Fiona O'Loughlin (Fianna Fail) | Oireachtas source

The issue I want to raise before the House, and it is not the first time that I have spoken about it here, is the area of hereditary amyloidosis. Like many Members, I would not have heard about this very debilitating and difficult disease if it had not affected somebody that I know very well. Pat Tinsley is a well known and well loved member of the Newbridge community whose life has been absolutely destroyed by this degenerative disease. This debilitating and fatal illness attacks the heart and nervous system of patients.As it progresses, it causes loss of sensation, limb weakness and pain. The drug patisiran, which helps alleviate and manage symptoms, is available in the UK and the US but is not available here.

Pat is running out of time and desperately needs this drug, as do approximately 30 other people in Ireland. Thankfully, the Department secured a significantly enhanced budget with an extra €50 million for new medicines in 2021 but I have been informed that this budget allocation will be insufficient to cover the costs of all new medicines in 2021. I know that the HSE is committed to providing access to as many new medicines as possible from the resources provided and I urge it and the Minister to include patisiran in that list.

Some 4,000 of my constituents signed a petition calling for patisiran to be made available to Pat and the other sufferers of this disease and I am speaking on their behalf. I have submitted that petition to the Minister for Health, the chief executive of the HSE and the Chair of the Oireachtas Committee on Health. According to the HSE, the required National Centre for Pharmacoeconomics, NCPE, health technology assessment report was received by the HSE on 24 February 2020. At that point, under a different Government and regime, it was recommended that patisiran not be recommended for reimbursement unless cost effectiveness could be improved relative to existing treatments. Patisiran was then considered at a meeting of the drugs group in July 2020 and, unfortunately, no recommendation was made then.

The agenda of the December 2020 drugs group meeting was full and patisiran was added to the list of items for the next available meeting. Patisiran currently sits as the third item for consideration on the draft January drugs group agenda. The drugs group is expected to provide a recommendation to the HSE executive management team on the basis of all of the available evidence at that time.

I understand that the HSE executive management team is required to consider a range of criteria which include unmet need, clinical evidence, economic evidence, budget impact and the resources available. I urge the executive to remember that behind these statistics and criteria lie real people who desperately need this drug. Those with amyloidosis understand that other people are also waiting for drugs but there is a huge sense of urgency for sufferers of hereditary amyloidosis due to the rapid progression of the disease. I am pleading with the Minister of State and the HSE on their behalf. They absolutely need to have this drug and if they do not get it, the quality of their lives is at risk, and even their lives are at risk.