Feasibility of a Reimbursement Pathway for Mobile Medical Applications (MMA) in Australia

Introduction: Mobile health (mHealth) applications (apps) are currently changing Australian healthcare. mHealth apps which have a therapeutic and diagnostic intended purpose are called mobile medical applications (MMA), and are being integrated into healthcare by patients and practitioners in Australia. MMAs have the potential to decrease the health burden of some chronic conditions as well as improve the delivery of healthcare. Any harms produced by the technology are mainly through the information provided and how it is used in clinical decision-making. The nature of apps presents unique challenges (such as their rapid lifecycle) to regulatory and reimbursement processes. There are currently no policies or frameworks available that can be used to conduct a health technology assessment (HTA) on MMAs. Therefore, the aim of this research was to determine what policy changes and assessment criteria are needed to facilitate the development of a system that evaluates MMAs for regulatory and reimbursement purposes in Australia. Methodology: In order to achieve this overall aim, the research was divided into four parts. Firstly, I reviewed the Australian Therapeutic Goods Administration (TGA) regulation of MMAs by evaluating it against international counterparts and the International Medical Devices Regulator’s Forum’s (IMDRF) guidance document for clinically evaluating medical software. This was achieved through the use of a policy analysis and case studies. The policy analysis evaluated MMA regulations internationally to determine whether the regulatory bodies of the IMDRF members addressed the IMDRF guidance on clinically evaluating software as a medical device (SaMD). The case studies reviewed how different MMAs in Australia and the United States of America (USA) were regulated to determine to what extent the SaMD: Clinical Evaluation (2017) guidance was applied. The second section evaluated existing frameworks for assessing MMAs and determined whether any were suitable for use in HTA and reimbursement decision-making. This was achieved through a methodological systematic review. The systematic searches were conducted in seven bibliographic databases in order to identify literature on MMA evaluation frameworks published between 2008 and 2016. Frameworks were only eligible for inclusion in the review if they evaluated one of the HTA domains of safety, cost-effectiveness and/or effectiveness of an MMA. Once a framework had been included into the review it was evaluated to determine what other elements of an HTA the framework addressed. The third section detailed the creation and testing of an MMA HTA evaluation module which was used to modify the current HTA guidelines in Australia. The use of the module ensures that the technology specific characteristics of apps would be properly appraised during an assessment. The module’s transferability to comparable HTA jurisdictions was also assessed. This was achieved in two stages. The first stage were in-depth interviews with stakeholders (healthcare practitioners, application developers, and policymakers) to determine possible impediments and pathways to MMA reimbursement in Australia. The findings of the interviews were integrated with those from the first and second sections of this research on MMA reimbursement and regulation to create an MMA evaluation module. The fourth and final section determined the feasibility of MMA reimbursement in Australia through the integration and synthesis of all the evidence generated from the preceding three sections. Results: The research found that there were policy gaps in the regulatory and reimbursement criteria used to evaluate MMAs. Regarding current regulatory policy, the TGA does not adequately evaluate MMAs according to the IMDRF criteria. Policy changes to current regulation processes should include an assessment of the harm from misinformation as well as potential risks associated with information and connectivity compatibilities, such as cybersecurity threats. Similarly, there were a number of policy changes that could be made to support the reimbursement of MMAs in Australia. The systematic literature review of MMA evaluation frameworks found that there was a greater need to evaluate the harms posed by MMAs (i.e. misinformation) as well as a fuller consideration of the likely comparator for the technology. Other considerations included, but were not limited to, equity of access to MMAs (i.e. by way of age, literacy, user disability, etc.), as well as the importance of secure and proper management of confidential data. Other technology specific concerns included: the possible effect of software updates on the effectiveness and safety of MMAs and possible variation in app performance on different operating systems (OS), mobile platforms, and generations of the same platform. Interviews conducted with stakeholders sought to explore possible pathways and impediments to MMA reimbursement in Australia and, highlighted a few policy challenges. These included: clarification around where the responsibly lies regarding data ownership, cybersecurity, and professional liability in the use of app data; the digital health literacy of healthcare practitioners, patients, and any other MMA users (i.e. carers); and finally, developing evaluative measures which address the technological evolution of MMAs, such as the technology’s rapid lifecycle and software updates. Contrastingly, the interviews indicated that stakeholders trust the evidence-based approach used by the Australian Medical Services Advisory Committee (MSAC) to conduct HTAs and make public funding decisions and felt it would be an appropriate evaluation mechanism for MMAs. Given these policy concerns, proper evaluation of MMA’s is needed before they can be reimbursed in Australia. To ensure that MMAs are properly evaluated, a module was developed which could modify the current HTA framework employed by MSAC. The module addressed both regulatory and reimbursement policy concerns. This is to ensure that the regulatory issues are addressed, as the current TGA process does not properly evaluate them. The utility of the MMA HTA evaluation module was assessed for adaptation to other comparable HTA jurisdictional bodies, such as the European Economic Area (EEA), Canada, and the United States of America (USA). Minimal modifications would need to be made to the module for it to be used by other HTA agencies in these jurisdictions. These adaptations would include the removal of any of the unique MMA items (e.g. software, updates, cybersecurity) that were already addressed by the jurisdiction’s regulatory authority. Adaptations to the cost-effectiveness domain would be dependent on the individual economic evaluations conducted by the respective jurisdictional HTA agencies, and their individual healthcare contexts. The development of the MMA HTA evaluation module, and the research that informed it, shows that MMA reimbursement in Australia is feasible. Thus, it is feasible to tailor the regulatory and reimbursement processes in Australia to evaluate MMAs properly. Conclusion: In conclusion, it is possible to tailor regulation and reimbursement processes in Australia to address the evaluation of MMAs. These modifications to current processes can be made through a variety of key policy and process changes. One process change would be the adoption of the MMA evaluation module as it is capable of adapting the existing MSAC evaluation framework to assess this technology. Other policy changes would include: facilitating the digital health literacy of MMA users (i.e. healthcare practitioners, patients, carers, etc.); providing clarification around who and where the responsibility lies regarding use of MMAs (i.e. data ownership, professional liability, and cybersecurity), and, finally, stipulating evaluative procedures which address the challenges posed by the ongoing technological evolution of apps (i.e. rapid lifecycle, software updates, etc.).Thesis (Ph.D.) -- University of Adelaide, School of Public Health, 202