The Alzheimer’s Association welcomes Aduhelm’s price drop, but insists

While calling the recent decision to reduce the US list price of Aduhelm (aducanumab) by about half by about half a “milestone,” the Alzheimer Association continues to advocate for more equitable access to the first new treatment for Alzheimer’s disease since 2003.

Specifically, the organization is asking Biogen, which developed and markets Aduhelm with Eisai, to extend its support to early-stage patients whose access to treatment may still be limited by cost.

He also continues to urge the Centers for Medicare & Medicaid Services (CMS) to cover antibody-based treatments designed to help remove amyloid plaques from the brain. These plaques, or irregular clusters of proteins, mark Alzheimer’s disease and are believed to be the cause of its symptoms.

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The United States Food and Drug Administration (FDA) approved Aduhelm in June despite continued uncertainty about its benefits. The indications are that therapy, a first targeted treatment for Alzheimer’s disease, gives patients more time in the early stages of the disease before more severe dementia sets in. Weeks later, the agency revised its approval label to target “patients with mild cognitive impairment or a mild stage of dementia.”

Other studies are in preparation to better assess the effectiveness of the drug.

It is “both reasonable and medically necessary” to provide access to this “approved treatment for people with early Alzheimer’s disease,” said the association in its Press release.

Aduhelm’s initial list price in the United States – around $ 56,000 per year – drew much criticism after its approval by the FDA, notably from the Alzheimer’s Association.

On December 20, Biogen announcement that effective January 1, 2022, the annual drug cost for the maintenance dosage (10 mg / kg) for an average weight patient would decrease by about half, to $ 28,200. The average weight is set at around 163 lbs or 74 kg.

“We have listened to feedback from our stakeholders and are now taking important steps to improve access to Aduhelm,” said Michel Vounatsos, CEO of Biogen, in the company press release. “Too many patients are not offered the choice of Aduhelm for financial reasons, and thus progress beyond the point of receiving the first treatment to treat an underlying pathology of Alzheimer’s disease.

“We recognize that this challenge must be met in a way that is seen as sustainable for the US healthcare system,” added Vounatsos.

Biogen predicts that, depending on insurance coverage and access to diagnostics and specialist care, some 50,000 patients could start Aduhelm treatment next year.

“While this corporate action is an important step in ensuring access that would be meaningful for people living with Alzheimer’s disease, we know more needs to be done,” said Joanne Pike, DrPH, president of the ‘association.

Specifically, he said the organization “will continue to advocate for coverage of this vital class of therapies. [monoclonal antibodies] for people with Alzheimer’s disease. We know that lack of coverage will further exacerbate health inequalities.

“Coverage for drugs that have the potential to help people with cancer, multiple sclerosis and other illnesses is covered. It shouldn’t be any different, ”Pike added.

Earlier this year, the association supported CMS in leading the necessary analyzes to issue a National Coverage Determination, which would better ensure coverage of patients noted by the FDA as eligible for Aduhelm, an intravenous injection treatment.

A few days before the announcement of Biogen’s price change, the Committee for Medicinal Products for Human Use (CHMP) formally recommended that Aduhelm not be approved in the European Union for the treatment of early-stage patients. Biogen should request a review of the CHMP opinion.

Questions also exist about the safety of Aduhelm, particularly regarding brain swelling or ARIA, with a recent study report that more than a third of patients treated with the approved dose of Aduhelm in phase 3 clinical trials developed ARIA, although most did not experience symptoms.

Andrew B. Reiter