USA – Biogen is providing its controversial and expensive new Alzheimer’s drug free of charge for some patients amid slow claim reviews by Medicare, according to sources familiar with the situation.
The development underscores the division among doctors about whether the $56,000-a-year drug helps patients and how uncertainty about reimbursement from Medicare, the U.S. government health plan for people over age 65, has 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 even though one of Biogen’s two large clinical trials failed to show a benefit for patients diagnosed with the incurable mind-wasting disease.
In order to expedite treatment, Biogen has begun to provide Florida’s First Choice Neurology with free-of-charge Aduhelm, according to Dr. Jeffrey Gelblum, a neurologist at the center’s Aventura, Florida, operations.
Biogen has said it has a number of plans in place to support patient access, but did not give further details.
A number of hospitals, as well as the Veterans Health Administration, have said there is not enough evidence to justify 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 further direction from Medicare before covering the drug.
In addition to the medication itself, costs of administering Aduhelm include diagnostic testing for Alzheimer’s and monitoring for side effects such as dangerous brain swelling.
Experts say Medicare could seek to lower the therapy’s cost to taxpayers by limiting 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 the treatment.
Aduhelm, developed in partnership with Japan’s Eisai Co Ltd, comes in two vial sizes of 300 milligrams (mg) and 170 mg. Patients are started out on a low dose, which is increased over time to the full dose of 10 mg per kg of a patient’s weight.
Sales of the drug are forecast to total US$81 million this year, US$1.3 billion next year and US$5.8 billion by 2026, according to Wall Street analysts polled by Refinitiv.