You might think that launching the first-ever drug to treat the underlying causes of Alzheimer’s disease would be a walk in the park, given the huge impact of the disease and high unmet need.
For Biogen’s Aduhelm (aducanumab), however, the road has been far from smooth, with intense criticism of its approval, consternation around its high price and resignations from the advisory committee. The company even requested a narrowing of the indication to reduce the impact on payers’ budgets, after estimates placed the bill for Medicare at $29bn for a single year.
However, for Biogen CEO, the problem seems to be more around communications. “There is clearly too much confusion, misinformation and controversy surrounding our data and the approval process,” he said, admitting the company faced some “near-term challenges” in launching the drug.
He cited three near-term priorities for the company as it seeks to overcome the many hurdles in the way of its drug. They are: to improve understanding of Aduhelm clinical data across the board, to expedite the development of the infrastructure necessary to launch the drug and to seek to clarify the reimbursement pathway.
With more than six million Americans living with Alzheimer’s disease, the price tag to the US healthcare system will be substantial, and it seems as though most doctors are waiting for more advice.
The Department for Veteran’s Affairs (VA) – a crucial payer for the drug in the US – has already announced that it will not include Aduhelm on its formulary, although the VA cited adverse events and “a lack of evidence of a positive impact on cognition” rather than the cost.
The number of doctors that are currently prescribing the new drug is unclear. Alisha Alaimo, Biogen’s head of US operations, stressed the high level of physician and patient interest in the drug but said that only 50 sites had begun infusions. This number has been questioned by other Biogen employees.
“Although we knew breaking new ground would come with some debate, this has been more pervasive than we initially anticipated,” said Alaimo. “We believe the majority of sites are waiting for clarity on reimbursement.”
However, the Centers for Medicare and Medicaid Services (CMS) is not expected to release its draft report on the drug until January.
Attention will inevitably focus on the price of the drug, which Biogen has launched at $56,000 per patient per year when cost watchdog, the Institute for Clinical and Economic Review (ICER), suggested the drug should cost no more than $8,300 per year.
“We are certainly revisiting our very low sales target we have already for 2021,” said Vounatsos.
After the Biogen leaders spoke about Aduhelm at the Morgan Stanley event the company’s shares were down by 7%.