The Medicines Adherence Challenge

With the loss of patent exclusivity affecting many blockbuster products, keeping skittish patients on their medicines ought to be a strategic priority for Big Pharma—but is it? With many experts openly questioning the effectiveness of traditional approaches to medicines adherence, the National Consumers League (NCL) has stepped into the arena with a new three-year campaign, "Script Your Future," that deliberately targets a more diverse array of stakeholders to attack—and hopefully reverse—declining rates of adherence for three key chronic diseases. In a joint initiative with NCL, Pharm Exec convened n expert panel on Oct. 12 to examine how best to make progress and agree on some practical steps for incorporation in the campaign agenda. A summary of key points follows below. The consensus? Start by influencing the behavior of the people behind the patient. – WILLIAM LOONEY, EDITOR-IN-CHIEF

PHARM EXEC: A barrier to change in health policy is the persistence of "silos:" institutions and the people that represent them simply don't talk to one another. The National Consumers League, our cohost for today's discussion, has launched a nationwide education campaign around medication adherence that seeks to address and reverse this "dialogue of the solitudes." I'd like to begin by asking our NCL colleagues to outline the objectives of its Script Your Future campaign to the stakeholders we have assembled here today—and to our readers.

Participants (from left to right): Gordon Littlefield, Alex Adams, Laurence Bostian, Larry Boress, Colleen McHorney, Tim Elsner, Paul Snyderman, Rebecca Burkholder, Edmund Pezalla, Elys Roberts. (John Halpern Photography)

REBECCA BURKHOLDER, VICE PRESIDENT, HEALTH POLICY, NATIONAL CONSUMERS LEAGUE: The NCL campaign builds on our history of engagement in medication safety issues, where we work closely with the federal Agency on Healthcare Research and Quality (AHRQ), among others. Launched in May, Script Your Future is a patient- and clinician-centered initiative designed to improve awareness about the importance of taking medicines as directed. The focus is to educate the patient and their family caregivers as well as the relevant healthcare professional—from physician, to pharmacist, to nurse practitioner—on good adherence practices in the treatment of major chronic diseases. We've identified three such conditions as priorities: respiratory disease, including asthma and COPD; cardiovascular ailments, led by hypertension and high cholesterol; and diabetes.

WIDENING THE CIRCLE OF ENGAGEMENT

PHARM EXEC: The adherence landscape is well plowed. What marks this initiative as unique?

BURKHOLDER: The campaign has enlisted one of the most varied and diverse range of sponsors anywhere in the healthcare space, with over 100 organizations now committed to endorse our goals and replicate these in their own activities. Partners include pharmacies, insurers, data service vendors, pharmaceutical companies, trade/industry groups, professional associations, patient organizations, interest group coalitions like the AARP, and key public health agencies, including the FDA, HHS, and NIH. This strong multi-stakeholder base, which includes many of you here in this room, frankly marks a break from the narrow approach applied in other adherence programs. Learning from past initiatives, we are also concentrating our resources in a few locations; for now, these include Baltimore, Birmingham, Cincinnati, Providence, Raleigh-Durham, and Sacramento. What each municipality shares in common is a higher-than-normal incidence of the three chronic conditions, the availability of partnering institutions, and a mid-sized media market.

What drives any education campaign is the message. Script Your Future takes as its starting point that our audience is diverse and that no one message works for all. We have invested in patient focus groups to shape an approach built on providing them with answers to three simple thematic questions: 1) What are the individual health consequences of failing to take a medication as directed? 2) What impact can this have on the patient's future, and in particular the family circle—children, friends, and caregivers? And 3) assuming patients do want to have greater say in treatment, how does adherence advance that goal of patient empowerment in relations with physicians, pharmacists, and other healthcare professionals? From this base, we structured a set of initiatives that relate to one overarching message: Initiate the conversation! Insist on talking to your health professional about your medicines. And introduce to that conversation the right questions needed to better manage your condition.

Tools and instructional materials on how to do this are presented in "script" form, in easily accessible formats, led by two new Web-based NCL platforms—one designed for the patient and the other for the healthcare professional in responding to that patient. These rely in turn on other existing resources, provided by our partners; it's an aggregation of the best tools out there. The patient website also has text reminders that patients can sign up for to remind them to take their medicines, and a pledge to encourage patients to commit to taking their medications. In the six target cities, we have local coalitions leading grassroots events encouraging adherence. Many linked efforts are under way with our partners. For example, we have a competition with the pharmacy graduate schools to come up with creative approaches to pharmacy-based adherence. NCL will announce the winner under the sponsorship of the US Surgeon General early next year.

EVIDENCING PERFORMANCE ...

PHARM EXEC: Script Your Future is a three-year commitment by NCL and its partners. What are your metrics and benchmarks for evaluating progress of the campaign?

BURKHOLDER: We are doing this several ways. Before the campaign launched in 2011 we conducted a baseline survey, nationally and in our six target cities, to measure consumers' awareness of medication adherence as a health issue, and their adherence behaviors. We will replicate that survey at the end of the campaign and compare the results. In addition, we are working with partners who have access to pharmacy claims data to track takeup and refill trends in several of our target cities. In our surveys, we found patients believe that the best way to increase adherence is automatic refillls, distribution of a "questions to ask" your healthcare professional guide, reduced copays, and use of pill boxes.

GUS LITTLEFIELD, NATIONAL PRESIDENT, MENDED HEARTS: We represent the patient community in the cardiovascular field. What I like about this campaign is its dual focus: you include the caregiver as well as the patient. I am also encouraged by the commitment to create an inventory of best practices and to work with the professional community to translate these into clinical guidelines. That is a very practical outcome that I believe will lead to improvements in health status.

... DEPENDS ON HOW YOU DEFINE THE CHALLENGE

PHARM EXEC: Good messaging depends on consensus around definitions. Given the multi-disciplinary nature of the NCL campaign, can we establish what is most important in driving a solution to poor adherence? Is it strictly about patient engagement, is it an employer/productivity challenge linked to disease prevention, or is it primarily about clinical awareness around the physician and the pharmacist?

LARRY BORESS, CEO, MIDWEST BUSINESS GROUP ON HEALTH: Adherence has many moving parts. First is the appropriateness of the prescription itself and maximizing its clinical profile. Second—and most important—is explaining to the patient why adherence matters to him or her. This is frequently never addressed in the interaction with the physician. Here basic health literacy is a key differentiating factor in promoting adherence. Our survey work buttresses this point over and over again. One example I can cite is when Hispanics with low facility in English are given a prescription showing the drug is to be taken "once" (as in one pill a day), they can misinterpret this as the Spanish number "eleven," and end up overdosing. Other issues include the failure of the dispensing pharmacy to ensure the patient understands how and when to take the medication, as well as to inform families or other caregivers about the prescription requirements and the competing economic priorities that the patient has to balance in managing those relationships.

ELYS ROBERTS, PRESIDENT, IPSOS HEALTH: Whether other factors intervene or not, adherence is ultimately a personal issue. It's a unilateral action, and what determines that action is unique to the individual. Hence, the objective of these adherence programs must be simple: What levers can be pressed that will encourage more positive behavioral patterns? We have a presentation based on research we conducted with 1,200 patients called "The Curious Case of the Missing Prescription." It seeks to explain why a patient who voluntarily makes an appointment to see a doctor to seek solutions to their healthcare needs does not follow the advice in taking any of the medications prescribed. The disconnect has a psychology all its own and the roots are very personal. However, I believe the solution is not a purely individual approach or a big standardized approach, but rather it requires you focus on specific segments of the non-adherence community, at each stage of the adherence journey, and to prioritize attention to these groups with a targeted plan.

COLLEEN MCHORNEY, SENIOR DIRECTOR, US OUTCOMES RESEARCH, MERCK: We've done focus groups with more than 1,000 patients over the past few years to understand the roots of this problem. Merck is using insights from this feedback to redefine the debate. Patients rarely talk about medication adherence, persistence, or fulfillment, and they rarely raise the process around obtaining a prescription. What they talk about is the uncertainty and ambivalence they feel about prescription medications. Research from UCLA and The Rand Corp. indicates that the average physician spends only about 49 seconds informing patients about newly prescribed medications. Medication uncertainty—that's how patients define the problem. There is a huge information deficit. Messages about the benefits of medications and the risks of non-adherence are not getting through.

THE COST FACTOR AND GENERICS

PHARM EXEC: From the employer side, are costs a factor in low rates of adherence?

BORESS: We recognize that high copays for drugs can be a barrier to compliance. To help patients avoid high copays, we're seeing the major pharma companies offer discount cards or rebate coupons directly to the patient. This can make the medicine more affordable, but for us as purchasers it can cost us more money because it hampers our ability to design benefits that will drive our insured population to lower-priced generics.

MCHORNEY: What is needed is a payment system that rewards cognitive dialogue with the patient about medications they have been prescribed. Physicians are paid for procedures and tests but not for providing patient-centered advice about medications. There is no billable code or mechanism to incentivize a discussion on prescribed medications as part of an office visit. It should be separated out.

ED PEZALLA, MEDICAL DIRECTOR FOR POLICY AND STRATEGY, AETNA: Rising copays for patients can lead them to forgo many elements of basic care, particularly on the prevention side. Health Affairs published a study last month with support from Brigham and Women's Hospital that show higher copays do lower costs to the insurer, but the overall impact is marginal. The results have motivated us to put more emphasis on adherence programs in a new benefit design platform we are rolling out in the context of health insurance reform. And we still don't have a good read from a data point of view on the impact of lowering copays on adherence.

MCHORNEY: Researchers from The Rand Corp. published work in JAMA that found for every 10 percent increase in copayments for drugs, rates of adherence dropped by between 2 percent and 6 percent. Yet it is also true that in countries where medications are basically free to the patient, there is essentially the same level of non-adherence.

PHARM EXEC: Many patients take multiple medications. How does that factor into adherence?

LITTLEFIELD: A factor that drives cost is that combination pills are often more expensive than single source medications. For example, patients want to know why Janumet is more costly than taking Januvia and Metformin separately. Is it purely a convenience factor? Is there a real clinical benefit? The patient wants answers to questions like these.

PEZALLA: The average diabetic is taking six-and-one-half drugs on a daily basis.

BURKHOLDER: Our focus group work finds that patients are worried about the overall "pill burden." A large percentage of our respondents seem to hit a certain limit, say seven drugs, where they say "no more." The problem is that some patients will scrap precisely the wrong drug(s). They are not in a position to differentiate clinical value, like dropping their blood pressure medicine because they must take a one-week course for an antibiotic.

PHARM EXEC: Specialty drugs and biologics are going to constitute a larger proportion of prescribing in the years ahead. How will this impact the rate of adherence?

BORESS: These drugs are very costly—the fastest-growing segment of drug spend for any payer/employer. We have commissioned a study on biologics drug management to identify how benefit designs can ensure only those whose clinical status necessitates them receiving the medications and those that do get the drugs have the educational tools and support to make certain the medications are used appropriately. We are also looking at programs that use nurses or pharmacists to intervene to evaluate the progress of therapy shortly after the initial fill toward the intended outcome. It's unsustainable to provide coverage to these expensive drugs and then find our patients fail to adhere.

IMPACT OF HEALTH REFORM

PHARM EXEC: I believe we have a group consensus that progress requires an integrated approach. Will the new federal health reform legislation do much to facilitate that?

BORESS: The law creates pilot programs for new forms of payment that act as incentives to encourage the formation of "Accountable Care Organizations" and "medical homes," where hospitals, physicians, and pharmacists work in tandem to fix a course of treatment for a specific condition. Again, there is a potential communications gap in how all this looks to the patient. The Medical Group Management Association recently did a focus group around understanding what "medical home" means; most of the survey population reacted negatively because it was seen as just another reference to a nursing home.

PHARM EXEC: Is the insurer community working together to promote adherence through more efficient and safe prescribing?

PEZALLA: It is hard for companies in the same business to do this on antitrust grounds. But Aetna is very proactive on behalf of its prescribers. We have a dedicated team in Pittsburgh where every night the new claims data flow is examined against existing claims and potential safety contra-indication problems are flagged and then forwarded to our network providers for action.

We also have the potential from electronic prescribing and health records. Physicians are now in a position to find out whether the patient has filled his prescription. Upwards of 30 percent of all scrips somehow disappear in the path to the pharmacy. As this is better tracked through new technologies, the opportunity exists to add tools to promote adherence as well. We also favor putting adherence on the research agenda for new groups established through health reform, like the Patient Centered Outcomes Research Institute (PCORI) on clinical effectiveness.

PHARMACISTS, PAYERS, AND THE PROMISE OF TECHNOLOGY

MCHORNEY: Pharmacy benefit managers have sophisticated data on longitudinal pharmacy claims. They can with little difficulty identify patients who have cycled off a drug after 35 or 40 days and then make an appropriate intervention. The issue is the ROI that would motivate them to do that.

PHARM EXEC: Where does the pharmacist come in here?

ALEX ADAMS, DIRECTOR, PHARMACY PROGRAMS, NATIONAL ASSOCIATION OF CHAIN DRUG STORES: Pharmacies are the face of neighborhood healthcare. At NACDS, we emphasize that pharmacies are key to improving health and reducing costs. One way pharmacists do this is through medication therapy management (MTM), a pharmacist-provided service to improve patient medication regimes and ensure patients are taking the right medications in the right way. Studies have shown that every dollar invested in MTM results in $12 of savings from downstream health costs, such as avoidable hospitalization and emergency room visits.

One opportunity the NACDS Foundation is exploring is "primary non-adherence," or what some have called the "strong start." It's that golden moment when a prescription is written for the first time, but the patient fails to present to pick it up. E-prescribing is providing the opportunity for a productive counseling session between the pharmacist and the patient. We're analyzing the best ways to improve: Is it an automated standard phone message, a live call from a pharmacist directly, or a message to the prescribing physician noting the status of the fill and whether a call from him or her is required as a reminder?

PHARM EXEC: Does technology carry the potential to change the paradigm on adherence?

PEZALLA: It has a role but the impact is often exaggerated. Adoption of the electronic health record will offer the opportunity to track what has been prescribed and minimize negative interactions. It also gives other providers the ability to avoid duplications and other sources of inefficiency.

PHARM EXEC: What other tools can be productively applied to build a root and branch strategy on adherence?

MCHORNEY: Merck has developed the Adherence Estimator. It consists of "three Cs" to measure the risk of non-adherence: 1) commitment to therapy; 2) concerns that relate to use of the medication; and 3) cost. This measurement tool takes less than a minute for the patient to complete, and from this information we can create motivational messages to address the domains where the patient scores sub-optimally. On a broader scale, one can apply the three Cs to try to create more structure around physician/patient communication related to prescription medications.

BORESS: A major barrier is that most health plans still fail to recognize the pharmacist as a provider. The pharmacist cannot charge for that counseling session, coaching, or the cognitive visit. To address this, my group and other employer coalitions are building on the Asheville, N.C., study on medications adherence, where an employer will directly pay pharmacists who serve as diabetes coaches, as well as reducing or waiving copays for diabetic drugs if the enrollee agrees to see a specially trained pharmacist for counseling. We call it a "mutual accountability" program, since the employee must take steps to manage their own care in return for the waived copays. The city of Chicago is one of my members committed to this approach.

PEZALLA: Incentives—including cash payments to reward appropriate behavior—do get the patient's attention, but experience demonstrates that these can diminish over time. We have to keep the momentum going around motivation. One that counts for a lot is showing the patient how adherence improves health and well-being so that he or she will be around to see their grandchildren graduate from college. There is a lot of promise in the application of behavioral economics, that sweet spot where you can convince the patient that paying for something now will deliver a real benefit down the road.

PAUL SNYDERMAN, CHIEF RESEARCH OFFICER, IPSOS HEALTH: We have yet to address the question of perceived risk. Has anyone read the average package insert detailing all the potential risks of taking a prescribed drug? It is a disincentive to adherence because of how vaguely these risk profiles relate at the level of the individual patient—does this apply to me or not? With all the negativity in the insert, can we blame those who conclude that, regardless of what the physician says, the safest thing is not to take the drug?

ROOTS OF A SOLUTION

PHARM EXEC: From this discussion, what are the optimal best practices that might serve as additional baselines for the NCL campaign?

ADAMS: In addition to MTM, I would emphasize the "strong start" concept combined with efforts to help patients deal with the pill burden through what is called "refill synchronization." This means that the pharmacist ensures that each of the patients' prescriptions come due on a single day, on a regular basis. It is a convenience measure that the evidence shows will promote better adherence. However, there are logistical issues with this approach.

Another innovation is the work that the Pharmacy Quality Alliance is doing to devise a standard metric to identify patient adherence through the "proportion of days covered" measure. Beginning next year, this metric will be used to evaluate the success of plans participating in Medicare Part D. Thus, there will be tremendous incentive for health plans to invest in strategies such as MTM that are proven to improve adherence.

BORESS: Approximately one-third of US employers have some sort of on-site health facility staffed with a health practitioner. It is usually not a physician, but the opportunity exists to leverage these sites to build in an adherence agenda. It relates to my earlier point that the best intervention may not lie with the physician but with others on the health delivery chain. We could also apply tax credits to encourage on-site health services. That would incentivize more of the large employers to do this, and eventually that might motivate smaller companies to address it—three-quarters of Americans work in companies with fewer than 10 employees.

PEZALLA: We need to energize the research agenda around adherence. From the payer side, we want to encourage everyone to engage and initiate good research and to publish the results for all to see.

SNYDERMAN: I advocate looking at adherence as a marathon, not a sprint. Pharma companies often have a short attention span in funding adherence activities. The ROI calculation has to be framed for the long-term.

ROBERTS: With the patent cliff and the increasing demise of the blockbuster drug, adherence should be a strategic priority for Big Pharma. The economics of the industry is dictating that the balance will need to shift further from patient acquisition towards patient retention. Adherence education and campaigns are the primary tool to keep the patient on his medications. That simple message must be delivered at the highest level in pharma so these programs are not relegated to the PR arena. There is no imminent rational alternative so I expect increased industry spending and prioritization of adherence to be the wave of the future.

LITTLEFIELD: I suggest that adherence activities be incorporated into the templates that result in the content of clinical guidelines, especially those that can be applied to high-risk populations of patients in the major chronic disease categories.

PEZALLA: This group might want to consider a joint endorsement of the work of the Pharmacy Quality Alliance in developing standard metrics of performance around adherence, and to pledge to apply them in our own organizations.

MCHORNEY: For the last 40 years we have concentrated on a "one-size-fits-all" strategy to increase adherence. It's time to think differently. Targeted and tailored interventions are the future; adherence is ripe for the "out of the box" mindset, particularly for the middle group of patients who begin therapy but then cycle off it at some point. And segmentation should not be limited to patients. We also have to learn to distinguish between physicians with high-adhering patients and physicians with lower records of adherence in the people they treat. The point is to learn from those who are successful and apply it to the sub-optimal performers. Sales reps can be another important resource in promoting adherence. They can educate healthcare providers about medication adherence as a useful adjunct to providing information on pharmaceutical treatments.

BURKHOLDER: In our campaign we are reaching out to non-traditional stakeholders—the family, the caregiver, the nursing professional, and even high school students who must know why adherence matters to the longevity of their parents and grandparents. Another point is the importance of reinforcing the idea that when patients are discharged from hospital, the goal is not to come back, but to avoid readmission. There is a perfect opportunity at discharge to educate about the use of medications. By improving patient understanding of the importance of medication adherence at discharge, hospital readmission could be avoided.

PHARM EXEC: These are all useful suggestions. We will all work jointly with NCL to ensure these are incorporated into the blueprint for the Script Your Future campaign.