US Veterans Health Administration rejects Biogen Alzheimer’s drug
pharmafile | August 12, 2021 | News story | |
The US Veterans Health Administration (VHA) has turned down Biogen’s Alzheimer’s drug, Aduhelm (aducanumab), opting not to include the $56,000-a-year drug on its list of approved drugs due to lack of safety and efficacy evidence.
In an emailed statement the VHA said: “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 is now the largest health system to reject the drug, made by Biogen Inc and Eisai Co Ltd, which has been steeped in controversy since its FDA approval in June, as its failed to show a benefit for patients in one of its two large-scale clinical trials.
The FDA itself called last month for an independent federal probe into its representatives’ interactions with Biogen ahead of the drug’s approval.
Biogen had said in a June press release that it was working “to finalise a multi-year agreement in order to support access for veterans throughout the VHA system […] with nine million enrolled veterans, approximately 48% of which are over the age of 65.”
Several other healthcare providers, including the Cleveland Clinic and Mount Sinai Health System, have also said they would not prescribe Aduhelm for patients.
However, VA facilities do have the ability to request access to drugs that are not on the list of approved medications. In a statement on Wednesday, Biogen said: “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.”
Some hospitals in the US have begun to use the drug, but patient numbers have been low as providers await clarity on whether Medicare, the federal Medicare health plan for people over the age of 65, will cover the drug’s cost.
Kat Jenkins
