Aug. 30 (Reuters) – Biogen Inc (BIIB.O) is providing its controversial and expensive new Alzheimer’s drug for free to some patients as part of Medicare’s slow review of claims, people familiar with the situation say , including a physician treating patients with the drug.
The development points to division among doctors over whether the $ 56,000-a-year drug helps patients and how the uncertainty over reimbursement from Medicare, the U.S. government’s health plan for people over 65, held back prescriptions and sales.
Aduhelm, which is given as a monthly infusion, was approved by the U.S. Food and Drug Administration in June, although one of Biogen’s two large clinical trials failed to show benefit for patients diagnosed with the disease. incurable disease that makes you lose your mind.
In order to speed up treatment, Biogen has started providing Aduhelm free of charge to First Choice Neurology in Florida, according to Dr. Jeffrey Gelblum, an operations neurologist at the Aventura center in Florida.
âWe used the Biogen access program – it’s almost like an example of a program – to get patients started,â he told Reuters.
Biogen said it has a number of plans in place to support patient access, but did not give further details.
Pharmaceutical companies can provide free drugs through patient assistance programs, “but we’ve never heard of this for an injectable and infused drug,” said Steven Lucio, vice president of Vizient Inc, who works with about half of US hospitals to buy drugs, in an email.
James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, said providing free drugs is a common strategy used by drug makers to increase patient prescriptions.
HPITALS SLOW TO USE
A number of hospitals, as well as the Veterans Health Administration, have said there is not enough evidence to justify the widespread use of Aduhelm.
Several commercial insurers, including UnitedHealth Group Inc (UNH.N), the largest private insurer offering Medicare Advantage coverage to seniors, have said they are waiting for new Medicare guidelines before covering the drug.
“Primarily due to the uncertainty surrounding insurance coverage … most physicians and systems are on hold,” said Dr Anton Porsteinsson, director of the Disease Care, Research and Education program. University of Rochester Alzheimer’s, which only uses Aduhelm, also known as aducanumab, on patients in clinical trials.
A recent Morgan Stanley survey of 78 neurologists found that half of them were ready to prescribe Aduhelm, but almost two-thirds don’t think the FDA should have approved the drug. Only eight of the neurologists surveyed had prescribed Aduhelm and six of their health insurance claims had been paid in early August.
Florida’s First Choice has so far infused over 30 patients with Aduhelm, but Medicare has only billed Medicare for the first doses for two patients – their second doses, and the first doses for others, were provided free of charge by Biogen, a said Dr Gelblum. .
He said the clinic was reimbursed by Medicare for the infusion component of the claims, but not for the drug itself, although he expects that to happen in the coming weeks.
Because Alzheimer’s disease is an age-related condition, about 85% of people eligible for Aduhelm are covered by Medicare, which recently launched a nine-month process to determine standardized nationwide coverage requirements for the drug.
For now, the government health plan deals with Aduhelm’s requests on a case-by-case basis.
In addition to the drug itself, the costs of administering Aduhelm include diagnostic tests for Alzheimer’s disease and monitoring for side effects such as dangerous swelling of the brain.
Experts say Medicare could seek to lower the cost of treatment 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 d ‘other costs related to treatment.
Aduhelm, developed in partnership with Japanese company Eisai Co Ltd (4523.T), is available in two bottle sizes of 300 milligrams (mg) and 170 mg. Patients start with a low dose, which is increased over time to the full dose of 10 mg per kg of patient body weight.
Sales of the drug are expected to total $ 81 million this year, $ 1.3 billion next year and $ 5.8 billion by 2026, according to Wall Street analysts surveyed by Refinitiv.
Reporting by Deena Beasley; edited by Caroline Humer and Jonathan Oatis
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