What are the implications of the Centers for Medicare & Medicaid Services’ decision to cover aducanumab with evidence development?

 In Functional Medicine

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Ready for the latest aducanumab news? Our Springfield clinic believes that Alzheimer’s treatment should be accessible to everyone with medicare or medicaid without having to participate in a clinical trial. The FDA approval of aducanumab excited our Springfield specialists and we are disappointed that the Medicare & Medicaid Services (CMS) is not making this treatment more available. In early 2022, CMS

proposed to cover Food and Drug Administration (FDA) approved monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease under Medicare through coverage with evidence development (CED). Essentially, that means Medicare would only cover treatments in this class – including Biogen’s ADUHELM® (aducanumab) – if the person is enrolled in a qualifying clinical trial performed in a hospital-based outpatient setting.

The decision is part of a long-standing process created by Congress to conclude whether Medicare should cover a medicine. To me, it is disappointing. It restricts access to the first FDA-approved, disease-modifying therapy for a condition that impacts 6.2 million Americans of which up to 3 million could be candidates. Biogen has taken a similar stance. In a statement responding to CMS’s proposal , the company said:

“Biogen believes that the proposed coverage with evidence development (CED) decision for anti-amyloid therapies denies nearly all Medicare beneficiaries from accessing ADUHELM® (aducanumab-avwa)… It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA.”

Let’s take a closer look at the evidence and potential ramifications of CMS’s proposal.

The evidence: Is aducanumab effective and safe?

The FDA green-lighted aducanumab under Accelerated Approval status, which focuses on the mechanism and scientific plausibility of clinical efficacy. Detractors suggest this class of treatment lacks evidence to support use among those suffering from Mild Cognitive Impairment and early-stage Alzheimer’s disease. However, this is simply not the case

Our Neurology team near Springfield disagrees with the latest aducanumab news and finds that there is substantial evidence that shows howaducanumab reduces amyloid-beta plaques, and this reduction is likely to result in a clinical benefit for patients. Data following the premature termination of the EMERGE and ENGAGE trials showed that the EMERGE trial met its primary outcome – high dose aducanumab reduced clinical decline. In ENGAGE, the subgroup of patients exposed to high dose aducanumab declined more slowly.

What’s more, the findings from the long-term extension of the PRIME trial also demonstrated the benefits of aducanumab. All patients received aducanumab through the extension and continued to experience a time- and dose-dependent reduction in amyloid plaques. In addition, in Eli Lilly’s Phase 2 donanemab trial, subjects who took the treatment earned a higher composite score for cognition and the ability to perform activities of daily living than placebo after 76 weeks.

The significance: Does aducanumab make a real difference to patients’ lives?

At Sharlin Health and Neurology near Springfield, we feel the FDA approval aducanumab warrants that the drug should be made accessible to people who have medicare or medicaid.
Aducanumab is not a magic bullet or miracle cure. But it is a start.

A drug that slows Alzheimer’s cognitive decline by 22 to 30% is much like the early disease-modifying treatments for multiple sclerosis (MS). These first-generation drugs slowed the relapse rate by 20 to 30%. They did not ultimately prevent those with clinically isolated syndrome from developing the full-blown disease, nor did they inhibit the transition to secondary progressive MS. But they may have delayed both inevitabilities. Yet, these medications, now largely replaced by higher efficacy drugs, were never the target of arguments over cost, efficacy, or safety. There was even a lottery for interferon beta-1b when it was first released because the drug was in high demand by those suffering from MS. Most (if not all) of the currently approved medications for MS cost more than the original $56,000 price tag of aducanumab and have a higher margin of risk associated with them, including a potentially fatal brain infection called PML (Progressive Multifocal Leukoencephalopathy).

Is slowing clinical decline by 22 to 30% insignificant? For a disease that spans a decade, to extend the Mild Cognitive Impairment stage of Alzheimer’s disease and delay the dementia stage could mean adding as much as three years of preserved daily activities, hobbies, and community and family engagement. This translates into a lower cost burden on the system and individuals. With 2021 costs of Alzheimer’s and other dementias expected to be about $355 billion , including $239 billion in Medicare and Medicaid payments combined, a drug that retails at $26,000 (the newer reduced price of aducanumab) currently is a relative bargain. Alzheimer’s is no joke! Our neurology team near Springfield believes that this Alzheimer’s treatment, which fends off the disease for up to an extra three years, is a magical gift to family and friends who have a loved one or who are personally suffering from alzheirmer’s.

The location: How accessible is aducanumab in the context of the pandemic?

A caveat of CMS’s decision is that qualifying clinical trials must be performed in a hospital-based setting, suggesting that hospitals are the only appropriate place for infusion of monoclonal antibodies directed against amyloid. This is untrue. My multi-disciplinary clinic, infusion, and research center with on-site imaging is a five-minute drive from the nearest hospital and has conducted clinical trials safely for years.

In addition, my staff and I have certification under Good Clinical Practice. We have written and practiced Standard Operating Procedures (SOPs), cardiac life support certification, on-site lab, EKG, oxygen tanks, and the appropriate drugs on hand for emergent needs. We have repeatedly passed the rigorous inspections, IRB approvals, and quality assurance standards held by pharmaceutical companies who have trusted us to help them investigate and ultimately bring their products to market.

In the context of a worldwide pandemic, confining clinical trials to hospital-based settings is likely to limit accessibility – particularly considering significant healthcare staff shortages. Furthermore, most of the country’s sick patients are concentrated in our hospitals. So why are we sending otherwise healthy patients with Alzheimer’s to high-risk locations if we don’t need to?

Here is some great aducanumab news that our Springfield neurology clinic has to share: A review of the package insert for aducanumab shows that the treatment is remarkably safe. Aside from anaphylactic reactions that can happen with any drug, the only other risk is amyloid-related imaging abnormalities. While these abnormalities are common, the vast majority are asymptomatic, benign, and resolve spontaneously. Only rarely have serious complications been observed. This standard of hospital-based clinic infusion centers is not required to reimburse any other drug, including many with far more toxicity and risk associated with them.

The possibly well-intentioned stipulation is likely to result in enormous delays and barriers to treatment. The label of “hospital-based” gives a false impression of a higher standard that does not exist.

Experience the future of Alzheimer’s treatment today

CMS’s proposed and unprecedented decision regarding monoclonal antibodies directed against amyloid protein is short-sighted, dangerous, prejudicial, and costly. Despite what many people living with Alzheimer’s have been told, there are ways to improve their quality of life and reshape the trajectory of their health, and aducanumab can be one of them. But my highly successful Brain Tune Up! Program is the other. Fortunately, no one has to settle for “either/or,” and the combination may be more powerful than either one alone.

If you or a loved one is interested in learning more about what my multi-disciplinary clinic can offer or to learn more about the latest aducanumab news, our Springfield clinic is happy to assist you! Please don’t hesitate to reach out to my friendly team. We can give you the answers you deserve.

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