Eli Lilly’s appeal against guidance which did not recommend donanemab has been upheld, forcing authorities to reconsider the drug for NHS use. 

The National Institute for Health and Care Excellence (NICE) published the outcome for Lilly’s appeal, after final draft guidance had not recommended NHS reimbursement of donanemab for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease. 

Donanemab is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.  

The decision means the final draft guidance will be returned to the relevant programme, and the committee will meet to consider estimates for infusion cost seen in the NHS and long-term data for donanemab. 

“This is a big moment in the battle against Alzheimer’s disease,” Chris Stokes, General Manager of the Northern European Hub at Lilly, said in a statement. 

“NICE was right to look again at the evidence in front of them and it’s welcome that our appeal has been upheld. For people living with Alzheimer’s disease, and for the families and carers who support them, this matters, perhaps now more than ever.

“We now look to NICE to use the flexibilities outlined in the manual, as it reassesses the evidence that Lilly, clinical experts and patient advocates have put forward, so that we can work towards our shared goal of ensuring all eligible patients with Alzheimer’s disease can access approved treatment options on the NHS as quickly as possible.” 

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