Second Alzheimer’s drug expected to be blocked for NHS use

Insiders tell The Telegraph that National Institute for Health and Care Excellence will ‘definitely’ reject donanemab

A second Alzheimer’s drug is expected to be blocked for use by the NHS, The Telegraph can reveal.
This week, the breakthrough drug lecanemab was declared safe by the medicines regulator but was not approved for use on the NHS by the health service’s spending watchdog.
Another new drug, donanemab, is even more effective at slowing down the progression of Alzheimer’s disease. 
It was hailed as the “best ever” treatment for the disease by scientists after trials found it slowed cognitive decline by more than a third and could halt the illness.
But health sources say it will have the same fate as lecanemab. Insiders told The Telegraph that the National Institute for Health and Care Excellence (Nice), which decides what drugs are available on the NHS, would “definitely” reject the second Alzheimer’s drug.
Nice is also unlikely to U-turn on its decision to reject lecanemab in draft guidance this week, they said.
A source said it would be “very tricky” for the body to recommend another similar Alzheimer’s drug, having set a precedent with lecanemab, even if the Medicines and Healthcare products Regulatory Agency (MHRA) approves it.
The MHRA may not approve donanemab because of concerns about the risk of serious side-effects. Both drugs have been approved for use in the US.
It is understood the MHRA’s approval of lecanemab, which was delayed by six months as officials struggled to agree, went down to the wire after counterparts in Europe declared that the risks were too great. 
A source said the Nice decision “was a lot easier” to make, with the cost per patient likely to range from £50,000 to £100,000 per year.
“Now Nice has rejected lecanemab, it definitely will not approve donanemab, which also has twice the risk of serious side-effects,” the source said.
Nice said the costs of lecanemab were “considerably above the range normally considered cost effective for routine NHS use” of between £20,000 and £30,000 per year. The Telegraph revealed this week that officials did not consider the cost borne by families looking after dementia patients.
The cost of donanemab is likely to be even greater, with the drug alone costing around £25,000 per year – 25 per cent more than lecanemab – although it is only administered intravenously once a month rather than every two weeks.
A decision on donanemab has been hit by delays, with the MHRA initially planning to make a call in July – the same time that it was approved for use in the US.
In trials, the drug, manufactured by Eli Lilly, slowed cognitive decline by 35 per cent, making it more effective than lecanemab’s 27 per cent.
But officials are concerned about the drug’s safety after one in three patients developed a brain bleed and one in four had brain swelling during trials because of a condition called amyloid-related imaging abnormalities. This was twice as many incidents as with lecanemab, which is manufactured by Eisai.
Both drugs work in the same way and are a form of monoclonal antibody, replicating the action of the immune system to target specific proteins, in this case the removal of amyloid from the brain.
Experts said it was hard to see Nice approving donanemab after rejecting lecanemab because “the problems are the same”.
Prof Sir John Hardy, the first person to identify the role of amyloid in Alzheimer’s and the chairman of molecular biology of neurological disease at the UCL Institute of Neurology, told The Telegraph the “outcome is also very likely to be the same” but that the more drugs that come to market, the more it could help push prices down.
“I don’t agree with Nice, but I don’t think they’ve been unreasonable. I don’t think they’re the bad guys. I would describe this as a rather constipated negotiation,” he said.
He added that he expects to see “a bit of fight” from patients and charities to pressure Nice into changing its decision.
Dr Tom Russ, a reader in old age psychiatry at the University of Edinburgh and the NHS Scotland dementia research lead, told The Telegraph “it would be a surprise to me if Nice decided to back donanemab and not lecanemab”.
“Scientifically these drugs are a great step forward, but the difficulty is that there are significant risks associated with taking them and they’re extremely expensive,” he said.
Campaigners have described the situation as “heartbreaking” and Alzheimer’s charities are preparing to submit evidence to Nice in hope of getting the decision overturned.
Alzheimer’s Research UK urged Wes Streeting, the Health Secretary, to intervene, and said in a letter that his leadership was “needed to help enable fast and equitable access to a new generation of treatments”.
The MHRA and Nice said they could not comment on ongoing appraisals.
Eli Lilly and Eisai were asked for comment.