Four Key Questions About Adherence/Compliance

PM360 asked experts in improving patient adherence to address key issues the industry should know about in 2018, including:

  • What barriers are the most prevalent to preventing medication adherence/compliance that pharma should be focused on? What are some lesser-known barriers that deserve more attention?
  • What are the keys to creating a successful adherence program? What types of programs or techniques are the most effective in improving adherence? What techniques have been the least effective?
  • How can pharma better leverage data and insights to tailor adherence programs to specific patients or general patient populations to ensure they are offering support that patients will use?
  • How can pharma better partner with payers, physicians, pharmacists, PBMs, and/or third-party service providers to help improve adherence?

Amrita Bhowmick

According to a 2015 survey of Health Union’s 18 condition-specific online communities, side effects and a lack of efficacy were the No. 1 and No. 2 reasons, respectively, for stopping medications. We noticed the same—though flip-flopped—results regarding reasons for switching medications.

The challenges with side effects and efficacy begin with the patient not having a clear—or any—understanding of what to expect and for how long. One of our community participants illustrates the side effect challenge, saying, “No one warned me about an ulcer. If anyone had, I would have been extra careful, as there’s a history of ulcers in my family.” Regarding efficacy, another said, “What I didn’t know then was that taking medication for only a few weeks wasn’t going to give it enough time to work.”

Given this understanding, pharma marketers can play an important role in removing adherence and compliance barriers by creating resources and programs for HCPs and their practices that encourage and assist with explaining side effects and efficacy, as well as understanding where the patient is and what they are willing to tolerate and accept as part of their treatment plan.

Cornell Stamoran

One driver of patient adherence challenges is wholly within pharma’s control: Drug product design. A growing body of research indicates that every single product design decision made during early development has the potential to impact patient adherence and outcomes. Selecting the best molecule variant, choosing the best formulation type, finding the optimal dose form design, and designing devices and packaging for maximum patient utility are all crucial steps to optimizing product design for outcomes.

Yet only one-quarter of R&D groups we surveyed pursue patient-focused drug design in a systematic way. The biggest challenge—the R&D team making these early, crucial decisions about product design often don’t have enough information on the real-world treatment administration challenges that patients, caregivers, and providers face. One large pharma R&D group even fielded their own primary research to understand patient challenges to fill this gap!

We are actively working with academic and industry experts to develop a systematic approach to incorporate patient-focused drug design insights into early development phases, to increase potential for improved patient adherence and, ultimately, outcomes.

Tom Kottler

For too long, healthcare has looked at the problem of medication non-adherence through the wrong lens, assuming it was a problem of simple forgetfulness or cost. But in Europe, where there are no copays, adherence rates are virtually the same as they are in the U.S.

We’re coming to realize that medication non-adherence is really a value problem, rooted in our mind’s biases and irrationality. How else do we explain a cancer patient not taking oral adjuvant therapy that could stave off recurrence?

People don’t take medications for a number of reasons. They don’t want to identify themselves with a chronic disease, they don’t like the side effects of the drug, or there aren’t any symptoms so what’s the drug really doing for them anyway? The main issue, though, is this: Taking a pill today is all about long-term rewards in preventing heart attack or stroke, or cancer recurrence, potentially years or even decades in the future. People are not wired that way. Our focus is on short-term benefits. We have a “present bias,” in behavioral economic terms. It’s the same reason that very few people save enough for retirement.

Unfortunately, there are no built-in short-term rewards in taking a medication for a chronic condition.

Jessica Brueggeman

There are three keys to creating a successful adherence program.

1. Recognize that medication adherence should NOT be your primary goal. Why? Because adherence is too narrow of a focus, and even though this endpoint is valuable to pharma, it has limited value to patients. Pharma’s focus should be on improving health outcomes. To accomplish this, pharma should address the clinical (functional) needs and psychosocial needs. Adherence is something that happens as a result of meeting the patient’s needs.

2. Go beyond education to change behavior. Information and education are important. However, research demonstrates that education alone is not as effective as education paired with evidence-based behavioral strategies. Why? Because education only builds knowledge. Other strategies help motivate patients and help them build skills to become (and remain) successful. Just knowing why it’s important is often not enough to make a difference.

3. Know that changing behavior takes time. Adherence should not be positioned as a one-off tactic or a single interaction, such as a refill reminder or patient brochure. Effective adherence initiatives should take a multi-channeled approach over time. These touchpoints should include evidence-based strategies designed for the patient and the HCP.

Jeffrey Freedman

The key to a successful adherence program is to first understand why your patients aren’t being adherent and then create interventions that are pushed to the patient at the time the average patient is calculated to go astray. As an example, if a side effect of your product is flushing, and the flushing could occur around day five, then at day four your patient should get an email about flushing and how to minimize its effects.

If your product is an injection that might cause injection site pain, educational material surrounding injection site rotation and skin healing should be sent to your patient before their second injection. Getting your patients on-ramped and opted-in to your CRM program is extremely important in order to communicate with them regularly and increase their chances of staying on medication.

The least effective programs are those where it is up to the patients to go and seek out the information on a general brand.com website. In addition to an overall lack of motivation to seek out the information, if they do, they could potentially come across additional information about irrelevant (for them) side effects that scare them into halting the medication all together.

Chris Hildebrand

Even the best adherence pilots are of little value if we cannot demonstrate success to warrant national roll-out and maintain long-term funding. Pilot programs often lack measurement rigor to identify small compliance gains, which—when spread across the full patient population—can make a big difference in patient well-being and corporate ROI. To prevent such lost insights, consider these core elements:

1. ANCOVA: Analysis of covariates (with similar test versus control groups) is crucial since very small adherence gains can signal program success. Consider at least 1,000 patients for statistical confidence, and be sure both test and control groups have similar characteristics to prevent other factors from muddying the data, such as patient age and time of year.

2. Use Pharmacy Fill Dates:Medical literature has consistently shown that patients are highly inaccurate in reporting their own compliance, so leverage pharmacy fill dates for an objective assessment.

3. Create an Opt-in Control Group:Adherence programs may require an opt-in component, which will skew the test group toward people more interested in the disease state and thus likely to be more compliant. Opt-in control eliminates this covariate to better calculate true program success.

Eric Cale

In a 2017 survey, pharma industry leaders overwhelmingly agreed that improving patient outcomes is the single biggest motivation to address patient non-adherence. Yet, nearly half of respondents report an “inability to prove ROI” as the main reason not to pursue such a program.

Driving both ROI and patient outcomes requires marketing teams to view the data that drives adherence programs as an appreciable asset. Effective data assets are developed by combining a company’s own first-party data with second- and third-party information to create 360° patient profiles. Companies can establish behavioral and attitudinal insights from key data sets such as demographics, disease understanding, physician and coverage dynamics, and geographic location. From there, 360° profiles allow organizations to improve adherence through delivery of personally and contextually relevant information.

Industries such as e-commerce and travel have extensively leveraged this approach to drive predictive algorithms that deliver personalized interactions. Machine learning then improves these interactions over time by adjusting based on behavior. Not only has this level of personalization been proven to drive better engagement and deliver improved metrics, but studies have shown that physicians are more likely to prescribe if they know the pharma company has demonstrated a commitment to driving better outcomes.

Jerry Barsz

Technological enhancements are creating data streams not previously available. For example, advanced technology has made it economically feasible, for the first time ever, to embed sensors and wireless technology directly into medication packaging. Combined with machine learning, this dose-level behavioral data can be used to measure and improve patient adherence at an individual level, at a scale not feasible a few years ago.

While there are many benefits to this daily data feed on patients’ compliance, two include:

  1. Specialty Pharmacy and Patient Support Services (hubs) having access to daily medication data of patients is enormously valuable. Texts and direct messages can be used for patients showing compliant behaviors while saving phone calls for those patients with regular compliance challenges in which a live conversation is needed.
  2. Interventions can be designed to educate or gain insight. A quick automated survey, for example, sent within a secure app via smartphone, yields information as to why there is non-compliance. This feedback then drives tailored resources to help patients as well as provide valuable insight to the marketing team.

Anton Berisha

Plenty of evidence supports a conclusion that medication adherence is heavily dependent on the socio-economic environment into which a person is born, lives, works, and ages. And data sets are available that can provide an excellent picture of a patient’s socio-economic profile—including data related to an individual’s financial well-being, education, professional licenses, housing, transportation, criminal and other court-related encounters, neighborhood safety, wealth profiles, etc.—that can be used to augment and improve the ability to predict the risks of non-adherence.

Further, the data can help providers develop proper intervention and outreach efforts targeting the most severe socio-economic drivers that impact an individual’s ability to pick up and take the medications as intended. That data should be made part of any initiatives targeting medication adherence. Moreover, the pharma industry—at all levels—should implement the findings as soon as possible if they want to change the behavior and improve medication adherence.

The healthcare industry is already implementing interventions to mitigate negative effects of the socio-economic environment. Perfect examples are Uber/Lyft driving patients to healthcare providers and facilities or various healthy food delivery initiatives, etc. Similar types of programs targeting socio-economic drivers should improve medication adherence as well.

Moses Zonana

Pharma seems to be in an analysis paralysis stage as it relates to implementation of new practices to improve adherence. They seem inundated by the buzzword of the season, IoT, AR, AI, Alexa, etc. All of those approaches are better than the archaic strategies used in the past, including reminder post-cards and blanket messages.

However, generic pharma doesn’t really have the margins to implement many of the novel approaches—and pharmacies have even narrower margins. In many cases—given price points—those in generic pharma have no choice but to continue with primitive low-cost approaches. But as a solution, especially for single-sourced generics or higher-priced generics, they could entertain funding programs via rebates to payers, third-party service providers, PBMs, and/or pharmacists.

Meanwhile, for branded pharma, value-based contracts will place pharma at risk if they can’t show that the medicine is being taken adequately to achieve targeted outcomes. It is imperative for such brands to take a proactive approach by funding novel ways to improve habits. As an example, pharma can fund a real-time visibility tool that sheds light into daily patient dosing habits and includes interventions and coaching via a third-party focused patient support group.

David J. Melvin

We are failing at driving adherence: In type II diabetes, the largest source of preventable costs in the healthcare system, most patients are not at their treatment goal—even with new classes of drugs with better efficacy, increased safety, and fewer side effects.

The large number of adherence programs available speak to both the difficulty and heterogeneity of the problem. Still, most are used only by patients who self-select and would probably be adherent anyway. This in no way diminishes program utility, it just points out that the non-adherent patients remain a problem. And little data exists to demonstrate how to engage patients in self-care and patient psychosocial issues—health literacy and health beliefs vary widely and defy easy solutions.

One possibility may be a joint effort between manufacturers, payers, and drug providers (PBMs/pharmacies) to offer non-brand-specific programs to educate patients and provide adherence tools. For patients on multiple medications, an adherence program for each product is burdensome. A program that uses a wide range of tools could be used to increase understanding of both the barriers and solutions to the adherence challenge. It goes way beyond brand and could help the pharma industry rehabilitate their battered image.

Daniel Sontupe

The partnership between pharma, payers (health plans, PBMs, etc.), and providers to drive adherence is extremely challenging. If pharma provides resources or incentives to ensure patients stay adherent, it can be viewed as an inducement to take a drug, and most, if not all, medical/legal review committees will quash the program before it gets started.

Additionally, copay cards, pharma’s biggest driver of adherence, are viewed through a combative lens by payers. Now, payers have developed copay accumulator programs that essentially penalize members for using copay cards. So how can partnership be promoted when both sides are constantly positioned against each other? It starts by checking ego at the door and realizing that the adherence hero has to be the payer.

Pharma must collaborate with payers to provide value-based contracts and include patient engagement programs and adherence copay support directly through the payer. Copay cards should go away, allowing payers to offer necessary medications at low to no cost for the patient, because pharma is subsidizing. If we are able to reach this point, brands will be able to compete on clinical prowess while working with payers and providers to ensure cost does not stop adherence.

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