“Shiny new treatment:” High cost means new Alzheimer’s drugs not available to all

While the approval of Alzheimer's disease modifying treatments like donanemab and lecanemab (Leqembi) continues to be hotly debated internationally, a verdict from the Australian Therapeutic Goods Administration (TGA) seems imminent.

The new treatments work by breaking up and clearing the build up of amyloid plaques (a hallmark of Alzheimer's disease) in the brains of people with mild cognitive impairment.

Both drugs have been approved by the US Food and Drug Administration (FDA), with lecanemab also passing the test in China, Hong Kong, Israel, Japan and South Korea.

Yet earlier this month, the European Medicines Agency (EMA) refused to grant marketing authorisation for lecanemab, saying the observed effects of the drug did not outweigh the risk of serious side effects such as swelling and bleeding in the brain.

Similarly, in a whiplash decision, lecanemab was both approved and rejected within 24 hours in the UK. Following a review of the risks and benefits the Medicines and Healthcare products Regulatory Agency (MHRA) approved lecanemab for use in Great Britain on August 22. Later that same day the National Institute for Health and Care Excellence (NICE) issued draft guidance not recommending lecanemab for use "because it is not a cost effective use of limited NHS funding."

NICE chief executive Dr Samantha Roberts said the clinical trial showed small but meaningful effects on delaying cognitive decline in patients with early signs of dementia but the cost of the treatment meant the drug is not considered to be a good use of National Health Service (NHS) funding.

"This is a new and emerging field of medicine which will no doubt develop rapidly. However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS," Dr Roberts said.

"It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side effects, plus the cost of purchasing the drug.

"Our independent committee has rigorously evaluated the available evidence, including the benefit for carers but NICE must only recommend treatments that offer good value to the taxpayer."

Related stories: FDA approves drug for early symptomatic Alzheimer’s disease | New Alzheimer’s drug trial shows promising results

Experts say that similar consideration should be given for the Australian market. Dr Tom Russ, of the Alzheimer Scotland Research Centre at the University of Edinburgh said he hopes that this is the start of a very positive period in the treatment of cognitive decline but high costs mean many people could miss out.

“I don’t want to be dismissive of the hope that these developments bring," Dr Russ said.

“But, equally, it’s just not fair if a tiny fraction of people living with dementia get some shiny new treatment and everybody else gets nothing.

“Rather, what I think would be fairer is that everybody gets an enhanced degree of support after a dementia diagnosis.”

“We can’t give that treatment to everybody because that amount of money doesn’t exist in Britain’s health system or in Australia’s."

Dementia Australia reports that currently in the US, a course of lecanemab costs around $40,000 AUD per year.

Further to that, Dr Russ estimates only five to 15 per cent of people living with Alzheimer's disease will be suitable for the new treatments.

“Scientifically, it’s a very exciting step," he said.

“[But] while we are developing the disease-modifying treatments of the near future, we need much more assistance for existing dementia services to diagnose, treat and support people who are currently presenting.”

The drugs are currently under review by the TGA.

Read more: New self-reporting tool revolutionises early dementia detection

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