Medicare evaluation or the Alzheimer’s drug Aduhelm. must cover

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

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

Two congressional committees have even launched an investigation into the drug’s pricing.

Now the Centers for Medicare and Medicaid Services (CMS) must decide whether they will bear the big price tag.

A final decision is likely not until next spring, the CMS said, although a first ruling could come in six months.

Currently, Medicare makes decisions on a case-by-case basis about whether or not to cover the medication, which is administered intravenously in a doctor’s office.

Whether Aduhelm will fall under Medicare will be decided in the near future, as the CMS officially launched the formal decision-making process on Monday. An expert analysis shows that the drug could cost the program $29 billion a year

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

The month since the approval has included the FDA launch and investigation into itself, and three members of an advisory panel who resign in protest at the drug’s controversial approval.

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

“Our process provides opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, publishers, industry professionals, and relatives and caregivers of people living with this disease.”

A 30-day public comment period began Monday, followed by two hearings to gauge differing opinions.

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

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

The Medicare announcement came the same day Democratic leaders of two House committees asked Biogen to hand over stacks of documents about the drug’s development and pricing, as well as dealing with government officials at the FDA.

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

“We are deeply concerned about the high 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 only 500,000 Medicare recipients received Aduhelm, it would almost cost Medicare $29 billion per year, far more than any other drug.

The committee chairmen noted that a not-for-profit think tank focused on drug pricing put the drug’s actual value between $3,000 and $8,400 per year, based on its unproven benefits.

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

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

Both were halted halfway through because researchers concluded that neither trial would ultimately achieve their goal.

Biogen found data from its second clinical trial showing that the drug could reduce cognitive decline associated with Alzheimer's disease by 22%.  If true, it would be the only drug capable of doing that

Biogen found data from its second clinical trial showing that the drug could reduce cognitive decline associated with Alzheimer’s disease by 22%. If true, it would be the only drug capable of doing that

The company later revealed updated data from the second study that showed patients had a 22 percent decrease in the rate of their cognitive decline.

It also showed that Aduhelm was able to remove amyloid beta plaques in the brain that some experts believe may reduce the cognitive decline caused by Alzheimer’s disease.

Some believe that removing these plaques could halt cognitive decline, making the drug the only available treatment for Alzheimer’s disease.

The FDA has since backtracked a bit on the drug.

Last week, the agency revised its label and now only recommends it be prescribed to people in the early stages of Alzheimer’s disease, or with milder cases of the condition.

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

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

dr.  David Knopman (pictured) was one of the biggest critics of aducanumab, saying that Biogen's trials of the drug do not show that the drug is effective in fighting Alzheimer's disease.

dr. David Knopman (pictured) was one of the biggest critics of aducanumab, saying that Biogen’s trials of the drug do not show that the drug is effective in fighting Alzheimer’s disease.

However, board recommendations are not binding, and the FDA may, and often does, make decisions that go against the board’s vote.

However, it is rare for a unanimous board decision to be ignored, and the agency is generally more conservative than board experts – which was not the case with Aduhelm.

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

Kesselheim also had some damning words about the drug’s approval.

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

“It is clear to me that the FDA is currently unable to adequately integrate the committee’s scientific recommendations into its approval decisions.”

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

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

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

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

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