More evidence is needed on the clinical and cost-effectiveness of
donanemab, a new treatment for mild Alzheimer's disease, NICE has
said in draft guidance published today.
The costs of providing donanemab, including the monthly infusions
and intensive monitoring for serious side effects, balanced
against the relatively small benefit it provides to patients,
means it cannot currently be considered good value for the
taxpayer.
The clinical trial evidence suggests that the monthly injection
can slow Alzheimer's disease progression by 4 to 7 months, NICE's
independent committee heard.
The committee also heard that clinical trial evidence suggests
there are significant health risks associated with the treatment.
A third of donanemab recipients experienced amyloid-related
imaging abnormalities (ARIA) caused by brain swelling and
bleeding.
Donanemab (also called Kisunla and made by Eli Lilly) has been
licensed today by the MHRA for treatment of mild cognitive
impairment or mild dementia due to Alzheimer's disease in some
adults.
At the same time NICE is issuing draft guidance for consultation
that does not recommend donanemab for use on the NHS as the
benefits it offers patients are too small to justify the
additional costs.
The independent committee examined the available research trial
evidence, real world data, and heard from patient representatives
and carers. Potential cost savings related to the NHS and
personal social services were also considered.
The committee recognised the importance of new treatment options
and has asked the company and NHS England to provide additional
information to address areas of uncertainty in the
evidence.
There are significant uncertainties to how much benefit donanemab
provides, and how long this lasts for after stopping treatment.
Further work is also needed to understand the costs of giving the
medicine in the NHS.
Helen Knight, director of medicines evaluation at NICE
said: “For NICE to be able to approve a medicine for use
in the NHS it must provide additional benefits to patients, and
it must also represent a good use of NHS resources and taxpayers'
money.
“Our independent committee looked at all the available evidence,
including the benefits for carers. This shows donanemab could
slow down cognitive decline by 4-7 months, but this is just not
enough benefit to justify the additional cost to the NHS. The
cost-effectiveness estimate for donanemab is 5 to 6 times above
what NICE normally considers an acceptable use of NHS resources.
“I know this will be disappointing news, but this is an emerging
field of medicine and there are other treatments being
developed.”
It is estimated that around 70,000 adults in England would have
been eligible for treatment with donanemab.
There is an evolving landscape for the diagnosis and management
of Alzheimer's disease.
NICE will be reviewing its guidance on the diagnosis and care of
people with dementia to ensure patients get the best care
possible while new and emerging medicines are still in their
infancy.
NICE has identified around 27 products that it expects to be
asked to evaluate over the next few years and is tracking the
work of the Blood Biomarker Challenge that is researching whether
blood tests are effective in diagnosing different types of
dementia. Work is also underway to revisit NICE's suite of
guidance on Alzheimer's disease including a review of quality
standard.
Donanemab is a type of drug called a monoclonal antibody, which
is given by infusion (through a drip in the arm), once a month in
hospital.
NICE previously issued draft guidance on lecanemab, another
monoclonal antibody for mild Alzheimer's which is given every two
weeks in hospital.
Both treatments require careful monitoring in hospital after
treatment is given.
Alzheimer's disease is thought to be caused by the abnormal
build-up of proteins in and around brain cells. One of these
proteins is called beta-amyloid. Deposits of these amyloid
proteins form plaques around brain cells and disrupt neurone
function. Donanemab works by targeting and reducing these
beta-amyloid proteins.
It has a recommended maximum treatment duration of 18 months. The
consultation on the draft NICE guidance on donanemab will close
on 20 November 2024. The independent committee will consider all
responses, including any additional analyses, at a second
committee meeting before producing its final recommendations.
The consultation on draft guidance for lecanemab ran from 22
August to 20 September. A second committee will be held in
November to consider all responses before producing final
recommendations.
Ends
- An embargoed copy of the draft guidance on donanemab for
treating mild cognitive impairment or mild dementia caused by
Alzheimer's disease is available at: ID6222 donanemab for
Alzheimers_ DG_FINAL - Reupload - 20241022160803499.docx
