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.
