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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.Methods: Information was extracted on health technology assessments (HTAs) of medical imaging tests published on the MSAC website, with a funding decision between 2006 to July 2021. Imaging tests with diagnostic, staging or screening indications were eligible. Data were extracted in test-indication pairs and included data on evidence quality, quantity, consistency of findings, cost-effectiveness and financial impact. Multivariate logistic regression analysis was performed with adjustments for clustered data.Results: Overall, 42 imaging test applications to MSAC were included, representing 91 clinical indications. Most were diagnostic tests. The most common evidentiary concerns reported by MSAC were limited evidence (36%), low quality evidence (26%), and applicability of the data (22%). The reference standard for diagnostic accuracy was imperfect or not appropriate in 25% of the indications. In regression analyses, uncertainty about cost-effectiveness of an imaging service predicted most negative funding decisions.Conclusions: The single biggest contributor to a negative funding decision by MSAC was uncertainty about the cost-effectiveness of the imaging service. This was likely driven by uncertainty regarding the impact on patient health. HTAs that are able to demonstrate the clinical utility of a new imaging service are more likely to publicly funded. [ABSTRACT FROM AUTHOR]

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. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story. The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way. HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed. [ABSTRACT FROM AUTHOR]

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.Results: Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians.Conclusion: An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module. [ABSTRACT FROM AUTHOR]

The International Network of Agencies for Health Technology Assessment (INAHTA) spans the globe as a network of 50 publicly-funded health technology assessment (HTA) agencies supporting health system decision making for 1.4 billion people in thirty countries. Agency members are non-profit HTA organizations that are part of, or directly support, regional or national governments. Recently, INAHTA surveyed its members to gather perspectives from agency leadership on the most important issues in HTA today. This paper describes the top 10 challenges identified by INAHTA members. Addressing these challenges requires a call for action from INAHTA member agencies and the many other actors involved in the HTA ecosystem. In opening this call for action, INAHTA will lead the way; however, a comprehensive undertaking from all players is needed to effectively address these challenges and to continue to evolve HTA in its role as a strong and effective contributor to health systems. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies.Methods: The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized.Results: All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences.Conclusions: The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated. [ABSTRACT FROM AUTHOR]

Objectives: To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies. Methods: Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework. Results: A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed. Conclusion: None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. Implications: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers. [ABSTRACT FROM AUTHOR]

It is uncommon to find published clinical trials that measure the health benefits of medical testing. As a consequence, policy makers often have to decide whether access to, or public funding of, medical tests is warranted without knowing the clinical impact of testing on the patient. In the situation where a policy maker is considering a companion genetic test and tailored drug therapy, deficiencies in the evidence base are exacerbated because two technologies need to be assessed and the proposed genetic biomarker needs to be validated. The Linked Evidence Approach (LEA) is a methodology that was developed in 2005 to cope with inadequacies in the evidence supporting medical test evaluations. In 2010 the approach was adapted to the evaluation of pharmacogenetic interventions. This article describes how LEA and similar analytic frameworks are used internationally, highlights particular challenges with the approach, and proposes ways that LEA might be applied to pharmacogenomic interventions. [ABSTRACT FROM AUTHOR]