Dismay but little surprise as NICE rejects Alzheimer's drugs

Eli Lilly and Eisai's hopes of making their Alzheimer's disease therapies available to NHS patients in England have been knocked back, but the companies aren't going to take the decision lying down.

Health technology assessment (HTA) agency NICE said this morning that Eisai's Leqembi (lecanemab) and Lilly's Kisunla (donanemab) should not be provided through the NHS in England – and the devolved nations that follow its decisions – for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's.

Lilly has already said it plans to appeal against the decision, while Eisai called for "an immediate overhaul of the NICE appraisal process for early Alzheimer's disease medicines." The window of opportunity to lodge an appeal closes on 8th July.

Both Leqembi and Kisunla were approved by UK drug regulator, the MHRA, last year, and are the first drugs shown to slow the progression of the disease, giving people a chance to live independently for longer.

However, in both cases, NICE immediately published draft guidance that concluded the anti-amyloid drugs were too expensive to be funded by the NHS, and reiterated that position in a March update. They are estimated to have a cost of around £20,000 per year, but would be offered to the NHS at a confidential discount.

This morning, NICE said its independent panel of advisors had concluded that the benefits of the two drugs "remain too small to justify the additional cost to the NHS" of providing them – a cost that includes regular visits to clinics for infusions and patient monitoring.

It said they have been shown to delay progression from mild to moderate Alzheimer's by four to six months, but "the overall costs of purchasing and administering the drug remain high and the benefits too small."

Responding to the news, the Alzheimer's Society said it was a "setback", but added that even if they had been recommended, "too many patients wouldn't be able to access them because the health system isn't ready to deliver them."

It has called for the UK government to commit to the long-term investment needed to fundamentally change dementia diagnosis so that we are ready for new treatments.

That theme was expanded on by Eisai's regional chief executive, Gary Hendler, who said the decision "protects a health service that is not yet ready to identify and manage patients in the early stages of their illness."

He also claimed that NICE's appraisal process "is simply not fit to evaluate medicines for early Alzheimer’s" and – given that there are dozens of drugs coming through the industry pipeline focused on the early stages of the disease, "we feel it is our duty to sound the alarm today that this appraisal process needs an immediate overhaul so that future medicines may be more appropriately assessed."

The recommendations did not, however, come as a surprise to Prof Rob Howard, professor of old age psychiatry at UCL, who said that the benefits of the drugs in trials were "too small to be noticeable" by patients.

Moreover, he added that "the treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse's salary for each treated patient. We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study."