The Veterans Health Association (VHA) will not offer the newly approved Alzheimer’s drug Aduhelm due to concerns it may not be effective.
The VHA joins others like Mount Sinai Health in New York and the Cleveland Clinic in not offering the drug that received accelerated approval from the U.S. Food and Drug Administration (FDA) in June.
It is yet another setback for Biogen, the Cambridge, Massachusetts-based manufacturer of controversial Aduhelm.
Over the past two months, the drug has been criticized for its high price and potential ineffectiveness, and the FDA has called to investigate itself for potential inappropriate communication between agency staff and Biogen.
The U.S. Veterans Health Administration, part of the Department of Veterans Affairs, will not offer Biogen’s Aduhelm to Alzheimer’s patients it treats
Aduhelm, a drug manufactured by Biogen, received controversial FDA approval despite limited data that it was effective in clinical trials
‘It is not being added to the VA National Formulary due to the risk of significant adverse drug events and to the lack of evidence of a positive impact on cognition,’ the VHA told Reuters in an email.
The VHA, part of the Department of Veterans Affairs, is the largest health system so far to decline use of the drug.
Biogen had said in a June press release that it was working ‘to finalize a multi-year agreement in order to support access for veterans throughout the VHA system…with nine million enrolled veterans, approximately 48 percent of which are over the age of 65.’
Still, VA facilities do have the ability to request access to drugs that are not on the list of approved medications.
‘Veterans in the VA system have a pathway to access Aduhelm…We will continue to engage closely with the VA as they evaluate potential updates to their guidance,’ Biogen said in an emailed statement.
Aduhelm received FDA approval despite two failed clinical trials in 2016.
Biogen later used data from the second trial to show that its drug could reduce the instances of amyloid beta plaques on the brain.
Some believe those plaques are the cause for cognitive decline associated with Alzheimer’s, meaning Aduhelm could potentially be the only drug with the ability to reduce the memory issues caused by the disease.
Biogen managed to get approval for Aduhelm after pulling data from its second clinical trial that showed the drug could potentially reduce amyloid beta plaques, and even the cognitive decline cause by Alzheimer’s
Many have been critical of Biogen’s findings, though, and one member of an FDA advisory panel even published a study disagreeing with the company’s conclusion.
Dr David Knopman, from the Mayo Clinic and lead author of the study, resigned from his role of the committee alongside Dr Jeol Perlmutter, of Washington University of St Louis, and Dr Aaron Kesselheim, of Harvard University.
All three men were among the panel that unanimously voted against the drug’s approval.
‘[Aduhelm] is probably the worst drug approval decision in recent U.S. history,’ Kesselheim wrote in a letter to FDA Commissioner Janet Woodcock.
Concerns over the drugs ineffectiveness have led to some health systems deciding not to carry it.
The controversial approval of the drug has also caused some rife within the FDA.
Janet Woodcock (pictured), acting commissioner of the FDA, called for an investigation into her own agency and communication between her staff and Biogen in the lead up to Aduhelm’s approval
Janet Woodcock, acting commissioner of the FDA, wrote an open letter to the Office of Inspector General of the U.S. Department of Health & Human Services for a probe into communications between FDA staff and Biogen representatives in the lead up to the drug’s approval.
‘Given the ongoing interest and questions, today I requested that [The Office of the Inspector General] conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm,’ she wrote on Twitter.
The agency also revised its original label for the drug, now only recommending its use in early stages or those with mild cases of Alzheimer’s.
The price of the drug has been under scrutiny as well.
A year of treatment using the drug will cost $56,000 a year, a huge premium to the $10,000 to $20,000 the drug was expected to cost.
Two congressional committees in the House have also launched an investigation into the FDA’s review of the drug.
The House investigations were announced by Rep Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep Frank Pallone Jr, chairman of the House Committee on Energy and Commerce.