By Jim Mittler, PhD, Medical Director, Palio jmittler@palio.com

Ask any professional athlete, and they’ll tell you: The key to peak performance lies in awareness and measurement. Awareness means knowing how you’re performing and how the surroundings – whether it’s the lay of a particular green at Augusta National or the distance to the right field bleachers in Yankee Stadium – impact that performance. And measurement means tracking what’s working (and what isn’t) with ever-increasing precision.

Together, awareness and measurement can turn an average performer into a superstar. And it turns out that, in healthcare, those two disciplines can have similarly big payoffs.

Healthcare professionals have known for years that feedback loops – whether it’s a blood-sugar measurement or a heart rate monitor – not only tell the patient how he or she is doing at the moment; such indicators also provide the patient with tangible metrics. People inherently want to do better; thus, providing relevant, real-time, personalized data can motivate them to change their behavior.

Biofeedback isn’t just a 1970s golden oldie idea – it’s a core tool for wellness. The current plethora of mobile healthcare apps springing up on phones shows that many pharmaceutical and healthcare companies know the value of helping patients record and monitor key data. But now, a Silicon Valley–based start-up is showing off a prototype device that takes such monitoring to the next level.

The company, Scanadu, plans to produce a small device that, held to the head for a few seconds, transmits readings of the patient’s heart rate, breathing rate, temperature, and other medical data to a nearby smartphone.

It’s a world of difference from the once-every-six-months collection of data taken during regular check-ups – and that’s the point, according to entrepreneur Walter De Brouwer, founder of Scanadu. De Brouwer says that rapid, hassle-free checking allows for long-term data collection and also allows patients to see how their health varies over time and in response to various life events and patterns.

As intriguing as the device is, the story of how Scandau tweaked it on the way to market is just as interesting – at least for pharma marketers:

• Several designs and sensors were tested before getting to the goal of a 10-second test. More-accurate readings were sacrificed to keep the cost down – and keep the device from being seen as a major purchase needing approval from an insurance company
• Picking where to test for readings was a marketing exercise as well – some locations gave good information for one reading but not others, and some testing methods were deemed too invasive
• Even the color of the device was driven by data: Black, while helping to keep out light, was scary to children compared to other colors

Scanadu currently has an alpha-stage prototype but the commercial product is anticipated to be available in late 2013. The company’s ultimate goal? The medical equivalent of Star Trek’s Tricorder – and a more feedback-driven, participatory framework for medicine in which doctors and patients collaborate to make better decisions about health care.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

In this #ChalkChat, Jim Mittler, PhD, Medical Director at Palio, discusses how social networks can improve and sustain positive health behaviors and health outcomes.

#ChalkChat is a weekly video series that brings you insights on branding, marketing and multichannel integration within the pharmaceutical industry. Follow us at #ChalkChat. Follow up with Jim at jmittler@palio.com or @jim_mittler.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

By Steve Toman, Account Director, Palio Managed Markets

Medicare is a federal healthcare plan run by the Centers for Medicare and Medicaid (CMS), and it is available to Americans aged 65 and older and to those with particular disabilities. It is divided into Parts A through D, each of which helps cover specific services:

• Part A: Hospital insurance
• Part B: Medical insurance
• Part C: Medicare Advantage (a plan offered by a private company that contracts with Medicare to provide the benefits covered under Parts A and B; most Part C plans include Part D drug coverage)
• Part D: Prescription drug coverage

Medicare Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Most Part D drug plans have their own formularies that define their drug benefits. Part D plans are required to include at least 2 drugs in each category and class covered by the plan, and CMS may require plans to cover more than 2 drugs for certain categories and classes.

There are 4 stages of Medicare Part D coverage for 2012. Depending on which stage a Medicare patient is in, the amount he or she pays varies substantially. It’s important for patients to understand and to be aware of the cumulative out-of-pocket (OOP) costs that they accrue as they move through the stages, particularly those patients who are on expensive therapies.

To illustrate the ins and outs of Part D, let’s consider Maude, a fictitious Medicare patient who works her way through the system by requiring brand-name drug therapies that total $20,000 in 2012. Her Medicare Part D plan provides a “typical” set of benefits.

• Stage 1: Deductible. Deductibles vary between Medicare Part D drug plans, with some having no deductible. In 2012, no Medicare drug plan can have a deductible greater than $320. Maude’s plan has a $320 deductible, so she is responsible for the first $320 of drug cost. Simple enough
• Stage 2: Co-insurance. Although co-insurance levels may vary from plan to plan, Maude’s plan covers 75% of drug costs, which means she is responsible for the remaining 25%. Stage 2 ends when the cumulative drug costs reach $2930
• Stage 3: Donut Hole. Medicare Part D does not cover prescription coverage during Stage 3. Maude is in the “donut hole” and hopefully has been able to save for this rainy day. The good news is that manufacturers do offer a 50% discount on brand-name drugs for patients in this stage, and both manufacturer and patient contributions are applied to the annual cumulative drug costs, up to $10,385
• Stage 4: Catastrophic Coverage. Once cumulative drug costs reach $10,385, Maude enters the fourth and final stage of catastrophic coverage. In this stage, her plan pays 95% of the drug cost, and she is responsible for 5% for the remainder of the calendar year. It is important to note that once the calendar year ends, coverage starts over again at Stage 1

So if Maude had no prescription coverage, she would have had to pay the full $20,000 for her medications. What is her responsibility under Medicare Part D? About $5560. And that includes her Part D plan premium of $30/month. No wonder Maude is a big fan of Medicare Part D!

Fortunately, most common medications, especially generics, are relatively inexpensive. But what if Maude doesn’t have $5560 a year for the medications she needs? Medicare does offer low-income subsidies for patients who qualify. In addition, some Medicare patients are eligible for charitable programs offered by foundations such as the National Patient Advocate Foundation and the National Organization for Rare Disorders. Additional information is available at http://www.medicare.gov/, and at the websites of individual charitable foundations.

But for Americans who can afford the standard benefits of Medicare Part D, there are changes on the horizon. The discounts that are applied to drug costs in the “donut hole” are scheduled to rise, courtesy of the Affordable Care Act. In 2013, the discount will rise from 50% to 52.5%, and by 2020, the “donut hole” is scheduled to close completely. By then, the memorable words of Ty Webb from the movie, “Caddyshack,” are projected to come true: “A donut with no hole, is a Danish.”

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate in the managed markets space. Follow up with Steve Toman at stoman@palio.com.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

In this #ChalkChat, Jim Mittler, PhD, Medical Director at Palio, discusses how the HITECH Act and the evolution of EHR technology will bring about an important shift in evaluating behavior in patients and prescribers to provide a more analytical and objective approach to gaining insight.

#ChalkChat is a weekly video series that brings you insights on branding, marketing and multichannel integration within the pharmaceutical industry. Follow us at #ChalkChat. Follow up with Jim at jmittler@palio.com or @jim_mittler.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

In this Managed Markets Monday, Jim Mittler, PhD, Medical Director at Palio, addresses the value challenge in the evolving pharma marketplace.

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate in the managed markets space. Follow up with Jim Mittler at jmittler@palio.com

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

By Micahlyn Whitt-Flicker, Copywriter, Managed Markets at Palio, m.whittflicker@palio.com

In this Managed Markets Monday, the final blog entry in our 3-part series, we provide a snapshot of comparative effectiveness research (CER) in action for managed care.

Do well-designed, industry-supported CER studies have a role in managed care decision-making?

By 2019, it is estimated that up to 32 million previously uninsured people will be enrolled for medical coverage, including a significant increase in the Medicaid population. In addition, economists estimate that over $700 billion is spent annually on unnecessary and ineffective treatments and procedures. It’s also estimated that more than half of treatments delivered today are not based on clear scientific evidence of effectiveness in real-world settings. This, in turn, contributes to substantial variability in how diseases are managed and significant variations in healthcare costs and outcomes nationwide. With this, payers are keen to engage tailored CER that can help inform and shape their decision-making and formulary processes to provide more meaningful coverage options for their member populations.

While the Patient Protection and Affordable Care Act discourages the use of CER findings as the sole determinant for coverage or reimbursement decisions, private payers and pharmacy benefit managers are permitted to use CER to inform formulary decisions and benefit design. Managed care organizations and insurers are working to determine the value of existing interventions by examining high-quality clinical data alongside real-world comparative effectiveness data. Payers are also spearheading CER initiatives tailored specifically for managed-care interests.

Case Study: WellPoint

In 2010, WellPoint was the first health benefits company to publicly release CER guidelines for use in evaluating pharmaceuticals. These guidelines were then used to develop CER criteria that informed the value of clinically proven osteoporosis agents. The research focused on use and outcome results from pharmacy and medical payment claims data for 25,000 WellPoint members who were prescribed 1 of 3 leading osteoporosis medications (each with comparable high-quality clinical-trial data). The results of the study showed that for 1 of the medications, patients experienced lower levels of compliance, higher bone-fracture rates, and increased total costs of care. These real-world data helped WellPoint reassess their formulary decisions, and the medication that was shown to have lower compliance rates and increased costs of care was relegated to tier 3 formulary status. Every quarter, WellPoint completes 2 or 3 comparative effectiveness studies, examining how treatments in a particular disease category stack up on effectiveness and cost.

Cast Study: Intermountain Healthcare

Intermountain Healthcare has employed CER data to develop disease-management programs that provide tools and information to help practitioners within the Intermountain system deliver care in a consistent and integrated way. Each disease management system includes an evidence-based care model, patient education materials, clinical support materials to make care delivery easier, and a data measurement and reporting process to analyze practice patterns. The goal of this CER initiative is to help reduce variations of treatment within specific disease states and to produce more consistent outcomes.

Payer-Centered vs Patient-Centered CER

The case studies above are examples of how private payer organizations are tailoring CER to inform specific managed-care interests. Critics, however, worry that these types of initiatives may not benefit patients in the manner intended by the American Recovery and Reinvestment Act of 2009 and the Patient-Centered Outcomes Research Institute. Will cost-effectiveness models contradict or undermine patient-centered models of CER? Will patients have access to the right treatments and interventions at the right time, or will cost issues hinder this process?

Payer utilization of CER may identify some established, low-cost treatments that yield better outcomes than high-cost alternatives, but it’s also important to acknowledge that the reverse is also possible: CER analyses can persuade cost-conscious payers, purchasers, and patients that a more expensive new medical innovation is more effective and offers better long-term value.

I hope you enjoyed this snapshot of CER in action in the payer space. It’s clear that the advent of CER has and will continue to have a significant impact on the policies and practices of professionals across the spectrum of healthcare, as well as patients in need of more innovative and effective treatments and innovations.

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate with the payer customer.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

By Micahlyn Whitt-Flicker, Copywriter, Managed Markets at Palio, m.whittflicker@palio.com

CER and the real world

Most of us are familiar with the basic principles of study design for randomized control trials (RCTs). While RCTs continue to be seen as the gold standard for providing unbiased clinical evidence for pharmacological and other interventions, by design, these studies omit specific variables that exist in real-world settings. For advocates of CER, these real-world variables provide the foundation needed to glean important insights into the utilization and effectiveness of interventions. Ultimately, it’s believed that these insights and outcomes can lead to the development and support of more effective, patient-centered interventions.

In a recent article in the American Journal of Managed Care, the head of Medco’s personalized medicine research department commented on the potential for CER. He said, “If we do it right, we can learn a lot about how drugs work and for who, in what I believe is a much more realistic real-world environment.”

Of course, doing it right begins with the implementation of sound study design.

To CER or not to CER

There are many methods for conducting comparative effectiveness research (CER) and even more opinions and debates about which of these methods are most effective in producing unbiased outcomes with meaningful applications versus the gold standard RCTs. Retrospective observational studies and prospective observational studies are often cited as an important foundation for robust and comprehensive CER outcomes. These methods also provide an interesting contrast of advantages and disadvantages to RCTs.

RCTs continue to be viewed as the most accurate form of study for determining whether a new drug should be approved for marketing. These studies are believed to most effectively control for diagnostic and prognostic factors that affect treatment decisions. In contrast, CER that seeks to demonstrate the effectiveness of the real-world treatment and other intervention practices of patients and physicians are particularly appropriate for observational studies. For example, large observational studies are often essential when treatment effects differ across types of patients, and when analyses of subgroups are needed to understand which patients are most likely to benefit. Let’s take a closer look at these distinctions.

CER by design

Retrospective observational studies typically employ existing secondary data sources in which both exposure to an intervention and the outcomes of that exposure have already occurred. Researchers conduct comprehensive reviews of current literature, large established databases, (in­cluding electronic health records), and results from RCTs.  Systematic retrospective observational studies are often utilized in CER initiatives as a means for summarizing a body of evidence, identifying information gaps, and generating ideas for new research in areas of unmet clinical need.

A prospective observational study is another form of observational study in which outcomes occur after the creation of the study protocol and analysis plan and study commencement. Patient exposure to interventions being studied may have been recorded prior to the study initiation. Prospective observational studies such as those conducted over a 20-year period by the United Kingdom Prospective Diabetes Study Group (UKPDS) have resulted in providing influential long-term data that have informed treatment guidelines as well as research and development of new interventions.

Observational studies have also been employed to examine multiple treatment paradigms simultaneously. For example, the wide range of approaches for treating hearing loss including cochlear implants, assisted listening and electric acoustic devices, and habilitation and rehabilitation methods. A prospective observational study of patients being treated for hearing loss would permit researchers to examine treatment preferences as well as the risks and benefits of the different treatments. In general, observational studies are considered to be best used to evaluate the real-world applicability of evidence derived largely through randomized trials; to study patients and conditions not typically included or studied in randomized trials; to better understand current treatment practices and how patients are assessed in order to design an appropriate clinical trial.

Did CER help to shape perceptions about heart disease in the United States?

Retrospective observational studies have been particularly useful in identifying and reporting on the inequity of important disease-state research results; notably, previously underrepresented patient experiences. During the 1980s, for example, several retrospective reviews of major disease-state research identified a stark absence in the number of females as subjects in research, resulting in the recognition of an alarming void of information across the spectrum of healthcare for the female population.  Subsequent retrospective studies demonstrated significant lack of research data for other underrepresented populations, such as nonwhite and female populations in cardiovascular diseases. With this in mind, it’s interesting to consider that in 1948 the American Heart Association’s (AHA) campaign to raise awareness of heart disease in the United Stated was called “Walking Man.” Today, the “Go Red For Woman” campaign is a hallmark of the AHA’s awareness initiatives.

Room for debate

Researchers cite several advantages of observational studies versus RCTs. For example, larger numbers of subjects can be observed at more affordable costs. And this, in turn, allows researchers to examine a broader range of patient experiences such as those for meaningful subgroups and comparison populations. Another noted benefit of CER is longer follow-up periods, which make it possible to examine long-term risks and benefits.

As we can see, observational research methods can provide many viable options for identifying key outcomes data for many types of interventions. However, one of the primary criticisms of CER, specifically observational research, is that there is too much room for bias and inaccurate reporting. Some believe that because patient characteristics influence real-world clinical decisions, there will always be un­certainty about whether the subject (the patient), or the intervention itself, causes the observed outcomes.

While the impact and application of CER methodology and study design continue to be hotly debated, at the end of the day, or at least the end of this blog, most seem to agree that it will continue to play an important role in the future of healthcare, informing everything from practice to policy. The general opinion held is that in order to arrive at the best possible decisions about patient care, we need research that has met the highest possible standards in its conduct and reporting. This includes outcomes from RTCs as well as a comprehensive range of high-quality comparative effectiveness research.  

Next on Managed Markets Mondays: Do well-designed, industry-supported CER studies have a role in managed care decision-making?

Stay tuned.

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate with the payer customer.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

By Micahlyn Whitt-Flicker, Copywriter, Managed Markets at Palio, m.whittflicker@palio.com

There are over 100 terms and organizations officially referred to by the acronym CER. From certified emission reductions to complete engine repair and Camp Eagle Ridge, CER means many things to many people. Even in the healthcare industry, where “our favorite” CER is currently a hot and frequently debated topic, meaning and application can, and often do, take on many forms for many different stakeholders.

Comparative effectiveness research. Now, say it 3 times fast. What do we need to know about it, and how can we better understand and apply it in the world of healthcare? Since the answer to this question can probably fill at least 10 volumes of government-issue utilization reports, we must consolidate and curb our discussion. This, therefore, is the first in a series of 3 CER-focused blogs that we hope will help illuminate its history, current definition, and utilization across the spectrum of healthcare.

A brief account of a long (and often forgotten) history

The concept behind CER has been in play since the 1970s, when leaders in healthcare and federal government turned to meta-analyses, health technology assessment (HTA) and evidence-based medicine (EBM) in an effort to improve the quality, consistency, and value of interventions. These efforts have been referred to in different terms over the past 4 decades:

• 1970s: Health technology assessment
• 1980s: Effectiveness research
• 1990s: Outcomes research
• 2000s: Evidence-based medicine and comparative effectiveness research

In 2009, the American Recovery and Reinvestment Act (ARRA) set forth an expansive government-researched and funded CER initiative; $1.1 billion were allocated to 3 overseeing agencies, each commissioned with a set of comprehensive CER objectives. Since then, federal agencies such as the ARRA-established Patient-Centered Outcomes Research Institute (PCORI) continue to commission CER initiatives through normal appropriations. Private organizations are also engaging CER by funding their own initiatives.

Defining CER

In one of the most widely referenced definitions of CER, the Institute of Medicine of the National Academies (IOM) describes CER as the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policymakers to make informed decisions that will improve healthcare at both the individual and population levels.

PCORI has expanded IOM’s definition by including the assessment of benefits and harms of varying interventions and strategies in real-world settings. Interventions and strategies considered in CER may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral changes, and delivery systems. CER initiatives should focus on patient-centered research to provide evidence-based information to patients, physicians, policymakers, and anyone else who needs to make a decision about healthcare. CER is designed to develop information that helps these parties make informed decisions about the appropriate options for individual patients and patient populations.

Some benefits of CER

CER aims to examine and illuminate the patient experience — including varying life experiences, medical histories, and values — in different healthcare environments, such as private medical practices, hospitals, pharmacies, and outpatient programs. Evidence produced by comprehensive CER studies may be utilized to help reduce the frequency of clinician error, and it may also improve patient awareness. Information derived from CER initiatives may help healthcare professionals be more consistent, transparent, and rational in diagnosing illness and prescribing treatment.

The future of CER

CER is anticipated to be an increasingly important tool across the spectrum of healthcare.

High-impact disease states and underrepresented populations will continue to be an important focus of CER initiatives in the United States due, in part, to the growing prevalence rates in nonwhites for major disease states like type 2 diabetes and HCV.

For managed care decision-makers, there is a growing recognition of the potential role that CER can provide for patients, physicians, and payers alike.

In upcoming CER blogs, we’ll take a look at CER study design (advantages and disadvantages of applied methodologies and outcomes) as well as specific examples of CER utilization in private managed care organizations. 

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate with the payer customer.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

In this segment of Managed Markets Monday, Palio’s John Guarino, SVP, Managed Markets and Payer Strategy, describes who Formulary Decision Makers are and what they do.

Managed Markets Monday is a weekly series that provides insight into what we think it takes to meaningfully and effectively communicate with the payer customer. Follow up with John Guarino at john.guarino@palio.com.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

By Steve Toman, Account Director, Managed Markets, Palio

Imagine a meeting of primary care physicians, the kinds of dedicated healthcare professionals who serve as the backbone of thousands of office visits each day. Get them in a room and ask, by show of hands, which is preferable: An under-educated patient who knows nothing about his illness, or a highly-informed patient who walks in the door loaded with knowledge and research?

Under the warm lights of the conference room, it’s a safe bet that the majority would prefer to treat the highly-informed patient. But later, over cocktails, nearly every practitioner would be able to share at least a few horror stories about patients who walked in the door knowing – with certainty as complete as it was incorrect – what was wrong with them. In many cases, the physician probably spent more time talking the headstrong patient out of an errant self-diagnosis than explaining the actual condition and discussing appropriate treatment options.

The sheer breadth, depth, and commoditization of information available to medical consumers these days means that it is increasingly common for patients to be enthusiastic online researchers. In fact, a 2011 Consumer Reports study revealed that 61% of patients reported that they had read about their condition on the Internet. Combined with increased use of social media, that invites opportunity for medical misinformation or misinterpretation.

Doctors are not convinced that online research is truly helpful. Almost half of physicians surveyed as part of the same research said online research helps very little or not at all and merely 8% thought it was very helpful.

What’s a healthcare professional to do in a world where patients are armed with the Web, an army of socially connected armchair medics, and mobile apps sponsored by pharmaceutical or medical-device companies? Helping patients become more effective citizen scientists, and improving practitioner-patient communications starts with the basics:

Be a guide, not a naysayer. Rather than asking patients to put down the keyboard and step away from the Google, physicians should suggest ways they can become smarter researchers. For example, they should discuss the value of sticking to a few reliable sites, like the Centers for Disease Control and Prevention for information on infectious diseases, the Food and Drug Administration for drug information, MedlinePlus for information about conditions and diseases, or the National Cancer Institute for information on cancers. High-quality academic center sites, such as those of the Mayo Clinic and the Cleveland Clinic, can also ensure patients have access to accurate sources of information.

Understand how patients consume information. Are they constantly monitoring their blood sugar with a smartphone app, searching from their personal computer, or getting input from a friend or neighbor about a condition? Understanding how patients gather and consume health-related information is a key to providing crucial, authoritative care information with context and in a manner that’s most likely to be absorbed.

Applaud the effort, if not the information itself. It’s in everyone’s interest to have engaged, informed patients. So, even when the information and self-diagnosis a patient brings to the table is little more than a glorified wives’ tale, healthcare professionals should respect and even encourage the effort, even as they steer the patient to more authoritative sources. And remember, not everyone will enter the brave new world of self-diagnosis via the Internet – 37% of patients surveyed preferred to trust their doctor’s judgment on all treatment decisions.

Citizen science is here to stay, so practitioners need to guide patients to be effective partners in their own care. If patients are taking on an increasingly empowered role, the roles of the physician, healthcare professional, manufacturer, and patient educator need to evolve along with it.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.