Dáil Éireann Debate, Monday - 11 September 2023
1695. Deputy Duncan Smith asked the Minister for Health to provide details on the measures in place to ensure the health service can fully access treatment for those with dementia or Alzheimer's disease, including resources such as CT scans, clinical leads, specialised units and specialty nurses, to leverage the remarkable breakthroughs in drug treatment for these conditions; and if he will make a statement on the matter. [38058/23]
View answer1696. Deputy Duncan Smith asked the Minister for Health the strategic plan he has in place throughout the country to provide equal and speedy access to these treatments for all patients affected by dementia and Alzheimer's disease; and if he will make a statement on the matter. [38059/23]
View answerI propose to take Questions Nos. 1695 and 1696 together.
Disease-modifying treatments for Alzheimer's disease offer the potential to slow down the progression of Alzheimer's disease in its early stages, thereby improving quality of life for people with dementia and reducing the burden on family carers.
Officials in the Department of Health are working closely with the HSE and funded partners to progress the strategic development of dementia services across the wider health system, including preparation for the future availability of disease-modifying treatments (DMTs) for Alzheimer's disease. The HSE has convened an expert working group to identify the necessary resources for the delivery of DMTs, which includes the identification of additional staffing requirements for DMT delivery and neuroimaging to support timely diagnosis and identification of people who may benefit from disease-modifying treatments. We will continue to collaborate with the HSE to ensure readiness for all matters pertaining to the health and wellbeing of people with dementia.
In terms of the process and timing around the availability of DMTs in Ireland, the European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU.
The EMA’s assessment of Lecanemab commenced on 26 January 2023.
To date the EMA has not granted a marketing authorisation for Lecanemab for the treatment of early Alzheimer’s disease. Once a marketing authorisation is granted for a medicine, a manufacturer must submit applications to individual member states.
In Ireland, the Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.
The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals. In order to submit a formal application, the manufacturer of a medicine must hold a marketing authorisation from the European Medicines Agency (EMA).
As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.
The Government is committed to providing timely access to new and innovative medicines to all patients. The dedicated funding of €98 million in the past three Budgets has enabled the HSE to approve over 130 new drugs.
