Medicare evaluation whether it should cover Alzheimer’s drug Aduhelm

Medicare launched a formal process on Monday to decide whether or not to cover Aduhelm, the controversial newly approved Alzheimer’s drug developed by Biogen. 

The drug will cost patients individual $56,000 a year for treatment, and an expert analysis finds that could cost Medicare up to $29 billion a year.

Two congressional committees have even launched investigations into the pricing of the drug.

Now, the Centers for Medicare and Medicaid Services (CMS) has to decide if they will take on the large price tag.

A final decision isn’t likely until next spring, said the CMS, although an initial ruling could come in six months. 

Currently Medicare is making case-by-case determinations on whether to cover the medication, which is administered intravenously in a doctor’s office. 

Whether Aduhelm will be covered by Medicare will be decided in the near future as the CMS has officially launched the formal decision process for it on Monday. One expert analysis finds the drug could cost the program $29 billion per year

Aduhelm, the commercial name of the drug aducanumab, received approval from the U.S. Food and Drug Administration (FDA) on June 7, kicking off a tumultuous month for Biogen. 

The month since the approval has included the FDA launching and investigation into themselves, and three members of an advisory panel stepping down in protest of the drug’s controversial approval. 

‘We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,’ Chiquita Brooks-LaSure, CMS Administrator, said in a statement.

‘Our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.’ 

A 30-day public comment period began Monday, followed by two hearings to solicit a range of views. 

The agency’s decision will hinge on whether the evidence for Aduhelm meets a legal requirement that covered services, medical devices and medications be ‘reasonable and necessary for the diagnosis or treatment of illness or injury.’ 

The $56,000-a-year price tag is a huge premium to the $10,000 to $20,000 the drug was expected to cost.   

Medicare’s announcement came on the same day that Democratic leaders of two House committees asked Biogen to turn over reams of documents on how it developed and priced the drug, and on its dealings with government officials at the FDA. 

Two House investigations into the drug’s cost were announced last month by Rep Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep Frank Pallone Jr, chairman of the House Committee on Energy and Commerce.

‘We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,’ Maloney and Pallone Jr said in a statement. 

An analysis published by the Kaiser Family Foundation estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost Medicare nearly $29 billion a year, far more than any other medication. 

The committee chairs noted that a nonprofit think tank focused on drug pricing pegged the drug’s actual value at between $3,000 and $8,400 per year, based on its unproven benefits. 

Some experts fear that the drug does not work at all, either, due to a rocky trial process by the drug manufacturer.   

Biogen launched two clinical trials for Aduhelm the drug in 2016.

Both were stopped midway because researchers concluded that neither trial would end up reaching its goal.

Biogen found data from its second clinical trial that showed the drug could reduce the cognitive decline associated with Alzheimer's by 22%. If true, it would be the only drug with the ability to do so

Biogen found data from its second clinical trial that showed the drug could reduce the cognitive decline associated with Alzheimer’s by 22%. If true, it would be the only drug with the ability to do so

Later, the company revealed updated data from the second study showed patients had 22 percent decrease in speed of their cognitive decline.

It also showed that Aduhelm could remove amyloid beta plaques on the brain that some experts believe can reduce the cognitive decline caused by Alzheimer’s.

Some believe the removal of these plaques can stop cognitive decline, which would make the drug the only available Alzheimer’s treatment to do so.  

The FDA has since rolled back a bit on the drug.

Last week, the agency revised its label, now only recommending it to be prescribed to those in the early stages of Alzheimer’s, or with more mild case of the condition. 

Three FDA advisory board members, Dr David Knopman of the Mayo Clinic, Dr Aaron Kesselheim of Harvard University and Dr Joel Perlmutter of Washington University St Louis, stepped down last month.

All three were among the opposition in the board’s 10-0 vote against approving Aduhelm.

Dr David Knopman (pictured) has been one of aducanumab's biggest critics, saying that Biogen's trials of the drug do not show that the drug is effective in combatting Alzheimer's

Dr David Knopman (pictured) has been one of aducanumab’s biggest critics, saying that Biogen’s trials of the drug do not show that the drug is effective in combatting Alzheimer’s

Recommendations from the board are not binding, though, and the FDA is allowed to, and often does, make decisions that go against the board’s vote. 

It is rare that a unanimous decision by the board is ignored, though, and the agency is generally more conservative than experts on the board – which was not the case with Aduhelm.

Knopman authored a study in November which analyzed the results of the clinical trials, and said he disagreed with Biogen’s claim that the drug was effective.

Kesselheim had some scathing words about the drug’s approval as well.

‘[Aduhelm] is probably the worst drug approval decision in recent U.S. history,’ Kesselheim wrote in a letter to FDA Commissioner Janet Woodcock obtained by Stat News.

‘It is clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.’

The FDA asked for a federal investigation into its approval on Friday.

Dr Janet Woodcock, acting commissioner of the FDA, announced she sent a letter to the Office of Inspector General of the U.S. Department of Health & Human Services for a probe into communications between FDA staff and Biogen Inc representatives in the lead up to the approval of Aduhelm, the company’s Alzheimer’s drug.

‘Given the ongoing interest and questions, today I requested that [The Office of the Inspector General] conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm,’ she wrote on Twitter.  

Woodcock has previously defended the drug’s approval from critics, saying it was ‘reasonably likely’ that the drug could help slow the cognitive decline associated with Alzheimer’s.

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