Colm Burke
Question:223. Deputy Colm Burke asked the Minister for Health the estimated cost of a health technology assessment for medical devices; and if she will make a statement on the matter. [28879/26]
View answerWednesday, 22 April 2026
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Health Technology Assessment (HTA) is a systematic process of evaluating health technologies, including medicines, vaccines, and medical devices. A HTA systematically gathers evidence to assist a decision-maker, generally the Department of Health, or a body such as the HSE, in informing policy decisions on adopting, funding, or disinvesting in a health technology. It considers clinical effectiveness, safety, economic impact, and wider societal implications. This is distinct from regulatory approval, which focuses solely on whether a medicine or medical device is safe, effective, and of high quality, and takes no account of the monetary costs to the health system. Regulatory approval determines if a product can be marketed, whereas HTA goes further by examining cost-effectiveness and broader ethical, social, and organisational impacts.
Under the Health Act, 2007, HIQA has a statutory remit to evaluate the clinical and cost effectiveness of health technologies and provide advice to the Minister or the HSE. HIQA conducts HTAs for programmes and services at the specific request of the HSE or Department of Health. HIQA HTAs for the most part do not focus on a specific medical device or diagnostic but often assess a class of medical devices or diagnostics as a component of a broader programme.
HIQA HTAs usually focus on assessment of national programmes. These “full HTAs” comprise all relevant HTA domains including description of the technology, burden of disease, clinical effectiveness and safety, cost effectiveness and budget impact, organisational aspects, and patient, social and ethical issues.
HIQA analyst teams independently review the available evidence and create the economic models as part of this work. Full HTAs take on average 12 to 24 months to complete depending on the complexity of the topic and whether a public and targeted consultation on the draft report is required.
Occasionally “rapid HTAs” are undertaken by HIQA which focus on a smaller number of domains such as description of technology, burden of disease, clinical effectiveness and safety only. Rapid HTAs take on average six months to complete.
A recent example of a HIQA full HTA was the “HTA of extending BowelScreen to those aged 50 to 54 years” which included a class of diagnostic tests as part of a national screening programme. A recent example of a rapid HTA for a medical device was the “Rapid HTA of the use of vesicostomy buttons in children”.
The cost of a HIQA HTA is typically proportional to the time taken (rapid versus full HTA). Generally, each HTA is conducted by a team of approximately four analysts (full time equivalents (FTE’s).