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Lilly wins appeal for donanemab, drug to be reconsidered for NHS
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The National Institute for Health and Care Excellence (NICE) published the outcome for Lilly’s appeal, after final draft guidance had not recommended NHS reimbursement of donanemab for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease.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The decision means the final draft guidance will be returned to the relevant programme, and the committee will meet to consider estimates for infusion cost seen in the NHS and long-term data for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.”
The post Lilly wins appeal for donanemab, drug to be reconsidered for NHS appeared first on Drug Discovery World (DDW).
BioNTech, in a move to streamline its operations, is set to close its factory in Singapore that it bought from Novartis just over three years ago.
The facility at the Tuas Biomedical Park, which employs …
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STAT+: Merck’s experimental HIV prevention pill could be made for less than $5 a year, researchers say
An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.
The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.
Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.
An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.
The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.
Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.
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Opinion: STAT+: Former Geisinger CEO: U.S. health systems must replace huge numbers of people with AI
About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians.
Only a fraction of the people in that room were clinicians.
That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate.
About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians.
Only a fraction of the people in that room were clinicians.
That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate.
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