1140. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains any national policy governing interim patient access to medicines awaiting reimbursement decisions for rare diseases. [38855/26]
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 under the heading Medicinal Products.
1,228 questions match, newest first.
1141. Deputy Ken O'Flynn asked the Minister for Health if the Department or HSE has examined establishing a formal compassionate or early-access medicines framework for patients with rare progressive conditions pending health technology assistant and reimbursement determinations. [38856/26]
1142. Deputy Ken O'Flynn asked the Minister for Health the number of reimbursement applications for orphan or ultra-orphan medicines remain under assessment by the HSE for more than 12 months as of May 2026. [38857/26]
1143. Deputy Ken O'Flynn asked the Minister for Health if the HSE records the number of patients who seek access to medicines through named-patient or exceptional approval mechanisms outside standard reimbursement arrangements. [38858/26]
1225. Deputy Ken O'Flynn asked the Minister for Health if her Department or HSE has considered establishing an accelerated reimbursement pathway for medicines relating to rare progressive neurological disorders. [39070/26]
1226. Deputy Ken O'Flynn asked the Minister for Health the average duration of the pricing and reimbursement process for orphan medicines since 2020, from initial application to final decision. [39071/26]
1227. Deputy Ken O'Flynn asked the Minister for Health if a review has been undertaken into the patient impact of delays in reimbursement decisions for orphan or rare disease medicines. [39072/26]
1230. Deputy Ken O'Flynn asked the Minister for Health if there is a mechanism permitting interim or conditional reimbursement for medicines treating progressive neurological diseases pending completion of the full reimbursement process. [39075/26]
1338. Deputy Duncan Smith asked the Minister for Health with reference to the framework agreement on the supply and pricing of medicines 2026-2029's commitment to develop an early access scheme for rare diseases; if she will consider the equity of creating a fast-track for patients with rare diseases versus the track for patients whose diseases may not be rare but may have a greater clinical need; if she will conside…
1353. Deputy Michael Cahill asked the Minister for Health if she will urgently intervene in the case of a person (details supplied) whose application for approval of a prescribed weight-loss medication under the medical card scheme and has been awaiting a decision from the HSE since February 2026, despite supporting documentation from both her GP and consultant orthopaedic surgeon; and if she will make a statement on…
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]
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]
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]
1468. Deputy Cathy Bennett asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy (SMA); and if she will make a statement on the matter. [40025/26]
1476. Deputy Pádraig Rice asked the Minister for Health the timeline for a decision regarding the reimbursement of a treatment (details supplied) for adults living with spinal muscular atrophy; and if she will make a statement on the matter. [40158/26]
323. Deputy Mark Ward asked the Minister for Health if she will consider running a pilot orphan drug early-access programme in order that children with Duchenne muscular dystrophy can access givinostat; if a pricing and reimbursement application is being progressed by the HSE for givinostat; and if she will make a statement on the matter. [38448/26]
324. Deputy Mark Ward asked the Minister for Health if givinostat will be made available for children with Duchenne muscular dystrophy; and if she will make a statement on the matter. [38449/26]