Health Technology Assessment (HTA) Services

AHTA conducts systematic literature reviews and economic modelling to help policy makers know which health care practices are safe, effective and good value for money. Health care interventions considered include:

• investigational tests for diagnosis, screening, monitoring or staging of diseases
• therapeutic interventions such as surgical procedures or medical devices
• combinations of tests and interventions (codependent technologies).

The systematic reviews we produce aim to:

• identify all the relevant literature describing studies on a given topic
• appraise the quality of the studies to determine the reliability of the results
• synthesise the results of the studies to decide whether the health intervention is better or worse for patients than existing alternatives.

The economic modelling considers all the associated costs, savings, health benefits and harms of the intervention—including long term consequences—and compares these to current clinical practice. This estimates the overall value for money of the intervention.

These health care evaluations help to inform Australian Government policy on a variety of topics.

AHTA prepares evaluation reports in response to industry submissions for the public funding of medicine. Evaluation reports identify the key uncertainties in the presented evidence, the methods used and the applicability to the Australian context, to inform decision making. The technologies under evaluation include:

• pharmaceuticals
• vaccines
• co-dependent technologies (i.e. test-drug combinations).

The following aspects of the technologies are rigorously evaluated:

• appropriate clinical place
• comparative treatment effect
• comparative safety
• cost effectiveness
• predicted use and financial impact on Government budgets.

We also review classes of medicines as part of post-market surveillance activities. Examples include a review of statins and of orphan drugs for rare diseases.

AHTA prepares clinical evaluation reports from drug dossiers (clinical study reports and administrative documents) to support decision making relating to authorisation for market access. The clinical evaluation for regulatory purposes involves an assessment of the following components:

• pharmacokinetics and pharmacodynamics
• dose selection
• clinical efficacy
• clinical safety
• supporting documents including the product information and risk management plan.

The clinical evaluation report provides an overall assessment of the benefit-risk balance, and proposed clinical questions to the sponsor to assist in progressing the application.

AHTA is contracted to provide clinical evaluation of medical devices on behalf of the Therapeutic Goods Administration (TGA). Each evaluation is based on clinical evidence submitted as part of submission dossier provided to the TGA by an applicant representing a medical device company.

The purpose of these evaluations is to assist decision makers (such as the Advisory Committee for Medical Devices - ACMD) to recommend or reject an application for the registration of a medical device on the Australian Register of Therapeutic Goods (ARTG). Evaluations may also consider devices already listed on the ARTG, which may require periodical review due to:

• changes in design, intended use, intended patient indications
• changes in the way devices are classified
• changes in legislation
• emerging trends or evidence indicating the possibility of a change in the risk profile of a device.

The devices evaluated by AHTA commonly fall within the following categories:

• orthopaedic prostheses
• cardiovascular devices to promote patency or functional flow within the cardiovascular system (e.g. stents)
• electrical impulse generators (e.g. pacemakers)
• prosthetic heart valves
• supportive devices – surgical meshes, patches, tissue adhesives, dressings
• implantable medical devices.

Other devices may include in vitro diagnostic or monitoring devices.

AHTA has a dedicated team of experienced health economists with a long history in conducting economic modelling and analysis for health technology assessments. AHTA's expertise and services provide support to both primary and secondary academic researchers and 'real-world' health administration decision-makers (including the Medical Services Advisory Committee and the Pharmaceutical Benefits Advisory Committee).

The following health economic consulting services are available:

• design, analysis and interpretation of clinical trial-based economic studies
• design, construction, analysis and interpretation of economic models
• critique and/or external validation of economic models and studies
• economic literature review, with consideration of contextual application and interpretation
• financial impact analysis
• reporting on methodological or policy issues associated with health economics.

From simple cost analyses to complex cost-effectiveness studies and cost-utility models, AHTA can provide bespoke economic evaluations to address the health economic issues relevant to your project.

AHTA's health economists have experience working closely with experts across all clinical areas and can access in-house statisticians and epidemiologists as required. Particularly where complex clinical and economic modelling is required, the AHTA team understands the importance of combining multi-disciplinary and methodological rigour to ensure analyses are both accurate and meaningful. 

AHTA conducts methodological research that has impacted on the way HTA and clinical practice guideline development is undertaken internationally, including:

• methods for evaluating the safety, effectiveness and cost effectiveness of diagnostic tests
• methods for producing and grading recommendations in evidence-based clinical practice guidelines
• methods for assessing co-dependent technologies (personalised medicines) and pharmaceuticals for reimbursement decisions
• methods for assessing pan-tumour biomarker testing to determine eligibility for targeted treatment.

AHTA staff were responsible for developing the

• 2016 Guidelines for Industry Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and associated commentary templates. 
• 2021 Guidelines for Preparing Assessments for the Medical Services Advisory Committee (MSAC) and associated submission and commentary templates.
• Framework for evaluating co-dependent technologies by PBAC and MSAC (Merlin, T, Farah, C, Schubert, C, Mitchell, A, Hiller, JE & Ryan, P, 2013 'Assessing personalised medicines in Australia: A national framework for reviewing co-dependent technologies'. Medical Decision Making. vol. 33, no. 3, pp. 333-342.)
• Pre-submission process, guidelines and templates for vaccine submissions to the Australian Technical Advisory Group on Immunisation (ATAGI).
• Technical assessment report for the Review of the Life Saving Drugs Program  on behalf of the Australian Government. 
• Review of Statin Therapies on behalf of the Australian Government.

AHTA's ethics consulting service is led by Dr Drew Carter, Research Fellow (Ethics). Dr Carter has conducted ethics research and teaching in the School of Public Health since 2009. He is also the Ethicist member of the SA Health Human Research Ethics Committee (HREC) and Clinical Ethicist for the Central Adelaide Local Health Network (CALHN).

Ethics consulting is available to researchers who want intensive support in thinking through ethical issues or in conducting research projects with pronounced ethical dimensions. Dr Carter can advise you on ethical issues in support of your HREC application or he can undertake research with and for you, especially when the research involves qualitative data and prominent ethical issues.

Dr Carter aims to substantially improve the quality of your thinking and research when it comes to ethical issues.

To make an enquiry, please contact Dr Drew Carter.

Integrated research support is a comprehensive service that includes advice on research fundamentals, including research design, methods and ethical issues.

Integrated support of this kind is rare. AHTA is well placed to offer it, since it employs experts in ethics, pharmaceutical and health care evaluation, health economics, biostatistics and data management.

Integrated research support could be especially valuable to researchers designing clinical trials, for example.

AHTA can also advise on research involving qualitative and deliberative methods.

Your research design, methods and handling of ethical issues should all improve, so the probability of securing research funding and HREC approval should increase.

For information about this service, please contact Dr Drew Carter.

Under the Australian Government's Comprehensive Management Framework for the Medicare Benefits Schedule (MBS), AHTA was contracted to review services that are publicly funded on the MBS to ensure they are safe, effective and appropriately used, and represent value for money. The reviews were:

• undertaken using an evidence-based process
• conducted in consultation with key stakeholders, including consumers and medical professionals
• recognise that MBS funding should align with contemporary evidence, ensuring appropriate patient groups receive best clinical practice.   

AHTA works with professional groups to help develop clinical practice guidelines. AHTA conducts systematic literature reviews to identify best practice in terms of prevention, diagnosis and treatment of a health issue. Under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for developing guidelines, the evidence assessment must consider:

• evidence base (number and type of studies)
• the risk of bias
• the precision of the effect estimates
• the consistency of the individual study results
• how directly the evidence answers the question of interest, and
• the risk of publication or reporting bias.

The evidence informs the guidelines which are subjected to public and professional scrutiny before being accepted. 

AHTA's expertise extends to preparation of brief assessments on new and emerging technologies to inform policy makers about the likely impact on the Australian and New Zealand public health systems. Often technologies are identified for reasons including, but not limited to:

• obvious safety concerns
• lack of previous assessment, despite rapid diffusion throughout the health system
• clinical impact which is applicable to a large proportion of the population, or to a small proportion of the population, but with obvious and far-reaching benefits.

AHTA has an established record of expertise in horizon scanning and has contributed to the International Information Network on New and Emerging Health Technologies. Activities have assisted in the exchange of information on emerging medical devices, surgical procedures and health care programs.