Good Practices for Health Technology Assessment Guideline Development: A Report of the Health Technology Assessment International, HTAsiaLink, and ISPOR Special Task Force.

Objectives: Health technology assessment (HTA) guidelines are intended to support successful implementation of HTA by enhancing consistency and transparency in concepts, methods, process, and use, thereby enhancing the legitimacy of the decision-making process. This report lays out good practices and practical recommendations for developing or updating HTA guidelines to ensure successful implementation.

Methods: The task force was established in 2022 and comprised experts and academics from various geographical regions, each with substantial experience in developing HTA guidelines for national health policymaking.

Good Practices for Health Technology Assessment Guideline Development: A Report of the Health Technology Assessment International, HTAsiaLink, and ISPOR Special Task Force.

Objectives: Health technology assessment (HTA) guidelines are intended to support the successful implementation of HTA by enhancing consistency and transparency in concepts, methods, processes, and use, thereby enhancing the legitimacy of the decision-making process. This report lays out good practices and practical recommendations for developing or updating HTA guidelines to ensure successful implementation.

Methods: The task force was established in 2022 and comprised experts and academics from various geographical regions, each with substantial experience in developing HTA guidelines for national health policy making.

Does regulatory and reimbursement parallel processing provide swifter funded access to medicines for patients? Evaluation of cancer medicines using the Australian parallel process.

Objective: To assess the impact of a parallel regulatory and reimbursement process on (1) direction of funding decisions, 2) time-lag until funding recommendation, and (3) type of evidence submitted, for cancer medicines.

Methods: Public regulatory and reimbursement decision documents were reviewed for cancer medicines considered by the Pharmaceutical Benefits Advisory Committee (PBAC) since the introduction of parallel processing. Medicine-indication pairs were identified from these documents and data extracted on the type and quality of evidence submitted, funding decisions and timelines, by type of review process.

Critical elements of successful partnership in public health-A case study.

Issue Addressed: Intersectoral action is integral in promoting population health and health equity. In South Australia, public health partnership authorities (PHPAs) are one mechanism to promote intersectoral collaboration for addressing complex public health issues. This case study examined contemporary evidence on the critical elements of successful partnerships, explored the role of formalisation in success, and examined how identified critical elements were operationalised over time in an existing PHPA.

Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

Objectives: Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.

Challenges in the Evaluation of Emerging Highly Specialised Technologies: Is There a Role for Living HTA?

There is currently deep uncertainty about the clinical benefits and cost effectiveness of highly specialised technologies (HSTs), like gene and cell therapies. These treatments are novel, typically have high upfront costs, the patient populations are small and heterogenous, there is minimal information on their long-term safety and effectiveness, and data are limited and often of poor quality. With the increasing number of these technologies and their high cost burden on governments and health care providers, policy makers are currently walking a decision tightrope.

Establishing a clinical ethics support service: lessons from the first 18 months of a new Australian service - a case study.

Background: Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting.

Methods: HOW THE STUDY WAS PERFORMED AND STATISTICAL TESTS USED: A qualitative case study approach was utilised.

Is the quality of evidence in health technology assessment deteriorating over time? A case study on cancer drugs in Australia.

Objective: This study aimed to assess whether there have been changes in the quality of clinical evidence submitted for government subsidy decisions on cancer medicines over the past 15 years.

Methods: We reviewed public summary documents (PSDs) reporting on subsidy decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) from July 2005 to July 2020. Information was extracted on the study design, directness of comparison, sample size, and risk of bias (RoB).

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

Objective: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions.

Design And Setting: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities.

Participants: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine.

Modelling the Future Clinical and Economic Burden of Antimicrobial Resistance: The Feasibility and Value of Models to Inform Policy.

Due to the increasing threat to public health and the economy, governments internationally are interested in models to estimate the future clinical and economic burden of antimicrobial resistance (AMR) and to evaluate the cost-effectiveness of interventions to prevent or control resistance and to inform resource-allocation decision making. A widely cited UK report estimated that 10 million additional deaths will occur globally per annum due to AMR by 2050; however, the utility and accuracy of this prediction has been challenged. The precision of models predicting the future economic burden of AMR is dependent upon the accuracy of predicting future resistance rates.

Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved.

Background: The Medical Services Advisory Committee (MSAC) is responsible for the assessment of medical imaging tests proposed for public funding. A number of factors related to the clinical or cost effectiveness of an imaging service may impact on the funding decision.

Objective: To determine what evidentiary and economic factors impact most on MSAC recommendations for the funding of imaging tests.

Inappropriate antibiotic prescribing: understanding clinicians’ perceptions to enable changes in prescribing practices.

Objective The aim of this study was to identify perceived barriers to appropriate antibiotic prescribing across different healthcare settings. Methods A cross-sectional survey of clinicians in Australian hospitals and primary care was undertaken between June and October 2019. The perceived barriers to appropriate antibiotic prescribing were considered as dependent variables, whereas age, sex, clinical experience, healthcare setting and the use of guidelines were considered independent variables.

South Australian Medicines Evaluation Panel in review: providing evidence-based guidance on the use of high-cost medicines in the South Australian public health system.

Objective The South Australian Medicines Evaluation Panel (SAMEP) was established in 2011 to make evidence-based recommendations on the funding of high-cost medicines in South Australian public hospitals via a high-cost medicines formulary. SAMEP represents one component of South Australia's process for state-based health technology assessment (HTA). The aim of this study was to describe the experience of SAMEP in the context of Australia's complex governance model for hospital-based care.

Factors That Impact the Adoption of Clinical Decision Support Systems (CDSS) for Antibiotic Management.

The study evaluated individual and setting-specific factors that moderate clinicians' perception regarding use of clinical decision support systems (CDSS) for antibiotic management. A cross-sectional online survey examined clinicians' perceptions about CDSS implementation for antibiotic management in Australia. Multivariable logistic regression determined the association between drivers of CDSS adoption and different moderators.

The representation of public values in health technology assessment to inform funding decisions: the case of Australia's national funding bodies.

Over the past few years, there has been an increasing recognition of the value of public involvement in health technology assessment (HTA) to ensure the legitimacy and fairness of public funding decisions [Street J, Stafinski T, Lopes E, Menon D. Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes. Int J Technol Assess Health Care.

Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

Introduction: In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity.

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective.

Background: The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs.

Objectives: To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation.

The rationale and design of public involvement in health-funding decision making: focus groups with the Canadian public.

Background: Worldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making.

Objective: To understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA.

Understanding Canadian Health Technology Assessment through a systems lens.

Objective: Governments around the world face challenges in maintaining sustainable, high-quality healthcare systems. Health Technology Assessment (HTA) is widely used as a method to assist in funding decisions. However, the scope and influence of HTA is still limited.

Evidence Synthesis International (ESI): Position Statement.

This paper is the initial Position Statement of Evidence Synthesis International, a new partnership of organizations that produce, support and use evidence synthesis around the world. The paper (i) argues for the importance of synthesis as a research exercise to clarify what is known from research evidence to inform policy, practice and personal decision making; (ii) discusses core issues for research synthesis such as the role of research evidence in decision making, the role of perspectives, participation and democracy in research and synthesis as a core component of evidence ecosystems; (iii) argues for 9 core principles for ESI on the nature and role of research synthesis; and (iv) lists the 5 main goals of ESI as a coordinating partnership for promoting and enabling the production and use of research synthesis.

Development of a health technology assessment module for evaluating mobile medical applications.

Objective: The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes.

Methods: In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs.

Feasibility of de-linking reimbursement of antimicrobials from sales: the Australian perspective as a qualitative case study.

Background: There is a disparity in the economic return achievable for antimicrobials compared with other drugs because of the need for stewardship. This has led to a decline in pharmaceutical companies' willingness to invest in the development of these drugs and a consequent global interest in funding models where reimbursement is de-linked from sales.

Objectives: To explore the perspective of stakeholders regarding the feasibility of de-linked reimbursement of antimicrobials in Australia.

Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

Introduction: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia.