementing a National Coverage Determination (NCD) that will determine how Medicare will cover Aduhelm and future therapies for Alzheimer’s disease.However, the Alzheimer’s Association, among other patient advocacy groups, has come out in support of Aduhelm’s approval. It is being heralded as the first of many innovative treatments for this disease.
- What is Abarca’s view? As of now, there is still a lot that needs to be learned about Aduhelm. But, at Abarca, we believe that patients should not take medications that aren’t effective. It is one of the reasons that we are aggressively pursuing value-based agreements, under which the drug manufacturer refunds the health plan for the cost of medications that are discontinued either due to side effects or because they aren’t effective.We are also keeping a close eye on the development of additional drugs for Alzheimer’s disease. After Aduhelm’s approval, there are several other amyloid-reducing compounds in development, and many that are targeting Alzheimer’s disease in other ways. In fact, there are more than 100 compounds in clinical trials currently.
We will continue to monitor the evidence about this therapy and make the necessary adjustments for our clients and members.
This blog was written by Timothy Mizak, PharmD, MS, MBA, Director, Formulary Management at Abarca.