American Geriatrics Society expresses misgivings about FDA-approved Alzheimer's drug

Photo: Jasmine Merdan/Getty Images

On Jan. 11, the Centers for Medicare and Medicaid Services announced a proposal to cover Food and Drug Administration-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease, including aducanumab, under Coverage with Evidence Development (CED) in CMS-approved randomized controlled trials. 

Currently, aducanumab is the only monoclonal antibody directed against amyloid that has FDA approval, and the American Geriatrics Society has expressed its concern about aducanumab in letters to the FDA.

In its recent letter to CMS providing input on issues to consider during the national coverage analysis – the precursor to the agency making a national coverage determination (NCD) – AGS recommended that CMS limit the NCD to aducanumab, given that this is the only treatment the FDA has approved. 

AGS continues to believe it's premature for CMS to issue a coverage determination for other monoclonal antibodies directed against amyloid that don't yet have FDA approval, the group said in its letter.

Although the organization is still reviewing the proposal, "AGS is very supportive of CMS' focus on ensuring that we have adequate safety and efficacy data for underrepresented, disproportionately affected or understudied populations so that we are able to conclude with certainty that this treatment is safe to generalize to the Medicare population," according to the letter.  

"AGS, and our members, understand the heavy toll of Alzheimer's disease and other dementias on patients, caregivers, and their families," wrote AGS President Dr. Peter Hollmann. "We are supportive of Medicare payment for treatments that have been shown to have clinical benefit for patients and remain hopeful that federal and private sector investments in research will lead to the discovery of efficacious, disease-modifying treatments for Alzheimer's disease and other dementias."

AGS is in the process of reviewing the proposed NCD and will be submitting comments to CMS by the Feb. 10 deadline. CMS will make its final decision in April.

WHAT'S THE IMPACT?

Earlier this month, CMS released a proposed NCD decision memorandum to cover Alzheimer's treatment for people with Medicare only if they are enrolled in clinical trials.

The proposed NCD would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease through coverage with evidence development, meaning for Medicare recipients enrolled in qualifying clinical trials.

Currently, Aduhelm (aducanumab), made by Biogen, is the only monoclonal antibody approved by the FDA for the treatment of Alzheimer's disease.

Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services and other routine costs, which may include positron emission tomography (PET) scans if required by a clinical trial protocol.

Currently, in the absence of a national coverage policy, the Medicare Administrative Contractors, local contractors that pay Medicare claims, decide whether the drug is covered for a Medicare patient on a claim-by-claim basis.

THE LARGER TREND

So far, reaction to CMS' proposal has been mixed.

Arguments over CMS's proposal appear to come down to Aduhelm's price tag, its questionable clinical benefit and why the agency is going against the FDA decision to approve the drug.

"We agree with CMS that there is a need to obtain more clinical data on efficacy, which will be essential to ensuring these new medications deliver real value to patients before broadening access," AHIP President and CEO Matt Eyles said earlier this month.

In an August letter to Tamara Syrek Jensen, director for coverage and analysis for CMS, AHIP, which represents insurers, said two failed clinical trials for Aduhelm were stopped because the drug did not help patients.

In the letter, AHIP had urged CMS to issue an NCD and consider providing guidance that reaffirmed Medicare Advantage plans' flexibility to determine whether and under what circumstances coverage of aducanumab was reasonable and necessary in the absence of an NCD.

"In fact, significant uncertainty remains regarding whether it has any impact addressing either current symptoms or the progression of the disease," AHIP said. "FDA's approval was based on the surrogate endpoint of the reduction of amyloid beta plaque in the brain that is expected to predict clinical benefit. However, the clinical trials found no clinical benefits from reducing that plaque and revealed serious safety risks to patients receiving the monthly infusions of aducanumab including swelling and bleeding in the brain." 

The Campaign for Sustainable Rx Pricing (CSRxP) said that despite Biogen's 50% price cut, Aduhelm still carried "an egregious price tag" for a "controversial and unproven brand-name treatment."

CSRxP Executive Director Lauren Aronson said, "The proposed (CMS) policy will help protect seniors, taxpayers and the U.S. healthcare system from shouldering undue costs from the outrageous Big Pharma pricing of this medication."

Biogen's reduced price tag for Aduhelm is still approximately three to 10 times greater than what an analysis by the Institute for Clinical and Economic Review (ICER) concluded would be a fair price for Aduhelm: somewhere between $2,500 and $8,300, CSRxP said in a statement.

In an opposing opinion on the CMS proposal, George Vradenburg, chair and cofounder of UsAgainstAlzheimer's, said Medicare is slamming the door on Alzheimer's treatments in second-guessing the FDA's decision to approve Aduhelm.

"This is absolutely unacceptable," Vradenburg said. "If this decision stands, for the first time in history, millions of Americans will be denied coverage, not just to a drug, but to a whole class of drugs – not by the agency that regulates drugs, but by the federal insurance bureaucracy. Why are treatments for Alzheimer's patients being held to a different standard than those treating cancer, HIV and other illnesses? Is it because there are so many of us? Is it because we're old? CMS should be ashamed of the way it is discriminating against this one group of patients."

PhRMA said the CMS announcement is another setback for patients suffering from Alzheimer's disease and for their caregivers.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com