Written answers
Wednesday, 5 November 2025
Department of Health
Medicinal Products
Colm Burke (Cork North-Central, Fine Gael)
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176. To ask the Minister for Health to outline the number of new medicines which were submitted to the NCPE in each year between 2015 and 2025; and the number of these new medicines that were non-oncology orphan medicinal products, in tabular form; and if she will make a statement on the matter. [60301/25]
Colm Burke (Cork North-Central, Fine Gael)
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177. To ask the Minister for Health to outline the number of non-oncology orphan medicinal products which were referred to the HSE Drugs Group by the NCPE in each year between 2015 and 2025; and to provide a breakdown of the number of successful, negative and pending reimbursement decisions for such products, in tabular form; and if she will make a statement on the matter. [60302/25]
Colm Burke (Cork North-Central, Fine Gael)
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178. To ask the Minister for Health the average length of time taken for non-oncology orphan medicines to receive a final reimbursement decision from the HSE Drugs Group after the submission of a pricing application by a manufacturer, in tabular form; and if she will make a statement on the matter. [60303/25]
Colm Burke (Cork North-Central, Fine Gael)
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179. To ask the Minister for Health the number of non-oncology orphan medicines which were approved by the HSE drugs group in each year from 2015 to 2025 and which did not satisfy the QALY threshold for cost-effectiveness, in tabular form; and if she will make a statement on the matter. [60304/25]
Colm Burke (Cork North-Central, Fine Gael)
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180. To ask the Minister for Health the number of new medicines which were submitted to the NCPE in each year between 2015 and 2025; to provide a breakdown of the number of these new medicines that were non-oncology orphan medicinal products, in tabular form; and if she will make a statement on the matter. [60305/25]
Colm Burke (Cork North-Central, Fine Gael)
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181. To ask the Minister for Health the number of non-oncology orphan medicinal products which were referred to the HSE drugs group by the NCPE in each year between 2015 and 2025; to provide a breakdown of the number of successful, negative and pending reimbursement decisions for such products, in tabular form; and if she will make a statement on the matter. [60306/25]
Colm Burke (Cork North-Central, Fine Gael)
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182. To ask the Minister for Health the average length of time taken for non-oncology orphan medicines to receive a final reimbursement decision from the HSE drugs group after the submission of a pricing application by a manufacturer, in tabular form; and if she will make a statement on the matter. [60307/25]
Cathy Bennett (Cavan-Monaghan, Sinn Fein)
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183. To ask the Minister for Health her proposals to ensure that patients are not forced to absorb the cost of blister-pack packaged medication, which assists patients to monitor their dosage under complex medication regimes safely and independently; and if she will make a statement on the matter. [60312/25]
Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Community Pharmacy Agreement 2025 does not remove phased dispensing.
Phased dispensing was introduced in 1996 for patient safety reasons. The supply of medication in instalments can support patients prescribed certain high-risk medications who are at risk of medication misadventure if these medications were to be supplied on a monthly basis, as is the norm under the community drug schemes. Where a phased dispensing claim is submitted, the current requirement is that an item must be dispensed across multiple supply occasions. Community pharmacies receive additional payments in respect of phased dispensing.
Monitored Dosing Systems are systems that enable the individual medicine doses to be organised according to the prescribed dose schedule. These are sometimes referred to as blister packs. The State has never agreed to fund Monitored Dosing Systems.
However, a practice has built up whereby the use of Monitored Dosing Systems are charged as if for phased dispensing. The State has never agreed to this. Phased claiming was never intended to be used to submit claims in lieu of the provision of Monitored Dosing Systems.
Whilst Monitored Dosing Systems may have a role for some patients there is significant uncertainty around the robustness of the evidence supporting its use. The National Centre for Pharmacoeconomics carried out an evidence assessment which indicated that the evidence was, at best, equivocal to support such a programme.
Significant expenditure is therefore being incurred where it was never intended by the State. It has been agreed to introduce improved controls in this regard and to limit the use of phased dispensing to specified high risk drugs, where a patient safety concern may exist.
This is being done in a way which puts patient safety first and allows the State to repurpose €20m of funding to be used to implement new patient-centred services.
It remains open to pharmacies to charge patients for the use of Monitored Dosing Systems as a private service.
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