Posted on September 1, 2021 by Kyle Walton
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Posted on September 1, 2021 by Kyle Walton
When pharmaceutical giant Biogen first announced the approval of Aduhelm, its latest drug-based treatment for Alzheimer’s Disease, it became the first medication of its type to carry this distinction in almost 20 years.
Unfortunately, high-costs associated with the medication would put Medicare on the hook for tens of billions of dollars in expenses, potentially raising prices for all Medicare beneficiaries and taxpayers alike, even if the drug were prescribed to just a fraction of people affected by the disease.
Fast forward to today, and the medication has been prescribed to an incredibly underwhelming number of patients. According to doctors, this is simply because health insurers are reluctant to pay such a high-price for a medication whose effectiveness continues to be hotly debated.
As a result of this debate, Medicare has been slow to decide whether or not Aduhelm will be covered under their government-regulated prescription drug policies.
As a result of Medicare’s slow claim review process, Biogen has taken it upon itself to provide its controversial new Alzheimer’s drug free-of-charge to select patients. According to professionals in the field, including many doctors, this is an effort on Biogen’s part to build public popularity for the medication, potentially putting pressure on Medicare to cover its use in treatment.
Biogen’s decision to offer Aduhelm to certain individuals at no cost serves only to underscore the debate surrounding whether the drug’s $56,000 annual price tag is even worthwhile in the first place. As a result, Medicare has been holding back prescriptions and sales of the medication.
Administered via monthly infusion, Aduhelm was approved by the FDA this past June, despite less-than-stellar clinical trial results, one of which entirely failed to show the medication’s benefit for those diagnosed with the disease.
Still, Biogen has made an effort to expedite treatment through Florida’s First Choice Neurology by offering Aduhelm for free, according to Dr. Jeffrey Gelblum, a neurologist at the aforementioned healthcare center.
“We have been using the Biogen access program – it is almost like a sample program – to get patients started,” Dr. Gelblum told Reuters.
Biogen has stated that it has even more plans in place to “support patient access” to Aduhelm, but declined to give further details.
A number of hospitals, including the Veterans Health Administration, claim that there is simply not enough evidence that Aduhelm is effective enough to justify the drug’s widespread use.
As a result, multiple insurance providers, including some of the largest distributors of Medicare coverage plans, have said they will continue limiting coverage of the drug until further direction from Medicare is received.
"Mainly because of the uncertainty around insurance coverage ... most doctors and systems are in a holding pattern," said Dr. Anton Porsteinsson, director of the University of Rochester Alzheimer's Disease Care, Research and Education Program, which is currently only using Aduhelm (known generically as aducanumab) on patients enrolled in clinical trials.
Alzheimer’s status as an age-related disease would mean that around 85 percent of people who would be considered eligible for the drug will be covered under Medicare. Recently, the government-regulated health insurance program has launched a nine-month process to determine national coverage regulations for the medication.
Experts say Medicare could seek to lower the Biogen Alzheimer’s drug Medicare cost to taxpayers by limiting beneficiaries access to the treatment, linking coverage to real-world evidence of patient outcomes, or setting a fixed payment that combines drug reimbursement with other costs related to Aduhelm’s administration method.
According to major Wall Street analysts, Aduhelm sales are expected to total $81 million this year, $1.3 billion next year, and $5.8 billion by 2026.
Kyle is a professional writer with several years of experience helping to inform the public on many diverse topics and industries, including healthcare. He is a Kutztown University graduate, Class of 2017.