Stakeholders have mixed reaction to CMS proposal to limit use of Alzheimer drug Aduhelm

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Reaction is mixed to the proposal by the Centers for Medicare and Medicaid Services to limit Medicare beneficiaries' access to monoclonal antibody treatments that target amyloid for the treatment of Alzheimer's to those enrolled in qualifying clinical trials.

CMS released the proposed National Coverage Determination decision memorandum and 30-day comment period on Tuesday, with a decision to be announced on April 11.

Aduhelm, the brand-name for the drug aducanumab, is the only FDA-approved monoclonal antibody treatment to target amyloid in the brain for the treatment of Alzheimer's disease. Effective January 1, drugmaker Biogen cut the wholesale acquisition cost of Aduhelm by 50%, from an estimated $56,000 a year to $28,200 a year. 

WHY THIS MATTERS

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," said AHIP president and CEO Matt Eyles.

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 a National Coverage Determination (NCD) and also to 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 by statement.

RBC analyst Brian Abrahams said the restrictive proposal by CMS narrows the use of Aduhelm. While this could change, he said, Aduhelm is no longer expected to be a meaningful contributor to Biogen's bottom line. 

"The determination creates a tough long-term hurdle for Biogen to grant broad access to the drug without additional data," Abrahams said. 

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 their caregivers. 

"With this proposal, CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA, positioning itself and not the FDA as the key arbiter of clinical evidence," PhRMA said.

THE LARGER TREND

The cost of Aduhelm was one reason CMS recently announced a $21.60 increase in Medicare Part B monthly premiums for 2022, an increase of 14.5% percent, which represents the largest dollar figure increase in the program's history. 

After Biogen slashed the price, Health and Human Services Secretary Xavier Becerra instructed CMS to reevaluate Medicare premiums. CMS has yet to make an announcement on premiums.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com