Medicinal Products

303. Deputy Marie Sherlock 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. [38289/26]

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]

1228. Deputy Barry Ward asked the Minister for Health the position regarding the approvement process for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37704/26]

1229. Deputy Barry Ward asked the Minister for Health the position regarding a timeline for the approval for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37705/26]

1230. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with the HPRA in relation to the approval for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37706/26]

1231. Deputy Barry Ward asked the Minister for Health if she will set out the mechanism and timeframe of reference for the HPRA to approve the use of a particular pharmaceutical; and if she will make a statement on the matter. [37707/26]

519. Deputy Brian Stanley asked the Minister for Health if melatonin and magnesium preparations are currently covered under the long-term illness scheme; if they were previously included; if so, the date and basis on which they were removed; and if she will make a statement on the matter. [35829/26]

520. Deputy Brian Stanley asked the Minister for Health if she will undertake a review of the clinical and policy basis for excluding melatonin and magnesium from the long-term illness scheme; and if she will consider reinstating these medications to the approved list; and if she will make a statement on the matter. [35830/26]

521. Deputy Brian Stanley asked the Minister for Health if her Department has assessed the impact on patients, particularly those with neurological, developmental, or sleep-related conditions, of melatonin and magnesium not being covered under the long-term illness scheme; and if she will make a statement on the matter. [35831/26]

536. Deputy Robert O'Donoghue asked the Minister for Health if she will outline the pathway available for access to the medication Miglustat for a child diagnosed with Juvenile Batten Disease (CLN3), where the medication is already approved and reimbursed in Ireland for other rare conditions, including Gaucher Disease and Niemann-Pick Type C; and if she will make a statement on the matter. [35902/…

538. Deputy Robert O'Donoghue asked the Minister for Health if she will review the case for access to Miglustat for children diagnosed with Juvenile Batten Disease, particularly where there is significant unmet clinical need and no alternative treatment currently available; and if she will make a statement on the matter. [35904/26]

540. Deputy Mark Wall asked the Minister for Health if she will consider including fibromyalgia in the long-term illness scheme; and if she will make a statement on the matter. [35908/26]

546. Deputy Pearse Doherty asked the Minister for Health if she will intervene to make the drug Givinostat available to children who need it, given that parents of a child that suffers from Duchenne muscular dystrophy has recently made a public plea for the drug to be made available urgently; and if she will make a statement on the matter. [35938/26]

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 sche…