“We know that this news will be disappointing for families affected by dementia,” says Alzheimer Society of Ireland.
The HSE should not consider reimbursing a ground-breaking drug found to slow disease progression in patients with early-stage Alzheimer’s, a State assessment has found.
Lecanemab is an anti-amyloid monoclonal antibody suitable for people with mild cognitive impairment, or mild dementia due to Alzheimer’s disease.
Research has shown that the drug can slow the progression of Alzheimer’s among eligible patients by about one-third, on average, over an 18-month period. Some patients have experienced benefits lasting a number of years.
Including the price of administering the drug and monitoring its effects, the treatment is estimated to cost up to €60,000 per patient each year.
However, the National Centre for Pharmacoeconomics (NCPE) concluded that lecanemab is not cost effective ‘at any price’.
Its assessment focused on the feasibility of providing the drug to patients with a clinical diagnosis of early Alzheimer’s disease, but do not carry the primary genetic risk factor for late-onset Alzheimer’s (APOE ε4).
Reviewing studies into the drug, the State body found that evidence shows ‘only a small effect on slowing the loss of cognition in patients with Early Alzheimer’s disease, as compared to placebo’.
The assessment also referred to adverse events associated with the drug, including ARIA-E (temporary swelling or fluid build-up in the brain tissue) and ARIA-H (tiny brain bleeds).
The NCPE’s plain English summary of its findings concluded: “After reviewing the data presented by the pharmaceutical company for lecanemab, we recommend that the HSE consider not providing this medicine.”
Responding to the ruling, The Alzheimer Society of Ireland (ASI), which has been campaigning for the drug to be made available here, said it is ‘not the outcome we had hoped for’.
“We know that this news will be disappointing for families affected by dementia,” said the charity’s interim research and policy manager Dr Diane O’Doherty.
“The NCPE recommendation is one step in the reimbursement process. The HSE will now consider the report alongside patient organisations submissions, including one from The Alzheimer Society of Ireland, and other relevant criteria. We will continue to monitor developments closely and provide further updates as information becomes available.”
She added: “Disease modifying therapy drugs have the potential to change lives by giving people affected by Alzheimer’s disease more quality time with their families.
“The current situation raises important questions about equity of access. For those who wish to pursue treatment, access should be determined by clinical eligibility and informed choice, rather than by financial circumstances, geography or socioeconomic status.
“While lecanemab is now available privately in Ireland, the cost of treatment places them beyond the reach of many people living with Alzheimer’s disease and their families. The HSE could consider a controlled managed access programme at selected specialist sites, ensuring equitable access for eligible patients whilst maintaining appropriate clinical oversight.
“The ASI will continue to support all those affected by dementia and we remain committed to ensuring that supporting and advocating for people with dementia and their families so they can live as well as possible for as long as possible.”
Lecanemab is one of two drugs recently found to offer, for the first time, the possibility of slowing disease progression in early Alzheimer’s disease.
The other drug is donanemab – a separate evaluation of this treatment is currently underway after an NCPE rapid review recommended that a full health technology assessment should be carried out to determine its cost effectiveness.
In May an Irish study of 174 countries found that significant price reductions would be needed before most would be able to afford the treatments for their populations.
The Trinity College research found that, at currently emerging market prices, neither of the two drugs would be considered cost-effective across the 174 countries examined.
Even when these medicines offer clinical benefit, the prices that would represent good value in low and middle-income countries are far below prices currently seen in the US market.