First patient set to receive controversial Biogen Alzheimer’s drug By Reuters

© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, USA January 26, 2017. REUTERS / Brian Snyder / File Photo

By Deena Beasley

(Reuters) – A U.S. hospital will give the first infusion of an expensive, controversial new Alzheimer’s drug from Biogen Inc (NASDAQ 🙂 on Wednesday before Medicare even said what it will pay for – and some doctors were upset with its approval last week .

The first administration of the drug Aduhelm outside of a clinical trial is expected to take place in Providence, Rhode Island, as part of Butler Hospital’s Memory and Aging Program.

“We’re opening a new era in treatment,” said Brown University Medical School neurology professor Dr. Stephen Salloway, opposite Reuters. He said the Butler Hospital program has about 100 patients who are likely good candidates for the drug, which is given as a monthly intravenous infusion.

Aduhelm was approved based on evidence that it can reduce plaques in the brain that likely contribute to Alzheimer’s, rather than proving it slows the progression of the deadly mind-wasting disease.

The US Food and Drug Administration has approved the drug for all patients with Alzheimer’s disease – despite the objection of its own expert advisory board – although Aduhelm has only been tested in patients with the early stages of the disease.

“Hopefully clinicians will follow clinical trial guidelines because we really don’t have any evidence of more advanced patients with Alzheimer’s,” Selloway said.

Some doctors are even cautious about prescribing Aduhelm for this group.

Dr. David Knopman, a neurologist at the Mayo Clinic in Rochester, Minnesota, was one of three experts to step down from an FDA advisory panel that recommended the agency not approve Biogen’s drug.

Between questionable study results and possible side effects, he saw no reason for most patients to get the drug. He said he treads the line between being paternalistic and being honest about his concerns about patients as Mayo prepares to treat them with the new drug.

“I may have talked a person out of using it,” he said. “I will put some of the responsibility on this team that we are putting together. You will hear my opinion.”

Biogen estimates that about 1.5 million of the 6 million people in the United States with Alzheimer’s are considered early-stage disease.

Cigna Corp. (NYSE 🙂 Chief Clinical Officer Steve Miller said he expected Cigna, along with other health insurers and Medicare, to only agree to cover the drug for patients with early-stage Alzheimer’s disease.

Biogen, who worked on the drug with the Japanese drug manufacturer Eisai Co (OTC 🙂 Ltd. collaborates, has set an average price of $ 56,000 per year, which the Alzheimer’s Association – a longtime open supporter of the company – described as “simply unacceptable.”

The vast majority of patients are covered by the federal Medicare health program. However, Robert Egge, chief public policy officer at the Alzheimer’s Association, said that most Medicare beneficiaries are responsible for 20% of the cost of medication administered by doctors, and about 10% of them have no cap on that cost.

“This could further exacerbate the health equity challenges we have across the country,” he said.

Biogen said it hopes the “value-based contract” it signed with Cigna last week, which will track the drug’s effectiveness, is a step towards “more efficient and affordable patient access.” It added that patients with Medicare service fees are believed to be automatically insured.

Butler Hospital’s first patient is a 70-year-old man with Medicare insurance. Selloway said the hospital would ask the government health plan to cover the cost.

The U.S. Centers for Medicare & Medicaid Services announced that they will have more information on coverage shortly.

The Institute for Clinical and Economic Review (ICER), an influential drug pricing research group, said study data for Aduhelm, known chemically as aducanumab, shows a cost-effective price of no more than $ 8,300 per year. If one only looks at the favorable study results – one of two aducanumab studies relevant for approval failed – the price rises to as much as 23,100 US dollars, according to ICER.

After discounts, Biogen’s net price for Aduhelm is likely to be around $ 30,000 a year, Oppenheimer analyst Jay Olson said in a research note. In addition to these costs, patients must have tests to diagnose Alzheimer’s, such as: B. A brain scan not covered by Medicare or tests with spinal fluid.

However, given that this is the first drug approved that could slow the deadly, memory-draining condition, hospitals are preparing. “All major centers with an interest in Alzheimer’s disease take this seriously,” Selloway said.

source https://dailyhealthynews.ca/first-patient-set-to-receive-controversial-biogen-alzheimers-drug-by-reuters/