\u201cWe know that this news will be disappointing for families affected by dementia,\u201d says Alzheimer Society of Ireland.<\/p>\n
The HSE should not consider reimbursing a ground-breaking drug found to slow disease progression in patients with early-stage Alzheimer\u2019s, a State assessment has found.<\/p>\n
Lecanemab is an anti-amyloid monoclonal antibody suitable for people with mild cognitive impairment, or mild dementia due to Alzheimer\u2019s disease.<\/p>\n
Research has shown that the drug can slow the progression of Alzheimer\u2019s among eligible patients by about one-third, on average, over an 18-month period. Some patients have experienced benefits lasting a number of years.<\/p>\n
Including the price of administering the drug and monitoring its effects, the treatment is estimated to cost up to \u20ac60,000 per patient each year.<\/p>\n
However, the National Centre for Pharmacoeconomics (NCPE) concluded that lecanemab is not cost effective \u2018at any price\u2019.<\/p>\n
Its assessment focused on the feasibility of providing the drug to patients with a clinical diagnosis of early Alzheimer\u2019s disease, but do not carry the primary genetic risk factor for late-onset Alzheimer\u2019s (APOE \u03b54).<\/p>\n
Reviewing studies into the drug, the State body found that evidence shows \u2018only a small effect on slowing the loss of cognition in patients with Early Alzheimer\u2019s disease, as compared to placebo\u2019.<\/p>\n
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).<\/p>\n
The NCPE\u2019s plain English summary of its findings concluded: \u201cAfter reviewing the data presented by the pharmaceutical company for lecanemab, we recommend that the HSE consider not providing this medicine.\u201d<\/p>\n
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 \u2018not the outcome we had hoped for\u2019.<\/p>\n
\u201cWe know that this news will be disappointing for families affected by dementia,\u201d said the charity\u2019s interim research and policy manager Dr Diane O\u2019Doherty.<\/p>\n
\u201cThe 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.\u201d<\/p>\n
She added: \u201cDisease modifying therapy drugs have the potential to change lives by giving people affected by Alzheimer\u2019s disease more quality time with their families.<\/p>\n
\u201cThe 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.<\/p>\n
\u201cWhile lecanemab is now available privately in Ireland, the cost of treatment places them beyond the reach of many people living with Alzheimer\u2019s 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.<\/p>\n
\u201cThe 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.\u201d<\/p>\n
Lecanemab is one of two drugs recently found to offer, for the first time, the possibility of slowing disease progression in early Alzheimer\u2019s disease.<\/p>\n
The other drug is donanemab \u2013 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.<\/p>\n