Medicinal Products

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]

327. Deputy William Aird 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; and if she will make a statement on the matter. [38468/26]

332. Deputy Erin McGreehan 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. [38500/26]

354. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to a campaign related to access to continuous glucose monitoring (details supplied); the actions she will take to engage with this campaign; and if she will make a statement on the matter. [38555/26]

355. Deputy Barry Ward asked the Minister for Health the position regarding any review of access to HSE supports for continuous glucose monitoring that would include those originally diagnosed with not being insulin dependent, but this diagnosis subsequently changing (details supplied); and if she will make a statement on the matter. [38556/26]

356. Deputy Barry Ward asked the Minister for Health her views on the fairness of the discrepancy in access to HSE supports for continuous glucose monitoring (details supplied); and if she will make a statement on the matter. [38557/26]

357. Deputy Michael Cahill asked the Minister for Health if she will intervene to ensure that the HSE urgently prioritises a conclusion to the skyclarys reimbursement negotiations (details supplied); her views on whether the current delay aligns with the 'equitable access' promised in the newly launched National Rare Disease Strategy 2025-2030; and if she will make a statement on the matter. [3856…

243. Deputy Marie Sherlock asked the Minister for Health if there has been engagement by the corporate pharmaceutical unit in the HSE with the manufacturers of miglustat with regard to juvenile Batten disease; if such medication can be reimbursed for an individual with the life limiting condition on compassionate grounds; and if she will make a statement on the matter. [37963/26]

251. Deputy Ruairí Ó Murchú asked the Minister for Health if she will consider purchasing from source, medication for people who are subsequently reimbursed by the State for the medication when they buy it in any case; and if she will make a statement on the matter. [38052/26]

286. Deputy Barry Heneghan 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) (details supplied); when an outcome from the HSE drugs group is expected; and if she will make a statement on the matter. [38237/26]

288. Deputy Conor Sheehan 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. [38242/26]

301. Deputy Colm Burke 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; and if she will make a statement on the matter. [38284/26]

302. Deputy Sinéad Gibney asked the Minister for Health if any policy or regulatory provision exists that restricts the ability of general practitioners to prescribe hormones to transgender patients; and, if so, the legal basis for this restriction. [38288/26]