Health Technology Assessment (HTA) is a multidisciplinary process that uses explicit methods to determine the value of a health technology (like drugs, medical devices (including digital technologies), diagnostics, and procedures) at different points in its life cycle. The purpose of HTA is to inform policy and decision-making to ensure technologies are used in a way that delivers the best outcomes for patients and value for money for the health system. While there is variation internationally, a HTA generally involves consideration of key domains such as relative clinical effectiveness and safety, and costs; cost effectiveness; and budget impact. Stakeholder engagement, such as with the public, clinicians or patients, is a core component and may occur before, alongside or after the HTA process has completed.
HTAs are produced in response to needs identified by decision-makers such as national health authorities, and/or national or regional governments for decisions related to relative efficacy and safety, pricing, reimbursement, and other types of decisions such as health system organisation and service delivery. The findings of a HTA may be binding, depending on the jurisdictional legal context or inform decision-making via recommendations or advice.
There are three main pieces of legislation that provide the legal basis for HTA in Ireland: The Health Act 2007, Health Act 2013 and EU HTA Regulation.
Under the Health Act 2007, the Health Information and Quality Authority (HIQA) has a statutory remit to evaluate the clinical and cost-effectiveness of health technologies and to provide advice to the Minister for Health and to the HSE. The Health (Pricing and Supply of Medical Goods) Act 2013 enables the HSE to consider cost-effectiveness along with other factors when making decisions about reimbursing medicines. As an EU Member State, Ireland is also subject to Regulation (EU) 2021/2282, also known as the Health Technology Assessment Regulation (HTAR), which became applicable in January 2025. This regulation mandates joint clinical assessments and scientific consultations at the EU level for drugs and for medical devices and in-vitro diagnostics.
“The purpose of HTA is to inform policy and decisionmaking to ensure technologies are used in a way that delivers the best outcomes for patients and value for money for the health system.”
Typically, the Minister for Health, the Department of Health or the HSE formally request a HTA by HIQA to inform national-level policy or health service decisions. HIQA can assess a broad range of health technologies (for example, drugs including vaccines, medical devices, diagnostic tests, surgical procedures, public health interventions, service delivery models etc.), though generally only when these are being considered as part of a national programme.
Dedicated teams within the HTA Directorate of HIQA focus on different types of technologies (for example, screening programmes, immunisation programmes, service delivery, medical devices and public health interventions). HTAs which relate to population-level screening programmes are formally requested by the National Screening Advisory Committee (NSAC), and HTAs which relate to immunisation programmes are formally requested by the Department of Health.
Assessments are undertaken by an evaluation team with expertise in evidence synthesis, epidemiology and economic evaluation. Typically, HIQA conducts a de novo (new, original assessment) that involves collecting and summarising evidence, as well as modelling outcomes, cost effectiveness and budget impact using robust methodologies, and generally considers the following domains:
A representative Expert Advisory Group (EAG) comprising of key stakeholders relevant to the topic under assessment is convened to support the HTA by providing advice and information, and by conducting an expert review of the draft report. Representation on the EAG is sought from relevant clinical, technical and patient organisations and other key stakeholder groups, for each HTA. For example, the IPU was represented on the EAG for the HTA of the addition of herpes zoster (shingles) vaccination to the adult vaccination programme. A targeted and public consultation of the draft report is often conducted as part of this process to obtain feedback from a broader range of stakeholders. The HTA is ultimately approved by the Board of HIQA and is then published on the HIQA website and advice is provided to the requester. This advice is used to inform decision-making but is not legally binding.
NCPE
The NCPE is an independent HTA body. The NCPE conducts assessments of HTAs to inform decisions regarding the reimbursement of new technologies, primarily drugs but also other technologies for which reimbursement by the HSE is sought. The NCPE also undertakes Joint Scientific Consultations and Joint Clinical Assessments of drugs as part of the EU HTARs, as well as HTAs under the Beneluxa Initiative and other Europe-wide collaborative initiatives. Regarding the national HTA process, the HSE commissions the NCPE to assess drugs following receipt of an application for reimbursement (typically from pharmaceutical companies or marketing authorisation holders). The NCPE assesses HTAs of all new drugs, and all drugs for new indications, for which reimbursement by the HSE is sought. The HSE may also request HTAs of other technologies where required.
The NCPE has a two-step process for national HTAs:
Step 1: All Applicants must submit a Rapid Review, giving an overview of current clinical practice and treatment options for the disease; how well the drug works compared to current standard of care; the comparative drug cost; likely budget impact; and information on cost-effectiveness assessments in other countries. The NCPE conducts an assessment of this Rapid Review. A Rapid Review report is issued to the HSE which summarises the NCPE assessment according to:
A recommendation on the need for a full HTA or reimbursement is made to the HSE.
Step 2: If a full HTA is required, the Applicant must submit a detailed HTA dossier. The NCPE conducts an appraisal of this submission. The NCPE assessment report provides an in-depth assessment of:
The NCPE seeks advice from relevant healthcare professionals. Patient organisations are invited to provide expertise, advice and insights through a patient organisation submission process.
The NCPE provides a recommendation to the HSE on reimbursement, but this is not binding.
Table 1: Summary of national HTA processes in HIQA and NCPE
| Characteristic | HIQA | NCPE |
| Who can request HTA? |
|
|
| Technologies considered | The following may be assessed if being considered as part of a national programme:
|
|
| Approach to HTA | De novo HTA. | Two-step process:
|
| Stakeholder engagement |
|
Seeks expertise from:
|
| HTA outcome | Non-binding advice. | Non-binding recommendation. |
I joined HIQA in 2018 and have assumed a number of different roles over the years. I am currently a Deputy Director of HTA with overall responsibility for the Strategy, Support and Research (SSR) function within the Directorate and I also support the Immunisation and Ionising Radiation teams.
As a pharmacist in HIQA HTA, I apply a broad range of skills and knowledge to a multitude of tasks, such as: data analysis; literature retrieval, interpretation and appraisal; report writing and reviewing; stakeholder engagement and consultation; strategy development and implementation; people and project management; risk management and quality improvement; grant applications, academic writing and dissemination etc. I can also wear my ‘community pharmacy hat’ and consider HTA projects through that lens. For example, having in-depth knowledge of pharmacotherapy, patient interactions and the community drug schemes is quite useful for the work we do.
It may be a cliché, but it is true that no two days are the same in HTA. There is huge variety in the type of work that we do. While the HTA methods are broadly standardised, each project presents its own challenges, which requires problem solving, extensive engagement with clinical and technical experts, policymakers and patient experts, and an element of pragmatism.
There are a number of pharmacists currently working in HIQA HTA and we also provide an APPEL pharmacy placement each year. The work is very interdisciplinary; on any given project, I could be working with medical doctors, physiotherapists, health services researchers, sociologists, health economists, modellers, radiation therapists, epidemiologists etc. It is really interesting to hear the diversity of perspectives, all focused on producing high quality, evidence-based outputs that can ultimately improve patient and population outcomes, and deliver value for money. I strongly believe that pharmacists can make valuable contributions to the work in this interdisciplinary and collaborative environment and have an important role to play.
As a senior health technology assessor (Chief II Pharmacist) in the NCPE, one of my main roles is to lead review groups, comprising of two to four staff members (HTA assessors, statisticians, project managers) in the appraisal of HTAs of medicines. This involves using project management skills such as delegating tasks, establishing timelines for assessment milestones, reviewing reports, providing feedback, liaising with colleagues outside of the review group and motivating staff to complete assessments in accordance with deadlines. The lead assessor has overall responsibility for the approach adopted by the Review Group in the assessment report (assumptions taken, text included in the report etc.). My training as a pharmacist has certainly helped me in this role. Pharmacists tend to have good attention to detail, have good scientific and medical understanding, are competent problem-solvers and are usually quite organised (due to having to manage a heavy college workload!).
The professional underpinning of pharmacy training is also fundamental; we are taught to think ethically when problem-solving and acknowledge the limitations of our knowledge. My experience working in Irish hospitals and subsequently in community pharmacy has proven insightful with regards to the workings of the Irish healthcare system. This translates to a good understanding of infrastructural and operational issues that might develop following the reimbursement of a new drug. Furthermore, pharmacists with experience in the community setting will have in-depth knowledge of state-subsidised schemes and the claiming process. In the NCPE, we often analyse reimbursement claims data from the HSE Primary Care Reimbursement Service (HSE-PCRS) to inform Rapid Reviews or HTAs. An understanding of how these data are collected, and their associated limitations is helpful in interpreting the results of analyses. Finally, it is enshrined in pharmacists to practice patient-centred care. The first principle of the Code of Conduct for pharmacists in Ireland is ‘Put the Patient First’. This is relevant to HTA as well. As HTA assessors, we want patients to have timely access to effective, evidence-based drugs that represent value for money for the healthcare payer. In hospital or community, the pharmacist tailors their approach to the individual patient; in HTA, we also need to consider what is in the best interests of the population. When medicines are funded that are not cost-effective (i.e. they do not represent value for money), there is an opportunity cost (the health forgone as a result of choosing to fund one intervention over the next best alternative intervention).
Highlighted Articles
