MOBILE HEALTH. Is there an appetite? COVANCE MARKET ACCESS. Experience Forward Thinking

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1 MOBILE HEALTH Is there an appetite? Michael Blackney, PhD Chloe Silk, PhD Eoin McAughey, MSc Emma Bagshaw, BA COVANCE MARKET ACCESS Experience Forward Thinking

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3 Mobile applications (apps) are fundamentally altering nearly every aspect of modern life from ordering and paying for food, summoning a taxi, transferring money and checking the news to listening to music, watching movies and exercising. If you ve ever thought, I wonder if there s an app for that?, there probably is. The phenomenal growth in the global app mar ket (the Apple and Android app stores opened nine years ago and now house more than six million apps) is symptomatic of our need for a fast, convenient mobile-supported life. In the healthcare industry, beyond tracking your step count, there appear to be vast opportunities for providers to leverage mobile health (mhealth) data these include improving disease management and patient engagement, increasing clinical trial efficiency and generating real-world evidence (RWE). However, the healthcare sector lags behind other industries in introducing and adopting such mobile technologies. For example, while in 2016 there were more than 250,000 mhealth apps available, pharmaceutical and device companies comprised less than 10% of app developers. 1 There is no doubt that the use of mhealth apps has the potential to revolutionise healthcare delivery, but how can pharmaceutical and device companies maximise this opportunity, and why aren t they already? With the help of industry experts, we discuss the current status of the mhealth app market in the UK, the opportunities and challenges it presents to the healthcare industry, and key considerations for successful mhealth app development, launch and utilisation. HOW COULD MHEALTH APPS BE UTILISED TO OPTIMISE HEALTHCARE DELIVERY? Figure 1. Areas in Which mhealth Apps Could Support Healthcare Delivery Manufacturers Clinical trial efficiency Medication adherence Real-world data generation Healthcare system System efficiency Large-scale data gathering and forecasting Population-scale health and wellness Clinicians Workload optimisation Closer patient monitoring Expanded disease management Patients Wellness and preventative care Access to care Ability to self-manage Health education and engagement 03

4 Given the numerous opportunities that mhealth apps appear to offer stakeholders across the healthcare pathway (Figure 1), it may be surprising that pharmaceutical and device companies comprise such a low proportion of app developers. However, the contrasting attitudes of the technology and healthcare industries may provide an explanation for this. Whereas cuttingedge technology companies seek to move fast and create something better by breaking what already exists, healthcare providers such as the National Health System (NHS) move slowly with the aim of preserving patient well-being.... it takes a lot of resources, both time and cost, to develop an app, and there seems to be a lack of tangible return. The simplest means of entering the mhealth app field for pharmaceutical and device companies, therefore, appears to be by developing direct-to-consumer apps as a revenue stream. However, an economic study of mhealth app developers found that 72% of publishers made less than $50,000 from their entire app portfolio in 2015, 1 meaning this may not be an attractive avenue for pharmaceutical and device companies. Indeed, understanding how apps can generate value remains an unresolved issue for pharmaceutical and device companies I think the biggest barrier to us moving forward with development of a health app is understanding what the return is it takes a lot of resources, both time and cost, to develop an app, and there seems to be a lack of tangible return (RWE-lead, midsize pharmaceutical company). Whilst app sales alone may not justify investment, the use of mhealth apps to support fundamental areas of drug/device development such as to improve clinical trial efficiencies, increase medication adherence or generate RWE could lead to cost savings and improved competitiveness for pharmaceutical and device companies and healthcare systems as a whole (Figure 2). Figure 2. Potential Uses of mhealth Apps AREAS OF DRUG/DEVICE DEVELOPMENT POTENTIAL USES OF MHEALTH APPS CLINICAL TRIAL EFFICIENCY Patient recruitment Data management Patient monitoring Outcomes collection Patient awareness of trials Enrollment feasibility Eligibility assessment and prescreening Electronic consent Patient profile management Direct patient-to-investigator information flow Study compliance tools and materials Patient-reported symptoms Real-time reporting Novel outcomes measurement via exploitation of stmartphone technology MEDICATION ADHERENCE REAL-WORLD DATA GENERATION Adherence and persistence reminders Medication/nutrition diary Symptom tracker Local trial information Patient forum Patient engagement and education Outcomes collection to support regulatory or reimbursement applications Patient-reported resource utilisation Identification of trends in medicine or device usage 04

5 HOW CAN PHARMACEUTICAL AND DEVICE COMPANIES NAVIGATE THE CHALLENGES PRESENTED BY MHEALTH APP DEVELOPMENT? For healthcare companies, successful mhealth app development, launch and uptake is a largely uncharted process. Insights from app developers and regulatory experts highlight four key areas in which pharmaceutical and device companies must build capabilities to fully exploit the potential of mhealth data (Figure 3). Figure 3. Key Challenges to App Development 1 Building a team with relevant expertise 2 Validating and demonstrating effect 3 Navigating an immature assessment pathway 4 Gaining healthcare professional and patient support and uptake 1 BUILDING A TEAM mhealth app development is a complex process that needs expertise in a range of skills it requires sophisticated internal teams of people in the organisation to come together and solve problems mutually, (Max Little, pioneer in app development). Whilst there will likely be many people in an organisation with the expertise required, those within the pharmaceutical and device industry, and app developers themselves, recognise that bringing everyone together is the real challenge, both in terms of resource use and time. Clinician and patient engagement is also strongly recommended by those experienced in the field; involving end users in the early stages of app design and development may help to improve uptake and engagement later. it requires sophisticated internal teams of people in the organisationto come together and solve problems mutually. The first step in the development of an app should be to identify current expertise within the organisation for example, those with coding skills, or specialists in design, planning, quality assurance or content development. A project manager will also be key to driving the vision of an app into a reality. Pharmaceutical and device companies can then bring on board additional expertise (such as clinical trial design, market access or market research capabilities), where necessary, to complete the team, with outsourcing from specialist agencies a common cost- and time-effective option. 05

6 2 VALIDATING AND DEMONSTRATING EFFECT Figure 4. Stakeholder Concerns Regarding Data Validation If you move away from a highly controlled environment where you are selecting people very carefully for participation in a trial to the use of real-world data, then the potential for bias and uncertainty increases reliability of this type of data is a real challenge for evaluators. Digital intervention expert, UK government body Validation of collected data is a real concern to us. If we spend hundreds of thousands creating health apps, and at the end of the day payers or clinicians don t believe the data we collect, then what use is that? RWE lead, midsize pharmaceutical company You can t just put an app on the app store, run a pilot and say it s okay to use. You need to demonstrate that what you are delivering is as effective as humanto-human interaction or reduces the workload. Ian Thompson, Strategy Director, My mhealth Validation and demonstration of the effect of an app is a key concern across stakeholders in the healthcare industry (Figure 4). However, whilst awareness of the need for such evidence appears widespread, methods and best practices for demonstrating it are less well understood I would like an app provider who knows the regulations, has done it before, knows all the nuances, knows how to integrate it with health records and how best to validate the data (RWE-lead, midsize pharmaceutical company). According to app developers who have succeeded in the mhealth market, apps designed to improve clinical outcomes should be considered as if they were novel drug therapies and assessed in randomised, standard-of-care-controlled, non-inferiority trials. It is also recommended that familiar endpoints, which resonate with payers and clinicians, should be used where possible in app validation. That being said, exploitation of mobile technology opens the doors to new ways of measuring patient outcomes, be that real-time reporting of changes in symptoms or motion sensor-assisted gait analysis; thus these novel endpoints, and interpretation algorithms if needed, should undergo testing for validity before the app is used in clinical trials or in practice. Further validation of safety and conformity, by way of a Conformité Européene (CE) marking, will also be required for health apps classified as a medical device. Apps, stand-alone software or diagnostic devices that gather data from a person, such as diet, heartbeat or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine or recommend treatment are classified by the Medicines and Healthcare products Regulatory Agency (MHRA) as medical devices. A CE marking will demonstrate that the app is regulated, acceptably safe to use and performs in the way the manufacturer/developer intends. 06

7 3 NAVIGATING THE ASSESSMENT PATHWAY UK regulators are evidently aware of the evolving digital healthcare environment, and their support is demonstrated by the creation of assessment and evaluation processes to accommodate this change. However, the assessment pathway for mhealth apps is still in its infancy, and pharmaceutical and device companies are keen to gain more clarity around the different regulations across Europe for the various types of mhealth apps.much like the various quality controls for drug therapies (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice), mhealth apps must also meet standards for platform reliability, interoperability and data security, which should be considered as early as possible. Without these standards, the NHS is reluctant to support many mhealth apps, and valuable opportunities may go unnoticed We may be missing some really valuable cost savings and impactful apps as we do not have the mechanisms to evaluate them (digital intervention expert, UK government body). The NHS is currently working to implement a national assessment pathway, which to date remains very much an evolving process. A series of Digital Assessment Questions has been published, 2 against which developers can self-assess their product on standards of safety, usability and data sharing, amongst others. The questions also provide advice about regulatory compliance, such as the potential need for MHRA medical device certification. Alongside the Digital Assessment Questions, the NHS has published several tools and guidelines to help developers meet the current standards. The idea is that successful compliance with the Digital Assessment Questions will result in a listing on the NHS Digital Library, 3 where apps can benefit from increased visibility to healthcare professionals and the public. From there, further stages of community and expert assessment may lead to a higher level of recommendation such as an NHS Approved badge on an app s library profile and in the future this may lead to possible routes to reimbursement, but it is still early. However, these more rigorous stages of evaluation are likely to only be applicable for a small number of apps those expected to have a substantial impact on clinical outcomes, patient behaviour, or cost-effectiveness and those that require access to NHS systems and patient records. As our digital intervention expert mentioned, Evaluation should be proportional to impact and risk. Figure 5. A Suggested Approach to Developing an NHS mhealth App Assessment Framework Stage 1 Stage 2 Stage 3 Stage 4 Assessment process Self-assessed Digital Assessment Questions Community evaluation: public and professional feedback Preparing a benefit case Independent impact assessment Benefit from assessment Apps published on NHS platform and available for community rating Community feedback published; possible assistance for benefit case Recommendation for NHS use, funding, prescribing, NHS brand This process is subject to further evaluation and may be modified. Adapted from National Information Board Work stream 1.2 Roadmap, Oct For a proportion of apps considered to have a strong value proposition for NHS use, the National Institute for Health and Care Excellence (NICE) has been working on a methodology to produce health app briefings, which will look at the technology, its place in therapy and summarise the evidence on effectiveness and likely economic impact. It is intended that some of these health app briefings will be published as part of a pilot, based on NICE s contribution to the work of the National Information Board, but it is not confirmed whether NICE will be producing more of these. Although explicit guidelines may change sporadically, insight can be gained from careful monitoring and evaluation of sources, such as mhealth app briefings or through advisory boards and key stakeholder interviews. 07

8 4 GAINING HEALTHCARE PROFESSIONAL AND PATIENT SUPPORT AND UPTAKE A key challenge that developers of mhealth apps, particularly pharmaceutical and device companies, must overcome is low uptake levels. Research shows that whilst each of the leading pharmaceutical and device companies offers an average of 65 apps in the Apple and Google stores, altogether they have generated 6.6 million downloads since 2008 and have less than 1 million active users. 5 We are asked by almost every clinical commissioning group: Has pharma been involved in the development? And is there any promotional content? Multiple reasons may exist for this low uptake, with one of the main barriers likely to be a lack of trust of pharmaceutical and device companies among healthcare professionals and patients. mhealth apps associated with pharmaceutical and device companies carry the risk of being perceived as purely marketing tools, and questions around security and exploitation of user data feature more prominently than for apps developed outside the pharmaceutical industry. Ian Thompson, Strategy Director, My mhealth told us, We are asked by almost every clinical commissioning group: Has pharma been involved in the development? And is there any promotional content? For this reason, apps developed by pharmaceutical and device companies that educate and provide platforms to improve disease management, without a product association, may be considered more favourably among healthcare professionals and patients, particularly in overlooked disease areas where there may be an unmet need for this type of service. Other methods to improve app uptake levels may include engaging in conversations with users early in the process and sustaining this interaction through the design, development and marketing process to demonstrate transparency and foster a sense of collaboration. If everyone is not engaged then it just won t work, it ll sit on the shelf,not being used. The NHS s app assessment and publication system will go some way towards providing reassurance for users, but user engagement is vital to an app s success; thus, manufacturers must make efforts to build the trust of prescribers and patients If everyone is not engaged then it just won t work, it ll sit on the shelf, not being used (Ian Thompson, Strategy Director, My mhealth). Finally, the process of acquiring and using mhealth apps must be straightforward. Developers must therefore be prepared to provide healthcare professionals with training, rollout assistance and ongoing support. 08

9 CASE STUDY MYCOPD IS A WEB-BASED SELF- MANAGEMENT TOOL FOR PEOPLE WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). Users can perfect their inhaler technique, improve breathing, reduce exacerbations, track medication and more. Clinicians are able to check in with their patients via the tool, track their condition and update medication details. mycopd is currently the only tool with an NHS Approved badge on the NHS Digital Apps Library, meaning that it meets standards for usability, safety and clinical effectiveness. HOW MYCOPD SUCCESSFULLY NAVIGATED AN UNCERTAIN REIMBURSEMENT PATHWAY 09

10 CASE STUDY To develop mycopd, the My mhealth project successfully gathered clinicians, clinical trialists, developers, designers and, over time, a cohort of engaged patients who were able to help develop the tool into something that people would genuinely want to use. Following a pilot study demonstrating that the tool could correct poor inhaler technique, My mhealth secured funding to support two randomised clinical trials. These trials were able to leverage the current treatments and measurements for COPD, comparing mycopd with the widely used face-to-face pulmonary rehabilitation classes (a costly intervention with low patient uptake) and measuring recovery with the familiar COPD Assessment Test patient-reported outcome. As well as being published in the British Medical Journal (BMJ), the strength of their results meant that My mhealth successfully applied for the NHS Innovation Accelerator Programme (NIA), which is designed to support the fast-track uptake of high-impact solutions for specific health needs. 6 The NHS then selected mycopd to be one of six innovations from the NIA that would be funded under a new Innovation and Technology Tariff (ITT). Through the ITT, NHS England funds mycopd licenses for up to 20% of the total COPD population per Clinical Commissioning Group (CCG), although CCGs can also purchase top-up licenses directly from My mhealth. The company has ensured compliance with NHS data governance concerns and is working with early adopters within the healthcare system to put structures in place for rollout, clinician engagement and training improving the likelihood of market penetration. In addition to improving patient well-being and engagement and generating revenue from reimbursement, mycopd will give My mhealth huge amounts of detailed data on patient activity and adherence, allowing them to break down uptake of, and response to, treatments by region, age and sex. These data could possibly be used to develop treatments, devices and even treatment pathways that are more tailored to real-world usage and thereby greatly improve real-world effectiveness. 010

11 FUTURE PERSPECTIVES After decades of slow progress, the mhealth apps field is now an exciting and rapidly evolving space. As discussed, the opportunities are being recognised by the NHS, which is in the process of building a solid assessment, publication and funding system. This sytem will hopefully pave way to increased uptake and integration of mhealth apps across the care pathway. As manufacturers gain familiarity with the development and validation processes, app creation and approval is likely to move towards a more standardised approach. For pharmaceutical and/or device companies able to navigate this new environment, the mhealth market offers a promising future I can see a future where we move increasingly towards using the power of the technology to collect the data we need, both for regulatory safety purposes and clinical evidence purposes (digital intervention expert, UK government body). For pharmaceutical and device companies, the best way to navigate the mhealth market may be to partner with a company that can guide them through the entire process, from strategy and exploration of ideas to platform design and development, validation and stakeholder insights, clinical trial execution, regulatory approval and market access. The immediate future of mhealth apps may be somewhat dictated by the apps developed and the populations they may target. For example, the wearable devices market continues to generate a lot of attention with companies looking beyond fitness and activity tracking towards preventing and managing chronic health conditions, such as diabetes and heart conditions. To do this, wearables are likely to contain sensors linked to mhealth apps, and such apps are seen to be a major driver for the next phase of growth in wearables. Another opportunity for mhealth apps may be in the social care environment for example, apps designed to support older people living independently. Mental illness is also likely to be a key theme, with the NHS confirming 35 million of funding across seven mental health global digital exemplar sites in response to plans submitted to develop a variety of apps and online platforms to better support people experiencing mental illness. Finally, as apps become increasingly more capable, as smartphones continue their march of dominance and as real-world data continue to be the hottest topic within healthcare, it is surely only a matter of time before the largest innovative technology companies with the most data (e.g., Google, Apple, Amazon, Microsoft) decide they want to be key players in the mhealth market. Currently, companies such as Google are primarily considered an enabler to the opportunities discussed above for example, by way of building platforms to collect patient data. However, Alphabet s (Google s parent company) recent acquisition of Senosis Health a small start-up that uses a smartphone s built-in sensors to monitor different health biomarkers highlights that large innovative technology companies might now be looking to move into areas that healthcare companies should, by all rights, be dominating. Pharma, time is of the essence. Opportunities in the mhealth market may decrease rapidly with the growing competition, so grab a slice of the pie while you can! 1. Research2Guidance. mhealth App Developer Economics Available at: Accessed: Oct Digital Assessment Questions - Beta. Available at: Accessed: Oct NHS Apps Library. Available at: Accessed: Oct National Information Board. Work Stream 1.2 Roadmap. Available at: uploads/attachment_data/file/467065/work_stream_1.2_with_tcs.pdf. Accessed: Oct Pharma companies in need of stronger mhealth medicine. Available at: pharma-companies-in-need-of-stronger-mhealth-medicine-11867/. Accessed: Oct Bourne R et al. BMJ Open 2017;7:e doi: / bmjopen

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