Stephen Donnelly (Wicklow, Fianna Fail)
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Sustainable 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.

Stephen Donnelly (Wicklow, Fianna Fail)
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Part 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.

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.