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]
Parliamentary questions
Questions
TDs ask ministers questions to get answers on the record, most of them in writing. Here is every one asked in the 34th Dáil, by the department it went to and the subject heading it was filed under. How questions work
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Showing questions asked by Ken O'Flynn under the heading Medicinal Products.
196 questions match, newest first.
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]
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]
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]
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]
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]
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]
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]
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]
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]
987. Deputy Ken O'Flynn asked the Minister for Health the number of medicines currently awaiting a commercial proposal from a marketing authorisation holder following an invitation by the HSE; the duration each application has remained at that stage; and if she will make a statement on the matter. [36586/26]
988. Deputy Ken O'Flynn asked the Minister for Health whether the HSE maintains any internal monitoring system tracking delays attributable to marketing authorisation holders during the pricing and reimbursement process; and if so, to provide details. [36587/26]
989. Deputy Ken O'Flynn asked the Minister for Health whether any assessment has been carried out regarding the impact on patient access arising from the absence of statutory or administrative deadlines for the submission of commercial proposals by marketing authorisation holders. [36588/26]
990. Deputy Ken O'Flynn asked the Minister for Health whether consideration has been given to introducing statutory or regulatory timeframes governing engagement by marketing authorisation holders once invited to submit a commercial proposal to the HSE. [36589/26]
991. Deputy Ken O'Flynn asked the Minister for Health whether the Department or the HSE publishes, or intends to publish, anonymised data on delays in the pricing and reimbursement process attributable to marketing authorisation holders. [36590/26]
992. Deputy Ken O'Flynn asked the Minister for Health whether any escalation mechanism exists where a pricing and reimbursement application remains inactive for an extended period due to the absence of a commercial proposal from a marketing authorisation holder. [36591/26]
993. Deputy Ken O'Flynn asked the Minister for Health whether the absence of formal timelines for commercial engagement by marketing authorisation holders has been identified as a governance, transparency or patient-access risk within the medicines reimbursement system. [36592/26]
994. Deputy Ken O'Flynn asked the Minister for Health whether any comparative review has been carried out examining how other EU jurisdictions manage delays by marketing authorisation holders during medicines pricing and reimbursement negotiations. [36593/26]
1030. Deputy Ken O'Flynn asked the Minister for Health the rationale and assessment process underpinning the 2022 reimbursement price uplift granted to Steri-neb Salamol 2.5mg/2.5ml. [36754/26]
1031. Deputy Ken O'Flynn asked the Minister for Health whether any cost-effectiveness, inflationary, supply-chain or market-availability assessment was undertaken prior to the Steri-neb Salamol price uplift. [36755/26]
1032. Deputy Ken O'Flynn asked the Minister for Health how many medicinal products received reimbursement price uplifts under PCRS arrangements in each year from 2020 to 2026. [36756/26]
1072. Deputy Ken O'Flynn asked the Minister for Health whether the primary care reimbursement service maintains data on incorrect or overturned claim rejections; and, if so, to provide the figures for 2024 and 2025. [36913/26]
562. Deputy Ken O'Flynn asked the Minister for Health the total expenditure by the HSE in each of the years on the reimbursement of medicines prescribed for erectile dysfunction, including sildenafil and tadalafil; medicines prescribed for menopause-related conditions, including hormone replacement therapy products and topical vaginal oestrogen preparations, under the general medical services scheme, the drugs paymen…
773. Deputy Ken O'Flynn asked the Minister for Health whether dispensing trends for salbutamol nebules are monitored as part of winter preparedness or respiratory surveillance planning. [36448/26]
774. Deputy Ken O'Flynn asked the Minister for Health whether the HSE maintains regional prescribing trend analysis for nebulised bronchodilator medications; and if so, to provide the latest available data. [36449/26]