Written Answers Nos. 572-583
572. Deputy Colm Burke asked the Minister for Health to outline the instructions given to the HSE concerning the level of spend on new medicines as set out in the letter of determination concerning Budget 2023, Budget 2022 and Budget 2021; and if he will make a statement on the matter. [51076/23]
View answerSustainable pharmaceutical expenditure is an important issue for all and is a continuing focus of my Department and the HSE. Each year, I issue a Letter of Determination to the HSE outlining my priorities and funding levels for the following year. This is the basis on which the HSE will draw up its National Service Plan (NSP) for the year.
The HSE must comply with the relevant legislation when considering investment decisions around new medicines. HSE decisions on pricing and reimbursement are made on objective scientific and economic grounds, seeking use available resources efficiently to deliver the best value possible on taxpayer-funded medicines.
The HSE undertakes commercial negotiations on behalf of the State to deliver substantial savings in the Medicines budget, thereby creating financial headroom to maximise budget utilisation.
The HSE is committing all resources to the provision of new medicines over time, notwithstanding any inter-year variations. Pharmaceutical expenditure has increased from €1.3bn in 2012 and will reach almost €3bn in 2023.
In the last three years, almost €100 million of dedicated funding has been invested by the State in new medicines funding to provide 127 new medicines or extended uses for medicines, to include 50 medicines for oncology and 39 orphan drugs for the treatment of rare diseases.
573. Deputy Colm Burke asked the Minister for Health the reason health technology assessments for medicinal products only consider clinical effectiveness, cost effectiveness and budget impact when assessing a medicines’ value; the reason other elements of the general criteria for assessing a medicine under section 19 of the Health Act 2004 are not considered, including the health needs of the public and the clinical need for the item listed; and if he will make a statement on the matter. [51077/23]
View answerPart 3 of the 2013 Health (Pricing and Supply of Medical Goods) Act outlines the criteria that the HSE are required to consider when making decisions on reimbursement of drugs.
The Executive shall have regard to—
(a) the health needs of the public,
(b) the cost-effectiveness of meeting health needs by supplying the item
concerned rather than providing other health services,
(c) the availability and suitability of items for supply or reimbursement, or
both, under section 59 of the Act of 1970,
(d) the proposed costs, benefits and risks of the item or listed item relative
to therapeutically similar items or listed items provided in other health
service settings and the level of certainty in relation to the evidence of
those costs, benefits and risks,
(e) the potential or actual budget impact of the item or listed item,
(f) the clinical need for the item or listed item,
(g) the appropriate level of clinical supervision required in relation to the item
to ensure patient safety,
(h) the efficacy (performance in trial), effectiveness (performance in real
situations) and added therapeutic benefit against existing standards of
treatment (how much better it treats a condition than existing therapies),
and
(i) the resources available to the Executive.
The NCPE full HTA reports provide a systematic evidence based assessment of the comparative effectiveness, cost effectiveness and budget impact of the drug relative to comparators. This includes an assessment of the efficacy (performance in clinical trial setting), effectiveness (performance in real world setting) and the added therapeutic value of the drug under consideration, compared to existing standard of care treatments.
The NCPE assessment is not limited to clinical effectiveness, cost effectiveness and budget impact. However, these are the quantitative elements that are included in the NCPE report. The NCPE also assess the proposed cost relative to comparator drugs and the comparative safety and risks associated with the drug under evaluation.
Another important part of the assessment is the level of certainty in relation to the evidence and this is described in the NCPE report.
Therefore, while the NCPE assessment addresses the comparative clinical effectiveness, cost-effectiveness and budget impact of drugs, wider criteria as outlined in the 2013 Health Act are also considered.
While the HTA conducted by the NCPE addresses a number of the criteria in Part 3 of the 2013 Health (Pricing and Supply of Medical Goods) Act – not just the aspects identified by Deputy Burke – it alone does not determine a reimbursement decision. This is reflected in the recommendations, which follow each of the NCPE’s HTAs, which always refer to the need to also have regard to the criteria specified in the Health Act.
In addition to the NCPE HTA report, input from other stakeholders is also considered by the HSE Drugs Group including the National Cancer Control Programme Therapy Review Committee, Rare Diseases Therapy Review Committee and submissions from Patient Organisations.
574. Deputy Colm Burke asked the Minister for Health if any health technology assessments regarding individual medicines have been subject to external review or audit, or if any international comparisons have been undertaken; and if he will make a statement on the matter. [51078/23]
View answerThe NCPE is an active participant in many ongoing international HTA collaborations including the Beneluxa Initiative, EUnetHTA21 and the International Horizon Scanning Initiative. The NCPE are a leading organisation in the BENELUXA initiative and have produced two joint HTA reports as part of this collaboration: Onasemnogene abeparvovec (Zolgensma) and Atidarsagene (Libmeldy).
The NCPE participated as authors/co-authors on four joint clinical assessments and collaborative assessments as part of Joint Action 3 of EUNETHTA. This collaborative work includes peer review with other international HTA agencies. The NCPE is also leading on the development of methodological guidelines on behalf of the EU Member State Coordination Group on HTA, for joint assessments on the comparative effectiveness of drugs.
575. Deputy Colm Burke asked the Minister for Health if any quality adjusted life-year thresholds are being applied to medicines assessment and reimbursement currently; and if he will make a statement on the matter. [51079/23]
View answerThe 2016 Framework Agreement between the HSE, Department of Health and IPHA outlined a Decision Authority Level Table which referred to cost per QALY thresholds of €20,000 and €45,000 per QALY. While the threshold values are not explicitly stated in the current Framework Agreement, the NCPE assessments present results of cost-effectiveness analyses for consideration by the HSE Drugs Group using both of these threshold values.
576. Deputy Colm Burke asked the Minister for Health the level of VAT payments made by the HSE’s corporate pharmaceutical unit to the Revenue Commissioners in 2022 relating to the supply of medicinal products; and if he will make a statement on the matter. [51080/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
577. Deputy Marian Harkin asked the Minister for Health how many full-time and part-time healthcare staff have been employed in a facility (details supplied); to provide a breakdown of each medical discipline; and if he will make a statement on the matter. [51094/23]
View answerAs this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently not in a position to answer PQs due to industrial action. It is hoped that normal services will resume soon. In the meantime, this Department will continue to refer PQs to HSE for their direct reply as soon as possible
578. Deputy Alan Kelly asked the Minister for Health if he will provide the number and categories of life changing injuries which have occurred as a result of the rise in road traffic incidents which caused fatalities and life changing injuries in each of the years 2016 to date, and by category with an explanation of what each category represents. [51098/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
579. Deputy Francis Noel Duffy asked the Minister for Health the status of the planned build of a primary care centre in the Rathmines/Terenure/Limekiln area; and if he will make a statement on the matter. [51105/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
The Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
580. Deputy Ged Nash asked the Minister for Health when the HSE will provide a date for a procedure for a person (details supplied); and if he will make a statement on the matter. [51108/23]
View answerI fully acknowledge the distress and inconvenience for patients and their families when elective procedures are cancelled, particularly for clinically urgent procedures. While every effort is made to avoid cancellation or postponement of planned procedures, the HSE has advised that planned procedures and operations can be postponed or cancelled for a variety of reasons including capacity issues due to increased scheduled and unscheduled care demand.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result there may be a delay in the Deputy receiving a response from the HSE.
581. Deputy Carol Nolan asked the Minister for Health if his Department has or is planning to conduct a risk assessment on the recently announced recruitment freeze within the HSE; and if he will make a statement on the matter. [51111/23]
View answerAs this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently not in a position to answer PQs due to industrial action. It is hoped that normal services will resume soon. In the meantime, this Department will continue to refer PQs to HSE for their direct reply as soon as possible.
582. Deputy David Cullinane asked the Minister for Health if he or his Department had communicated to the Department of Public Expenditure; National Development Plan Delivery and Reform the make-up of the deficit for 2023, and his commentary in Dáil Éireann that two-thirds of it was made up of high health inflation and increased demand; to outline the nature of that communication; if this was done by way of email, letter, in-person meeting; if not, the manner of the communication; and the date or dates on which this was communicated. [51112/23]
View answer583. Deputy David Cullinane asked the Minister for Health if he or his Department had communicated to the Department of Public Expenditure; National Development Plan Delivery and Reform the element of the deficit for 2023 which is recurring and could not be saved by cost controls; the extent of that element of the deficit; to outline the nature of that communication; if this was done by way of email, letter, in person meeting; if not, the manner of the communication; and the date or dates on which this was communicated. [51113/23]
View answerOfficials in my Department are in ongoing contact throughout the year with officials in the Health Vote section of the Department of Public Expenditure, National Development Plan Delivery and Reform in relation to expenditure forecasting and expenditure management. These matters are also discussed on a monthly basis in the Health Budget Oversight Group.
On 9th November 2023, as part of discussions on a Supplementary Estimate for the Health Vote 2023, my officials submitted, by email to officials in the Department of Public Expenditure, National Development Plan Delivery and Reform, a forecast of projected expenditure to year-end for the Health Vote. This forecast was based on HSE expenditure data to end-August being the latest month available, as well as other relevant information. Following this, officials in both Departments engaged on the detail of this expenditure forecast, and a final forecast of Health Vote expenditure for 2023 was submitted, by email to officials in the Department of Public Expenditure, National Development Plan Delivery and Reform, on 16th November 2023. This forecast formed the basis for the Supplementary Estimate for the Health Vote for 2023 agreed between both Departments, subject to Oireachtas approval.
The Department of Health's expenditure forecast projected a Vote deficit for the Health Vote of €1,034 million for 2023, comprising a HSE Current expenditure deficit of €1,430 million and a a Capital requirement for an additional €22 million, offset by movements in HSE working capital €369 million, savings on Departmental spend of €22 million and transfers to the Department of Children, Equality, Disability, Integration and Youth of €27 million. It should be noted that of the projected Health Vote deficit of €1,034 million for 2023, it has been agreed that €70 million in Capital funding that will be unspent at end-2023 can be carried forward into 2024, meaning that the net cash drawdowns by the Health Vote in 2023 will be €964 million above the original allocation.
Within the projected HSE Current expenditure deficit of €1,430 million, this includes a projected HSE Core expenditure deficit of €1,251 million, and a projected HSE COVID expenditure deficit of €179 million on an accruals basis. Of the projected HSE Core expenditure deficit of €1,251 million, the Department projected that €243 million related to pay deficits to be managed in 2024 within the available pay budget allocation, and €1,008 million related to non-pay and income deficits in 2023 that would be carried into 2024. Taking into account of the fact that €383 million in non-Core funding has been allocated in 2024 to meet expenditure pressures arising from price inflation and demographic demand, this leaves €625 million of a funding gap carried forward, requiring either additional funding or expenditure management actions to be implemented in 2024. These figures were communicated by email from my officials to officials in the Department of Public Expenditure, National Development Plan Delivery and Reform as part of the final expenditure forecast submitted on 16th November 2023.
The Department of Health, the HSE and the Department of Public Expenditure, National Development Plan Delivery and Reform are all committed to implementing a range of expenditure management actions in 2024 in order to mitigate as much as possible the potential expenditure pressures on the Health Vote, without adversely affecting patient access to health care.
