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Pharma’s guide to finding success in an outcomes-driven environment

Adapting to Value-Based Care

Major changes are afoot in this country’s healthcare industry, and they’re coming from all sides—healthcare providers and payers, pharma and patients. Value-based healthcare seeks to address all angles. Barbara Peck reports

S ince the launch of the Affordable Care Act, more and more Americans have been able to take health insurance into their own hands—

figuring out their needs, learning how the system works, researching the best options. For many of these consumers, it can be a daunting task.

Meanwhile, with the population aging and chronic diseases on the rise, healthcare costs are spiraling. And as the num-ber of insured Americans rises, so too do payers’ healthcare bills. That explains today’s intense focus on value-based healthcare. A recent article in The Economist described it this way: “Value-based health-care is enabled by a data-driven, evidence-based approach, which can significantly reduce inefficien-cies in traditional health systems by reallocating resources and stream-lining operations according to their impact on outcomes.” Basically, it means achieving better patient out-comes at an acceptable cost.

Value-based healthcare is hardly a new concept. The term joined the lexicon back in 2006, when Harvard Business School Press published Redefining Health Care, by Michael E. Porter and Elizabeth Olmsted Teisberg. The book’s useful insights are still talked about in the industry. To many it issued a rallying cry that resonates even more deeply in the current environment.

Putting Patients FirstWith the new emphasis on “patient-centricity,” health-care isn’t just about dispensing pills. It’s about which pill makes the patient better and able to get back to enjoying everyday life. It’s about which treatment gets

the patient out of the hospital fast, and which approach manages a chronic condition in the most efficient (and most cost-effective) way.

Of course, the concept of successful healthcare is different for patients and providers. In a recent MM&M article titled “Operation Patient-Centricity,” Jessica Brueggeman, VP of the health behavior group at MicroMass Communications, wrote, “For patients, success centers around a positive experience with staff and providers, being included in treatment deci-sions and having questions answered. Providers gauge success based on their ability to provide quality care, although definitions of ‘quality’ vary among clinical outcomes, patient satisfaction and practice success/business metrics.”

However success is interpreted, there’s mounting evidence that consumers who are directly engaged in their own care show better health outcomes than

those who are less involved. While levels of engagement might seem difficult to measure, it can be done using an assessment tool developed more than a decade ago by Profes-sor Judith Hibbard and colleagues at the University of Oregon.

Patients who score high on Hib-bard’s Patient Activation Measure take charge of their own health by having regular checkups and screenings, eating well and exercis-ing. They’re better able to interact with their healthcare provider and less likely to require extended hos-pital care or emergency room visits. As a result, the cost of their care is lower—that is, highly “activated” patients can help keep healthcare expenditures from rising.

Considering that the informed consumer makes healthier choices

and better decisions, there’s definitely a role for phar-ma in helping to educate patients. During an MM&M SkillSets Live session on Engaging Patients, Tony Romito, managing director of Accenture’s Life Sci-ences Practice, pointed out that 76 percent of patients responding to a recent Accenture survey said they don’t just want more services from pharmaceutical companies—they expect them.

But note that “services” means more than prod-uct information. It can mean collaboration with and

mmm-online.com x Copyright 2015 Haymarket Media Inc. 1

“The US marketplace has changed significantly, with an exceedingly competitive payer landscape … The entire sector is facing new challenges due to pressures on price and access.”—Abbas Hussain, GSK’s president of global pharmaceuticals

76%

of patients responding to a recent Accenture survey said they don’t just want more services from pharmaceutical companies—they expect them.—Tony Romito, managing director of Accenture’s Life Sciences Practice

Overview: More Than Molecules Book

A MM&M Digital Publication

The book that launched the phrase “value-based healthcare” back in 2006, thanks to Harvard Business School Press


BookA MM&M Digital Publication

support for patient advocacy groups. And, as Bruegge-man suggests, it can be offerings like skill-building initiatives that make patients and providers become partners in achieving optimal outcomes.

The Payer PerspectiveAs the Economist article put it, “Value-based health-care is enabled by a data-driven, evidence-based approach.” So more than ever, payers are focused on the metrics of price and performance when it comes to deciding which products they decide to cover.

The same article points out the broader implication: that payer responsibilities have increased “from that of contracting and reimbursement to being gate-keepers of accountable care.” And don’t neglect the growing numbers of pharmacy benefit managers who are tasked with negotiating discounts with pharma companies.

So the time has come for pharma marketing to change direction. Demonstrating value must be a prime consideration. And as Zoe Dunn, a principal at Hale Advisors, points out in an MM&M editorial on the “Payer-Marketing Power Shift,” DTC will be less effective—“and could actually hurt us if patients are frustrated with not being able to get a product they ask for.” As payers gain control over access to prod-ucts, writes Dunn, “We’ll need to strive for innovation in communication with these payer stakeholders the same way we do with providers and patients.”

Overview:More Than Molecules

The Doctor’s Role Healthcare providers face increasing pressure to con-tain costs, reduce hospital stays and ramp up preventa-tive care. In the process new subsets enter the field—among them, hospitalists, or physicians who only treat hospitalized patients, and healthcare extenders, whose job is “primarily to educate, support and motivate patients,” to quote Todd Greenwood, VP of strategy and innovation at HealthEd, who spoke at MM&M ’s SkillSets Live Session on Engaging Patients.

Then there are the Accountable Care Organiza-tions, in which providers join together to coordinate patient care. ACOs that save money for the Medicare program can share in those savings as long as their quality of care meets certain high standards. Such an approach limits in-efficiencies and unnecessary expenditures yet ensures that patients get needed care, ba-sically hitting the hallmarks of value-based healthcare.

What do these provider changes mean to pharma? In recent years sales reps have faced more obstacles in gaining access to doctors in hospitals, and the new hospitalists are even harder to reach. As small (and fis-

cally inefficient) medical practices disappear, access to physicians becomes even more difficult. On the other hand, HealthEd feels that the new healthcare extenders are “woefully undertargeted” by marketers. Because these providers work directly with patients, their influence can only improve patient adherence.

What Lies AheadClearly, value-based healthcare presents both chal-lenges and opportunities to pharma. This industry, his-torically slow to change, is being pushed to re-examine its role. As Sara Holoubek, CEO of Luminary Labs, said during last year’s MM&M Roundtable on “Get-ting Beyond the Pill,” “I believe that the industry will no longer reward the company that simply sells the most pills.” It’s time to make the move from selling pills to providing value-added programs that deliver healthcare solutions—and improve lives. n

“I’m hoping that the ACA will be a waterfall of new approaches.” —Zoe Dunn, co-founder, Hale Advisors

20%possible US health-care costs as percent of GDP by 2022 Source: The Economist

Comparing Healthcare spending as % of GDP

Source: The Economist

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If only changing patient behavior were this easy.

Experts in Human Health Behavior WeAreSpecialists.com

More than 20 years ago, MicroMass introduced the idea of using evidence-based behavioral strategies to shift attitudes,

build skills, and improve patient outcomes for pharma brands. Our award-winning creative translates behavioral science

into compelling programs that change the lives of patients.

Why trust your patient marketing to anything less than a specialist?

Email Jude today at [email protected] to find out how our specialized expertise can lead to more effective

patient support and marketing initiatives.

But it’s not. Changing behavior requires a specialist like MicroMass.

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Healthcare drivers have traditionally been subject to change, both from physician focus and patient outlook. Pharma is now increasing physician “self-efficacy” through skill-building initiatives that incorporate—and integrate well with—other communications

T raditional routes for getting physician buy-in to pharmaceutical products are fast losing ground. These days it takes much more than

sales reps visiting hospitals and doctors’ offices to hand out samples and product information.

Physicians are busier than ever: Their patient hours are squeezed by administrative duties, and the Afford-able Care Act has increased patient loads. For health-care providers in ACOs, reimbursement is dependent on outcome. The emphasis on value-based care makes costs and efficacy prime considerations.

“It’s definitely harder than ever to gain access to physicians,” says Rob Peters, SVP of strategy at Micro-Mass. “That’s why pharma needs to find new ways to reach out to prescribers.” In 2014 MicroMass published a white paper titled “Products, Patients, and Persua-

sion: Uncovering What Really Influences Physi cian Behavior.” Rob Peters and co-author Meredith Terry surveyed 341 physicians to uncover the biggest predic-tors of prescribing behavior. According to their report, one of the top two is physician self-efficacy, “feeling

confident in one’s ability to make the best treatment choices to benefit patients.” The other is perceived control: “a physician’s beliefs about how his/her deci-sions and actions influence patient outcomes.”

Fortunately, they note, “These drivers are, in fact, changeable. Physician self-efficacy and perceived control can be increased through skill-building initia-tives that integrate well with pharma communications efforts.” The white paper recommends that pharma offer physicians training in such things as “motiva-tional interviewing to improve patient adherence and make them more receptive to behavior change.”

This kind of patient engagement can lead to bet-ter clinical outcomes. “What the Evidence Shows for Patient Engagement,” a paper by Judith Hibbard and Jessica Greene, sums it up this way: “Several studies have reported that patients with higher activation scores are more likely than patients with lower scores to have biometrics such as body mass index, hemoglo-bin A1c, blood pressure, and cholesterol in the normal range. These findings … were significant even after sociodemographic factors, disease severity, and insur-ance status were controlled for.”

“Pharma has started using the Patient Activation Measure [PAM] in a lot of initiatives,” says Hibbard. “Until recently, pharma and the healthcare industry

have been narrowly focused on the condition; use of PAM moves the focus to the individual.”

Anthony Antonelli, manager of patient engagement marketing for GlaxoSmithKline, tells how using PAM helped create strategies for increasing patient engage-



Doctor Drivers: What Moves the Physician

“If patient engagement were a drug, it would be the blockbuster drug of the century.” —Leonard Kish, digital healthcare strategist, VivaPhi

50%Cases in which medication is not continued as prescribed—CDC

A MicroMass study showed that self-efficacy (physicians’ belief in their medical skills) and perceived control (their beliefs about how their actions influence outcomes) were the top Rx-writing drivers and can have a tangible ROI

© 2014 MicroMass Communications, Inc.

Why self-efficacy and perceived control matter

Our study determined that self-efficacy and perceived control are the top drivers for prescribing

decisions. These drivers have been studied in the behavioral sciences for decades.

Self-efficacy

Self-efficacy is feeling confident in one’s ability to make the best treatment choices to benefit

patients. This is not a personality trait or based on the amount of knowledge a physician has.

It’s a belief in one’s skill or capability.

Perceived control

Perceived control is a physician’s beliefs about how his/her decisions and actions influence patient

outcomes. In many chronic diseases, the burden of management largely falls on the shoulders of

the patient. The choices patients make every day such as what to eat, whether to exercise, and how

to manage symptoms are in their hands, which may make physicians feel that they have limited

ability to influence outcomes.

The good news is that these drivers are, in fact, changeable. Physician self-efficacy and perceived

control can be increased through skill-building initiatives that integrate well with pharma

communications efforts. Physicians and extended-care teams need to be equipped with practical

data, tools, and training that increase their ability to influence patient behavior. These can include

evidence-based communication approaches such as motivational interviewing, goal setting, and

problem-solving.

When physicians see the positive impact that their behavior change efforts have on patients, their

self-efficacy and perceived control over outcomes will increase.

Every 1-unit increase in self-efficacy increases the odds of writing a prescription 1.5 times.

Every 1-unit increase in perceived control increases the odds of writing a prescription 1.3 times.

Self-Efficacy 1 1.5

Perceived Control 1 1.3

Rx-writing drivers

ment. “For our oncology patient support program, we measured patient levels to determine what type of information to offer. For low-level patients struggling to put things in action, we offer educational materi-als to raise awareness. For high-level patients, we offer actionable tasks. We’ve found that as patients become more engaged and build more skills, they increase adherence—and require less hospitalization.”

Hibbard’s findings agree. “Even when you look at people with different conditions,” she says, “the level of activation is the main predictor of adherence to medication.”

Despite all the evidence that patient engagement is important for improving quality of care, progress is still lagging. Greene and Hibbard’s report “Why Does Patient Activation Matter?” points out that “pro-grams to support patients in these areas are not yet well developed or widely implemented … The lack of expe rience in supporting patient activation and engagement has been cited as a potential pitfall as healthcare organizations seek to improve quality and decrease healthcare costs as ACOs.” In other words, the door is open for pharma to walk right in. n



Doctor Drivers: What Moves the Physician

Assessing Activation

The Patient Activation Measure was developed back in 2004 by Judith Hibbard, professor emerita in the Univer-sity of Oregon’s Department of Planning, Public Policy, and Management, along with her colleagues. This com-monly used assessment tool produces a 0–100 score based on patients’ responses to 13 statements about how they manage health-related tasks. The statements focus on confidence, beliefs, knowledge and skills, such as “I know how to prevent problems with my health” and “I am confident that I can tell a doctor my concerns, even when he or she does not ask.” Most patients score somewhere between 35 and 95 points; they’re then ranked in one of four levels of “activation.”

“Even when you look at people with different conditions, the level of activation is the main predictor of adherence to medication.” —Judith Hibbard, professor emerita, University of Oregon

The patient is “the single most unused person in healthcare.” So says cardiologist and writer Eric Topol in his new book, The Patient Will

See You Now: The Future of Medicine Is in Your Hands. The work, published in January to much acclaim, discusses how “the mobile internet is giving us unprecedented control over our healthcare.”

No wonder the buzzword “patient-centric” gets tossed about so much now. However, it seems that there’s no one definition. To pharma, it can mean prior itizing the patient experience and addressing patients’ needs beyond the product. But in this heav-ily regulated landscape, how does pharma move from being product-centric to patient-centric? For decades the healthcare provider has been the key customer. Engaging with the patient can seem both risky and difficult. And measuring success isn’t so easy without the simple metrics of, say, increased sales.

Many drugmakers have created new staff positions to promote patient engagement. Notable examples include Dr. Lode Dewulf, a physician who has prac-ticed in Belgium and South Africa and is now the chief patient affairs officer for UCB; and Thomas Sellers, the former CEO of the National Coalition for Cancer Survivorship, now at Millennium/Takeda as the senior director for patient advocacy and corporate philanthropy. Last year Sanofi made Dr. Anne Beal, a pedia trician and public health specialist, its chief patient officer.

And many more in the industry are toiling in the field of patient engagement. Anthony Antonelli, patient engagement chief at GlaxoSmithKline, talks about how GSK developed its marketing platform, the Patient Value Framework. “Our team looked at 50 years of behavioral science research in healthcare and identified a comprehensive list of what makes patients engage.”

GSK isn’t going it alone: “MicroMass became a designated partner three and a half years ago,” says Antonelli. “They’re behavior-change experts

More than merely a new healthcare buzzword, “patient-centric” means many things to different people. Does pharma measure success by counting its provider interchange or by prioritizing patient experience and needs?

and we’ve really worked with them to understand customer-relationship marketing.” MicroMass helped develop the language and content on GSK’s patient support websites, MyAsthma and COPD.com, both rated highly by the National Committee for Qual-ity Assurance, which enlists patient focus groups to review sites to confirm their value to patients.

Besides offering advice on managing an illness on a day-to-day basis, the sites connect with patients on an emotional level, covering such subjects as “learn how the right support can help you move forward.” For pharma, connections like these are evolving slowly. During last year’s MM&M Roundtable on “How Do We Get Beyond the Pill?” Jim Curtis (chief revenue officer at Remedy Health Media) opined, “From the dawn of marketing, everybody from Oreos to cars has been connecting with you emotionally and then pro-viding the cookie, providing the car. Now pharma’s trying to catch on. If you emotionally inspire a patient, he’s more apt to take your medication longer and ask for a brand name … and go to the doctor more often.”

Making connections needs to start at the clinical trial stage. Dottie Caplan, Sanofi’s VP of corporate affairs, launch readiness and life-cycle management, says, “It’s important to gain awareness of patients’ needs as ear-ly as R&D. For example, we asked patients to help us design Phase-III trials for an asthma medication. We adjusted the trial according to feedback about meet-ing their lifestyle needs—what’s realistic and what’s challenging. When trials are patient-friendly, it’s easier to recruit subjects and we get results that reflect the real world.” n



Don’t Just Sell: Putting the Patient in the Picture

“Healthcare consumers are truly the Rodney Dangerfields of medicine: ‘I don’t get no respect.’ ” —Eric Topol, author of The Patient Will See You Now

Finding the Right Path

Sanofi’s Partners in Patient Health 2012 Forum gath-ered more than 130 North American health advocates to discuss the whole-care path, from choosing the right care giver to finding the best treatment options. The forum came up with four key areas to incorporate in every launch:

1 Support patients where they are physically and social-ly—those moments when patients are most receptive to behavior change can occur anywhere, anytime.

2 Improve the dialogue between patients and health-care professionals, using plain talk that patients can understand.

3 Support allied health professionals, peers and caregivers, who are becoming more experienced in educating patients and facilitating treatments.

4 Involve the patient in the innovation process. Patients want to be part of the story from the beginning.

Finding and implementing ways to engage patients, both to encourage patients to stay on their drug regimen and to get them to make requisite accompanying lifestyle changes to improve overall health, can prepare pharma for a future in which reimbursement for their drugs is based on adherence

F or payers, price and performance have always been prime considerations—and now more than ever before. Who knows where we’ll go

from here? Here’s one conjecture that came from Damon Basch (team leader for pharma partner-ships at Practice Fusion) during the MM&M Round-table on “ Beyond the Pill”: “It’s not unreasonable to think that in the future pa-tients are going to get reim- bursed for their drugs based upon adherence and other things they’re doing to ensure that they’re managing the disease state properly.” Something like the way you can cut your car insurance premiums by taking a defensive driving course.

It’s not just the ACOs and Affordable Care Act initiatives that are adding pressure to phar-ma pricing and insurance for-mulary decisions. Big pharmacy chains are gaining negotiating power as they align with phar-macy benefit managers (PBMs): In February Rite Aid announced it was purchasing Envi sionRx, a top national PBM, in a move that would help it compete with chains like CVS (which bought a PBM back in 2006). EnvisionRx’s CEO, Frank Sheehy, called this integrated healthcare offering “a natural fit that is increasingly preferred by plan sponsors.”

Clearly, pharma must roll up its sleeves to dem-onstrate their products’ efficacy and value. Helping patients manage their own care is one key to this, since patient engagement can make treatment more successful and result in reduced medical costs.

Changing Behavior There are a number of innovative approaches to patient engage ment that address the stubborn issue of medica-

tion adherence. Obviously, non-adherence doesn’t just erode profits: It also can create disease-related compli-cations that can cause healthcare costs to skyrocket.

“Luckily, these days there are more ways to engage with patients than ever, through mobile phones and mobile apps,” says Rob Peters of MicroMass. “That’s good because you can’t just teach behavior change in little chunks, especially with chronic conditions that have to be managed all day—that is, how you eat, how you move around.”

By stealing a few tricks from mobile games, new healthcare apps boost motivation and are fun, engag-ing and rewarding. For instance, take Mango Health’s free mobile app, which alerts users when it’s time to take their medication and also advises them about side effects and possible drug interactions. When you keep taking your meds on time, you earn points—and the

chance to win gift cards and chari-table donations in weekly raffles.

Other initiatives go even fur-ther. AstraZeneca partnered with Exco InTouch, a provider of digi-tal patient engage ment solutions, to develop a management tool for patients with chronic obstructive pulmonary disease. Patients who are enrolled in Me&MyCOPD can use their smartphones to track and transmit information and to receive coaching help.

Not incidentally, the data collect-ed allows healthcare providers to adjust treatment according to each COPD patient’s needs—and also to keep tabs on adherence and follow

up on signs of sudden deterioration. Such oversight may translate into reduced treatment costs for payers by cutting hospital stays and alleviating the effects of exac erbations.

MicroMass is another company that is developing behavior-change programs. Its Time2Focus mobile app, currently in clinical trial for Type 2 diabetes patients, helps patients develop the skills to manage three key areas of their condition: healthy eating, physical activity and blood glucose monitoring. Earn-ing points keeps them engaged as they use the app. “If the trial proves effective,” says Jessica Brueggeman, SVP of the health behavior group at MicroMass, “we plan to take the app to our pharma clients to explore using it in combination with medication.”



Coverage & Convergence: Low-Cost Tech and Outcomes

20%-30%of medication prescriptions are never filled. —CDC

“Until now, the purpose of clinical trials has been to get regulatory approval. For value-based care, we need to focus on how pharma affects outcome.” —Rob Peters, SVP strategy, MicroMass

Mango Health’s app alerts patients to take meds: Can such tools boost outcomes?

Doing the MathLast August MM&M posed the question, “Can value vanquish payer pressure?” One response came from John Guarino, then Palio+Ignite’s EVP of managed markets and global payer access [he’s now managing director, inVentiv Managed Markets Communica-tions]: “To speak the payer language you have to do the math: Demonstrate the financial impact of your brand to the system, as well as the clinical benefits.”

To communicate value in a way that can be recog-nized by payers, a study conducted by AstraZeneca used real-world evidence—claims, electronic medical records and more—to show that patients treated with AZ’s Symbicort Turbuhaler are significantly less likely to suffer from COPD-related exacerbations and need hospitalization than those treated with GlaxoSmith-Kline’s Seretide. “We are using [the study] compliantly with payers to show them data they may not be aware of,” said Brian Sweet, executive director, US payer and real world evidence at AZ.

Partnering with payers is also a way to make the case. In 2013 pharma giant Eli Lilly arranged with Humana to share the insurer’s “de-identified” claims data. The collaboration allows both companies to study the impact of interventions on outcomes, adherence pro-grams, disease management and pharmacoeconomics (comparing the value of one drug to another). “Work-ing together,” says Dara Schuster, MD, medical fellow for Lilly Diabetes, “we hope to provide patients with insights and guidance that will help them tailor their care to best match their individual needs.” n



$2BPaid by Rite Aid to acquire pharmacy benefit manager EnvisionRx

MicroMass’s mobile app Time2Focus helps diabetics self-monitor eating, activity and blood glucose levels

If the trial proves effective, we plan to take the app to our pharma clients to explore using it in combination with medication.” —Jessica Brueggeman, MicroMass

Coverage & Convergence: Low-Cost Tech and Outcomes

As consumers come to the realization that they can both own their health and also measure their health status, companies are coming forward with devices that help make those consumers’ dreams reality

W ith strict government regulation oversee-ing its every step, there is little wonder that the pharmaceutical industry is risk-

averse. FDA guidance is notoriously hard to interpret and can be translated in countless ways. But just as change is accelerating everywhere in our brave new interconnected world, the FDA appears to be recog-nizing the need to loosen its grip.

Take TV commercials, for example: In January the FDA announced plans to investigate altering the rules that require virtually every side effect to be disclosed in a DTC drug commercial. The new guidelines may take a while to implement, but the announcement is promising: Instead of sowing fear about possible treat-ment, advertisers will be able to make medicines more patient-friendly by condensing risk information.

Similar changes are coming to consumer-directed print advertising. In February the FDA issued new guidance about disclosing risk information, encour-aging “a conversational tone or language designed to engage the reader” and requiring the disclosure of only the most serious and most common risks.

Wear It WellOther advances are under way as well. There’s a lot of buzz about inexpensive wearable fitness devices (such as Fitbit and Jawbone, often called wearables) and how they can be used in healthcare to monitor movement, sleep cycles, heart rate and other health parameters. For instance, a wearable could record the time between tremors for a Parkinson’s patient.

The good news is that the FDA is pulling back on regulating this side of the industry, too. As Rob Peters at MicroMass explained it, “The FDA just softened guidelines for mobile technology that doesn’t directly impact a clinical parameter, like Fitbit. We’ll see a lot of changes this year and next as wearables shift from fitness to wellness.”

Consumers are already seeing the value of innova-tions from start-ups in wearables. MC10 partnered with Reebok to create the CheckLight, headgear

that warns when an athlete has suffered a blow to the head that may need medical attention. A sensor on a Spandex skullcap connects to a small LED screen that lights up yellow or red, depending on impact severity.

When MC10 tested the CheckLight on seventh- grade football players, they found an added benefit: To avoid triggering a light and having to leave the game, said Elyse Winer, senior manager, marketing and brand at MC10, “the athletes started to keep their heads up and out of impact during tackles.” Since it’s not a diagnostic tool, the Checklight didn’t need FDA approval to go on the market.

MC10 is also testing Biostamp, a tiny skin patch that monitors temperature, movement and heart rate and sends this data wirelessly to patients and doctors. And developers at Novartis have teamed up with Google to develop a smart contact lens that measures blood-sugar levels from the eye’s tear fluid and transmits info via microchip to a mobile device.

A Fast Company article on wearables quoted Dr. Joseph Kvedar, director of the Center for Connected Health, as saying, “Research has shown that devices with sensors can help lower the rate of ER visits, reduce trips to the doctor, and keep people healthier.” Not surprising, the article notes, “There are a number of companies racing to track patients in real time.”

New PathsAll these devices cater to consumers’ growing desire to take wellness into their own hands. Recently, dads of young diabetes patients gained national attention when they hacked their children’s glucose monitors, adding an app that sent info on their kids’ blood sugar levels to the parents’ mobile phones. “We believe it’s a good thing,” the FDA’s Courtney Lias told the magazine Wired regarding the invention. As long as people aren’t distributing the technology to others,



The Way Forward: Building on Consumer Desire

$11.6B Predicted value of the wearable electronic market by 2020 —MarketsandMarkets

“The latest round of FDA changes opens the door to new channels that give us the opportunity to have an authentic dialogue with patients.” —Jennifer Thomas, product director, oncology marketing, Janssen Biotech

Who’s Your Granddaddy?

Digital medical data is pouring in from all over—and spawning unusual creative partnerships. Consider 23&me, a biotech company that sells DNA kits to individ-uals and then draws up ancestry-related genetic reports for them. So far the company has genotyped more than 800,000 people; 80 percent of them agreed to release their data for genetic studies. Not surprisingly, Pfizer, Genentech and other pharma companies have jumped in to gain access to 23&me’s vast databank.

she added, “It’s unlikely we would do something.” (In February the maker of glucose monitors, Dexcom, gained FDA approval for a component that transmits glucose data directly to smartphones.)

These revises “open the door to new channels that give us the opportunity to have an authentic dialogue with patients,” says Jennifer Thomas, product direc-tor, oncology marketing, Janssen Biotech. To take advantage, “Pharma needs to be more proactive,” says MicroMass’s Rob Peters. “Instead of waiting for guid-ance, pharma should approach the FDA to see how they can work together to generate new guidance for more effective value-based operation.”

And since patient engagement can improve out-come, devices that involve the patient are likely to offer the most value. Consider what happens when patients start measuring their own blood pressure: In 52 studies, according to Eric Topol’s book The Patient Will See You Now, people who took self-measure-ments had better blood pressure management than those whose only monitoring came through usual care, such as at the doctor’s office.

Big DataThe corollary? An unprecedented amount of biomet-ric data is being collected, not just through mobile devices but also in pharma trials and patients’ elec-tronic medical records. How can the healthcare indus-try mine that information? To start, the various data streams will have to flow together. With electronic medical records stuck in a slew of silos, the govern-ment is working to create a centralized database, the Health Information Exchange, that’s accessible across organizations. It seems clear that patients could better manage their own health journey if all the biometric data could come together in their records.

But as FTC Commissioner Julie Brill recently pointed out, the proliferation of mobile health apps and connected devices only heightens the need for a Consumer Privacy Bill of Rights. Meanwhile, as patients ask more questions and find more informa-tion online, pharma must be ready to provide its own answers—in ways that reach the individual patient. Luckily, it appears that lighter restrictions will make it increasingly easier to connect. n



“Research has shown that devices with sensors can lower the rate of ER visits and keep people healthier.” —Joe Kvedar, Director, Center for Connected Health (as quoted by Fast Company)

WEARABLES: Clockwise from top left: the MC10 CheckLight, MC10’s Biostamp, the Fitbit family of products, and the customizable Jawbone Up Move

The Way Forward: Building on Consumer Desire

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