september 2015 fiercepharma healthcare companies...

Thank you to our sponsor:

Healthcare Companies Capitalize on the New Mobile Health Climate

FiercePharmaAn eBook from the editors ofSeptember 2015

share:

http://www.facebook.com/sharer/sharer.php?u=https://pages.questexweb.com/Mobile-Health.html?source=share

https://twitter.com/intent/tweet?source=webclient&text=Check+out+this+@FiercePharma+eBook+on+the+new+healthcare+climate:+https://pages.questexweb.com/Mobile-Health.html?source=share

https://www.linkedin.com/shareArticle?mini=true&url=https://pages.questexweb.com/Mobile-Health.html?source=share

http://plus.google.com/share?url=https://pages.questexweb.com/Mobile-Health.html?source=share

mailto:?body=I%20thought%20you%20might%20be%20interested%20in%20this%20eBook:%20https://pages.questexweb.com/Mobile-Health.html?source=share &subject=FiercePharma%20eBook:%20Mobile Health Companies Capitalize on the New Healthcare Climate


Sponsored Content: Leveraging Digital Health Data to Improve the Drug Design Process

Healthcare Companies Capitalize on the New Mobile Health Climate // September 2015

FiercePharmaAn eBook from the editors ofshare:

Toward the end of 2010, the agenda for a new one-day meeting called “Mobile Pharma” promised to “answer the age old question ‘Is this finally the year of mobile’?” A few months later, Ernst & Young published a report that seemed to answer that question with a resounding “yes.”

Not only had pharma companies increased their investment in digital media by 78% over the previous year, but mobile healthcare (mHealth) had risen from 16% of pharmaceutical digital initiatives to approximately half. In 2010, the report added, smartphone apps, which had previously been limited almost exclusively to diabetes, expanded into 14 disease areas, and pharmaceutical companies launched a total of 40 apps.

Ever since, pharmaceutical participation in mHealth has grown rapidly. By 2014, the top pharmaceutical companies were offering an average of 65 apps each, over 700 apps total, in the Apple and Google Play app stores, according to a report from research2guidance (R2G).

David Collins, Senior Director of Health Information Systems for the Healthcare Information and Management Systems Society (HIMSS) and host of the mHealth Summit, cites two paradigm shifts that occurred in 2010 as drivers for the continuing growth in mobile healthcare.

First, the Affordable Care Act (ACA), signed into law in 2010, shifted the emphasis of the healthcare system

Healthcare Companies Capitalize on the New Mobile Health ClimateBy Beth Ellen Roberts










to align with the “Triple Aim” approach focused on improved care, improved population health, and reduced per capita cost. “The whole premise behind the ACA is more efficient care at a lower cost and having patients engaged,” Collins explains. “And,” he asks, “how do you do that? Technology.”

At about the same time, the introduction of new platforms and faster technology for mobile apps puts greater ability to manage healthcare in the hands of clinicians and patients. Apple launched the iPad in 2010, popularizing tablet computers, and the first 4G mobile phones hit the market in the US. With the upgrade from 3G to 4G, notes Collins, app developers finally had the bandwidth and speed to transmit images in a way that lead to effective use of mobile technology in healthcare.

These days, Collins suggests, “I think we’re moving out of the pilot stage; I think we’re in a proof-of-concept stage, it’s moving to the next step where it’s less about ‘does this stuff work,’ but ‘how do we scale it, how do we sustain it, is there a business model’?”

For all of the increased investment in mHealth, only a handful of pharmaceutical companies have successfully navigated the challenges to creating consistently successful mHealth applications to date. The multitude of pharmaceutical apps published, R2G points out, had only 6.6 million downloads between 2008 and 2014, and 1 million active users in 2014. In contrast, popular fitness app MyFitnessPal had approximately 8.7 million users in 2014.

To succeed long-term in mHealth, companies will have to overcome multiple challenges, starting with the stakeholders whose interests must be balanced and extending to regulatory issues, security and privacy concerns and ever-changing technology. Those who do will share in a market that is growing exponentially. Global revenue from mHealth, which according to R2G totaled approximately $104 million in 2010, has been predicted to reach the $25-30 billion range by 2017.

Competing stakeholder needs A task force convened by the Federal Communications Commission (FCC) in 2012 affirmed the U.S. government’s interest in promoting mHealth and set a goal “that by 2017 mHealth, wireless health and e‐Care solutions will be routinely available as part of best practices for medical care.” That goal might be difficult to achieve, however, until mHealth companies can fill the needs of all the stakeholders.

HIMSS’s mHealth Roadmap notes that data from 2012 consistently show “payers willing to pay for more mHealth services than providers were willing to offer,” with payers prepared to spend on mHealth based on its potential to improve outcomes while decreasing costs and providers reluctant to adopt technologies whose efficacy and “economic attractiveness” they doubt.

Complicating the issue is the fact that the US payment environment has become extremely complex in the past few years; an increase in unfavorable formulary placements coupled with rising deductibles and co-pays

Continued on page 5






Mobile Health Companies Capitalize on the New Healthcare Climate // September 2015

Sponsored Content

The drug design process is a challenge in healthcare that calls for the better use of data at every turn. Research from the Tufts Center for the Study of Drug Development states that this multi-phased endeavor costs an average of $2.6 billion. The utilization of connected devices can help reduce costs and streamline associated processes. Below are four ways pharmaceutical organizations can leverage patient-generated data from mobile health devices during the drug design process:

1. Identifying clinical trial participants. Contract research organizations (CROs), which often conduct studies on behalf of prescription drug manufacturers, nurture communities of people who share common disease states. These communities enable patients to support one another, but CROs also use these groups to identify potential clinical trial participants.

Data from digital health devices and applications can help CROs quickly and clearly identify which patients are most appropriate for specific trials. This task is said to account for about 70 percent of total trial costs.

2. Collecting remote data during clinical trials. At the start of clinical trials, researchers typically capture precise sets of measurements to determine exactly how a molecule metabolizes. They also zero in on potential side-effects. As such, they need to constantly monitor participants’ vital signs to verify if they are responding positively or negatively.

Digital health devices can significantly streamline this process. If trial participants collect this information via a mobile device that transmits data back to clinicians, the need to conduct costly in-person evaluations diminishes. As a result, participants do not need to drive to a clinic several times a week but can instead simply transmit their vital signs from home. This remote monitoring makes it possible to shorten the duration of a trial, as the necessary information can be amassed quickly and more conveniently.

3. Developing a holistic view of patients’ disease states. The prescription drug is only one variable affecting clinical results and the patient’s overall health. Collecting and analyzing various lifestyle-related data via digital health devices can help researchers arrive at a holistic view of

a patient. This makes it possible to pinpoint the combination of factors that will lead to overall improved health. For example, diabetic trial participants not only need their medications monitored but also their diet, exercise, nutrition and stress to understand the full effect of a prescription.

4. Monitoring long-term efficacy. After receiving Food and Drug Administration approval, pharmaceutical companies still need to verify that the molecule is fully delivering on its intended results. When patients use mobile devices to collect health data, drug makers can track long-term effectiveness. Such surveillance can result in a better understanding of the drug’s real world, long-term value. Additionally, pharmaceutical companies can make adjustments or recalls, sooner rather than later – avoiding the costs associated with large-scale recalls or court settlements.

Pharma is the next frontier for digital health innovation. Gathering remote clinical information enables pharmaceutical companies to collect more data, more efficiently. Leveraging this data during clinical trials enables more streamlined processes and lower costs. n

Leveraging Digital Health Data to Improve the Drug Design Process





means that the patient is now often the payer, health economist and consultant Jane Sarasohn-Kahn points out. Sarasohn-Kahn is the author of the Health Populi blog and a member of the HIMSS mHealth committee.

Patients increasingly demand greater control over their own care, and express an interest in mHealth as an opportunity not only to reduce costs, a 2012 PricewaterhouseCoopers (PwC) report found, but also to have more convenient access to providers, greater control, and the ability to get information that they can’t get from their providers or other sources.

Doctors faced with patient adoption of mHealth, on the other hand, “are likely to resist the loss of power implicit in greater patient control,” the report suggests. Despite that resistance, PwC forecasts that eventually, “all stakeholders—physicians, hospitals, health insurers, pharmaceuticals, medical device companies and government—will likely shift their practices toward patient/consumer models that will focus on clinical outcomes, value, and patient satisfaction.”

As a result, Sarasohn-Kahn says, “We come to the era of value beyond the pill, the value beyond the product, and what can you do as a pharma company in addition to researching, manufacturing and marketing a pill or device? What else can go around that to add value, to enhance a patient outcome?” The answer, she says, is in digital devices and digitally enhanced therapeutics, but companies will need to find a way to avoid creating an information overload.

With over 40,000 medical apps available to consumers, plus numerous wearables and smart devices coming onto the market, it’s no surprise that many apps get ignored. In addition, approximately 20% of Americans take 3 or more different prescription drugs, and 10% take 5 or more, according to the CDC, and it’s difficult to imagine patients downloading and using 5 separate apps for each of their prescriptions.

Sarasohn-Kahn points out that physicians are equally unlikely to have any interest in monitoring 5 different data streams for each of their patients. “This stuff has to get corralled and managed,” she argues; “There’s so much fragmentation in health apps in general, plus an individual may have other health apps tracking food and exercise and sleep in addition to Rx apps. The bet is that we can streamline those in one dashboard and put it all together.”

mHealth with a purpose With the proliferation of mHealth products, launching an app for an apps sake, or simply to promote a brand,

“The whole premise behind the ACA is more efficient care at a lower cost and having patients engaged. And how do you do that? Technology.”

DAVID COLLINS, SENIOR DIRECTOR, HEALTH INFORMATION SYSTEMS, HEALTHCARE INFORMATION AND MANAGEMENT SYSTEMS SOCIETY (HIMSS)










is likely be a waste of time and effort, the experts caution. In fact, one of the leading reasons cited by R2G for the failure of pharmaceutical companies to publish successful mHealth apps has been a tendency to build app portfolios around products instead of in response to market demand.

Fortunately, observes Tim Davis, CEO of information technology company Exco InTouch, although pharmaceutical companies in past years often published apps just because they thought they had to have an app, today they tend to have a better idea of what they want to accomplish and have a greater desire to create “people-centric” apps with a focus on adding value for patients and providers.

To ensure the best chance of success, Sarasohn-Kahn suggests bringing together different stakeholders within the organization at the brand level early in development to start thinking about how an mHealth project can best be used to drive outcomes. The increasing use of mobile data collection in clinical trials offers pharmaceutical companies the opportunity to build on mobile experience from early in development in order to understand patient needs and interactions around the product, Davis adds.

One positive shift in direction Davis has observed is a movement away from static apps that aimed solely to increase refill rates by providing information to patients. The trend is now towards more responsive apps where the flow of information goes both ways. While using

mHealth to help improve medication adherence has obvious value to pharma companies’ bottom lines, collecting real-world data through mHealth technology allows them to demonstrate the value of their products to patients and payers as well.

Pharmaceutical companies are also more frequently looking at the role of mHealth in helping patients with chronic diseases to understand and be engaged in their own care. According to the Centers for Disease Control (CDC), over 85% of healthcare spending in 2010 went toward treatment of patients with one or more chronic conditions, and the ACA contains a number of incentives and penalties designed to encourage preventive care and reduce the number of costly hospitalizations for those patients.

That recognition has led to a spotlight on mHealth projects related to population health management and remote patient monitoring, with the goal of reducing ER visits as well as hospital admissions and readmissions. A 2013 report from Juniper Research estimates that remote patient monitoring alone would save up to $36 billion worldwide over the next 5 years.

Several recent collaborations centered around diseases with large patient populations such as asthma/COPD, diabetes and cardiac disease indicate a growing recognition of the value of remote patient monitoring components for pharmaceuticals. In the respiratory disease area, AstraZeneca and Boehringer Ingelheim have partnered with inhaler monitoring companies






https://validic.com/contact





Adherium and Propeller Health, respectively. Novartis CEO Joe Jimenez has also indicated that his company is looking to add value to the heart failure drug Entresto by supplying it with digital remote monitoring tools designed to reduce hospitalizations.

Overcoming regulatory hurdles One factor that has held back mHealth says Collins has been uncertainty about the regulatory environment; obviously, app developers want to know what the regulations are. With the technology evolving rapidly, agencies are scrambling to clear the way for mHealth progress while simultaneously protecting patients.

In the US, The FDA has worked in conjunction with the FCC and the Office of the National Coordinator for Health Information Technology (ONC) to develop a “strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”

From Collins’ point of view, the FDA is making a concerted effort to balance innovation against bureaucracy. “If app developers have to go through an expensive FDA review process, that can challenge them in a competitive environment. But,” he asserts, “there comes a point where patient safety is king, and innovation is queen, for lack of a better analogy, and safety’s got to rule.”

In February 2015, the FDA updated its Guidance on Mobile Medical Applications, which specifies that the agency regulate only apps that can be considered medical devices, and affirmed that it will not enforce regulations on apps that could be considered medical devices but that pose little risk to patients, including “technologies that receive, transmit, store, or display data from medical devices.”

mHealth developers must, of course, comply with the Health Information Portability and Accountability Act (HIPAA) in the US and the Data Protection Directive (DPP) in the EU, and data security is a big concern for many of his clients, Exco nTouch’s Davis acknowledges. However, he says, most companies know that they can overcome their concerns through due diligence, by requiring evidence that suppliers are compliant, accredited, and have the procedures and technology to ensure that data remain within the borders of the countries where the patients reside, to

“There’s so much fragmentation in health apps in general, plus an individual may have other health apps tracking food and exercise and sleep in addition to Rx apps. The bet is that we can streamline those in one dashboard and put it all together.”

JANE SARASOHN-KAHN, HEALTH ECONOMIST AND CONSULTANT










prevent inappropriate release, and to encrypt and store data appropriately.

As to overcoming the related issue of patient concerns about privacy of their personal health information, data show that “when a patient is really sick they’re willing to trade off some aspects of privacy for value in return,” Sarasohn-Kahn says, as long as the app’s privacy policy is expressed clearly and simply and “isn’t 10 pages long in legalese.”

Designing for maximum engagement “If you are expecting a high level of uptake,” Davis suggests, “the design is key.” Patients expect an active, engaging experience; providing static content such as a digital version of the patient information leaflet and some general lifestyle tips won’t do. “You need to insure that you’ve got responsiveness, that it actually interacts with the data that’s been entered into it and then pushes more information, more current information, down as the patient progresses through their treatment program.”

Beyond responsiveness, apps must address the needs of specific patient populations while also providing a unified experience. In its analysis titled, “Why Pharma companies fail to have an impact on the mHealth app economy,” R2G partially blames the lack of a consistent, recognizable design across an app portfolio and also cites a lack of global availability, with almost half of pharma apps available in three or fewer countries.

That analysis matches Davis’s experience. When companies do create an app for launch in multiple countries, he has found, “it’s still a very territorial initiative,” with apps for different countries configured individually. “I think more effort could be made by pharmas in trying to create a global sort of solution,” he suggests, “and then allow some minimal sort of tailoring. That would of course be more cost effective if we’re not having to build an app 20 times, and I think that would help with the overall uptake of these solutions.”

At the same time, it’s important to differentiate each version of an app beyond translating materials into the language of the country where it will be launched and ensuring that materials comply with regional differences in marketing regulations. Developers must also take cultural differences between patient populations into consideration, the experts emphasize, whether those differences are based on nationality, gender, age or other factors.

In addition to accounting for cultural differences in the health content of the app, mHealth developers need to account for differences between patient populations when it comes to their relationship with technology. Elderly COPD patients have very different expectations and abilities when it comes to technology than teenaged diabetes patients, and as the PwC report points out, patients in established markets are much less comfortable with mHealth than those in emerging markets.










The digital team at Stiefel, a subsidiary of GSK, faced all of those challenges when they developed an acne tracker app designed to encourage teenagers to document their conditions and to better communicate with their healthcare providers. Called “Face the Day” in English-speaking markets, the app has been published in different versions for the U.S., U.K., Latin America, Italy, Brazil and India, with English and French Canadian versions in the works.

“We really wanted to ensure that had the flexibility to adapt the app to meet the needs of a specific market,” explains Rachel Garcia, Stiefel’s Director, Global Digital Strategy, “so we designed a global template that could allow for national nuances—in the translation obviously, but also in some of the different cultural aspects of how the condition might be viewed and in how teenagers in particular interact with their technology.”

In addition to using images specific to each market, the team focused on details such as what types of language patients used to refer to symptoms and environmental aspects such as the need for sun care in Brazil. So far, Garcia says, the app has been most popular in Brazil, where it has been downloaded an average of 400 times

per month and has garnered positive feedback from both patients and dermatologists. In India, where it has been available for only a few months, reviewers have rated the app 4.9 out of 5 stars on the Google app store.

Scalability and technology changes Another concern for Garcia and her team was researching any changes that might be planned for global platforms, looking at coming software updates by Apple and Google, to ensure that the app will continue to hold up over time as technologies change. Beyond upgrades to operating systems, tech companies are quickly introducing products like Google’s health wristband and smart contact lens and Apple’s Healthkit that add a range of possibilities for mHealth applicaitons.

One common challenge, says Davis, in that medical device technology is often more cutting edge than smartphone technology. For example, he notes, some of the devices that Exco InTouch has been integrating with pharmaceutical apps use a newer Bluetooth protocol than many older smartphones, and the two protocols are not compatible. “If you are working with medical devices,” he says, “you need to ensure that the smartphone the patient has can actually deal with that level of complexity.”

Davis also mentions that many pharma companies conduct pilot programs before undertaking a wide launch of an mHealth application, which means that they will need to scale up. “And at that point,” he

“If you are expecting a high level of uptake, the design is key.”

TIM DAVIS, CEO OF INFORMATION TECHNOLOGY, EXCO INTOUCH










cautions, “you need to insure that the system you’re using and the vendors you’re working with can deal with scale and capacity” when it comes to servers and other infrastructure.

“Think about it,” he says, “if you’ve got 10,000 users in one time zone, and if they all want to get some kind of prompt when they wake up in the morning, that means that 10,000 in-app messages are going to be hitting your server at the same time.”

Moving mHealth into the future Streamlining will be even more important as the world moves towards the era of the so-called “Internet of Things,” where every object in our homes, in the environment, and on our bodies is connected the Internet. “Eventually, sensors, which are getting smaller and cheaper and more and more smart will permeate our lives everywhere and be in forms that we don’t have to wear; they’ll just be embedded around our lives wherever we are,” Sarasohn-Kahn comments, noting that patches and tattoos for collecting medical data are already in development.

In the world of the Internet of Things, she suggests, pharma companies might partner with athletic equipment companies or consumer appliance makers or even automobile manufacturers to integrate healthcare into every aspect of a patient’s life: “Pharma is a piece of the ecosystem, but it’s not at the center of the health ecosystem at all, it’s just a player, so pharma has to play in the sandbox with all those other stakeholders who can impact a patient’s life. It could be one day, you’ll see a vertical integration of R&D which goes all the way through the lifecycle of the product into the patient’s home.”

“The thing about mobile health,” she says, “is it should just be seen as a platform for helping deliver health. It’s not a thing in itself; it has to be part of a larger strategy. When we think about mHealth, think about the way we used to talk about eBusiness a few years ago. We don’t talk about eBusiness anymore; it’s just business that happens to be online generating a lot of data and moving through the cloud. I think mHealth is the same.” n






september 2015 fiercepharma healthcare companies...

Documents