Analysis: Biogen Alzheimer drug slow to take off as US Medicare struggles with coverage

Aduhelm, Biogen’s recently approved controversial drug for the treatment of early-onset Alzheimer’s disease, is seen at Butler Hospital, one of the clinical research sites in Providence, Rhode Island, United States, June 16, 2021 Jessica Rinaldi / Pool via REUTERS.

July 21 (Reuters) – US hospitals slated to be the first to adopt Biogen’s Alzheimer’s disease drug (BIIB.O) have only treated a handful of patients since its approval in early June as they await the first payments from the government Medicare program for people aged 65 and over.

The United States Food and Drug Administration has approved the drug, called Aduhelm, based on limited evidence that it may slow the decline of cognitive function in people with the disease that steals memory. Read more

Some leading doctors, hospitals and health insurers have criticized the FDA’s decision and said they will not offer the drug. The agency itself has invited an external investigation into its decision-making process.

Other leading institutions, including Michigan, Florida and Rhode Island, were eager to make the therapy available to patients in the hopes it will provide a benefit, but told Reuters this week that ‘They were moving slowly as Medicare determines how it will cover Aduhelm, initially at a cost of around $ 56,000 per year.

Medicare has launched a nine-month process to define standardized national conditions for Aduhelm coverage that may seek to limit its use.

For now, the government health plan processes drug requests on a case-by-case basis. The first centers to use the drug as a commercial product said those claims had not yet been paid.

“Medicare does this very, very rarely for drugs and issues these coverage restrictions, again, very rarely,” said Dr Aaron Kesselheim of Brigham and Women’s Hospital in a co-presented online interview. by The Forum at Harvard TH Chan School of Public Health and Reuters. Kesselheim resigned as a member of the FDA advisory board that reviewed Biogen’s drug after the agency chose not to follow its recommendation against approval.

The slow adoption raises questions about the 2021 sales potential for the treatment ahead of Biogen’s second quarter earnings report on Thursday.

‘BE VERY CAREFUL’

The Michigan Institute for Neurological Disorders (MIND) said it had only treated one patient with Aduhelm.

Sonda Rossman, head of state disease, therapeutics and clinical research initiatives at MIND, said the institute was testing more patients for eligibility for Aduhelm, but was “very cautious.” with regard to financial and medical risks.

Florida’s First Choice Neurology program and Butler Hospital’s Memory and Aging program in Providence, Rhode Island, treated three patients each. Butler’s program is led by Dr. Steven Salloway, an Aduhelm supporter who called the drug’s approval “a turning point in Alzheimer’s disease research.”

The Mayo Clinic, which has partnered with Biogen to provide clinical tests to diagnose whether a person is eligible for the new drug, said it is still considering whether to offer Aduhelm to its own patients.

The FDA approved Aduhelm for patients who test positive for a component of amyloid plaques in the brain, but then reduced that number to those in the early stages of the disease – the group has tested in clinical trials.

UCLA Health System said none of its vendors have requested to use Aduhelm, with many awaiting additional data before making a final decision.

Biogen declined to comment on the number of centers using its drug, but said it expects the rollout to be gradual.

MEDICAL LIMITATIONS

Because Alzheimer’s disease is an age-related condition, about 85% of people eligible for Aduhelm are covered by Medicare, which could lead to an increase in annual spending of $ 29 billion, according to the Kaiser Family Foundation.

Experts say Medicare could seek to lower the cost of therapy to taxpayers by limiting access to treatment, tying coverage to actual evidence of patient outcomes, or setting a fixed payment that combines drug reimbursement with other costs related to treatment.

“Given the potential budgetary impact, things could be deviating from normal,” said Dan Ollendorf, of the Center for the Evaluation of Value and Risk in Health at Tufts University Medical Center in Boston.

Tufts and others have called on Medicare to move beyond a national coverage determination and institute a policy known as coverage with evidence development.

As part of such a program, data on the effectiveness and safety of Aduhelm in the real world would be compiled into a Medicare patient registry, quickly providing new data for analysis.

Medicare could also institute a more stringent “demonstration project” for Aduhelm that would pay for the use of the drug in a limited number of medical centers and for a fixed amount that includes the costs of testing, tracking and monitoring side effects. .

While Medicare is prevented by law from negotiating drug prices, this type of approach could limit reimbursement to hospitals, possibly to an amount below Aduhelm’s list price. This could put pressure on Biogen to lower the price if it wants Aduhelm to be used, said Chris Meekins, analyst at Raymond James.

Reporting by Deena Beasley Editing by Caroline Humer and Bill Berkrot

Our Standards: Thomson Reuters Trust Principles.


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