Amid outcry over Aduhelm price, Biogen says it may consider 'adjustment'

Biogen has hinted that it may consider altering the price of its controversially-approved Alzheimer's therapy Aduhelm – but only if its assumptions on population size and uptake are different from what it expects.

In a joint statement with Aduhelm (aducanumab) development partner Eisai, Biogen said it is expecting slow take-up of the drug and an eligible patent population of around 1-2 million people with mild Alzheimer's in the US, saying it has no data on more advanced cases.

If its assumptions are wrong, "we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability," said the companies.

There has been a lot of criticism directed at the FDA's approval of Aduhelm – with a label spanning all Alzheimer's patients – on what is widely considered to be scant efficacy data, and at Biogen's decision to set the price of the drug at $56,000 per year, which some fear could put the US healthcare system under a massive strain.

An analysis published by the Kaiser Family Foundation this month estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost Medicare nearly $29 billion a year.

That price is well above the value-for-money range of $2,500 to $8,300 calculated by the US Institute for Clinical and Economic Review (ICER), as well as the predictions of many analysts tracking the medicine.

The FDA has justified its decision to approve Aduhelm by opting for a conditional approval, which means it can be prescribed to patients while Biogen and Eisai carry out another clinical trial to back up its supposed effects in Alzheimer's.

The timeframe for completing that trial and filing the data is long though – nine years has been allowed by the FDA – which means Aduhelm could generate tens of billions of dollars in sales before it faces the risk of Aduhelm being withdrawn from sale.

The statement says that the two companies are "working with urgency…towards the goal of completing the confirmatory trial ahead of the nine-year timeframe."

Leaving aside the controversy, Biogen and Eisai were handed another fillip by the FDA this week when the agency granted a breakthrough designation for lecanemab (BAN2401), another anti-amyloid candidate for Alzheimer's.

The designation was awarded on the strength of a phase 2b clinical trial of the antibody in 856 patients with mild cognitive impairment due to Alzheimer's and mild cases of the disease, and according to the drugmakers "showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest dose."

Lecanemab is currently in a phase 3 trial called Clarity AD involving 1,795 patients with early Alzheimer's, with results due before the end of the year. Another late-stage trial – AHEAD 3-45 – is also testing the drug in people with amyloid deposits in their brains but no clinical evidence of Alzheimer's symptoms.