Conducted across 46 states and with a group of 400 respondents, the sample was representative of just how many nurse practitioners, physician’s assistants, clinical nurse specialists and certified nurse midwives there are in the US. The demand for NPPs is leading to higher pay and an increased respect within the payer community. Aetna now considers nurse practitioners, for example, to be primary care providers and reimburses them for their services thusly.

When considering what influenced their behavior as prescribers the most, the survey found that NPPs tend to consider efficacy, their experiences with the drug, and price, in that order. As 82% of the respondents indicated they had no restrictions when dealing with sales representatives (17% had certain restrictions, and 11% said they were completely restricted), and that most respondents were open to support from them, why have sales reps and pharma by and large neglected to address this demographic?

Brenda Rizzo, author of the report and an advanced practice nurse herself, says sales reps make calls “based upon prescribing behaviors, and on that basis alone, NPPs are pretty much invisible.” Misconceptions about NPPs abound, according to the report, including that they prescribe based on a protocol set by their physician practice partners, that if they have the ability to prescribe, they rarely do, or that they are simply refilling prescriptions that have already been decided on by a physician. Pharma “doesn’t realize that this is an audience that makes independent prescribing decisions, and that having the right information to make those decisions is incumbent on pharma companies; to provide it to non-physician prescribers is equally important as it is to provide that information to physicians,” emphasizes Rizzo.

So what kind of information do non-physician prescribers want? As a group shown to be active attendees of national conferences and maintaining exchange of advice among colleagues and fellow professionals, first and foremost the information should be sharable and accurate to provide trustworthy resources that can further facilitate dialogue and be spread easily. Secondly, NPPs listed printed education materials from pharmaceutical companies as one of their top-rated tools when looking to improve patient compliance. More specifically, 61.3% of respondents, when asked about what kind of support they’d expect from pharma companies, said “Education about the pharmaceutical drug or medical device directed to the NPP for the patient,” 54.5% responded “Disease state information to educate the patient.” and 51.5% said “Assessment tools to help identify problems that can be addressed.”

NPPs, as this study shows, not only want to engage, but expect valuable engagement tools from pharma to help make their jobs easier. With primary care taking on a new definition that includes long-term, patient-focused care, the physician’s ability to orchestrate outcomes is increasingly being diluted and in need of help from nurse practitioners, physician’s assistants and other NPPs. As such, pharma needs to keep a keen eye on these providers: payers, private practices, and health care facilities have already gotten the memo.

As you look over the last 12 years of CBI conferences, a phrase relevant to this business issue comes to mind: “If at first you do not succeed, try, try again.”  For those of us engaged in this work, we know the challenges, results and skepticism from more than a decade of experience.  How do we ensure adequate funding and measurement of programs, to prove that program ROI is possible?  To do this requires support of senior leadership from your company or your client.

In 1984, I developed a patient adherence program with a chain drug store, to demonstrate the ROI.  We tracked the impact this program had on prescription refill lift.  The 6-month pilot showed a 2 to 1 ROI, in terms of test versus control.  However, our senior leadership did not support a larger program implementation, as the pharmacist at the store level was difficult to engage.  This is changing with recent initiatives, where scripts used by pharmacists, at first fills, are resulting in 38%+ refill persistence over 6-12 months.  Additionally, many chain drug stores have developed smart phone apps that automate adherence reminders and simplify prescription refill, with a 5 to 1 ROI.  So, guided interactions and technologies may to help solve this industry problem at very little additional cost.

There continues to be broad acceptance that medication adherence is a problem and that the industry stands to benefit the most from its implementation.  What is most needed is the continuous presence of adherence in the brand strategic plan.  We believe that, along with senior level commitment, this is the primary barrier to resolving the problem.  Why?  Without a plan based on evidence for what works, vendor tactics drive brand strategy in this area.  And, without experience with this planning, skill sets will not develop and be rewarded.  One top 5 pharma company has had 4-5 task forces/leaders of medication adherence in this past 12 year time frame, without changes in corporate policies and procedures to integrate and institutionalize programming to ensure revenue generation.  Perhaps this is one reason that some companies are looking outward, to a value based contracting model, to help solve the adherence challenge.  So, there is innovation and determination, but without the commitment of senior management, this issue cannot be solved.

The April 2013 CBI Patient Adherence and Support Summit (PASS), and the Strategic Patient Adherence (SPA) Awards, will highlight companies and initiatives where corporate and brand strategies have provided the ROI needed to make patient adherence an integral part of business.  I hope to see you at the conference this month.

Epigenetics is the study of changes in human gene expression, in particular from environmental factors.  Pharma is also experiencing epigenetic change.  Human genes are formed from DNA, which are instructions much like a blueprint.  Similarly, the environment is changing pharmaceutical DNA and how brand marketing is instructed.

For example, pharma’s genetic dependence on traditional blueprints (and standard agency recipes), targeting revenue from new molecules in the pipeline, is no longer sufficient for survival.  The environment has limited the availability of new blockbuster brands.

Similarly, the environment is changing the DNA of our belief systems. Here I am speaking of the evidence for effectiveness of patient medication adherence interventions.  How is this changing the DNA of brand marketing?

For more than a decade, we have believed that medication non-adherence was the result of patient knowledge and capabilities.  This has driven marketing focused on “patient education”, “segmentation” to identify profiles of patients based on their “barriers” (or “deficits”) and “tailoring” to help customize needed changes in the foregoing.

We have assumed that patient knowledge, of their disease and treatment, and their health literacy capabilities, for example, are critical to patient adherence.

However, the evidence now tells us that our assumptions were wrong.  More than 100 published studies show no correlation between a patient’s level of knowledge of their disease and treatment, and medication adherence.  How many valid studies show a correlation?  None of which I am aware.  Studies have shown that patient knowledge can be increased, but no increase in medication adherence has resulted.

Similarly, recent systematic reviews show no evidence that health literacy is associated with medication adherence in adult or pediatric populations.  As one of these review papers summarizes:

“A critical element of successful self-management is medication adherence. On this front, the evidence has been mixed. Although patients with limited literacy have more trouble understanding primary and precautionary medication label instructions and are less likely to be able to report the name of their medication, there is no consistent finding of worse medication adherence among patients with limited literacy.”

In fact, there is evidence that patients with “adequate health literacy are more inclined to purposefully not adhere to their discharge instructions.”

Do health literacy interventions improve adherence?  A 2011 systematic review found no evidence.

What about the promotion of health literacy programs?  Again, a 2011 review reports:

“…current research on health promotion for participants with low health literacy provides insufficient information to conclude whether interventions for health literacy can attract the target population, achieve an effect that is sustainable, or be generalized outside of clinical settings.”

“Tailoring” messaging based on patient characteristics has been a proposed as a solution to patient barriers.  However, a 2012 review paper, on the efficacy of tailored interventions for self-management outcomes of type 2 diabetes, hypertension or heart disease, concluded:

“Tailored interventions had no impact on self-management activities such as medication adherence, self-monitoring, exercise, smoking, or diet control.”

So, there is no peer-reviewed evidence to support developing pharma marketing strategy or tactics based on these assumptions of patient deficits.  Money spent in interventions based on these beliefs will produce limited or no ROI, as industry cost-effectiveness evaluations show.

What does the evidence, both academic and industry, show improves medication adherence?  This will be part of what you will hear at the Keynote Panel Discussion at CBI’s Patient Adherence and Support Summit (PASS) on Monday, April 29^th in Philadelphia.  I look forward to seeing you there.

Grant Corbett is principal at Behavior Change Solutions, Inc. He can be reached at grant.corbett@behavior-change-solutions.com.

Despite an ever-expanding digital medium, with new channels for conversation and new collections of disease-related information popping up all the time, patients still prize face-to-face interaction with experts. According to recent research conducted by McKesson, 72% of patients cite doctors as the top source for information related to their conditions. The internet comes in second, at 54%, followed by pharmacists at 44%.

Physicians may have time to give patients a rough overview of their disease, but discussions around the importance of drug adherence are lacking. Patients who don’t adhere to their medication regimen – an ongoing and multifactorial problem that not only drives up healthcare costs due to unnecessary hospitalizations, but also punches holes in drug sales – are often not getting the kind of instruction from their physicians that could help move the needle on adherence.

“We know from talking to physicians that they aren’t really armed and able to have those conversations around adherence,” says Derek Rago, VP marketing and strategy at McKesson. “Physicians get detailed on a product, but they don’t get detailed on the specific barriers that patients may face when taking the medication.”

Enter the pharmacist, whom Rago calls “the most trusted advisor in the healthcare continuum.” The role of the pharmacist is changing as patients, shooed out of their doctor’s offices, require more instruction on managing chronic conditions, and dealing with the associated challenges of staying on a medication. To address this need, McKesson, on behalf of its pharma clients, has recruited pharmacists working in retail pharmacies to become behavioral coaches, and to discuss adherence issues with patients on their first and second prescription fill. Participating pharmacists are trained to provide “behavioral coaching sessions” which, in the case of a diabetes program for one client, led to an additional four prescriptions dispensed over 12 months, says Rago. By speaking directly with individual patients, pharmacists can ascertain the barriers to adherence, and accentuate the positives of a medication regimen. “We’ll say, ‘what did your doctor tell you about the medication and what you can expect?’ Then we know what they’ve already been told, so we can properly inform them in a very positive way, and see if they have the conviction and belief that they can stay on medication,” says Rago. Patients can then be segmented and engaged differently based on different needs.

Whether or not they’re a part of McKesson’s network of behavioral coaches, pharmacists in general are playing a more active role in patient care, according to recent Manhattan Research survey data. Of the 752 US pharmacists surveyed, roughly two-fifths said they spend more time providing care and support for patients than they did two years ago. Seventy-five percent of the pharmacists surveyed said they wanted access to online patient education materials from pharma.

Just a few years ago, retail pharmacies fretted over the emergence of mail-order pharmacy, and the large pharmacy benefits managers (PBMs) that hoped (and still hope) to convert their patients to mail order, a cost-saver for PBMs. But for the second year in a row, consumer satisfaction with mail-order pharmacy has declined, according to J.D. Power report released in late September. “Customer service is becoming an increasingly important advantage of the brick and mortar pharmacy experience,” said Rick Miller, senior director of the healthcare practice at J.D. Power and Associates, in a release on the survey data. The study also found that 37% of customers using in-store pharmacies are asked if they’d like to speak with a pharmacist, up from 35% in 2011.

Technology shouldn’t be discounted of course; with a rise in ePrescribing, and the ongoing adoption of electronic health records, pharmaceutical companies will be able to deliver co-pay assistance to patients through their prescribing physicians – docs can pin digital co-pay coupons to an ePrescription, for example – with less of a hassle. And all of this tech-enabled automation is freeing up pharmacists to spend even more time working the floor.

“Newer pharmacists coming through the system are more clinically educated, and they have the highest frequency of patient interaction” among HCPs, says Rago. Those bricks and mortar pharmacies eying the future are “moving the pharmacist from the back of the store to the front, because they think that’s what will differentiate them in terms of the pharmacy business as a whole,” he says.

FDA’s approval of Truvada, a once-a-day oral combination of tenofovir and emtricitabine, for pre-exposure prophylaxis (or PrEP, a method for preventing HIV infection) arrived during a chorus of optimism surrounding major developments in the fight against AIDS.

At conferences in the UK and the US last month, the possibility and even likelihood of an AIDs-free generation in our lifetime graced the lips of innumerable activists, academics and government officials including Secretary of State Hillary Clinton and NIH director Francis Collins. “I honestly believe,” rock star Sir Elton John told an audience at the International AIDS Conference in Washington DC, “that before I die, I will more or less be seeing the remains, the last remaining people infected with AIDS.”

Much of this optimism is a result of the HIV Prevention Trials Network (HPTN) – an international collaborative clinical trials network – and the findings from its key study, HPTN-052. That study was halted last April after demonstrating that HIV-infected individuals, when treated with antiretroviral therapy (ART), experienced an astonishing 96% reduction in transmission of HIV to an uninfected partner.

Prior to that discovery, the National Institute of Allergy and Infectious Diseases (NIAID), in partnership with the Bill and Melinda Gates Foundation and Gilead Sciences, sponsored the iPrEx study, which looked at uninfected men who have sex with men, and transgendered women who have sex with men, with an eye toward prevention. That study, which served as the basis for Truvada’s PrEP indication approval, found that study participants who took a daily dose of Truvada experienced an average of 43.8% fewer HIV infections than those receiving placebo. Study participants who said they took the drug 90% of the time – 100% representing perfect, daily adherence – had 72.8% fewer HIV infections, a finding that points to the necessity of adherence for full benefit.

Combine these studies with viral load testing capabilities and comprehensive educational measures, and the picture starts to look almost rosy, despite a continuing need for access to education, testing and ART in many parts of the world. The case for treating HIV-positive patients with ART as a preventative measure – known as Treatment as Prevention, or TasP – is easily justified in environments where healthcare coverage is accessible and affordable, particularly for patients who want to begin treatment earlier. As for prescribing Truvada in “high-risk individuals” as a protective measure, many questions remain, not least of which is cost-effectiveness.

Of the 48,000 to 56,000 new HIV infections in the US each year, 56% to 61% occur among men having sex with men (MSM), according to original research published in the Annals of Internal Medicine last April. Within the MSM population, researchers designated 20% as “high-risk;” in the high-risk population, Truvada provided considerable savings, with a caveat. “Because PrEP provides the most value in reducing HIV transmission when used in high-risk MSM, efficient clinical PrEP will depend on a clinician’s ability to identify high-risk MSM,” according to the authors. Indeed, it will be critical for physicians to determine who’s high risk and who isn’t, by asking questions about frequency of condom use and the number of sexual partners a man has had in the last year; the research points to diminishing returns cost-wise when PrEP is used in larger MSM populations, beyond the highest-risk populations.

At the joint International Association of Physicians in AIDS Care (IAPAC) and British HIV Association (BHIVA) conference in London, Michael Horberg, director of HIV/AIDS at Kaiser Permanente, estimated that PrEP treatment – including lab work and appointments, would cost private payers approximately $17,450 for the first year of treatment. These costs are estimated for MSM populations only. At the same conference, Jim Rooney, Gilead’s VP, medical affairs, said stakeholder meetings were underway in the US to get feedback on PrEP use in MSM populations, but “subsequent meetings have included discussion of PrEP in heterosexuals as well.” Gilead will provide education via third parties, and will not promote the drug directly, said Rooney.

Will payers get behind an expensive preventative treatment that only makes sense for patients carefully selected by physicians educated on high-risk MSM lifestyles, and willing to ask the necessary questions? Will payers pony up for a treatment that only works half of the time if patients don’t strictly adhere to the daily dose? Truvada looks to be a solid test case in the ongoing value discussion. Pay for an expensive new drug now, or a potentially more expensive condition later?

At CBI’s 7th Annual Rare Disease and Orphan Drug Leadership Congress, speakers and attendees identified areas where pharma can improve the way it approaches rare disease and treatment.

It’s no secret that rare diseases, and the orphan drugs pharmaceutical and biotech companies make to treat them, represent a unique business opportunity. Often, there is no treatment available at all for a given disease, which is the most fundamental definition of an unmet need. Today, treatments are available for around 3% of the approximately 6,800 rare diseases identified globally.

For patients with a rare disease, the emergence and value of a new treatment is self-evident; lives are dramatically altered for the better. From a business perspective, orphan drugs have much to recommend them. Many receive an expedited review from FDA and other regulatory bodies; most products are priced at a premium, given the lack of competition; patient populations and their families are often eager and willing participants in clinical trials, and smaller populations are more easily managed; and many orphan drugs, once approved for a rare disease, move on to label expansions for broader indications.

It’s also cost-effective to invest significantly in a rare disease population. Because the population is small, and each patient – or “walking asset,” as one financial analyst put it – represents significant revenue, pharma companies can afford to provide the kinds of services “beyond the pill” that everyone seems so keen to deliver. One of the current problems, according to speakers at CBI’s 7^th Annual Rare Disease and Orphan Drug Leadership Congress in Philadelphia yesterday, is that these services aren’t being administered effectively, because they aren’t being designed from the end user – the patient and physician – point of view. “It’s not like pharma isn’t creating the right programs” – programs around patient assistance, adherence and education, specialty pharmacy distribution, reimbursement, nursing services, REMS compliance, etc. – “they’re checking the boxes but not harmonizing all of the components so that there is a seamless experience for patients and doctors,” said Kristin Keller, EVP at Compass Healthcare Marketers, an agency focused orphan drug patient marketing. “People will drop out of the funnel if everything isn’t integrated from a patient point of view.”

On REMS programs, Keller noted that industry is “being myopic about the opportunity it affords.” As a regulatory action, REMS programs are typically governed by a conservative approach, and not exactly celebrated. “Because REMS programs enable companies to have direct contact with all patients on therapy, there’s an opportunity to go beyond regulatory requirements to use that contact to deliver even greater education and support to the patient,” said Keller. Industry should look at REMS as a data asset instead of a regulatory headache.

With respect to missed opportunities in data management, one speaker wondered why “no one incorporates learnings and protocols from the clinic into adherence and education programs for patients.” This question becomes especially pertinent when a new drug is introduced for a rare disease currently being treated with an older drug that perhaps doesn’t work as well, or has unwanted side effects. Even so, patients are scared to switch to the new drug, and risk going back to a full-blown disease state. Pharma, according to the speaker, isn’t doing a good job explaining the benefits of the new drug, and tying that treatment to the here and now: what life might be like tonight, tomorrow, or a week from now. One reason for this has to do with med/legal and pharma’s inability to make comparisons that aren’t clearly backed up in the clinic or on the label. One speaker proposed a “patient-friendly compliance expert” with medical claims knowledge, but also a knack for translating that knowledge into a dialogue with patients that would leave them with a better understanding of a drug’s benefit, so they can make a more informed decision.

What do rare disease patients think about all of this? Unfortunately, no actual patients took the stage to give presentations, but there were a few in the audience. One sickle cell patient set off a flurry of discussion among the audience when he asked about how to deal with faith – i.e. God and His followers – in the sickle cell community. “Patients will often listen to their pastors over their doctors,” he said. One audience member said her company had dealt with the same problem among members of the Ashkenazi Jewish heritage, which is plagued by high incidences of genetic disease. Her answer? A KOL is a KOL. “We targeted messaging to temples and to rabbis,” she said.

Other topics discussed at the meeting included the importance of managed access programs, also known by many other names including expanded access programs, early access programs, etc., etc., all of which provide medicine to patients where it isn’t commercially available. Interestingly, companies are now beginning to collect real-world data as part of these programs, which can then be used – particularly in the case of a managed access program conducted while a drug is still in phase 3 – to augment a drug’s dossier at registration. “We did incorporate data from an access program in the safety profile submission for a biologics license application, to support the traditional clinical data,” one speaker said.

During a question and answer panel with several patient advocacy group speakers, everyone emphasized the importance of pharma engaging early with their organizations. “Don’t wait for an approval and then show up with an educational piece and say, ‘What do you think of this?’ said one of the speakers. Another underscored the importance of keeping advocacy groups informed about clinical trials and other developments, so that patients’ expectations can be more efficiently managed. Managing expectations is a crucial role of patient advocacy groups, as more and more patients become involved in the system. Three factors are contributing the rise of patient advocacy, one speaker said: the increase in transparency of company pipelines; the growing empowerment via education of patients and their families; and the connection to other patients provided by social media and emerging technologies.

For companies working in the orphan disease space, or looking to move into it, the days of focusing exclusively on developing a treatment, and then chucking it out into the market for patients to purchase are over. From the early development stages, to access, to patient monitoring and adherence, now it pays to take a walk in the patient’s shoes.

New insights into customer behavior fostered by the revolution in information technology are finally being applied to the age-old quandary of why most patients stop taking prescribed medications after a few months of therapy. This was a key conclusion of last month’s 11th annual Forum on Patient Adherence sponsored by Pharm Exec’s sister organization, the Center for Business Intelligence (CBI). The optimism of the more than 200 registered participants was reflected in what has become a regular feature of the Forum: the Strategic Patient Adherence Awards, which recognize excellence in adherence programs administered by drug manufacturers, PBM organizations, and—for the first time this year—employers.

“Our 2012 awards reflect the increasing capacity to leverage technology so that it can be tailored to the needs and motivations of the individual patient,” said judging panel member Robert Nauman, principal at BioPharma Advisors. “The insights follow—and the harvest is rich.” At a Forum discussion on the winning entries, all the judges noted that technology was enabling improvements in the design of programs, including the ability to reach out to more constituencies and to build coalitions, with a multiplier effect on results. Applicants are also doing better in addressing ROI, which is essential for maintaining support for these programs among senior management. “We call it the ‘why factor,’”  Larry Boress, CEO of the Midwest Business Group on Health, said during the panel debate.

PBM giant Medco—now Express Scripts, after a merger with its former rival approved earlier this spring—snagged the award in the managed care category for its Specialist Pharmacy Care model, which builds on a network of Therapeutic Resource Centers staffed by trained Specialist Pharmacists to provide members with customized information on their condition. This takes the form of periodic written materials, alerts, and, if necessary, direct contact by phone or in person.  The company applied its proprietary Health Action Plan software technology to develop individual profiles of member’s priority conditions, number of medications, gaps in treatment, and potential opportunities for cost savings through preventive care interventions. The network of Specialist Pharmacists has been trained to interpret this highly integrated data set and to make appropriate contacts with the member or his/her physician on ways to ensure medicines are taken for the duration of treatment.

To obtain the greatest benefits, the initiative is focused on 15 prevalent chronic care conditions that account for some 96 percent of Express Scripts total pharmacy spend. “Our company has enormous channels of data that we have synthesized into a tool directed to empowering the pharmacist as advocate for the patient,” Ellen Franzblau-Isaac, Director, Clinical Quality, told Pharm Exec. “Their access to this easily referenced data brings the pharmacist to another professional level, much higher than the norm. It has had a positive impact on member engagement as well as the job performance satisfaction of the employees who serve them.” Franzblau-Isaac relates that the toughest part of the program is classifying members within the 15 covered conditions, since it is often the case that members suffer from multiple chronic disorders.

Coming out tops in the employer category was Chicago-based Evive Health, which serves a varied industry client base with programs that apply insights from data to create personalized adherence communications that shape and change patient behavior, in a positive way. It was recognized for the breadth and variety of these communication programs—applied to a pool of nearly one million covered lives since 2008—in improving evidence-based care, including medication adherence, using new tools like the lessons from behavioral economics. “We have borrowed much of our engagement strategies from outside of healthcare,” relates CEO Peter Saravis. The main delivery channel is direct mail, but the messaging is cutting-edge. “Our goal is not simply to remind the patients about taking their medicine. We build beyond that with approaches designed to elicit a response and persuade them to reveal something about themselves that we can apply to good use later, this time emphasizing prevention and wellness extending beyond the simple act of taking the pill. It’s all about the right information, at the right time, and in the right way.” The judges were particularly impressed by Evive’s ability to document an average 15 to 28 percent increase in adherence over baseline in the populations covered by its sponsor programs.

Rounding out the winners was German-based drug manufacturer Boehringer Ingelheim, which applied the findings of a novel 2009 study on factors that lead patients to cycle off medications—The 11 Dimensions of Non-adherence—to create a highly focused, pharmacist-driven, patient-specific adherence program covering some 950 patients using prescribed B-I chronic use medications. The Patient Empowerment Program was built around a customized non-branded website, integrated with sophisticated pharmacy management software and offering easy access for participating patients. Patients start the process by completing an assessment, which generates an individual patient profile from the 11 dimensions of non-adherence. This profile provides an ongoing series of printed intervention tactics to share with patients when they fill or re-fill a prescription.

On the pharmacist side, a simple training module was designed to introduce the concept of the 11 dimensions and to demonstrate how to administer the program, from using the website to guidance on how to structure the discussion with patients. “Our goal from the start was to design a program that conforms to the workflow of the pharmacy—something that would complement their tasks, not compete with them,” Robert Belknap, Executive Director Trade Sales and Operations, told Pharm Exec. There is a perception that all a pharmacist does is point to “sign here” when you pick up a prescription. “This is an untrue depiction of a profession that wants to do more and has the skills and accessibility to get results from patients. Our program is designed to unlock the potential of the profession by making it easier for them to engage with the person on the other side of the counter.”

For its part, B-I has already unearthed a rich pool of data and insights from the program and is now considering how to “seed it” for a wider audience. “The template is literally something that everyone can own,” says Belknap. “There is no downside, as it represents a win for all—patient, payer, retailer, and manufacturer.”

No two patients are alike, but drug-makers may not consider how different a single patient’s perspective can be when viewed over time. A patient’s progress through disease management is a journey, and perceptions change over time. Changes in perceptions influence the meaning of “usability” and can have tremendous implications for how a drug delivery system supports the patient. To understand this concept better, consider two different points during the patient journey – a newly diagnosed patient and a patient further along with their condition – as examples of how different usage must influence the design of a drug’s delivery system.

The New Patient: Struggling to Adapt and Learn
Early on, patients who use delivery systems in their medical therapy struggle to cope with significant life disruptions. They often do not feel very well physically. Emotionally, they may be fluctuating between fear, anger and deep concern or depression. At the start of their disease management journey, these patients are asked to take on new responsibilities for their condition, learn new and sometimes difficult tasks, and become experts in managing parts of their disease, such as administering their own medication.

What does this mean for a drug company? Ease of use is a critical consideration; pharma should ensure that drug delivery requires as few steps as possible, guaranteeing that users can learn, remember and quickly master the process. Especially for the newly diagnosed, drug delivery devices need to provide clear, absolute confirmation that they were used properly, and that the medicine was successfully delivered. Any ambiguity heightens patient anxiety and will leave them questioning whether they received the proper dose. Such anxiety can lead to overdosing and create doubt that the device – and the drug – is trustworthy or effective, which quickly erodes adherence.

For a patient in an early stage, “ease of use” should translate to “ease of training.” With the rise of biologic therapies, patients rely on the support of healthcare practitioners and family to learn how to self-inject, for example, as they acclimate. Optimizing a drug for both self-administration and demonstration means manufacturers need to carefully consider how humans learn, and the differences between processing information by watching others, versus doing things ourselves. Failing to support these early stage requirements can lead patients to abandon therapies before they even have a chance to take hold.

Further Along: Staying Faithful
Later in the disease management journey, patients return to a more stable condition and reasonable quality of life. They have mastered their drug regimen and delivery system – but now the patient is more demanding of how the device supports quality of life. Reduced anxiety makes room for motivations based on convenience and the confidence that “I have this disease under control – at least for today.” As patients settle into this “new normal,” such attitudes can lead to skipped doses and lapses in adherence, often throttling the patient back to a state where the disease manifests itself more seriously.

At this point, the delivery system needs to not only continue to support efficiency with minimal steps, but also, and for different reasons, it must be designed based on convenience and lifestyle enhancement. Patient feedback must be considered differently and used to select a delivery design that encourages and incentivizes patients to remain adherent. For instance, compliance metrics, goal-oriented achievements or physiological measures might be tracked in order to encourage adherence, helping patients control their disease and improve their condition.

The Journey Determines Everything
Realizing that patients are on an ongoing journey is an important step in understanding the complexities behind how user-centered design can support adherence. Armed with this awareness, pharmaceutical companies are better enabled to select and develop safe, reliable and desirable drug delivery solutions.  These considerations can help to address the shifting nature of what usability means for any type of patient we may become, while traveling on our individual disease management journey.

Drug Usage by Demographic in 2011

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011, according to research published on Wednesday.

The decline observed in overall out-of-pocket spending last year was the “first on record,” and was “largely related to the introduction of the ‘donut-hole’ subsidy for Medicare Part D beneficiaries,” a highly-touted element of the ACA, according to the IMS Institute for Healthcare Informatics. While copays for commercial providers and Medicaid were flat (average commercial plan copays increased by $1.14, to $26.10 in 2011), seniors covered by Medicare Part D got the largest break, with average copays decreasing by $2.66 – from $25.97 in 2010, to $23.31 in 2011 – according to the report.

The dip in copay costs for seniors didn’t translate into an increase in volume for chronic or acute medications, however; in fact, patients 65-years and older reduced their drug usage by 3.1%. Prescription use among the same group declined in 2010 as well, by 2.7%, but the last two years represent an inflection from prior years, when “seniors’ usage of medicines grew on average at 4%,” the report found. College-aged patients (19-24 years old), on the other hand, were the only age group to increase their drug usage, by a modest 2%. That increase “coincides with the first full year of implementation of the provision of the ACA allowing under-26-year-olds to stay on their parents’ health insurance,” according to the report.

Michael Kleinrock, director of research development at the institute, said on a call with reporters that patients over 65 years old are foregoing the medications they use the most. Drug usage for hypertension, the most common disease among this population, decreased more than any other class of drugs. “This correlates strongly with the economy…seniors are on a fixed income, and costs [of living] are rising,” said Kleinrock on the call. Kleinrock called the development a “tipping point,” adding that seniors are resetting their expectations around how often, and under what circumstances, they will visit a doctor.

Per capita figures adjusted for currency changes showed a 0.5% growth in total drug spending in 2011 – to $320 billion. Other fun facts from the report include:

• New York state had far and away the largest growth in per capita retail prescription usage at 5.6%, bucking the national trend. Volume rates fell in 41 states.
• Visits to the ER increased by 7.4%, while doctor’s office visits decreased by 4.7%, from 2010 to 2011, a “possible result of continued high levels of uninsured patients associated with long-term unemployment,” according to the report.
• Copay card usage increased in 2011, but only by 1.4%. Still, patients used copay cards or vouchers for only 3.8% of dispensed brand prescriptions last year. The average copay card subsidy provided by drug manufacturers grew by 20%, from $19.34 in 2010, to $24.28 in 2011.
• Spending on new brand drugs – products approved in the last 24 months – was $12.2 billion, up from $8.5 billion in 2010.
• 34 new molecular entities (NMEs) launched in 2011, the most in “at least 10 years,” according to the report
• Key blockbusters that expired in 2011: Pfizer’s Lipitor, GSK’s Advair Diskus, Lilly’s Zyprexa, and J&J’s Levaquin and Concerta.
• Hydrocodone, an opioid for pain, was once again the most dispensed drug last year, at 136.7 million prescriptions.
• Among therapeutic classes, anti-depressants were dispensed most often, at 264 million prescriptions in 2011.

If the Supreme Court decides in favor of the Affordable Care Act, particularly the mandate to buy insurance, the spate of newly insured patients would likely curb the rise in emergency room admissions, and could also turn around the decrease in office visits, which are “the lowest-cost medical interventions,” according to the report.

Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the Fourth World Congress on Social Media and Web 2.0 in Health Medicine) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a focus on research findings and scientific data to dialogue around the future of science, medicine and emerging technology, innovators and thought leaders congregated from around the globe at the state-of the-art Stanford venue, Li Ka Shing Center for Learning & Knowledge. Through the congress, Stanford extended an invitation for open scientific inquiries into the pursuit of teaching, learning, and research, in alignment with its motto. ¹

The energy in the room was contagious starting with the unique conference badges that featured personal QR codes (eliminating the need for business cards), lively twitter feed and building of a #med2 community (over 5,000 tweets!), to the theatrical presentations that conveyed unconventional solutions to healthcare issues. From theory to practice–patients, healthcare professionals, academics and executives discussed and debated concepts such as participatory medicine, patient self management, behavioral change, decision making, the quantified self, communities of practice, social networking, gamification, personalized healthcare, and innovation in medical education. There were so many interesting points made at Med2.0, but I’ve captured a few highlights below:

Abraham Verghese, MD eloquently walked us through the bedside ritual of examining the patient as a critical but threatened skill that is the foundation to the patient-physician relationship. He explained the potential of displacing the patient during the digital age and reliance on technology during the clinical encounter —with more emphasis placed on patient data, rather than the person being treated.

Jennifer Aaker, PhD delivered a brilliant keynote that demonstrated the impact of social media saving lives through storytelling, collaboration, and enabling the wider community to quickly act. The story began with 2 Indian men with AML in search of bone marrow matches and ended with 20,000 South Asians registering as a result of a powerful awareness and social media campaign. Attendees had the opportunity to have their cheeks swabbed and sign up for the Be The Match Registry during the break in the corridors.

The eclectic BJ Fogg, PhD shared his behavior change model which shows that three elements must converge at the same moment for a behavior to occur: B = MAT (Behavior = Motivation x Ability x Trigger).

Susannah Fox gave the closing keynote on the impact of “peer to peer healthcare” where patients are seeking and sharing health advice online. Roadblocks included pockets of offline patients, patients not motivated to engage in their healthcare, silo tools/communities, and lack of awareness of resources. Opportunities included leveraging the power of online caregivers, engagement prompted by life changing diagnoses/events, rise of mobile adoption, and emerging focus of technology that bridges silos and allows data flow. The beacons of change in these efforts include patient, clinician, and technology leaders.

There was a major focus on patient self management platforms in chronic diseases, the Quantified Self and use of digital devices to collect real-time quantifiable patient data, decision support tools to make informed choices, and gaming to change behavior by rewarding patients for meeting health related goals. With all the data being collected, the question is how do you give back the data to patients, synthesize, and set context in a way they can understand?

The use of technology as a catalyst in healthcare improvement was prevalent.  From the use of social media and mobile health tools by physicians to communicate and improve clinical workflow to the use of virtual community platforms by patients to share experiences, understand options and obtain social support–It was clear that patients and healthcare professionals are embracing the impact of technology—although not necessarily at the same pace. Patient online usage to share and obtain healthcare information is on the rise; however a research abstract (764) demonstrating physician attitudes towards social media for their own professional education and knowledge sharing showed that usage and intent to use is fairly low. Plagued with social media privacy concerns and associated risks, traditional modes of learning, and lack of clear guidance and policies—physician usage is growing at a snail’s pace in comparison.

There was a spotlight on the e-patients, of which 23 received scholarships to attend the conference. Each had a compelling story to tell regarding their personal but at times unfavorable experiences with the healthcare system and how they made informed medical decisions by becoming more empowered and engaged in their healthcare. These real life interactions crystallized key themes conveyed throughout the conference.

Larry Chu, MD was the skilled conductor of this colorful performance, which set the bar high for future Med2.0 conferences. We were each given the opportunity to challenge both established and new orthodoxies in healthcare, infuse innovation and creativity into potential solutions, and explore collaborations among the diverse Med2.0 community to make things happen!

Planning for the 2012 Med2.0 Congress is underway to be held September 15-16^th at Harvard Medical School. Stanford will also debut MedicineX in 2012 focused on the intersection of emerging technology and the future of medicine.

¹ Die Luft der Freiheit Weht-unofficial Stanford Motto, Ulrich von hutten, 16^th century

Sarah Krüg is executive director at Cancer101, a patient organization. She was previously Global Education Director in the Medical Education Group at Pfizer