Written Answers Nos. 1444-1463
1444. Deputy Ken O'Flynn asked the Minister for Health whether any adverse incident reviews, crisis response reviews, or emergency department escalation reviews referenced the absence of SCAN services in the Mid-West. [39821/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1445. Deputy Ken O'Flynn asked the Minister for Health how many dedicated SCAN nurses are currently operating in each HSE region. [39822/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1446. Deputy Ken O'Flynn asked the Minister for Health whether the HSE has established recommended staffing ratios or population benchmarks for SCAN services nationally. [39823/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1447. Deputy Ken O'Flynn asked the Minister for Health whether the Department or HSE considers the provision of only two SCAN nurses sufficient for the Mid West population and crisis demand profile. [39824/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1448. Deputy Ken O'Flynn asked the Minister for Health when the two approved SCAN nurse posts for the Mid-West are expected to become operational. [39825/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1449. Deputy Ken O'Flynn asked the Minister for Health whether the posts have been advertised, filled, or remain vacant. [39826/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1450. Deputy Ken O'Flynn asked the Minister for Health whether any business case or service development proposal supporting the Mid-West SCAN expansion will be published. [39827/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1451. Deputy Ken O'Flynn asked the Minister for Health whether the HSE formally reviewed reimbursement, managed access, or pricing decisions relating to omaveloxolone (skyclarys) in France, Germany, Italy, Spain, Belgium, the Netherlands or the United Kingdom as part of the Irish reimbursement assessment process; and if she will provide details of any such comparative analysis undertaken. [39831/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1452. Deputy Ken O'Flynn asked the Minister for Health whether the National Centre for Pharmacoeconomics considered any international managed access agreements, risk-sharing agreements, conditional reimbursement models or outcomes-based reimbursement arrangements in respect of omaveloxolone (Skyclarys); and if she will provide details of the jurisdictions and models reviewed. [39832/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1453. Deputy Ken O'Flynn asked the Minister for Health whether any orphan-drug specific weighting, modified cost-effectiveness threshold, severity adjustment or rare disease reimbursement framework was applied in the assessment of omaveloxolone (skyclarys); and if she will make a statement on the matter. [39833/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1454. Deputy Ken O'Flynn asked the Minister for Health whether the assessment of omaveloxolone (skyclarys) included analysis of indirect societal costs associated with Friedreich's ataxia, including disability supports, caregiver burden, loss of educational participation, workforce impacts and long-term health service utilisation; and if she will provide details of the methodology used. [39834/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1455. Deputy Ken O'Flynn asked the Minister for Health whether Ireland currently operates a distinct reimbursement or pharmacoeconomic assessment pathway for orphan medicines or ultra-rare disease therapies; if so, to provide details of the framework and criteria applied; and if she will make a statement on the matter. [39835/26]
View answerIreland operates a reimbursement and pharmacoeconomic assessment pathway as outlined in the Health (Pricing and Supply) of Medical Goods Act, 2013. Health (Pricing and Supply of Medical Goods) Act 2013
1456. Deputy Ken O'Flynn asked the Minister for Health the number of orphan or ultra-rare disease medicines which received a negative reimbursement recommendation from the National Centre for Pharmacoeconomics in each year since 2020; and the number subsequently approved for reimbursement following commercial negotiation or further review. [39836/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1457. Deputy Ken O'Flynn asked the Minister for Health the average period between European Medicines Agency authorisation and final reimbursement decision in Ireland for orphan medicines in each year since 2020; and how this compares with the EU average where such data is available. [39837/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1458. Deputy Ken O'Flynn asked the Minister for Health whether the HSE has undertaken any comparative analysis of Ireland's orphan drug reimbursement timelines and approval rates against comparable European jurisdictions; and if she will provide details of any such analysis. [39838/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1459. Deputy Ken O'Flynn asked the Minister for Health whether patient organisations or rare disease advocacy groups were consulted or invited to make submissions during the reimbursement assessment process for omaveloxolone (skyclarys); and if she will provide details of the process involved. [39839/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
1460. Deputy Ken O'Flynn asked the Minister for Health whether the HSE Drugs Group considered the progressive and degenerative nature of Friedreich's ataxia, including irreversible disease progression during reimbursement delays, in its consideration of omaveloxolone (Skyclarys); and if she will make a statement on the matter. [39840/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1461. Deputy Claire Kerrane asked the Minister for Health the position regarding access to a drug (details supplied) for people suffering with Duchenne muscular dystrophy; when this drug will be available for children and young people in Ireland; and if she will make a statement on the matter. [39872/26]
View answerThe State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly patients with rare diseases.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date,72 of these new medicines were for rare diseases. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
With respect to Givinostat, the HSE received a commercial proposal from Italfarmaco, the marketing authorisation holder for Givinostat on 08 May 2026.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
The Programme for Government contains a commitment to examine the development of early access schemes for rare diseases.
The State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases. This will be a proof-of-concept initiative, aligned with the commitments in the Programme for Government and recommendations in the National Rare Disease Strategy 2025–2030.
1462. Deputy Conor Sheehan asked the Minister for Health the specific timeline for the completion of the comprehensive scoping exercise regarding the preferred model for a dedicated Sexual Assault Treatment Unit (SATU) in the midwest region; the exact metrics, data thresholds and clinical criteria that constitute the “demonstrated local need” required to greenlight the facility; and if she will make a statement on the matter. [39911/26]
View answerAs this is an operational matter, this PQ is referred to the HSE for direct response to the deputy.
1463. Deputy Roderic O'Gorman asked the Minister for Health the number of persons in County Tipperary waiting for home support hours; the number approved but not yet in receipt of hours; the average waiting time; and if she will make a statement on the matter. [39932/26]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
