Closing The Circle On Patient Adherence

There is a renewed sense of urgency over patient adherence, even in the face of discouraging results from years of efforts to improve overall rates of success. When a pharma company does nothing to enhance patient adherence, generally speaking, the number of patients who stay on their regimen falls by 50% within six months. When the company supports a comprehensive program, it can raise adherence by five or ten percentage points for a while, but then the rates slip again.

“Addressing adherence problems is better than not addressing them, and the pharma industry is way ahead of healthcare providers in appreciating the complexity of this,” says Paul Keckley, PhD, executive director of the Deloitte Center for Health Solutions (Washington, DC). “But the improvements have been incremental, and not very repeatable. If you’ve studied one company’s program, you’ve studied one company’s program. No one has cracked the code on this yet.”

Nevertheless, several drivers are energizing both the industry and healthcare providers of all stripes to do better with adherence. One is simply the rising cost of healthcare. Insurers, employer plans and governments are recognizing that the cost of non-adherence, in increased emergency-room visits or hospitalizations, is avoidable. Studies cited by the National Council on Patient Information and Education (NCPIE; Bethesda, MD), in its 2007 “National Action Plan for Enhancing Prescription Medication Adherence,” that non-adherence adds $100 billion per year to overall healthcare costs, and the indirect costs (in absenteeism or lowered productivity) add another $77 billion.

For years, pharma companies have supported call centers to maintain contact with patients, have printed tonnage quantities of patient literature and physician advisories, and, for specialty pharmaceuticals, trained and sent out patient counselors. Brand managers have overseen the development of sophisticated sample starter kits to introduce patients to a new med and spur refills (see next story). These efforts are continuing, and industry representatives note a heightened level of interest among pharma companies in sponsoring them. But the evolving nature of healthcare and prescribing—especially in better use of information technology—is opening some new pathways to addressing adherence.

A third driver is the simultaneous trend toward specialty pharmaceuticals for both broadbased diseases such as cancer or heart disease as well as rare or orphan diseases, and the increasing conversion of disease from acute to chronic care. More patients are getting more attention from pharma companies, pharmacies, PBMs and providers, simply because the medicines available are expensive, complex to administer, and the disease states are more chronic. Examples are the biotech drugs for cancer, antivirals for AIDS and other diseases, and immunoglobulins for blood disorders. Specialty pharmaceuticals are the fastest-growing component of today’s pharma industry; at the same time, chronic diseases are estimated to constitute, now, 75% of overall healthcare costs.

A fourth driver could be what is coming to be called consumer-driven medicine, in which the patients themselves take a more active role in their care, partly because they are paying for more of it, and partly because the American consumer is focusing more on it. But this is a mixed message; many consumers are putting less faith in the advice of their doctors. The drive toward shared information to monitor adherence may conflict with the seemingly growing concern over patient privacy.

Money, memory and side effects

Why are patients non-adherent? Although the subject has been studied for decades, the causes vary across disease states, patient profiles, types of health plans and many other factors. A dated—but demographically interesting—study by Harris Interactive in 2002 found the leading reason was simply forgetfulness (Fig. 1).

More substantive—but less prevalent—reasons include the cost of medicine (a heightened concern now, with reports of cash-strapped patients having to choose between paying bills and buying medicine), and side effects of the medication, which can differ from patient to patient.

“There is certainly not a one-size-fits-all approach to this,” says Derek Rago, VP of strategy and marketing at McKesson Patient Relationship Solutions (Scottsdale, AZ). “A lot of it boils down to identifying the motivations and behaviors of patients, and then addressing those concerns in effective ways.”

Although the existence of non-adherence is well-known, documenting it is hardly straightforward. The usual measure is to track refills, but if a prescription is refilled at a different pharmacy (or under a different plan), the continuity is lost. The usual measurement is the “medicine progression ratio,” a calculation based on the sum of the days of supply (say, 30 pills for a 30-day prescription) divided by the number of days between successive refills. But calculating this ratio can be difficult, given the quality of scrip data available from distribution channels, and more so when an attempt is made to correlate a group that is receiving adherence services with a control group that is not.

Thomas Balzer, PhD, an industry consultant with project experience at Verispan (now part of SDI), TNS Healthcare and other data-compiling firms, gave an example (at a Frost & Sullivan-organized meeting on patient adherence in March) of an adherence study that showed that patients using a voucher actually had poorer adherence that a control group without the voucher. But close analysis showed that a) the voucher users could have been from a lower socioeconomic group, one for whom the opportunity to obtain low-cost medicine was justified with or without continued adherence; b) the pharmaceutical consumption within the voucher group represented additional product sales that would not have occurred without the voucher and c) the physicians who had handed out the vouchers became significantly higher prescribers of the drug, independently of their patients’ adherence.

Another expert, Andrea LaFountain, president of Mind Field Solutions (Philadelphia) has explained that it is more appropriate to focus on non-adherent patients, as a group, than to look at all patients and seek higher adherence across the board. “If [for example] 78% of patients are already taking at least 80% of their drug, can we move the needle any further in that segment?” she asks. “Shouldn’t we be focusing on the 22% of patients who truly are struggling to maintain therapy?” To that end, her company has developed what is claimed to be the industry’s only patented model to predict patient adherence.

Service options

As an extension of their trade-partner relationships with manufacturers, each of the Big Three wholesalers have business units dedicated to adherence and related patient services. McKesson organized a Patient Relationship Services unit from ongoing businesses in 2007; ABC’s Specialty Group has built out patient services over the past several years, and most recently acquired Xcenda (Charlotte, NC), a managed-markets and health-outcomes consultancy. Cardinal offers a pair of programs called AdhereAssist, an opt-in voucher and communications process, and a sample vouchers/coupons program.

“One of the latest developments affecting patient adherence is that the quality of a manufacturer’s program has become part of its negotiations with formulary placement at managed care organizations and PBMs,” says Mike Eaddy, a director at Xcenda. He adds that these considerations also come into play with patient-assistance programs and co-pay support for patients, so that an adherence program is part of a larger, coordinated marketing plan for a product, especially when it is being launched.

ABC Specialty Group also handles patient adherence goals through distribution services in its ICS specialty-distribution group. “Adherence can mean outreach both to patients and to providers,” says Jan Nielsen, VP of client services at ICS. “A new infusion drug, for example, might need training of physicians and staff in applying the drug. Staff at hospitals might need better case-management resources, which we can provide.” Both Eaddy and Nielsen emphasize that an adherence program works best when it is integrated into an overall commercialization process that includes patient communication, provider coordination, and reimbursement, formulary and outcomes analysis for payers.

A range of services are also available at McKesson’s Patient Relationship Solutions (PRS) group. It emphasizes the success of its LoyaltyScript program, which has been used at over 12,000 pharmacies (both inside and outside McKesson’s Health Mart franchise system), and could be connected with more than 40,000 other pharmacies through McKesson’s RelayHealth service, which provides back-end connectivity to pharmacies for adjudicating script payments.

LoyaltyScript is a patient identity card that, when presented at a pharmacy, connects the prescription to any type of co-pay reduction, sample incentive, or discount that a manufacturer (or other party) might provide.

Most recently, PRS has connected two distinct services—the LoyaltyScript program and McKesson Rx Pack, a contract packaging/repackaging unit of the company. Rx Pack (see next story) has a partnering relationship with a packaging design firm, BurgoPak, and will be combining the LoyaltyScript card with the BurgoPak compliance package.

Technologically, this might not be particularly challenging, but operationally it represents an innovative way to both get the card in the patient’s hands (complementing its handout at a physician’s office) and presenting an adherence-enhancing form of packaging. A program using the combined card and package is about to get under way with an undisclosed client.

PRS also has a call center for patient outreach, and programs for distributing samples and medication guides. But overall, the company emphasizes its connectedness to pharmacies, and looks to pharmacists as key partners in promoting adherence. PRS’ Derek Rago notes that pharmacists are routinely face-to-face with patients, and are highly trusted authorities, so that adherence-support dollars spent in that channel have a high probability of success. One of PRS’ offerings is a straight-up discount that can be applied when a prescription is adjudicated (thus reducing the out-of-pocket expense for the patient) at the pharmacy counter. Another is an incentive program for pharmacists to provide on-the-spot counseling for several minutes to a patient; the incentive shows up in the adjudication system, alerting the pharmacist, and the reimbursement is funded by the manufacturer.

Another element of this service is to train pharmacists in “motivational interviewing,” a type of psychological counseling that tries to elicit responses from patients that improves their own understanding of the value of compliance. “We employ behavioral psychologists to study the entire spectrum of patient adherence,” says Rago. “One of the advantages of motivational interviewing is that you can scale the service across a broad number of interventions.”

Timothy Davis, an independent Health Mart pharmacist in Beaver, PA, told the Frost & Sullivan conference attendees that this system fits well into the workflow of busy pharmacists in that they can do the intervention on the fly, as opposed to the structure of the medicine therapy management (MTM) of Medicare and other programs, which require setting aside a block of time for counseling. “The incentive might be a small amount of money, but believe me, independent pharmacists value any revenue stream that can enhance their customer interaction,” he says.

PRS claims an ROI as high as 8:1 in money spent on adherence programs it offers, in terms of higher medicine consumption.

Loyalty card programs are available from a number of sources, including Adheris, a unit of inVentiv Health based in Burlington, MA, and Group DCA (Parsippany, NJ). Many other systems provide coupons at the point of sale (or through mailings to patients). Overall, patients have become accustomed to the use of a card both as a necessary part of belonging to a drug plan, and as a desired part of retail shopping. Most of the larger pharmacy chains have in-house loyalty card programs. A 2005 study by AC Nielsen (Markham, ON) found that 62% of Canadian households made use of a loyalty card with drugstores, and that 57% of all households rated the cards as a “likely” or “very important” element of their choice of store.

Marketing effects

Even though the stereotype of physician’s interactions with patients is that they seldom spend sufficient time explaining drug therapies, or monitoring adherence, those healthcare professionals are still the most cited source of guidance by patients. A February study just released by PharmaForce International (Reading, PA), found that physicians are cited by 46% of patients surveyed more than double any other healthcare professional (Fig. 3).

Pharma companies have by no means been standing still in adherence efforts; anecdotally, most industry sources say that funding and project activity are on the upswing at many firms. Typically, programs are organized with the leadership of brand teams, and with the input of medical affairs, client or customer service functions, and with the sales force as the conduit to distribute samples and educational materials to physicians.

A 2006 study from Cutting Edge Information (Durham, NC) noted that getting a patient to refill a prescription costs 62% of what getting a patient to start a therapy does, making the point that marketing dollars can be well-spent when directed to adherence.

Pharma companies can call on a number of service providers to assist in this physician communication. One, PharmaCentra (Atlanta) has a patented service called Welltouch that combines data collection from patients on adherence with reporting to physicians on the condition of their patients. A call center can provide either interactive voice response (IVR) or a live operator to check on patient condition, and verify refills.

“Compliance rates for chronic medications tend to fall off over time, and doctors typically spend only six minutes with the average patient, says Dan Berman, CEO of PharmaCentra. “If drug companies would spend even a small percentage of their DTC budgets on programs to improve patient literacy across the board (tailoring their materials to account for such factors as age differences, socioeconomic issues and so forth), they’d get a lot more bang for the buck in terms of shoring up long-term sales,” he says.

Another is InfoMedics (Reading, MA), which introduced a service called Adherence Advisor last fall. The service features patient segmentation to refine the appropriate messaging for patients where it can be most effective, and follow-up communications from patients back to physicians. “The fact is, about 20% of patients will effectively comply with a medication regimen if their physician asks them to and another 20% will not, no matter what steps are taken,” said Dr . Stanley Wulf, MD, VP and chief medical officer at InfoMedics, when Adherence Driver was introduced. “Pharma needs to focus on the remaining 60%: Patients whose path towards nonadherence can be halted with the right education, motivation and monitoring.”

Pharmacy steps up

“Adherence” is generally the term of art within the pharma industry for improving the regularity of pharmaceutical usage among patients. In the healthcare provider world the topic shades over to “disease management,” while in the pharmacy world, it shades toward “medication therapy management” (MTM). “From my perspective, there is a thin line between where one leaves off and the other begins. Adherence improvement involves a collaborative, sustained commitment on the part of patients and their providers to address medicine use issues to ensure that optimum treatment continues,” says Ray Bullman, EVP of NCPIE. “Similarly, disease management programs, addressing lifestyle, behavior, stress reduction, anger management (e.g.) involve a sustained, collaborative approach in order to have any chance of success.”

Spurred both by health plans seeking to lower overall costs, and healthcare-delivery systems looking to enlarge the range of services they offer, healthcare providers have been actively developing disease management programs for which medication adherence is a key component. Many of these are aimed at the broadscale health conditions such as diabetes, obesity, smoking cessation, or drug abuse. The flip side of this is rare or orphan diseases, for which most general healthcare delivery systems are ill-equipped to handle. Specialty distributors are making adherence a key part of the bundle of services that they offer to assist patients of these diseases.

A number of vendors have targeted the pharmacy channel for delivering adherence-related services. A recent addition is AssistMed (Beverly Hills, CA) which is building out a system that employs patients’ cell phones to send reminder messages or other communications. AssistMed has announced a relationship with Amada Health Care (Short Hills, NJ), a specialty-pharmaceutical group purchasing organization that has many specialty-pharmacy members. “We see this as yet another important step in defining the scope, reach and service capability of the specialty pharmacy trade segment,” says Lawrence Irene, RPh, CEO of Armada.

Chain and community pharmacy associations are bidding for a more central role in patient adherence MTM. A “Pharmacy Principles for Health Care Reform” issued by the leading business and professional pharmacy associations in December lists incorporating reimbursement for pharmacy-sourced patients services as one of the key principles, noting that “Pharmacists are a highly trained and valuable resource, yet they are currently underutilized.”

The National Community Pharmacy Assn. (Alexandria, VA) set up Mirixa, Inc. in 2007 to enable independent pharmacists (and others) to streamline the delivery of MTM services and certain back-office functions via a standardized network. Most recently, the American Pharmacists Assn. has partnered with Mirixa to deliver APhA-originated services.

An IT connection

The ability to track patient activity in ordering and refilling prescriptions is getting stronger, partly because loyalty-cards and opt-in websites create more connections between consumers and providers, and partly because of the consolidation of “megachannels” like CVS Caremark, major chain pharmacies and PBMs, and major insurers, each of whom represents tens of millions of American consumers.

Out of this is coming a new wave of “longtitudinal” data—which can track patients over time, and with less reliance on individual healthcare providers or chain drug stores. “Accurate longitudinal patient data is making the job of analyzing adherence issues easier,” says industry consultant Thomas Balzer. “It has the potential to change the difficulties of this area.”

One example come out of McKesson PRS, where Derek Rago says that a new service the unit is developing will attempt to address “abandoned” prescriptions—those that were issued by a physician, delivered to a pharmacy and filled, bu the prescription was never picked up. “the number of abandoned prescriptions is very large—25% or more of written scrips for some drugs,” he says. The advent of e-prescribing (which is being practiced by about 10% of physicians now, but is expected to jump as CMS rules create implementation incentives) will be a spur to this effort.

Mention of abandoned scrips is relevant here because it is just one type of drop-out in the flow of information from patient to manufacturer. There are others in the distribution process, at healthcare facilities and elsewhere. In one case, though, two IT services companies believe that they have at least one information dropout solved—reconciling inventories of pharmaceuticals in supply chains with patient consumption of that inventory. And from this can come not just better inventory management, but better tracking of adherence initiatives.

The two companies are ValueCentric (Orchard Park, NY) and PDX-Rx.com (Fort Worth, TX). The former is a developer of ValueTrak, and IT services that reconciles supply chain inventories with EDI transaction records (and thus provides results for fee-for-service programs for wholesalers, or chargeback data for manufacturers). The latter is one of a handful of companies that developed back-end IT services for pharmacies in the past, and now has a network of chain pharmacies, independents and mass merchandisers as clients.

According to Dave Janca, president of ValueCentric, by combining the EDI data in ValueTrak from inventory movements with the prescription data from PDX-Rx, a manufacturer can gain precise insights into the effects of adherence programs, vouchers or coupons to patients, or comparable marketing campaigns, such as the auto-refill service that PDX-Rx offers (see Figure). Steven Friedman, VP of pharma services at PDX-Rx, notes that the company’s dispensing and adjudication software, when engaged for auto-refill, has been shown to add as much as two additional months on therapy (i.e., two more months of adherence) in a six-month period—a substantial improvement both in adherence and in pharmaceutical sales.

A key part of the data-integration process is to link the dispensing of individual prescriptions to the 500-count (a typical size) bulk “bottles” of pills or medications in which pharmaceuticals are delivered to pharmacies. According to Janca, this occurs primarily by tracking the size of the shipment along with its destination, so that, in effect, an inventory of what is on the pharmacy’s shelf is being measured. And Friedman adds that all of this linking is done via de-identified, HIPAA-compliant processes, so that patient privacy is preserved.

“Manufacturer inventory data and pharmacy claim data had been two disparate data streams,” says Janca. “Now, that break in the data stream has been bridged, and the manufacturer has better visibility across the entire supply chain.”

Patient privacy looms

An IT linkup such as that performed by ValueCentric and PDX-Rx has the potential to greatly streamline the process of gathering information on adherence. The same mindset is at work in overall electronic medical records (EMR) efforts among healthcare providers. But patient-privacy advocates are pushing for tightening the procedures around which patient data is shared. In the runup to President Obama’s American Recovery and Reinvestment Act passed in February—which included a hefty $19-billion dollop of funding for EMR—privacy advocates sought, and obtained, language requiring patient permission for selling EMR data, and tightened auditing and monitoring requirements. How this legislative language will translate into actual CMS (or other) policies remains to be seen.

The concerns of groups like the Patient Privacy Rights Foundation (Austin, TX) and others is to prevent personal health data from being used for insurance qualification, employment—but they are also against the pharma industry marketing directly to consumers. “We stand ready to fight with you to protect consumers and ensure that our most intimate information, our health records, is only used to improve our health,” wrote Deborah Peel, MD, in a letter to Congress.

Change to Win, a labor-union-sponsored advocacy group, has targeted CVS Caremark specifically with a campaign called AlarmedAboutCVSCaremark.org over its patient-data practices, and has been a vocal supporter of a bill (SB 417) under consideration in the Maryland legislature that would “outlaw the practice of selling prescription information,” according to the group, saying that the data are being sold “to be used in marketing for drug companies and other purposes.” According to Change to Win, at least 13 other states are considering such laws.

Inevitably, there is going to be an ongoing confrontation between the interests of the pharma industry, insurers and healthcare providers on one side, and privacy advocates on the other, over use of EMR data. Managing adherence programs might be a casualty. In favor of more extensive adherence programs, on the other hand, is the expectation that more accurate health outcomes data, solidifying the benefits of better adherence, will drive everyone in that direction. According to Deloitte’s Keckley, who takes the lead in this effort is up for grabs. “Patients are seeking better information and better resources. There’s no reason why the pharma industry couldn’t be that trusted source.” PC

SIDEBAR: NCPIE National Action Plan Recommendations

• Elevate patient adherence as a critical healthcare issue. Until healthcare policy makers, practitioners and other stakeholders recognize the extent of non-adherence, its cost, and its contribution to negative health outcomes, this problem will not be solved.
• Agree on a common adherence terminology that will unite all stakeholders. The public health community is called on to reach agreement on standard terminology that will unite stakeholders around the common goal of improving the self-administration of medical treatments.
• Create a public/private partnership to mount a unified national education campaign to make patient adherence a national health priority. A national education campaign where all stakeholders coordinate resources and speak with one voice. This will entail creating a national, collaborative clearinghouse to share information and ideas and to coordinate activities.
• Establish a multidisciplinary approach to compliance education and management. There is a growing recognition that a multidisciplinary approach to medication taking behavior is necessary for patient adherence to be sustained. This model has the patient and all members of the healthcare team working together to treat the patient’s condition, while recognizing the patient’s key role at the center of the process.
• Immediately implement professional training and increase the funding for professional education on patient medication adherence. Professional societies and recognized medical sub-specialty organizations are encouraged to translate existing research findings into professional education through continuing education courses and lecture series on patient adherence issues.
• Address the barriers to patient adherence for patients with low health literacy. Widespread adoption of existing tools to convey medicine instructions to the estimated 90 million Americans who have difficulty reading, understanding and acting upon health information is required.
• Create the means to share information about best practices in adherence education and management. Today, stakeholders have access to more than 30 years of research measuring the outcomes and value of adherence interventions. Building on this foundation, the report calls for action to begin collecting data on best practices in the assessment of patient readiness, medication management and adherence interventions, incentives that produce quality outcomes from adherence interventions, and measurement tools so that this information can be quantified and shared across specialties and healthcare facilities.
• Develop a curriculum on medication adherence for use in medical schools and allied healthcare institutions. To address the lack of awareness among clinicians about basic adherence management principles, required courses at medical, nursing, pharmacy and dental schools as well as courses for faculty members that focus on adherence advancement and execution of medication-related problem solving.
• Seek regulatory changes to remove roadblocks for adherence assistance programs. A number of federal and state laws and policies now limit the availability of adherence assistance programs. These barriers must be identified for lawmakers and regulators to address. Increase the federal budget and stimulate rigorous research on medication adherence.

--from the 2007 NCPIE report: Enhancing Prescription Medicine Adherence: a National Action Plan