Improving medication adherence — something’s got to give

Poor adherence to prescribed medications creates one of today’s most pressing public health issues. When patients fail to take their medications as prescribed — either stopping before the course of treatment is complete, abandoning long-term therapies prescribed for chronic conditions, or taking the medications incorrectly — it creates far-reaching clinical and financial consequences for all stakeholders:

• • Patients are unable to control painful or debilitating symptoms or disease progression, and may face premature death
• • Payers (and society) shoulder the cost burden of avoidable emergency room visits, hospitalizations, and medical and therapeutic interventions, as well as the financial toll of worker absenteeism
• • Brand teams lose potential revenue (impacting both profitability and ongoing R&D efforts), and market share.

Today, despite concerted effort already underway to improve patient adherence to therapy, roughly 50% of all prescribed medications don’t actually get taken by patients, according to the U.S. Centers for Disease Control (CDC). [1] In the U.S. alone, this leads to $100 billion or more of avoidable healthcare spending, and accounts for 33–69% of all hospital admissions, according to the agency. [2]

Studies show that poor adherence impacts nearly every disease state — even progressive, chronic potentially debilitating and deadly conditions that have the highest stakes. These include diabetes, cancer, cardiovascular conditions, immune-system disorders, infections (HIV sidebar?) and post-organ-transplant treatment.

Frustration among stakeholders is palpable. “Even in a category like hepatitis C, where patients can be cured, we still see significant adherence issues,” says Amanda Rhodes, director of client sttrategy and solutions, McKesson Specialty Health.

Similarly, “within the realm of organ transplantation, you’d think we’d see perfect adherence but adherence in this area can be a real challenge, adds Heather Black, PhD, Director of Health Quality Research for Merck’s Center for Observational and Real-world Evidence (CORE). “However, some of the regimens can require the patient to take many pills/day, at specific time intervals, and that’s incredibly difficult to maintain over time.”

Patients with asymptomatic conditions and those that don’t experience pain or suffering often do not appreciate how sick they really are. “With a broken leg, it’s obvious, but for patients with diabetes or cardiovascular disease or high cholesterol, they often say ‘Well, today I feel pretty good,’ and that undermines their need for vigorous adherence to therapy and healthy lifestyle choices,” says Michael N. Dubroff, DO, FACOP, president of consultancy LeadershipRx LLC, who was, until his recent retirement, senior director of managed care support for Genentech.

Wanted: Fresh ideas

All parties with skin in the game — drug developers, payers, physicians, pharmacists, pharmacy benefits managers (PBMs) and the many third-party service providers operating throughout the pharma supply chain — are digging deep, working to try something, anything, that might be able to move the needle in adherence. Static text or email reminders for patients to take or refill their medications — once a breakthrough concept — are simply not enough.

“Traditionally, everyone’s been focused on education, but over the past 25 years, we’ve all seen that we can’t simply educate our way out of this — there are so many other factors at play,“ says Black of Merck. “Don’t chronically ill patients realize they could die from this? Of course they do, but for so many reasons large and small, many still don’t faithfully take their medications.”

“Historically, the approach was to treat all patients in the same manner, for the same disease,” adds Susan Stinson, BSN, FACHE, SVP of Operations, Clinical Services Lash Group, an AmerisourceBergen company. “Over the years, we’ve learned that a patient-centric approach is critical. We have rethought and retooled our approach and are now dedicated to first understanding each individual patient’s needs and unique barriers to care, and then tailoring our services to best support them along their journey. We are all making progress but there is still so much work to be done.”

Main drivers of poor adherence

The factors that are to blame when patients fail to take their medications as prescribed generally fall into four buckets:

• Clinical or therapy related — Patients have concomitant conditions and co-morbidities (including depression) and/or cannot tolerate the side effects and adverse events associated with the medication
• Operational — Patients have limited access to doctors, poor post-hospitalization care, and struggle with confusing dosing or administration protocols (such as complex self-injectible routines or requirements to take one or more medications at highly proscribed times of the day, with food or without food, or away from other prescribed medications)
• Behavioral or attitudinal — Patients lack an overall understanding of the disease (and the implications of its progression) and/or the prescribed drug regimen, and may show skepticism over the role or capabilities of the medication itself (this is especially challenging with asymptomatic conditions)
• Financial or socioeconomic — Patients face barriers related to drug access and affordability, insurance coverage, and the out-of-pocket burden for their medications.

“It’s critical to help physicians and pharmacists to have meaningful conversations with patients, to help them figure it out and make their lives easier,” says Black of Merck. Many agree that more can be done by brand teams to enable more well-informed conversations between physicians and patients. The goal is to find ways to ensure that the patient understands several key elements — the benefit of the medications, the benefits of controlling the condition (diabetes, hypertension, high cholesterol, and so on), and the potential harm associated with failure to control the chronic, progressive conditions that can lead to loss of mobility and functionality, loss of limbs, adult blindness and even death.

“For many patients, denial is a major factor that impedes adherence,” adds Stinson of Lash Group. “Physicians play a major role when it comes to supporting the patient through that acceptance, which means physicians themselves may need additional educational tools to help them articulate the advantages and potential ramifications of disease progression or one therapy over another.”

Merck has developed Conversation Starters, an interactive video experience (as part of its Adherence Estimator tool), which can help health care providers speak more authentically with patients about the medicines have been prescribed. The one-minute assessment tool provides insights on three issues that are closely associated with adherence:

• Commitment to therapy — Do you understand the importance of taking the medication as prescribed?
• Concerns — Do you have concerns about this medication and are they being addressed by your prescriber?
• Cost — Do you feel financially burdened by the out-of-pocket expenses for this medication?

“There may be many other factors at play, but if the patient is shaky on these first three then you have a pretty good idea that they’re likely to fall down,” says Black. And importantly, prescribers are able to use this assessment as a less-confrontational framework to start a more interactive conversation. “It changes the power dynamic in a better way — avoiding a tone that can seem confrontational or condescending when the doctor just asks, ‘Have you been taking your meds?’” she adds. It is being used by a range of organizations, including Aetna and Pharmacy Quality Solutions (a joint venture of Premier and Pharmacy Quality Alliance).

“Adherence-related outreach must become more humanistic and less mechanical — it’s not just about turning the knobs but about really looking at the so-called social determinants of health (SDOH),” says Black of Merck. These are the socioeconomic and demographic factors — including housing instability, food insecurity, lack of education and neighborhood violence — that add further burden to a patient population that may already struggle with adherence. Such details are not typically captured by the provider in the patient’s case notes or in the EHR system, but if the doctors were more aware, they may be able to help tailor the recommendations better to promote adherence more effectively.

Meanwhile, Dohmen Life Science Services (DLSS), a service provider for supporting orphan drug commercialization, has developed the Patient Journey Map to capture “a 360-degree understanding of the patient’s viewpoint, combining analytical data, anecdotal insights and social listening, to better understand what they’re feeling and what challenges they’re facing through the progression of diagnosis through ongoing therapy,” says Kathi Henson, chief patient service officer for DLSS. “We are seeing improved adherence, more-tailored emotional care, better logistical support, mitigation of adverse events and increased understanding of dosage and administration requirements.”

DLSS, McKesson Specialty Health, Lash Group and others are well known among the pool of service companies known as hub services providers, integrating prior authorization paperwork, reimbursement support, and follow-on services like adherence programs on behalf of pharma clients. While the business is growing, not all observers are uniform in their praise. “A lack of integration among the many groups offering different support programs leads to the left hand not knowing what the right hand is doing, and from the patient or physician perspective, the outreach can appear chaotic and ineffective,” says Dubroff of LeadershipRx LLC. A key ingredient is that all patient-facing parts of the pharma company—sales, medical affairs, marketing and internal patient support—coordinate their activities to make the hub services known to physicians and patients.

Focusing on cost barriers

The high cost of medications continues to become more pronounced when the patients has been prescribed one or more of today’s biologics or other specialty medications. In the U.S., the specialty drug share of net drug spending rose from 23.6% in 2007 to 42.9% in 2016, according to recent IQVIA (formerly, QuintilesIMS) data. This year alone, Americans are expected to spend more than $328 billion on prescription drugs — and of this amount [3], individuals will pay about $50 billion out of pocket, says Sheila Arquette, executive director of the National Assn. of Specialty Pharmacy (NASP).

Product-specific coupons and copay-offset programs that help to reduce co-pay costs for patients, and branded or charitable patient assistance programs (PAPs) that provide free medication for patients who meet the eligibility criteria, can help to improve adherence. But there’s still room for improvement to increase utilization. This includes simplifying electronic access and streamlining enrollment requirements, through the product’s centralized hub, or via text messaging and mobile apps.

Betting on behavioral coaching

As noted, more and more, adherence is being seen as a behavioral issue, not necessarily just a medical one. As a result, a growing number of pharma brands are now moving beyond simple prescription reminders to focus instead on ways to empower patients to become more active participants in their own treatment plans by offering behavioral coaching resources, typically through the product hub.

“We have to meet patients where they are and identify their barriers over time — not merely relying on information they provided six months ago at enrollment,” says Rhodes of McKesson. “That’s the beauty of live coaching — it’s adaptable and evolves over time to address the current issues at hand, uncovering a need, then partnering the need with a resource (for instance, injection training) and messaging to help patients to overcome it.”

A recent diabetes program administered by McKesson on behalf of one of its pharma clients improved patient adherence by providing highly individualized behavioral coaching. Results demonstrated that patients who were coached were 25% more adherent to therapy (translating to nearly 31 additional days on therapy, as measured by Symphony Health Analytics) vs. a matched control group during a 9-month study.

Pharmacist into sharper view

While the online hub provides an invaluable way to provide a range of wraparound services for patients, many argue that community pharmacists still have a big role to play, especially for senior citizens who may not be so inclined to rely on computer- and gadget-based support programs.

“With so many patient-related factors at work — behaviors, attitudes, aptitude, comprehension, and the need for support programs —it’s important to remember that the final mile of the path connecting the brand team with the patient is the pharmacist,” says Arun Ghosh, principal, digital enablement practice for KPMG. “Too often, the patient walks out of the pharmacy and does not ask any questions of the pharmacist, and that’s a missed opportunity.”

A common knock against the neighborhood chain pharmacy is pharmacists are too busy to spend time with patients; to remedy this situation, “To make these initiatives sustainable and scalable, we need payers to pay for them. Once you can show the reduction in hospitalization costs related to improved drug adherence, such an investment begins to make sense,” adds Michael J. Wolf, managing director at KPMG.

Turning to technology

While text and email reminders have been used for years to help patients stay on medication, a recent pilot study conducted by Avella Specialty Pharmacy showed a 29% increase in medication adherence among those designated as “low-compliance patients” (as measured by refill rates through the specialty pharmacy) using more interactive, bi-directional text messaging, which provide patients with daily medication reminders, refill reminders, disease-specific education, adverse-event monitoring, clinical interventions and weekly adherence reporting and a chance for interaction with the sender.

Meanwhile, the parade of apps, devices and gadgets that are aimed at improving patient adherence continues to grow. Today, patients can not only track their blood glucose levels (diabetes) or monitor blood pressure (hypertension) at home, but can see readings and view graphs of current status and trends in real time. Many agree that for patients, seeing the critical readings translated into a rising or falling line on a curve, or data that is clearly shown outside some target range, can be powerful and empowering than simply seeing the measurement data.

Glooko's diabetes tracking. credit: Glooko

Novo Nordisk, the world’s largest insulin producer, recently partnered with Glooko, a diabetes data-management platform, and IBM Watson Health, to further expand its existing digital health offerings. In July, Novo Nordisk and Glooko launched its first co-developed product, the Cornerstones4Care (C4C) app, based on Glooko’s digital platform and data-analytics expertise, to help patients with diabetes manage their treatment. The C4C app lets patients use their smart phones to sync their blood glucose and activity data and integrates the data with up-to-date clinical content and resources, and the company’s personalized support program (Cornerstones4Care.com).

In June, biotech company Roche acquired mySugr GmbH, maker of a mobile diabetes-management platform; muySugr already has more than a million users worldwide, according to the company. It will now become an integral part of Roche’s existing patient-centric digital platform for diabetes care, the Accu-Chek brand of blood glucose meters and related services.

In September, FDA announced a first-of-its-kind program dubbed Pre-Cert for Software Pilot [4], which offers the fast-track approval process for nine technology companies to gain regulatory approval for their new digital health technology solutions (software, apps and devices). The initial participants includes Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche Holding AG, Samsung Electronics, Tidepool, Verily (the life sciences arm of Google parent Alphabet, Inc). More than 100 companies were interested in joining the pilot program, according to FDA.

KPMG’s Wolf notes that a growing number of drug companies are beginning to experiment with artificial intelligence (AI) modeling help patients integrate all of the data points and best practices and translate it into realtime, actionable insights to change behavior, adding: “The ubiquity of Google and Amazon gives us the platform to branch out — to put logic and embedded thinking in there with voice-enabled AI capabilities.”

Meanwhile, several companies have also launched a so-called “smart pill bottle”. The PillsyCap from Pillsy uses Bluetooth technology to sense when the bottle is opened and closed, providing relevant tracking and messaging via a companion app to indicate when a patient has taken his or her pills, and can send reminders or warnings if doses were skipped or were taken at incorrect intervals. Caretakers can also connect to the app, and the tracking tool includes a ChatBot to reach out to patients who didn’t take their pills. AdhereTech, Medisafe and PillDrill also offer similar devices and interactivity. However, the jury’s still out as to whether such devices can truly make a difference. One recent study of smart-bottle technology, published by JAMA Internal Medicine in July [5], suggested they were not able to make a demonstrable difference in changing adherence rates.

Trying to combine technology with behavior modification, Groove Health (Chicago) has developed a proprietary analytics profile to help health insurance companies, hospital systems and self-ensured employers to improve medication adherence using predictive analytics and personalized engagement. The analytics tool combines existing healthcare data with patient-generated input from Groove’s mobile app and other sources “to create a 360-degree understanding of each patient’s unique adherence profile,” which can then be used to promote health-positive behaviors in high-risk patients.

“You start with the expectation that your adherence-support programs are going to work, but at the end of the day, people are people, so you need to keep refining the outreach and support mechanisms based on new findings,” says Dubroff of LeadershipRx LLC. “The branded hub approach seems to have the best shot at coordinating multi-layered partners and program offerings into one centralized offering, but it’s still going to come down to the question of whether the patient shows up and remains motivated to keep showing up.”

References

1. National Assn. of Chain Drug Stores Pharmacies: Improving Health, Reducing Costs, July 2010 (Based on IMS Health data).

2. Overcoming Barriers to Medication for Chronic Diseases, U.S. Centers for Disease Control, February2017; https://www.cdc.gov/cdcgrandrounds/pdf/archives/2017/GR_02-21-2017.pdf

https://intjem.springeropen.com/articles/10.1186/s12245-017-0150-y

3. https://www.aging.senate.gov/imo/media/doc/Drug%20Pricing%20Report.pdf

4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577480.htm

5. Volpp, Kevin G., et al, Effect of Electronic Reminders, Incentives and Social Support after Myocardial Infarction, JAMA Intern Med. August 2017;177(8):1093-1101. Doi:10.1001/jamainternmed.2017.2449; https://www.ncbi.nlm.nih.gov/pubmed/28654972