Alzheimer’s Association Welcomes Aduhelm Price Cut, But Presses On
While calling the recent decision to slash by about half the U.S. list price for Aduhelm (aducanumab) an “important step,” the Alzheimer’s Association continues to advocate for more equitable access to the first new Alzheimer’s therapy since 2003.
Specifically, the organization is calling for Biogen, which with Eisai developed and markets Aduhelm, to extend support to early-stage patients whose access to the treatment may still be limited by its cost.
It also continues to urge the Centers for Medicare & Medicaid Services (CMS) to cover antibody-based treatments designed to help clear amyloid plaques from the brain. These plaques, or irregular protein clumps, mark Alzheimer’s and are thought to cause its symptoms.
The U.S. Food and Drug Administration (FDA) approved Aduhelm in June despite some lingering uncertainty regarding its benefit. Indications are that the therapy, a first targeted treatment for Alzheimer’s, gives patients more time in early disease stages before more substantial dementia takes hold. Weeks later, the agency revised its approval label to target “patients with mild cognitive impairment or mild dementia stage of disease.”
Further studies are being readied to better gauge the medicine’s effectiveness.
It is “both reasonable and medically necessary” to provide access to this approved “treatment for people with early Alzheimer’s,” the association stated in its press release.
Aduhelm’s initial U.S. list price — about $56,000 annually — sparked widespread criticism after its FDA approval, including from the Alzheimer’s Association.
On Dec. 20, Biogen announced that, effective Jan. 1, 2022, the medication’s yearly cost for maintenance dosing (10 mg/kg) for a patient of average weight would drop by about half, to $28,200. Average weight is set at about 163 lbs or 74 kg.
“We have listened to the feedback of our stakeholders, and we are now taking important actions to improve access to Aduhelm,” said Michel Vounatsos, Biogen CEO, in the company’s press release. “Too many patients are not being offered the choice of Aduhelm due to financial considerations, and are thus progressing beyond the point of benefiting from the first treatment to address an underlying pathology of Alzheimer’s disease.
“We recognize that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system,” Vounatsos added.
Biogen anticipates that, depending upon insurance coverage and access to diagnoses and specialized care, some 50,000 patients may begin Aduhelm treatment next year.
“While this action by the company is an important step to ensure access that would be significant for people living with Alzheimer’s disease, we know more needs to be done,” said Joanne Pike, DrPH, the association’s president.
Specifically, he said the organization will “continue to advocate for coverage of this vital class of therapies [monoclonal antibodies] for those with Alzheimer’s disease. We know that lack of coverage will further deepen health inequities.
“Coverage of drugs that have the potential to help people with cancer, multiple sclerosis, and other diseases receive coverage. This should be no different,” Pike added.
Earlier this year, the association supported the CMS in conducting the analyses necessary to issue a National Coverage Determination, which would better ensure coverage to patients noted by the FDA as eligible for Aduhelm, an intravenous injection treatment.
Days before Biogen’s price change announcement, the Committee for Medicinal Products for Human Use (CHMP) formally recommended that Aduhelm not be approved in the European Union to treat early stages patients. Biogen is expected to request a re-examination of the CHMP’s opinion.
Questions also exist about Aduhelm’s safety, particularly regarding swelling of the brain or ARIA, with a recent study reporting that more than a third of patients treated at Aduhelm’s approved dose in Phase 3 clinical trials experienced ARIA, although most did not show symptoms.