First Choice Neurology

Medicare to Restrict Coverage of Anti-Amyloid Antibody Therapy for Alzheimer’s Patients

By Jeffrey Gelblum, MD

As a practicing neurologist with over 25 years of experience treating Alzheimer’s disease, I strongly oppose the proposed intention of Centers for Medicare & Medicaid Services (CMS) to restrict coverage of anti-amyloid antibody therapy to only those patients who must participate in an approved hospital-based clinical trial (Coverage with Evidence Development, CED). This measure will deny access by most Alzheimer patients to any type of private practice environment and immediately shuts off care for the majority of Alzheimer’s victims.

Alzheimer's imageAfter eighteen years of therapeutic nihilism, the FDA – our nation’s ultimate drug regulatory authority – approved the first agent of its kind in this treatment space. An accelerated approval program developed by the FDA is specifically designed to carefully assess the efficacy and safety of the new class.

Since the June 2021 approval, our large group of private-practice neurologists has had the opportunity to treat many patients with this new medication. Our patients have found this process to be transparent, interactive, communicative, seamless, affordable, well-tolerated, and beneficial. In the very near future, we are also looking forward to the introduction of other new drugs in this treatment space which may offer an even more robust response.

As in other private neurology practices around the country, our patients are scrupulously assessed in accordance with FDA-package labeling, as well as, guidelines published by the Alzheimer’s Association, and American Academy of Neurology – Practical Considerations in the Administration of Aducanumab for the Neurologist {Neurology: Clinical Practice DOI: 10.1212/CPJ.0000000000001144).

The treatment of minorities (African-American, Latino, Eastern European, and Asian) — all well represented in our large South Florida practice — has been a source of extreme gratification.

CMS’ novel restriction now intends that most patients who fulfill the FDA-approved criteria will not receive any treatment whatsoever. The following catastrophic consequences will immediately unfold:

1. INTERRUPTION of continuity of care to patients presently receiving an FDA-approved treatment;

2. SHIFT of Alzheimer’s care onto hospital systems already reeling from an intractable Covid endemic. Most hospitals don’t even have research departments, so rural and suburban communities will be inordinately disadvantaged. Imagine the new burdens involving registration, intake, nursing, physician, laboratory, radiology, and billing. If the patient has an urgent side effect, who will take that phone call? We all know that a costly emergency room visit usually ensues. Which of these services – all easily managed in the private-practice setting – will be billed under Medicare part A or B? We all know that hospital fees are exponentially higher than those of traditional outpatient care.

3. RESTRICTION of care to minority, rural, and economically disadvantaged patients, given their historic reluctance to engage in clinical trials, much less in a remote institutional setting;

4. CURTAILMENT of real-world post-approval analysis of new-drug safety and efficacy;

5. DISCOURAGEMENT of new drug development by restricting a class of therapy;

6. CANCELLATION of the mandated role of the FDA to ultimately determine drug efficacy, safety, and surveillance;

7. CESSATION of coverage to commercially insured patients, whose payers always follow a Medicare lead;

8. DUMPING of multibillion-dollar commercially funded drug research away from private pharma and now into the laps of taxpaying Medicare beneficiaries.

I am certain that other commentators will add to this list of critical objections.

The statutory role of CMS is to provide coverage to Medicare beneficiaries of FDA-approved treatment. This new restriction evades that legal mandate and injures an entire population of the most fragile folks among us. I urge immediate retraction of the CED restriction and implore CMS to rely upon the scientific methodology as put forth by the competent resources of the FDA, the Alzheimer’s Association, and American Academy of Neurology.



Resource: FDA Accelerated Approval


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