patient adherence

How Behavioral Economics Can Inform Adherence Interventions

Katrina S. Firlik MD — Wed, 23 Apr 2014 14:13:52 +0000

Précis:

Although future advances in population-wide health may well be driven less by new drugs and devices and more by behavior change, there is no denying that initiating and sustaining healthy behaviors can be very difficult.

Historic efforts at motivating patients to exercise, eat right, quit smoking, and stick with their medications have typically fallen short of expectations. Why? There are many reasons, but I would like to focus on the fact that most traditional tactics have ignored—rather than embraced or harnessed—natural human irrationality.

Behavioral economics is the study of human psychology as applied to decision making, typically economic in nature but applicable more widely beyond economics to health decisions and behaviors. A major premise is that humans are “predictably irrational” rather than purely rational. In other words, they don’t always act in their best interests as more traditional models assume.

Perhaps the most relevant tie between economics and health is the concept of “present bias,” or “present-biased preferences” in the parlance of behavioral economists. This means, simply, that people tend to value short-term benefits over long-term benefits. We’re myopic. We overweight the now and underweight the future. In personal finance, this leads the average person to save insufficiently for retirement, as the benefits of putting money away are not realized or appreciated until years or even decades into the future. It’s more enjoyable to spend and realize the benefits today.

Similarly, taking a daily pill to treat a chronic and “silent” condition like hypertension is similar to putting money away for retirement. The benefit of stroke or heart attack prevention may be years in the future. A patient enjoys no short-term benefit of that pill and, in fact, often faces immediate annoyances such as transient side effects, copays, and trips to the pharmacy. For these reasons, although it is irrational from a long-term health perspective to stop hypertension therapy, skip doses, or even avoid filling the first prescription, it feels psychologically justified in the here and now.

Present bias affects most healthy behaviors. It’s more fun to eat cake today than to worry about weight gain down the line. It’s more pleasurable to enjoy a cigarette today than to suffer through a cessation program designed to decrease lung cancer or COPD risk in the distant future. It’s easier to sit on the couch today than to go through the inconvenience of exercise for some future benefit.

The key then, from a behavioral economics perspective, is not so much to continually educate and remind patients of the long-term benefits of various behaviors—they can probably recite those benefits already—but to harness present bias to refocus the conversation on the short-term.

So, for example, with exercise, the key is often finding a form of exercise that is actually enjoyable, so that at least some benefits are realized the same day. In nutrition, the focus should be on making a healthy diet enjoyable and tasty, not a chore; less about what you need to exclude and more about what you should include.

Medication adherence in some ways is an easier healthy behavior than most and in some ways a little trickier. From a pure physical perspective, the act of swallowing a pill is simple, far simpler than spending half an hour on a treadmill or cooking a healthy dinner. From a psychological perspective, however, it’s harder to reframe in terms of appreciating a present benefit. For that reason, the idea of adding rewards (as in a points-based loyalty program), or incorporating gamification to make the process more immediately enjoyable may be particularly relevant in adherence to chronic medications. Interestingly, according to a recent Accenture report, the pharma service that patients most desire from pharma (but least receive) is rewards.

Given the perspective on human psychology that behavioral economics leverages, it becomes easier to understand how traditional “rational” approaches to the medication non-adherence problem, such as cost reductions (even giving away drugs for free), reminder programs, and educational campaigns often fall short.

So, rather than trying to deny our irrational tendencies, why don’t we instead harness them for the greater good?"

There are a number of other concepts in addition to present bias that hold promise in better tailoring adherence and other behavior change programs to match the realities of psychology and to improve upon past efforts.

“Fear of regret” and the related “loss aversion” refer to the fact that we tend to feel losses more acutely than gains. In other words, the magnitude of hurt experienced upon losing or losing out on something (money, points)is often greater than the magnitude of joy in earning the same. In a loyalty or rewards program, then, maintaining transparency as to points forfeited—“You could have earned 100 points if you had taken your medication”—can serve as a powerful motivator. “I really don't want to miss out on 100 points again” can pack more of a psychological punch than “That’s nice, I just earned 100 points.”

“Optimism bias” or “overweighting of small probabilities” speaks to the potential value of adding a lottery or sweepstakes element to adherence or other behavior change programs. Patients often think nothing of spending hundreds of dollars per year on the lottery while at the same time complaining about their copay costs. The concept of winning is fun, the anticipatory element is exciting, and people tend to be irrationally optimistic, greatly overweighting their actual chances of winning. While the concept of adding a sweepstakes to an adherence program may, at first, seem odd or even frivolous, when viewed in light of its potential to naturally engage patients, it makes sense.

And finally, “peer effects” is the simple concept that competition and comparison can also serve as powerful motivators. The addition of a leaderboard competition, for example, gives patients the benefit of knowing that they are not alone and that other people “are in it to win it.” Obviously, the prize of better health should be enough of a reward when it comes to healthy behaviors—if we were all purely rational actors—but we know that health alone is often insufficient. So, rather than trying to deny our irrational tendencies, why don’t we instead harness them for the greater good? Plus, who wouldn’t mind winning, say, a $100 Starbucks gift card in addition to doing what’s best for their long-term health?

Questions or comments? You can share your thoughts with our audience in the comments section below, alternatively you can email the author directly at kfirlik@healthprize.com

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Cash for Health: Are Financial Incentives Really the Best Approach to Encourage Adherence?

Zuzanna Fimińska — Tue, 04 Feb 2014 11:39:54 +0000

Précis:

Zuzanna Fiminska looks at the growing practice of “cash for health” – rewarding adherent patients with cash bonuses and asks, is this really the correct route to healthy patients?

Last autumn a group of psychiatrists working in East London disassociated themselves from the FIAT (Financial Incentives for Adherence Treatment) study saying that in their view it is “fundamentally wrong to offer patients a financial reward conditional on them accepting … medication,” and urged fellow professionals to “reject such attacks on the autonomy of people with mental health problems.”

The statement was supported by Timothy Evan, a consultant psychiatrist from a Swansea hospital, who said the way to tackle mental health problems is “not through money for medication but by interventions to reduce the damaging effects of social exclusion, neglect, and stigma.”

Still, a focus group involving different stakeholders from across the UK identified clinical success of methods used to increase medication adherence as critical, and highlighted the need for evaluating effectiveness of financial incentives to be established by systematic research, a call answered by a controversial study published in the British Medical Journal.

The BMJ reported that offering modest financial incentives indeed increases adherence to antipsychotic maintenance medication.

“It’s not a breakthrough in the treatment of schizophrenia, but a potential solution to one important problem,” admitted Stefan Priebe, professor of social psychiatry at Queen Mary University of London, and the study’s main author.

“There are various concerns about this practice, whether it’s a form of coercion, and so on,” Priebe commented. “The most important one is whether you bribe people into doing something they normally wouldn’t do. In this study we did not include patients who from the beginning said they don’t want the medication. It was all about the patients who in principle agreed to take the medication. All the patients provided informed consent to taking the medication, but didn’t do it regularly, so it’s not bribing into doing something they otherwise wouldn’t have done,” Priebe said.

Is it sustainable?

We don’t yet have data on long-term outcomes, but it looks likely that behavior change can be achieved in some cases.

Ethical doubts are not the only controversy surrounding the study. The bigger worry is whether the approach can generate a permanent behavior change.

“On the whole, I doubt it,” said Tom Burns, professor of social psychiatry at the University of Oxford, one of the principal investigators of the study, and Priebe’s collaborator. “The hope that all psychiatrists have, is that a sufficiently long and stable period of health in an individual with psychosis could lead to a gaining of insight about their illness and an acceptance of the value of medication. If this is achieved the incentive could contribute to a permanent change.”

Priebe echoes this sentiment: “We don’t yet have data on long-term outcomes, but it looks likely that behavior change can be achieved in some cases, but the length of the intervention would depend on the case,” he said.

Previous research suggests that once the incentives are withdrawn, adherence to treatment decreases, but not in all cases. A study that looked at adherence to physical exercise as a form of treatment demonstrated effectiveness of payments 50 days after they ceased.

What about other disease groups? Are financial incentives equally promising?

One study published in the New England Journal of Medicine has shown that financial incentives positively affect smoking cessation rates, an effect sustained 15-18 months after enrollment. Similar results were shown in a study of weight loss as well as warfarin adherence (warfarin prevents stroke and bleeding complications in millions of patients each year), but research into blood pressure control failed to support those findings, suggesting that paying patients might not be as effective across the board.

Interestingly, financial incentives for organ donors has been shown to increase the number of performed transplants by 5% or more, while remaining cost-effective when taking into consideration the cost of dialysis. Overall, it appears that investigations into the impact of financial incentives on treatment adherence is limited and contradictory, and further analysis is needed to establish the efficacy and sustainability of the method.

Who should pay?

The ultimate question, however, is how the system should be organized and who should cover the cost of the incentives.

Insurance companies, employers, pharmaceutical companies, and the government stand to benefit financially in the long-term from patients’ healthy behaviors and adherence to medication, so they should all contribute, concludes a paper published in the Annals of Family Medicine.

The author, Joanne Wu, suggest that patients who meet evidence-based healthcare goals, such as keeping their blood pressure less than 140/90 mm Hg, could receive financial incentives in form of health care credits, which could be used towards discounts on medications, health insurance, procedures, and co-payments.

She also speculates that this way, with the reward being on-going, the behavior change could be sustained. It should be noted, however, that those incentives are not direct financial rewards.

According to Priebe, the burden of payment rests on whoever funds healthcare, without room for a contribution from pharma. Burns agrees: “I think that payment by the pharmaceutical industry firms would be wholly unacceptable for all involved and would spell the end of the approach.”

Antipsychotics and financial incentives

Adherence to treatment was 11.5% higher in the intervention group compared to the control group, leading to an average adherence of 85%.

Antipsychotic maintenance medication is something patients take for a very long time mainly to prevent relapse. “It has been reported as one of the most effective treatments in all of medicine, [but when not taken regularly, it leads to] very distressing symptoms,” Priebe explained. “Estimates vary between studies, but most say that 15-20% of patients do not take their medication regularly.”

Depot injections have been introduced as an alternative to pills. Injections are administered weekly, bi-weekly, or monthly, and the medication is slowly released into the body over a fixed period. It is the exact same medication that is normally administered orally, so the benefits and side effects are the same as if the drug were taken by mouth.

In the present study, Priebe enrolled patients with schizophrenia, schizoaffective disorder, or bipolar disorder who were prescribed depot injections, and who were under the care of community mental health teams, or assertive outreach teams across England and Wales. Community mental health teams receive referrals from general practitioners, a population of between 20,000 and 70,000 people. Such teams carry a caseload of 200 to 300 patients, of whom over half have long term psychotic disorders. Assertive outreach teams carry a caseload of 60-100 patients who are mostly psychotic and difficult to engage, referred to them by community mental health teams. Of these about 20-40% of community mental health patients, and 50% of those assigned to assertive outreach teams will receive depot injections.

To be included in the study, patients had to be under the care of the team for at least four months; aged between 18 and 65 years; have a diagnosis of schizophrenia, schizoaffective, or bipolar disorder according to the international classification of disease; be prescribed depot injections; show low adherence to medication; and have the capacity to provide informed consent to participate in the study. Exclusion criteria were intellectual disability and poor command of English. Overall, 68 participants were enrolled in each group.

“Originally we thought we would enroll patients with adherence 50% or lower, but we discovered that patients with less than 50% adherence to depot injections are very, very rare, meaning that community team are good at following those patients and achieve higher adherence. We eventually decided to go for adherence of 75%,” Priebe explained.

Participants in the intervention group were offered £15 for each depot injection over a 12-month period. Patients in the control condition received treatment as usual. Clinicians gave money in cash directly to patients after each injection, and patients signed a receipt.

“We decided to offer £15 per injection. We did it for a number of reasons. First, we’ve had a positive experience with something like that. Second, we didn’t want to provide that much money that later could be seen as making patients finally dependent. It also had to be under £20 because that would interfere with benefits entitlements, and that’s important because 99% of our patients are on benefits,” Priebe elaborated.

The primary outcome was the percentage of prescribed depots received in the community within the 12-month trial period. Time spent in hospital or prison was excluded, unless shorter than one depot cycle.

Secondary outcomes were the percentage of patients with at least 95% adherence, which was meant to reflect practically full adherence (allowing for one depot to be missed in patients receiving fortnightly prescriptions), clinical improvement, subjective quality of life, and time spent in work, training, and education.

The study proved quite successful. Adherence to treatment was 11.5% higher in the intervention group compared to the control group, leading to an average adherence of 85%, which represents more than half of the potentially possible maximum improvement. Furthermore, the proportion of patients achieving adherence of 95% was eight times higher in the group receiving financial incentives.

Although there was no difference in clinical improvement between the two groups as reported by physicians, the intervention group did experience higher quality of life. Regarding secondary outcomes, five patients in the intervention group (one in control group) were employed during the study period, no patient was in formal education, and seven patients in the intervention group (five in the control group) attended some type of training course, suggesting that regular treatment might have allowed patients to organize their lives better, cope with problems, and engage in satisfying activities. The authors also speculate that receiving money from services had a psychological effect in some patients, increased their confidence, and facilitated a more positive view of life.

It seems that, although controversial, financial incentives do hold some promise of improving the health journeys of people suffering from psychotic illnesses. Improved medication adherence, more positive experience of the health services, better quality of life are much sought-after outcomes in the treatment of schizophrenia and bipolar disorder, and no avenue of research should be discarded.

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Adherence: The Mother Lode of Value Added Services – Or Not?

David Laws — Tue, 04 Feb 2014 10:12:04 +0000

Précis:

This is the third in my series of articles about Value Added Services and no discussion on the topic would be complete without a deep dive into Patient Adherence. At least from a pharmaceutical company perspective.

It should be pretty obvious why adherence is so intrinsically linked to this topic. The numbers being thrown around for non-adherence are truly staggering!

It is important to recognize though that while adherence is talked about as a win, win, win service, when one speaks with non pharma healthcare stakeholders, adherence does not often feature at the top of the list of services and solutions they need and want. Ask a physician what services they need and adherence is usually not near the top (many don’t think adherence is a problem for them and their patients), ask the same question of patients and adherence is not there, payers too have a different set of needs they would like help with.

Pharma needs to be careful about selective hearing and translating a verbalized customer need and turning it into an adherence solution.

Yes, some of the problems these stakeholders vocalize could benefit from improved adherence, but, pharma needs to be careful about selective hearing and translating a verbalized customer need and turning it into an adherence solution. Certainly, for pharma, adherence is a very high priority issue.

Having said all of that though, I would certainly agree that adherence solutions can be a useful value-add if done differently. But, it may be that pharma should not think of it in terms of a Value Added Service, but rather a Beyond The Pill strategy. More on that later.

We have discussed in previous articles that adherence is nothing new. Pharma has worked hard to try to impact medication adherence for many years, and despite some success, it clearly has not managed to turn around the staggering lack of compliance.

Agreed, this has, up until now, been very much a support tactic to drive increased product sales and the resources allocated to it have been insignificant in the overall scheme of things. So, is it simply a matter of money, resources and focus? If pharma was to spend more money would this solve the problem?

I personally don’t think so, doing more of the same is likely not the solution the industry would hope for.

“But what about technology?”I hear you say! “Technology can provide the solution!”

We need to be realistic about the role of technology. It will not be the magic bullet that some folks hope for.

I’m not so sure of that either. The technology to support innovative adherence solutions has been around for years. Gone are the days when adherence meant reminder calls from a contact centre, direct mail, patient information, pill reminders via SMS to mobile phones, patient telephone counseling and the rest. Now we have patient apps, social media sites, communities of interest, websites, smart phones, wearable devices, and almost anything you can think of.

It is here today, it’s been here for years.

But the adherence issue persists.

We need to be realistic about the role of technology. It will not be the magic bullet that some folks hope for, but it can provide a useful set of tools that can help address the issue for many, but perhaps not all, patients and caregivers. Technology alone will not solve this issue – this is a people issue, so let’s not look at the latest social media tool as a quick fix for adherence.

What technology can do, is enable pharma to talk to patients one at a time, to offer individualized and personalized approaches to solve individual patient problems.

It is time to rethink adherence, to be clear what success looks like and address this problem differently from today and the past., so, what is going to have to change? What lessons should we have learnt over the years regarding adherence? Here are my thoughts, in no particular order:

· This is not about the science or the drug.

· There is no magic silver bullet.No single, simple solution will fix this problem. What works for one patient may not work for another and it will change over time. So we need a multiplicity of approaches tailored to the individual patient or caregiver.

· Technology alone will not provide the solution.Solutions need to be crafted using all the available channels and technologies that are available, including more expensive options - people and contact centres for example.

· How can pharma be patient focused one brand at a time?The most engaging adherence programs will likely address patients holistically and not be purely brand focused.

· Patients do not want to be compliant, adherent or anything like that.They have their own health goals and ambitions and the healthcare industry should better understand what these are and align around how to better help patients achieve their objectives.

· Align incentives and measures to accurately reflect what programs are trying to achieve.

· Patient data, as it has always been, is tremendously important.The industry needs to build a deep and longitudinal understanding of customers (patients, healthcare consumers, caregivers etc), that assists in the improvement of outcomes without running foul of legal. Big data after all is about customers not products!

· While patient behavior may seem irrational to pharma – it makes perfect sense to patients.Pharma needs to better understand and appreciate the patient’s objectives.

· Adherence should not primarily be about education.The axiom ‘if only patients had more information’ is not helpful. They want solutions to their problems.

· Of course, adherence needs to focus on the patient.It’s easy to say, put the patient first, but it has proven much harder for pharma to do in practice, as, for most of them, the drug always comes first.

· There is nothing wrong with building traditional adherence programs to support an individual brand. But it is going to be increasingly difficult to convince healthcare consumers to use them once the next generation of solutions becomes available.

· Change the name. Change the thinking. Words are important.

As I mentioned before, maybe it is better for pharma to think of adherence as a ‘Beyond the Pill’ strategy, where the value to payers, patients and physicians is more than just the pill – Pill Plus if you like...

Attached to the pill are a range of tools, services and solutions to help patients get the most benefit out of their treatment. Here the product (the pill) is integrated with an adherence program and marketed as an single package

If you want to take the idea further, then disincentives would apply to patients who do not take advantage of the additional services offered in the adherence program.

The pill is prescribed on the basis that the adherence program will be utilized. Pricing etc should also reflect this Pill Plus thinking.

Value Added Services on the other hand can focus on higher priority customer needs and broader adherence, lifestyle challenges etc and be completely separate from pill sales and, more than likely, will generate additional revenue for pharma.

These two approaches can easily cohabit together and would help to reposition pharma away from only a pill sales organization to a broader healthcare company, but one that still focuses on medications and better health outcomes.

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Is Pharma Branding at Odds with Patient Engagement?

Katrina S. Firlik MD — Fri, 31 Jan 2014 13:23:12 +0000

Précis:

Regular columist Katrina Firlik, MD, looks at the negative impact pharma branding can have on patient adherence programs.

A few years ago my company ran a six-month digital medication adherence pilot sponsored by RealAge (now a part of Sharecare). It was branded as “RealAge Rewards.” It was a relatively small pilot, about 300 patients, all with asthma or COPD.

Our engagement metrics well surpassed our hopes. The mean number of logins per user per week was above 7. The weekly quiz and survey completion rates were nearly 70%. Only about 17% of the patients stopped engaging with the program altogether. When we presented our data to potential customers, some thought we must be padding the numbers somehow. We weren’t.

For one of the weekly survey questions, I decided to ask the following of this patient cohort: “How would you feel if RealAge Rewards were sponsored not by RealAge, but instead by a pharmaceutical brand or company?” Here were the responses:

31% “Fine, I would be just as happy to participate”
30% “I would still participate, but I would not be as enthusiastic”
27% “Not sure if I would still participate”
8% “I would not participate”

Now that we are running programs overtly sponsored by pharmaceutical brands, I sometimes question to what degree enrollment and engagement are potentially compromised by pharmaceutical branding.

I wonder if “fun” and “pharma” are dissonant in people’s minds, and whether or not that poses a challenge.

On the flip side, I have to assume that pharmaceutical branding is actually a plus for many patients, rather than a neutral or a negative. I’m sure it can help to convey credibility, gravitas, and seriousness of intent.

However, given that a primary purpose of our platform and others like it is to bring a sense of enjoyment—even fun—to the chore of staying adherent to a chronic medication, I wonder if “fun” and “pharma” are dissonant in people’s minds, and whether or not that poses a challenge.

We don't have clear answers yet, but to hedge our bets we do mention the following in our Implementation Guide for brands:

“There are a number of considerations regarding how a HealthPrize program should be branded, depending upon the sponsor’s goals. Please determine which of the two is the primary goal of the program:

Maximizing consumer engagement and adherence (in which case the sponsor might consider minimizing pharma branding) or
Enhancing consumer exposure to the brand or company name (in which case pharma branding would be more prominent)”

Branding affects a number of elements, including which entity is listed in the “From” line in emails, to the name and logo of the program, to whether or not Important Safety Information (ISI) is required, hogging precious space on computer and smartphone screens.

I’m not suggesting that we unduly obfuscate sponsorship (in the setting where pharma branding is kept to a minimum). A patient should know exactly who is paying for programs they chose to engage with, and they shouldn’t accept attempts to conceal this information. Instead, it’s simply an issue of degree. Is the name of the company and the medication pervasive across the site and its educational content, or is there simply a logo at the bottom of the page and in the footer of all emails?

A nice way to attempt to answer the question would be to run an adherence or engagement pilot with two cohorts of patients: one arm would be exposed to minimal pharma branding, the other would see more aggressive branding. You could then gauge enrollment and engagement differences between the two groups.

Given that digital programs in pharma—with dynamic content, multiple pages, and often a mobile app—require a significant amount of work to get approved through the medical-legal-regulatory processes (in many cases, requiring a hard-copy print-out of every possible screen shot displaying each day’s planned content, and every permutation of each screen shot, including separate copies of the accompanying mobile screens), this would be a tall and expensive order, but probably worth it.

Thinking about my own personal experience, I signed up for a digital pharma-sponsored diabetes wellness program a while ago, to see what the user experience was like. I don’t have diabetes but regardless, much of the general wellness advice targeting people with diabetes applies quite nicely to general public wishing to avoid diabetes as well, so therefore is widely applicable.

I opened the emails for a while but then stopped. One thing in particular that struck me as slightly off kilter was the pharmaceutical branding in close combination with recipes and photos of healthy entrees. Activities like visiting farmer’s markets, cooking at home with fine, fresh ingredients, and enjoying a healthy meal are more personal activities that I was somewhat averse to linking to pharmaceutical branding. I naturally and logically link pharmaceutical branding to pharmaceutical products, but I’d prefer to keep the “medical” separate from the “culinary” (even if I were a diabetic). Eating well is certainly key to a healthy lifestyle, but I feel that the “medicalization” of food is not healthy, and sometimes even counterproductive.

In other words, if I’m looking for enticing recipes, I’m seeking out a trusted culinary source, not a pharmaceutical source.

This is only one example of where branding may be a bit out of sync with a program’s intent (others may not share this sentiment regarding recipes, in particular), but I think it’s worthwhile keeping top of mind, when creating a new patient engagement program, how consumers feel about different brands. Another example: would you seek out a pharma brand or Nike in order to get motivated about exercise?

Programs with a focus on medication adherence specifically—as opposed to some form of all-encompassing lifestyle program—are perhaps less tricky, given that the branding refers directly to the products, but I would still argue for a careful consideration of degree of branding, and whether prominent pharma branding enhances vs. erodes engagement and the “fun factor.”

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Patient Adherence & The Marshmallow Effect

Kevin Dolgin — Wed, 22 Jan 2014 15:43:12 +0000

Précis:

This month Kevin departs from the business end of patient support to examine an interesting cause of non-adherence among patients - The Marshmallow Effect.

For the last year and a half I've been talking a lot about adherence and how important it is for the pharmaceutical industry. I've been blowing that trumpet for some time now, so I’ll assume you get it. If you don't, I'll refer you to columns one through however many there are now, as well as the far more convincing, erudite work done by everyone else who's been saying the same thing.

Right, so now that we all agree that pharma should be investing as much in promoting adherence as they do in promoting their drugs to prescribers, let's take a look a little at the phenomenon itself. Why don't people take their drugs?

It should be a no-brainer in most cases. Let's say you have received an organ transplant. You spent months in trepidation on a waiting list, hoping that someone else's tragedy would allow you to avoid your own. That day came; you received a telephone call, were rushed to the hospital, went through a complicated operation and finally left with a new lease on life. Some other person on the waiting list wasn't so lucky; they didn't get the organ that was transplanted into you. You try not to think about that.

And then a few months later, you die because you didn't take your immunosuppressents properly.

Not believable? Twenty to twenty-five percent of transplant patients do not fully adhere to their post-operative medicinal treatment. According to the WHO, this is the principle cause of transplant rejection. Why?

There are a few phenomena at work. Forgetfulness is part of it, but generally that accounts for less than a third of non-adherence, the rest is the result of a patient deciding not to adhere. So why do people decide not to adhere to treatment?

There are a number of reasons. One has some interesting academic names but I'm going to call it the "Marshmallow Effect". This comes from that adorable video (alas, we live in the age of adorable videos. At least it doesn't have any kittens) in which children are given a very difficult choice about marshmallows. A version of said video can be seen below:

This was actually based on an experiment conducted by psychologist Walter Mischel in the 1970's to study delayed gratification. Mischel put individual children in a room alone, sitting at a table upon which was a plate with a single marshmallow. They were told that they could eat the marshmallow if they liked, but if they waited for 15 minutes an adult would come and give them two marshmallows.

What a dilemma. One marshmallow now or two marshmallows in 15 minutes. I'm pretty sure that the videos you see on the internet are recreations of the experiment, but it's the same premise; they consist of watching the children during the fifteen minutes in question. In the beginning, most of the children hold out, but as the minutes pass, that marshmallow is looking better and better and sooner or later, most of them cave and end up eating it. Why? Sure, two marshmallows are better than one, but the one marshmallow is right now and the two marshmallows are off in some distant, hazy future.

This is one of the principle problems with adherence to treatment. Of course I want to live longer and better, and yes, taking a pill every day is a small price to pay when weighed against my health, but the benefits of better health are off in the future and the benefits of shedding the constraints of my treatment, maybe just for today, are right now. There's a lot of good research and discussion about this in adherence circles, and I'll refer you in particular to the work of Dr. Gérard Reach, but this is a short column and I'll use short words, so we'll stick with the marshmallow effect.

What does this mean for adherence programs? Well, it means that in order to counteract the marshmallow effect, there are basically three strategies:

1) Increase the potential value of the long-term reward

How about if it were ten marshmallows in 15 minutes? Some would still crack, but I'm willing to bet that a lot more subjects would hold out. What if you could make the long-term effect seem really, really important? While I'm amazed that there's 25% non-adherence for transplant patients, it's still a whole lot better than hypertension or even diabetes. Why? Because the future reward - survival - is more striking than some reduced risk that may never come into play. A good adherence program will try to demonstrate the long-term benefits of the treatment in great detail.

2) Decrease the attractiveness of the short term award

What if it weren't a marshmallow now, but that nasty, salty black licorice you get in Scandinavia versus two marshmallows in 15 minutes? OK, I apologize to my Scandinavian readers, but you got to admit it's an acquired taste. In terms of adherence programs, this means reducing the attractiveness of non-adherence, which generally means making the treatment easy to follow. If I have to store the thing at a prescribed temperature, then mix two elements carefully before administering an injection then clearly non-adherence is more tempting than if I just have a take a pill once a day. This is doubly the case if I never really understood the details of how I'm supposed to prepare that injection in the first place. Making your drug easy to take; through packaging, formulation, administration devices and training can help your adherence rates.

3) Bring the benefits forward

How about one marshmallow now or two in five minutes? A good adherence program will try to find treatment benefits that are solid, understandable and short term. Consider smoking cessation (I confess, I just wrote a detailed paper on smoking cessation adherence for a client... very interesting stuff). You can get much more success if you mix your message about long-term benefits with some clear, short-term benefits as well: enhanced taste, better stamina, increased virility (that always perks up the ears of your male patients). What are the short-term benefits of your drug?

The marshmallow effect isn't the only factor driving non-adherence, but it's a very real and very pervasive one and you'd best consider it when building a patient adherence program.

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The Cost of Being a Caregiver

Mary Assimakopoulos — Tue, 14 Jan 2014 15:22:52 +0000

Précis:

This month Mary concentrates on one of the most oft-overlooked stakeholders in healthcare, the caregiver, and asks: for someone so integral to patient adherence and support, is there more we can do to provide care for the carer?

There is now a concerted effort on the part of the leading pharma manufacturers to try to understand patient needs as much as the needs of physicians – aptly demonstrated by this quote from Petteri Jarkka, Customer Engagement Manager of Janssen:

"The most common reason for failure we've had is that we haven't been close enough to the customer to understand the need. That is the most common - in fact the only reason. When you do understand the need and you're able to provide the service, that's pretty much it."

Which is certainly good news for patients and a step in the right direction. But what about the needs of the caregiver? According to American charity, the National Alliance for Caregiving (www.caregiving.org), 29% of the US population have been identified as having a caregiving role. The caregiver, whether they be a spouse, parent, child or other person related to or friends with the patient, is often overlooked as a provider of frontline care. Unfortunately, their emotional, financial, practical needs and wellbeing can be insufficiently taken into account. Support can be limited and poorly formalised. Yet research shows they have a very important role in disease management and in determining the outcome and quality of life for the patient.

Studies such as that carried out for the Alliance for Aging Research amongst US oncologists, demonstrate that caregivers are believed to have a major impact on patients’ disease management. The study, conducted by Harris Interactive, revealed that 90% of oncologists felt that the caregiver has a moderate to major impact on the decision-making process, and 77 percent feel that older colon cancer patients experience better disease outcomes with a caregiver’s involvement. About 80 percent of oncologists surveyed say that they depend on caregivers somewhat or a great deal to act as an intermediary between themselves and the patient.*

As well as understanding the needs of the patient, big pharma has an opportunity to increase their understanding of and identify ways of supporting or providing channels of support to the caregiver, as a deliverer of frontline care.

Recent research projects we’ve been involved with have certainly identified unmet needs amongst caregivers. According to a study carried out in multiple myeloma, the carer’s journey during the patient’s treatment is one of isolation and apprehension. They report feeling scared and confused at diagnosis, worried and alone with nobody to talk or confide in during initial treatment and unsupported during the treatment review stages. One patient stated “I am a bit overlooked in all of this. The doctor never asks how I am. I know she is busy and can’t do everything, but it would be nice if she sometimes asked if I was OK“.

A patient from one of our studies said, “They offer a psychologist for the patient, but I’ve never heard anyone say it was also for the family."

Amongst other needs, carers’ identified the need for more forums where they could exchange information and share concerns, and were also looking for more honesty from the HCP as to the extent of the disease, side effects and the likely outcomes from transplants. In other research where we looked at how caregivers access support, we found that associations and advocacy groups are often seen as being a great help, and perceived to offer much more information and support than HCPs. Family and friends are often quoted as the most important source of emotional support, but the internet can also be very helpful with many citing facebook pages and disease websites.

Bearing in mind that carers are often old and may be unwell themselves, or they may be a sibling who has a full-time job and maybe a family of their own to take care of, the burden on them, both emotional and physical, can be very significant. The caregiver often has to take on responsibility for the majority of household chores and managing household finances, as well as looking after the patient in terms of washing them and dressing them, helping them eat, providing their medication, taking them to appointments and providing emotional support.

A patient from one of our studies said, “They offer a psychologist for the patient, but I’ve never heard anyone say it was also for the family. It might help you continue to live your own life and not be completely swamped by the disease, because it takes up a big space in the house and in your life as a couple.”

The carer often has different priority needs at each stage of the patient journey. Our research revealed that the length of time to diagnosis for some diseases can mean a long period of uncertainty, fear and confusion, which some carers can find very difficult to cope with. At this stage, many carers, as well as patients, require emotional support and information to help them through this time. During the progression stage of the disease, caregivers need coping strategies, support groups and mechanisms of support. The carer can suffer intense pressure during time of relapses. If the patient is a child, then the caregiver needs to be able to help the child as they progress into adulthood. And if the patient does pass away, the caregiver will require support with grief, loss and being able to cope with living alone or without the patient.

Like patients, pharma needs to recognise that caregivers have different profile types, and in fact these profiles can often mirror that of the patient. So for example, the patient who is fighting the disease may also have a caregiver who mirrors this “fighting” behaviour and language. The depressed patient, who feels overwhelmed by their disease, may have a depressed caregiver. As they have begun to do with patients, so pharma needs to recognise the significant role of the caregiver in the patient journey and see how it can provide better support to the caregiver for improved outcomes.

Questions or comments? You can share your thoughts with our audience in the comments section below, alternatively you can email the author directly at marya@researchpartnership.com.

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Using Electronic Patient-Reported Outcomes (ePRO) for the First Time: Lessons Learned

Darja Turner — Thu, 19 Dec 2013 10:02:09 +0000

Précis:

The importance of patient-reported outcomes (PROs) is evidenced by their increased use in clinical trials and in drug and device label claims. Here Darja Turner shares her experiences using an electronic PRO tool for the first time.

In many cases, the best way to measure symptoms and functional status is through insights provided by the patient, but few people know how to go about integrating ePRO (electronic patient-reported outcomes) into their clinical trials. I completed a Phase 2 clinical trial using electronic an ePRO for the first time and identified the key decision points, responsibilities and lessons learned for incorporating ePRO into our clinical trial practices.

ePROs improve data capture, quality andtransparency, but few people are experts at integrating ePRO into their clinical trials. Here are my “lessons learned” for integrating ePRO in a Phase 2 clinical trial, along with suggestions on how to plan and use these insights for future projects.

Study Protocol and ePRO

FDA Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims states, “If a patient diary or some other form of unsupervised data entry is used, the clinical trial protocol is reviewed to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected.”¹This is a critical requirement!

The protocol in this proof of concept trial required patients to complete a daily questionnaire in the evening between the hours of 6:00 PM and 11:59 PM using a visual analogue scale (VAS) score as the primary data endpoint. Other protocol features included:

A complex algorithm that analyzed patient criteria for enrollment and randomization (masked from both sites and monitors):
- The ePRO instrument calculated eligibility from data collected from the patient. The algorithm processed patient data and once the algorithm calculations were complete, eligible patients were enrolled and provided with a bi-weekly schedule of study visits.

Three different ePRO questionnaires were due for completion at different collection times:

Daily, between 6 PM and 11:59 PM;
Bi-weekly at every visit, activated at every visit and available until 11:59 PM; and,
The ePRO collected patient diaries using either US English or US Spanish.

Benefits of Using an ePRO

There are numerous benefits to using PROs, and very clear advantages of ePROs over paper-based tools. Although additional training for study sites is required with ePRO, the use of this technology offers cleaner data capture so study coordinators can spend more time with their study participants and potentially enjoy higher patient compliance. Electronic PRO eliminates missed, illegible, or illogical responses.

Study coordinators are exempt from manual calculations, and from spending precious time reviewing or deciphering patients’ handwritten diaries.

Efficiencies are realized with accelerated data availability from electronic capture, including the elimination or reduction of missing data. Data collected by an ePRO is in real-time within the context of the patient’s life. The ePRO collection of diaries and questionnaires improves the data quality for analysis and trial management.

Depending on the study design, patients cannot backfill or forward-fill diaries, because questionnaires can be programmed to appear and disappear at set times.

Here’s how it works: A time and date stamp is created when the subject logs in, so an audit trail is created. Time and date stamps are “proof” that patients complied with the protocol and completed the questionnaire during the intended time. In my study, patients were asked to choose to receive their instruction in English or Spanish, whichever language was most suitable to them, thereby eliminating the need to estimate how many questionnaires to print in each language for every site.

Selecting an ePRO System: Assessing Advantages

Careful upfront planning can save time and money during study execution. With less than two months to set the entire trial up, I selected two electronic systems to collect study data: an interactive web response system (IWRS) and an ePRO system. Study planners noted that in their experience, integrating IVRS/IWRS and ePRO resulted in fewer errors, minimized the number of data clarification forms (DCFs), and allowed better control of keeping study costs aligned with budgets. Each technology system captured the applicable study data.

If the patient met the eligibility criteria, the investigator logged into the IWRS and received a study patient number. The patient number was manually entered into the ePRO device.

When the patient number was manually entered on the ePRO mobile device, the device was then given to the patient. It was used to collect patient data in transit.

We chose an ePRO system that offered a number of advantages to address the complexity of this trial. The ePRO system provided to study participants included mobile eDiary device, a Wireless Pak for transmission, and in case the wireless transmission failed, a TeleCradle for analogue transmission. The mobile eDiary device was portable and lightweight, with a compact screen.

Two devices were ordered for each of the investigative sites since expectations were to have no more than two active patients enrolled at each site at any one time. The working plan was that if one subject did not meet the criteria and had to be discontinued, the device would be reassigned to a new patient. The same held true for those that finished the trial; once a patient completed the study the device would be reassigned to a new study patient meeting enrollment criteria. However, the initial plans were inadequate and it became necessary to re-order additional devices; in some cases, many more than two per site.

The study sites had several responsibilities for monitoring patients once they were enrolled. These included the daily checking of patient compliance through the online reporting portal and contacting any patients at risk of non-compliance, or just needing to charge the batteries of their device. During training, site investigators or study coordinators were required to demonstrate an understanding of how to work with the eDiary and to answer questions about the device (or, know when to refer questions to the vendor’s Support Center). Each patient was expected to receive 15 to 30 minutes of training from the study coordinator on how to use the eDiary.

Initially, many patients called the vendor’s Support Center for eDiary training and questions, either because they didn’t remember some of the instructions once they had departed from the study site or the initial training wasn’t intensive enough. The solution was to develop a study-specific Troubleshooting Guide to address the most common questions, with the aim of reducing the Support Center call volume. It took approximately 10 days while waiting for the guide to be approved by the IRB.

Once patients received their ePRO device from the study coordinators or investigator, they were required to complete their diaries each day for two weeks. At the first visit following the initial screening, patient compliance was assessed with the touch of the button on the ePRO LogPad. With three separate questionnaires distributed at different points within the study, the potential for human error (and disseminating an incorrect questionnaire) was real. The ePRO system provided the right questionnaire to each patient at the right time and helped mitigate the potential for human error. If a patient withdrew early or completed the study, a final questionnaire was provided at the time of study withdrawal or completion.

Study sites were further supported by PHT with 5 key elements:

An online reporting portal: For the study coordinator to monitor patient compliance.;
An eDiary training kit: For study coordinators this was included that showed how to use the ePRO device with instructions for training their patients. Each patient was allowed to practice on the training eDiary before being issued their own;
A 20-25 page site support guide: Specific to the Phase 2 trial. It included directions on how to log into the online reporting portal, the expectations of each study visit, and how to train and work with participants for ePRO study success;
Documents generated by our study team: Providing instruction on how to use the ePRO system were approved by the study Institutional Review Board (IRB). Power adaptors, power cords, a universal pictorial step-by-step “getting started” card, and support materials were supplied by the vendor; and
A study archive of all data collected at the site: Furnished at the end of the trial.

Items to Consider: Where We Erred and Some “Lessons Learned”

Human Error

Data entered into and analyzed by the eDiary determined eligibility, randomization and study medication kits. Since a single patient number connected the IWRS to the eDiary, it was critical that the Sponsor Clinical Trial Manager ensure that the correct patient number had been transcribed from one system to the other. Discrepancies can only be resolved with Data Clarification Forms (DCFs).

Lesson Learned: When two technology applications are used, such as IWRS/IVRS and ePRO, enable them to transmit data between the systems.

High and Low Enrolling Study Sites

Don’t forget that the success of any clinical trial is largely determined by the investigative sites that enroll patients, so have adequate ePRO devices when and where they are needed. Every study has high performing sites and low performing sites, and this trial was no exception. Costs add up quickly when ePRO devices must be shipped urgently overnight. Additional devices need to be on hand for keeping the high performing sites stocked.

Lesson Learned: Order your ePRO devices wisely in the initial contract to keep trials and budgets managed and on track.

Data Transmission

Find out up front if the patient lives in an area that supports wireless transmission of data. There are areas in the US (and other countries as well if you are considering using ePRO for global trials) that do not have adequate cellular reception to support wireless transmission. It’s best to provide each ePRO device with a choice of transmission methods, both digital and analog just in case. Having options avoids downstream frustrations for both patients and the investigative sites. However, in this experience, even on the occasions when disruptions with transmission did occur, the data were retained in the PHT LogPad, so no study data was lost. In those circumstances, the investigative site transmitted data during the bi-weekly patient visits.

Lesson Learned: Ensure whatever ePRO device you select retains study data until transmission is possible.

Site Support and Training

Despite carefully scripted training and mentoring for our sites, reality sometimes trumps expectations. The vendor’s Support Center received a higher call volume than expected for general questions and ePRO training. Study sites should check StudyWorks on a regular basis.

Site-specific emails went out to each site every week to identify patients where follow up with study coordinators was warranted (i.e. compliance, missed entry, low battery status, etc.). Additional ancillary training was provided throughout the course of the trial to address concrete, not hypothetical, questions arising from hands-on experience. Summaries of key messages were disseminated in bi-weekly newsletters so sites could learn from each other. We also scheduled regular “town-hall” meetings where, whoever wanted to, could call in at a specified hour and ask questions, talk or share experiences with others. Our efforts paid off with very high compliance across all sites.

Lesson Learned: Schedule at least two hours for an ePRO Investigator meeting so everyone has plenty of time for hands-on training. Consider refresher training for sites and monitors to bridge any gap between the Investigator Meeting and first patient in. Stay involved. Ultimately it’s the sponsor’s responsibility to keep sites and patients engaged as active participants.

Plan for Success

Here are some additional suggestions to successfully plan for an ePRO study:

The ePRO Vendor

Select your ePRO vendor early and take time to understand their processes, document flows, and timelines. Get to know your Project Manager and Coordinator to establish who is responsible for what at each stage of the study, so handoffs are smooth. Leverage the ePRO vendor’s years of operational experience by including them during protocol writing and all planning phases so reasonable endpoint data and instruments (according to FDA guidelines) are used for protocol development.

Any modification to existing questionnaires requires more time to prove fit for purpose. If a combination of collection solutions is used, such as IWRS and ePRO, consider integrating these devices to eliminate the chance of manual errors. This will deliver fewer errors, reducing frustration and costs. However, some integrations may increase the trial timeline, so plan accordingly.

The Clinical Trial Team

Assemble the core team early. Your data management, site management, and biostatistics colleagues need the same understanding of timelines as you to facilitate rapid approval of documents such as Confidential Disclosure Agreements (CDAs), ePRO contract, Statement of Work (SOW), Data Summary (DS) and Data Transfer (DT) Specifications, and User Acceptance Testing (UAT).

Review the ePRO Requirements Document carefully, as this determines what the trial will look like, and all that is required at each step along the way. Any change to this document later, even a minor modification, has an impact on the trial timeline. Changes require that the ePRO vendor program and test the trial changes in all languages.

While every document is important, the Requirements Document is the most important.

More extensive protocol amendments can disrupt budgets and timelines. A thorough Requirements Document review allows for solid initial software deployment and avoids subsequent updates. Test the ePRO device extensively during the user acceptance testing, and document the findings. These test results will be needed later for the test data transfer.

The Investigator Sites

It’s important to confirm and verify each site’s mobile network and signal strength before determining which transmission devices to ship to the site for an ePRO study. If possible, select “technology-loving” sites and study coordinators. If the site is ePRO naïve, be sure the study coordinator is familiar with electronic devices (especially computers and mobile phones). Consider adding an extra study coordinator if the study coordinator is not comfortable with technology.

Study coordinators are training the patients enrolled in the trial, so plan adequate time (preferably 2 hours) for the investigator meeting. The better they know how to use the eDiary, how to charge it and transmit data, the better the patients will be trained. Better training means higher compliance.

Keep sites involved and informed. Remind them to check their online reports daily. It is important to monitor the eDiary battery level and patient compliance. Remind study coordinators that the sponsor can review a Support Center report. Consider publishing a monthly newsletter featuring anonymous questions/answers about the trial, or the most frequent questions addressed by the vendor’s Support Center. This is a very effective reminder for sites that are reluctant to ask questions of the sponsor.

Conclusion

The keys to ePRO success are to:

1. Plan early

2. Pick an experienced ePRO vendor as a guide

3. Properly educate and allow hands-on training for users

4. Anticipate some human error

5. Provide on-going training and communication of best practices to the sites

Ideally, it takes six-eight weeks to set up and troubleshoot an ePRO system, not counting legal review, so allow plenty of time for contingencies.

Undoubtedly there is more upfront work required to use an ePRO System but in the end proper planning can save time, money and frustration. An experienced ePRO vendor will be familiar with data transfers, communication, training and integration of the ePRO with IWRS/IVRS, so it’s important to pick a knowledgeable partner. As more outcomes data are required for claims by regulatory agencies and payers, ePRO is the way of the future.

¹US Dept. of Health and Human Services. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid.... 2009: Accessed August 1, 2012.

About the Author

Darja Turner, lic.phil.I, Clinical Psychologist, studied Clinical Psychology at the University of Basel where she completed her training in 2001. Her experience includes management of numerous trials including the first ePRO trial of a leading pharmaceutical company. Ms. Turner’s views and opinions expressed are personal and should not be attributed to any organization. She can be reached at D.Turner@gmx.ch

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Does the ‘Healthy Adherer’ Effect Muddy the Waters in Medication Adherence?

Katrina S. Firlik MD — Wed, 27 Nov 2013 14:42:17 +0000

Précis:

It’s quite clear that across medical conditions, higher levels of medication adherence are associated with better health outcomes. You may or may not have noticed my careful word choice: “associated with.”

Certainly, it’s widely believed that most approved medications have a strong hand in causing positive health outcomes, with better adherence causally linked to better outcomes. But there are a few wrinkles here. Medicine is not quite so neat and tidy. Consider these interesting findings:

A meta-analysis published in the British Medical Journal showed that better adherence to placebos are correlated with better outcomes, specifically lower mortality rates.¹This was across a number of conditions, including coronary artery disease, HIV, and diabetes.
A study published in Circulation demonstrated that high statin adherence is associated with a significantly decreased risk of motor vehicle and workplace accidents.²
In a double-blinded, controlled, randomized clinical trial of placebo vs. medication in congestive heart failure, published in The Lancet, higher adherence was associated with better outcomes—35% lower mortality—for both arms of the study.³

What’s happening here? The “healthy adherer effect” is a key consideration, which is the concept that patients who are careful about adhering to their prescription medications are the same sorts of patients who are likely to adhere to other healthy behaviors that can influence outcomes, like eating right, exercising, avoiding smoking, limiting alcohol, attending regular doctor visits, undergoing screening tests and getting flu shots. I might as well add a few other critical behaviors also linked to decreased mortality: wearing a seatbelt, driving at the speed limit, and avoiding drinking and driving. Probably the same patients here, too.

As an aside, it’s also worth acknowledging that some medical studies, when later repeated by different research groups, reveal completely different results, casting uncertainty on the original studies. This could potentially be the case, for example, with that third study of CHF patients. See this fascinating piece in The Economist…but I digress.

You might even extend the healthy adherer concept to other behaviors. Consider the ridiculous notion of studying the “effect” of statin adherence on voting compliance during election years. I’m almost positive that higher statin adherence would be correlated with a statistically significant higher rate of voting.

Such a study would never make it into the medical journals, but other studies with questionable underpinnings most certainly do, particularly in the lesser journals. The healthy adherer bias may be particularly strong in the study of vitamins and supplements, leading to unwarranted claims, as patients who go out of their way to purchase them out-of-pocket are particularly concerned about their own health and well-being and likely to follow a host of helpful behaviors.

In any medication adherence vs. outcomes study, then, it can be a serious challenge to isolate the specific role of the medication. Most studies, actually, don’t even try.^4,5After all, consider how difficult it would be to accurately assess every other healthy behavior in a population, or even to figure out which behaviors mattered most. You certainly wouldn’t want to rely simply upon self-reported questionnaires of adherence to exercise, diet, smoking, seat-belt use, etc. Not to mention factors beyond the behavioral that might also affect outcomes: air quality, income, intelligence, social support, and so on. The promise of big data, with big sample sizes, diverse data sets, and longer timelines, may help clarify things going forward, assuming that we have the right data and data of adequate quality.

It’s reasonable to assume that disentangling the healthy adherer effect from the effect of medication adherence alone is trickier in certain conditions as compared to others. The influence of diet and exercise in diabetes, for example, is arguably stronger than it is for a condition like Gaucher’s disease, where adherence to medication is likely—far and away—the most critical form of adherence.

Regardless, the point here is not to despair that when it comes to medication adherence, nothing can be known for certain. Disentangling behaviors is simply too hard and health outcomes are maddeningly multi-factorial. Instead, the point is to always keep the healthy adherer effect in mind when assessing medication adherence studies, to see if the authors at least tried to account for it, and to maintain a healthy dose of skepticism (but not cynicism), like all good scientists do.

Shrank et al conclude: “Failing to account for behaviors that correlate with medication adherence will lead researchers to conclude that preventive medication use and adherence to preventive medications are more strongly associated with outcomes than is the case.”⁴

Dormuth et al conclude, in their statin and car accident study: “Our study contributes compelling evidence that patients who adhere to statins are systematically more health seeking than comparable patients who do not remain adherent. Caution is warranted when interpreting analyses that attribute surprising protective effects to preventive medications.”²

I conclude that yes, the healthy adherer effect does muddy the waters when it comes to interpreting the magnitude of the role of medication adherence in health outcomes. But I would also conclude that in an effort to improve outcomes, we need to promote adherence to as many healthy behaviors as possible, including taking necessary prescription medications. Isn’t that what the modern “holistic” approach is all about?

References

Simpson SH, Eurich DT, Majumdar SR, et al. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ 2006 July 1; 333(7557):15.
Dormuth CR, Patrick AR, Shrank WH, et al. Statin adherence and risk of accidents: a cautionary tale. Circulation 2009;119(5):2051-7.
Granger BB, Swedberg K, Ekman I, et al. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHARM programme: double-blind, randomized, controlled clinical trial. The Lancet 2005;366(9502):2005-11.
Shrank WH, Patrick AR, Brookhart MA. Healthy User and Related Biases in Observational Studies of Preventive Interventions: A Primer for Physicians. J Gen Intern Med 2011;26(5):546-50.
Bitton A, Choudhry NK, Matlin OS, et al. The Impact of Medication Adherence on Coronary Artery Disease Costs and Outcomes: A Systematic Review. Am J Med 2013;126:357.e7-357.e27.

Questions or comments? You can share you thoughts with our audience in the comments section below, alternatively you can email the author directly at kfirlik@healthprize.com.

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Patients in China: the Silent Stakeholder

Mary Assimakopoulos — Mon, 25 Nov 2013 11:09:36 +0000

Précis:

This month Mary Assimakopoulos, talks about the issues around healthcare access for patients in China and highlights some of the adherence issues unique to the region.

As a person living in China, a socialist country, you might expect healthcare to be offered free of charge or at least heavily subsidised. The truth is, according to a study published in the Lancet, patients in mainland China in 2010 self-paid 60-70% of their outpatient costs and at least 50% of the cost of inpatient treatment. The implications of this are that the patient and their immediate family need to be considered as key stakeholders in treatment decisions for three key reasons:

In the absence of a formal primary care system, patients are free to present to any health facility/doctor specialty that they choose.
Patients typically have to pay out of their own pocket for a significant proportion of their healthcare costs.
As payers, patients decide their own duration of therapy and adherence to treatment.

The impact of having no formal primary care

Some patients in China are suspicious of doctor’s prescribing decisions, referring to them as “white wolves.”

Currently only around 10% of healthcare spending is delivered at a primary care level. Effectively this means that there are no General Practitioners and no formal referral process. In the absence of a classic screening and referring model, patients are free to present to any hospital they want to (or more correctly where they can afford).

How does a patient decide where to go? Patients who want the best treatment must educate themselves as to which is the best doctor/hospital to attend. So they actively seek out information to make an informed choice. They turn to the internet, searching both domestic and international websites, and to friends and family, valuing personal recommendation. As a consequence, patients in China are arguably more health aware than patients in other countries. They are also more engaged and play a more proactive role in their treatment decisions.

Patients typically pay 60% of the cost of their treatment out-of-pocket

Patients and their family must bear a significant cost of healthcare even if they are covered by social insurance. As a result, many patients cannot afford anything more than basic treatments. Those who can afford them must decide whether they are willing to pay. The hospital system makes money by marking up the cost of medicines and some believe this creates an incentive for doctors to prescribe more costly treatments. Consequently, some patients in China are suspicious of doctor’s prescribing decisions, referring to them as “white wolves”.

However, the healthcare system is now being overhauled and (slowly) moving towards a fee per service. The patient will be able to decide what level of specialty they want to see (42 RMB for the equivalent of a GP up to 106 RMB for a specialist) and will still play an active role in their treatment decisions.

Duration of therapy

If [traditional Chinese medicines] are thought to be mild and gentle, then the opposite is true of western style medicines, which are thought of as being very strong and possibly detrimental to the patient’s long-term health.

As many patients are footing their own healthcare bill, the duration of therapy is impacted by affordability and willingness to pay. This is especially true for chronic conditions, and even more so for asymptomatic illnesses such as hypertension. However, there is a concept of patient reluctance that goes beyond just money.

In Chinese philosophy when a patient becomes ill because their body is out of balance. Traditional Chinese Medicines (TCMs) are thought to gently restore the body to balance and therefore bring the patient back to health. However this does not hold for allopathic medicines and many patients are concerned about the impact of taking medication over an extended period. If TCMs are thought to be mild and gentle, then the opposite is true of western style medicines, which are thought of as being very strong and possibly detrimental to the patient’s long-term health. This perception can have a negative impact not only on the duration of therapy but also on adherence to ongoing therapy. Patients are known to reduce doses or skip doses altogether. They don’t refill their prescriptions on time and take drug holidays. Obviously this behavior can impact the efficacy of treatments and if a patient’s condition is not improving then they question the drug’s effectiveness.

In China, the patient is a very important stakeholder. They decide when and where to present, whether to start a treatment, how much they are willing to pay and for how long. All of these factors have a direct impact on brand uptake, treatment adherence and the duration of therapy. If pharmaceutical companies want to understand the treatment flow and the buying process then they are strongly advised to include the patient in China.

We have seen a willingness on the part of patients to be actively involved in their treatment journey, from information seeking all the way through to paying for medicines. We would suggest that Chinese health consumers have a greater health awareness than in other countries and engagement in their treatment decisions, not because they want to but because they have to. In the absence of primary care, patients must be actively involved if they want to ensure the best treatment.

Questions or comments? You can share you thoughts with our audience in the comments section below, alternatively you can email the author directly at marya@researchpartnership.com.

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Adherence Measurement: More Complex Than one Might Think

Katrina S. Firlik MD — Tue, 29 Oct 2013 13:59:52 +0000

Précis:

Medication adherence is on the radar more than ever before, so it’s important to understand the basics of how adherence is typically measured and the shortcomings of these measurements.

At first, measuring adherence seems like it should be quite straightforward but it’s actually far more complex than one would initially think.

Overview of Adherence Measurements

In the academic literature, adherence is typically measured in one of two ways: compliance and persistence.

Compliance: a measure of the number of days over the course of a specific time period (typically one year) that a medication is “on hand” and available to the patient. The two common forms of measurement are:

MPR: medication possession ratio, expressed as a percentage or ratio. An MPR of 50 percent or 0.50 means that based on actual fill frequency through the course of the year, a patient had a medication on hand and available to take 50 percent of the time.
PDC: proportion of days covered. This measurement is nearly equivalent to MPR but is less likely to slightly overestimate adherence in the event that a patient consistently fills early (in which case an MPR measurement would “double count” those days).

Note that the terminology here is not always consistent. Many people use “compliance” and “adherence” interchangeably. The important thing is to define what, exactly, is being measured and how.

Persistence: a measure of how long a patient continues to refill until they “quit,” typically measured in terms of the number of months. This measurement is variable and completely dependent upon how one defines the grace period. In other words, after what period of time, without a refill, is a patient deemed “off therapy”: 30 days? 60 days? 90 days? Longer?

Consider the following factors when evaluating persistence. A persistence of 6 months does not necessarily mean that a patient filled six consecutive 30-day fills (that would require 0 “gap days” between fills—a rarity). It could mean that they filled only twice during that 6-month time period. It depends upon the above definition. In reality, many patients tend to go on and off therapy. They may persist for 4 months the first time around but then be convinced by their physician a year or two later to go back on therapy.

The tricky issue, of course, is that patients who have quit refilling tend to fall off the radar screen, despite being the ones in greatest need of adherence interventions.

The pharmaceutical industry often refers to persistence as “persistency,” although whether or not there is any true distinction between the two terms is unclear.

When it comes to evaluating long-term health outcomes, persistence is arguably the more significant factor, given that outcomes are likely to be worst in patients who have quit therapy altogether, in comparison to patients who continue to fill but are imperfect in their day-to-day medication taking, thereby demonstrating “gap days” between fills. The tricky issue, of course, is that patients who have quit refilling tend to fall off the radar screen, despite being the ones in greatest need of adherence interventions.

Commercial Considerations

For purposes of measuring the return on investment for a commercial adherence program for a pharmaceutical brand, the most logical form of measurement is mean number of fills per patient over a specific time period (such as one year), given that the above academic measurements do not directly reflect the number of fills.

Calculating a return on investment, though, requires some comparison to a control. The control could be: (1) the brand’s historic mean number of fills per patient, or (2) comparison to a concurrent—same time period—control group (in other words, comparing the mean number of fills for people on a specific adherence program over one year to the mean number of fills for people not on the adherence program over that same year). In our experience with pharmaceutical companies at Healthprize, not all brands have an accurate handle on their historic baseline fill data, which can be problematic in designing ROI methodology.

How accurate is adherence tracking?

There are a number of considerations regarding accuracy, largely based on which database is being used to determine adherence rates. Regardless of database, the simple data typically being tracked is the date of fill of a specific medication.

There are, of course, dozens of devices available that track the opening of a pill container, or even the ingestion of a pill, with new devices seemingly arriving on the scene every month, but these are not included here in the discussion. Obviously, the use of such a device can be a valuable adherence intervention in and of itself, as the patient’s knowledge that they are being tracked can improve adherence, at least short-term.

Reliance on any one database comes with the risk of underestimating true adherence in the following scenarios:

Copay card database: the patient stops using the copay card but continues to fill or switches their pharmacy and therefore loses copay card continuity. Alternatively, the copay card may be expressly time-limited (good only for the first 12 fills, for example).
Pharmacy, PBM, or insurer database: the patient continues to fill but has switched their pharmacy, insurer or PBM.
Adherence program database: the patient continues to fill but has stopped engaging with the program (and hence, verifying their fills through that program).

A patient who switches from statin #1 to statin #2 may be considered non-persistent from the standpoint of statin brand #1, but not from the perspective of a health plan or PBM.

A critical question that must be asked in order to evaluate adherence accurately is: How are 30- vs. 90-day fills handled? Does a 90-day fill count as one fill or three fills? From a commercial ROI perspective, the preference wouldbe to count a 90-day fill as three 30-day equivalent fills (although, given that a brand may not earn precisely three times the revenue for a 90-day fill, this nuance could be factored into the equation if ROI is being measured). Given the greater push for 90-day fills—an adherence intervention in itself—this is a key consideration.

Another critical consideration is how drug switches are handled. Clearly, this is a matter of perspective. A patient who switches from statin #1 to statin #2 may be considered non-persistent from the standpoint of statin brand #1, but not from the perspective of a health plan or PBM.

A final question, especially when it comes to evaluating adherence interventions, is: How are patients who quit the program handled? In this case, there are two forms of adherence: (1) adherence to the medication and (2) adherence to the program. Are patients who quit and “lost to follow-up” excluded from analysis, as they might be for a drug trial? Or are their fill rates after quitting the program analyzed, if possible? After all, the best adherence programs are ones that would continue to have a lasting effect, even after only a couple months’ worth of engagement.

So many considerations here, and far more complex than one might think.

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Stakeholder Collaboration in Support of the Patient

Thomas Disley — Tue, 15 Oct 2013 14:40:00 +0000

Précis:

Dr. Detlev Parow, Statutory Health Insurance, DAK-Gesundheit shares insights into how patient support is valued at DAK-G and why stakeholder collaboration is key to delivering next-generation patient support.

The story with patient support programmes at DAK-Gbegins over decade ago, when they began providing a service for patients with chronic conditions who were changing from one care setting to another, “There was an issue with continuity of care, which was being lost when a patient went from a hospital setting to say a home setting,” says Dr. Parow.

DAK-G put in place a system to track these movements of the patient and ensure consistency in the delivery of care. It was also around this time, in 2002, that DAK-Gstarted implementing disease management programmes for certain chronic diseases such as diabetes, coronary heart disease, COPD or asthma. Not only were they one of the first to start doing this, but they managed to implement this on a regional and national level. As Dr. Parow puts it, “DAK-Greally did support patient services from the start.”

Fast-forward to the present day and DAK-Gare still very much at the forefront of delivering next-generation patient care. Dr. Parow iterates that “it remains a real goal to assist the patient and deliver help to the patient where possible.”

Although it remains too early to share details, Dr. Parow confirms that they have “a few special programmes that they are currently developing for people with chronic conditions.” DAK-Gis currently working closely with external partners for these projects, including pharma, to conceptualise and define what better support could look like. The primary goal is to look for new approaches to help people who are suffering from hard to manage chronic conditions who still need help with adherence.

In the past, when pharma would turn up with a readymade solution for one of their products, the patient solution would not make sense at all from the insurer’s perspective.

Dr. Parow stresses that this development, whereby they are collaborating closely with pharma, presents an important step forward in terms of how patient support programmes are being created and designed. “In the past, pharmaceutical manufacturers & insurance companies were not 'friends', but now it is changing, they are collaborating more and more. Previously selling the product was pharma's goal and of course insurance companies had a different focus. But now there is a change. Pharma now engage to deliver patient support even in areas where they don't even have a product. Of course, in these situations it is much easier to collaborate and discuss how to work together.”

The process of collaborating to produce patient support programmes does slow development down significantly, but this negative should be balanced against the significant positives of engaging and partnering. Dr. Parow explains that “In the past, when pharma would turn up with a readymade solution for one of their products, the patient solution would not make sense at all from the insurer’s perspective. Our needs and our priorities to the patient, as insurers, were not being met by solutions being designed by pharma, whose key goal was to sell their product.” Taking the extra time to collaborate and understand the needs of different stakeholders is proving a credible strategy to build something which actually effective in meeting patient needs.

Dr. Parow also pointed to clear synergies between the knowledge and skill base of pharma and insurers. “Manufacturers obviously possess incredible amounts of medical knowledge of the patients, but there are clear ways in which insurers can bring benefits too.” The closer interaction that insurers have with patients both through their intimate working relationships with physicians and through the resources that they invest in getting feedback from patients, has given significant insight into what patients actually want from support systems. This allows them to help shift the focus on developing these programmes away from 'how this service will help reimbursement' towards 'how do we actually need to structure the delivery of this therapy to meet patient needs'.

Another key benefit which local insurers can offer is their deep knowledge of the workings of regional and national healthcare institutions. Through their long history of working with these institutions they are able to help develop highly nuanced systems which will integrate well with the specific structures which are unique to each geographical region. With their additional experience from implementing programmes of their own, DAK-Galso understand the difficulties involved in scaling these sorts of programmes nationally.

It is clear there are significant benefits to be gained from a collaborative approach to developing patient support solutions, and that this is a strategy which can help pharma achieve the hard-to-reach goal of developing adherence & engagement solutions which actually meet the needs of the patient. Through collaborating healthcare stakeholders can draw on their independent abilities and combine to create something far more effective and far more tailored for patient needs than could have been achieved alone. Dr Parow also notes that “these discussions create a hugely valuable forum for pharma and insurers,” to move beyond product focused support, and start a bigger conversation on how they can work together to deliver value beyond pill. As DAK-G's collaborative projects develop, and a wider audience starts to get insight into some of the innovations being discussed, it seems that we have a lot of exciting things to look forward to.

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Barriers to Biologic Treatment - Is Injecting Such a Pain?

Mary Assimakopoulos — Thu, 10 Oct 2013 14:46:01 +0000

Précis:

Mary Assimakopoulos examines a common yet often unaddressed patient concern – the very human fear of needles!

Insights from our market research into autoimmune diseases clearly demonstrate that patients who are treated with a biologic are more satisfied with their treatment, report significant improvements in their symptoms, are more likely to be able to live a “normal” life and have more positive feelings about coping with their disease. Biologic treatments halt the progression of the illness, rather than just deal with the symptoms.

Time to switch?

Despite this, it often takes a long time for a doctor to discuss biologic treatment options with their patient, during which time their symptoms may have been getting progressively worse. Factor in the time to presentation (often more than a year) and time to diagnose (another 18 months or more) and our findings reveal that RA patients, for example, are looking at around 7 years before they are switched to a biologic. In a previous column, I talked about the RA patient journey and the fact that only around half of patients reported having discussed biologic treatment options with their doctor. Similarly, around half of patients with psoriatic arthritis report not being given a full understanding of treatment options and 62% said they had not discussed the possibility of a biologic treatment. Over half (59%) of patients with AS and SpA have not discussed this option either.

What are the barriers?

So what is preventing some patients being treated with biologics? There are a number of factors we can identify, not least amongst them the cost of this form of treatment. Some patients are not eligible, perhaps because their symptoms aren’t yet severe enough. Some are responding well with their current DMARD treatment. For some who are too frail it wouldn’t be a sensible option. However, where the choice for treatment is in the hands of the patient, there are a proportion who have taken the decision themselves not to switch.

...of these patients around one third to one half state that this is because they dislike the idea of injection.

Biologics are strong drugs which come with side effects and contraindications. They need to be given by IV or injection, something which is scary for some patients, particularly the idea of administering the injection themselves. In our ‘Living With’ surveys, 15% of RA patients, 10% patients of SpA patients and 11% of PsA patients have refused a biologic treatment offered to them by their doctor and of these patients around one third to one half state that this is because they dislike the idea of injection. Online RA forums are full of people saying they just can’t inject themselves as they are too frightened and their partner can’t do it for them either. This means regular trips to the hospital, which means a higher risk of non-adherence, which is not good for long-term outcomes.

Fear of injection

The findings from our research reveal that despite this, just under half of patients who aren’t on a biologic are willing to accept an injection-based treatment, most likely because there are no other better options. Two thirds of patients from our RA study said if they were offered a pill which gave them the same efficacy as a biologic, they would prefer this. But for today, many patients say they are willing to accept injection as a mode of administration because they want greater health benefits. One patient said “I would be willing to try almost anything to relieve my condition and I trust my doctor's opinion and advice”.

Communication and Support

Patients who are on a biologic seem to cope well with injections overall. In our study, patients across all disease areas report feeling ‘comfortable’ and ‘confident’ around their injection. We found that those who can self-inject found the training they were given to be a positive experience. Many also reported being very happy with the support they were being given by their healthcare professional during the process.

So could the patients who are refusing a better treatment be persuaded with the help and support of their doctor?

An analysis of our patient and physician data seems to suggest so. We sought to understand if there is a causal link between the type of relationship an RA patient has with their Rheumatologist and their willingness to take their biologic treatment. We also sought to understand if there are “typical” demographic elements to an RA patient who is more likely to actively seek ownership of their biologic treatment.

We found that RA patients who felt their treatment decision was a result of “joint decision-making” between themselves and their rheumatologist felt more positively about their RA disease and the impact the treatment was having on their lives. They were also less likely to skip doses, whereas patients who felt they were allowed full control over the decision, were more likely to skip doses. It seems that a collaborative approach, where both the doctor and RA patient make the decision to start a biologic treatment, results in a more positive outcome for the patient.

So the barriers to being given a biologic treatment can be overcome with the right education, communication and support from the healthcare network.

It will be interesting to see what effect the arrival of new oral drugs and biosimilars will have on the treatment landscape for autoimmune in the not-too-distant future. The race is on among manufacturers to come up with the new gold standard improved delivery system for injectables – spanning autoimmune, diabetes, MS, growth hormones etc. A new solution will revolutionise the market. Who is going to claim this ‘holy grail’?’

Questions or comments? You can share you thoughts with our audience in the comments section below, alternatively you can email the author directly at marya@researchpartnership.com.

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Why Pharma Reps Should Sell Adherence

Katrina S. Firlik MD — Wed, 25 Sep 2013 10:04:32 +0000

Précis:

For the pharmaceutical rep, is the goal of patient retention in conflict with the more traditional goal of patient acquisition? Patient acquisition primarily demands a focus on the prescribing physician, whereas patient retention demands a focus on the patient. Is there even time for both?

Pharmaceutical companies are interested not only in selling pills, but in selling pills that actually work. Given that drug efficacy and, therefore, clinical outcomes are critically dependent upon (1) the patient actually filling—and refilling—the prescription and (2) the patient actually taking the medication as prescribed, promoting adherence needs to be a top priority in the quest to sell effective products. Increasingly, pharmaceutical brands recognize this.

We know that, given decreased access to and limited time with physicians, many pharma reps chose to focus primarily on the copay card. Copay cards are a commonplace and familiar method of overcoming the “first fill” barrier—but not necessarily the “next fill” barrier—and one that physicians quickly appreciate at face value and look favorably upon.

However, many physicians have become jaded about the problem, figuring it is simply not possible for them to detect, and then to adequately counsel, the non-adherent patient who is at risk of poor outcomes.

I would argue that selling adherence—whatever solution a brand has “wrapped around the pill”—is a very worthy additional sell, even to a time-strapped physician. Why? Doctors intuitively understand the critical role that adherence plays in clinical outcomes. They know that medication adherence is a key “healthy behavior” along with diet, exercise, and smoking cessation. All too frequently, they witness the downstream and otherwise preventable complications of non-adherence, and it’s quite demoralizing (as I can say from first-hand experience; see here).

However, many physicians have become jaded about the problem, figuring that in their harried fifteen minutes with a patient, it is simply not possible for them to detect, and then to adequately counsel, the non-adherent patient who is at risk of poor outcomes.

Further, I would argue that the time constraint of the typical office visit is not the only challenge when it comes to physicians having a sufficient motivational influence on their patients. There are a host of additional limitations. Consider frequency of messaging. How often does a patient see a physician? Once a year? Twice, maybe? There simply isn’t enough frequency of adherence messaging for it to stick when delivered in the doctor’s office. Add to that the fact that some physicians simply aren’t motivational dynamos, and the challenge is compounded.

So, a pharma rep that comes bearing not only copay cards or samples, but also a novel approach to one of healthcare’s most intractable problems will be most welcome by most physicians.

A medication adherence solution, whether online, mobile, or otherwise becomes a valuable physician-extender in a sense. And arguably, the best solutions will nicely serve the dual purpose of patient retention and acquisition. Particularly in crowded therapeutic categories, more favorable long-term adherence to a product should prove to be the most important clinical differentiator of all.

Physicians care deeply about medication adherence. It should be an easy, and welcome, sell.

A few years ago my company decided to test the potential differentiating power of an adherence solution and commissioned an online survey of one hundred physicians who treat patients with diabetes. We introduced these physicians to a new adherence solution via a screen shot and a brief description, then asked them how their prescribing decisions might be affected if the solution were added to Brand A vs. Brand B, and then vice versa.

The two brands we chose were, at the time, the only two medications in their class of oral diabetes agents, and felt by many physicians to be “me-too” competitors. The addition of a new adherence solution “wrapped around the pill” was compelling enough to sway prescribing preferences by more than 30 percentage points. Although this was a survey and not real-world prescribing data, what it shows—clearly—is that physicians care deeply about medication adherence. It should be an easy, and welcome, sell.

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Patient Power: Too Much of a Good Thing?

Mary Assimakopoulos — Tue, 10 Sep 2013 15:34:28 +0000

Précis:

Mary Assimakopoulos, reveals findings from the company’s Therapy Watch market research data, investigating patient behaviour in Crohn’s Disease and discusses how pharma can benefit from improved patient understanding.

In an earlier column I discussed the issue of non-adherence in diabetes and proposed that a better understanding of patient behaviour may improve compliance. In this column, I’m going to be looking at Crohn’s Disease and asking if too much patient power is always a good thing.

Crohn’s disease is a form of Inflammatory Bowel Disease that can affect any part of the gastrointestinal tract and has a wide range of symptoms. It commonly causes abdominal pain, diarrhoea, weight loss and vomiting but because it affects the immune system it can cause other problems such as anaemia, arthritis, lack of concentration, tiredness and inflammation of the eye.

Nineteen percent of patients in the US and nine percent of patients in the EU who are being offered a biologic are refusing to take it, largely because of concerns about side effects.

The Research Partnership conducts a regular tracking research study amongst physicians treating patients with Crohn’s disease in Europe and the USA. Data from this research reveals that surprisingly, despite how much it can affect day-to-day living, a proportion of patients are actively refusing biologic treatment.

According to our study, nineteen percent of patients in the US and nine percent of patients in the EU who are being offered a biologic are refusing to take it, largely because of concerns about side effects. A proportion, around one third of American and one quarter of Europeans, also express fear over self-injection / IV infusion.

Around 700,000 Europeans are diagnosed with Crohn’s disease each year. There is no known cure and, if severe, it can be very hard to live with. Some patients are successful at managing their disease with a controlled diet. A young patient with Crohn’s describes her symptoms on support website www.meandibd.org: “Before diagnosis I lost 3 dress sizes and bled continuously. It took a while to be diagnosed, although I'd had symptoms since around the age of 14. I was off school a lot. People thought I was lazy as I felt so exhausted I couldn't do anything.”

Most treatments such as steroids will only help to reduce the symptoms. There are currently only two biologic treatments available to patients, Humira and Remicade, which are employed to bring patients with moderate to severe Crohn’s to a state of remission. In extreme cases patients can opt to have surgery, but as this involves removing large parts of the colon, physicians prefer non-interventional options and will only recommend this as a last resort.

What more can be done to appropriately manage patients’ fears to get them on these more effective treatments? Why do some patients accept the (small) risks and others can’t get past them?

Have the short-term fears of the patient sometimes become too powerful, at the expense of the individual’s longer-term health needs?

Other findings from the survey suggest that patients do eventually “give in” and accept biologics, despite their initial fears, but at what cost to their overall health? Our data reveals that around a third of all current biologic patients in EU and US could have been treated earlier. Almost half (42%) of patients in the US and a quarter of patients in Europe had their biologic treatment delayed because the patient had refused to take the biologic up to that point. It takes between 3-5 years from presentation for a patient to be diagnosed with Crohn’s and the earlier the patient is treated, the better the outcome. Have the short-term fears of the patient sometimes become too powerful, at the expense of the individual’s longer-term health needs?

Therapy Watch found that whilst discontinuation rates are generally low with biologics, there is a small cohort of patients – around 8% - who elect to stop their own treatment, although we don’t know whether this is because they believe that their disease has improved or whether they are experiencing strong side effects. It would seem that the biggest challenge for the healthcare industry is getting patients to accept biologic treatment rather than persuading them to stick with it.

Can too much patient power be a bad thing for patient outcomes? Maybe not, provided the patient is well informed and educated about their treatment options and their benefits. According to our survey, around three times the number of US patients (17%) versus EU patients (6%) actively asked to be put on a biologic. This may be a response to direct-to-consumer advertising, which is only legal in the USA. Are US patients more informed about treatment options? In which case, is patient education the way to improve patient outcomes? Something for the pharma brands to ponder….One thing is for certain, patients who are refusing biologic treatment need to be better informed. Perhaps a deeper understanding of patients’ needs will give further insight into why this group of patients are refusing treatment and reveal ways of changing perceptions and behaviour.

Questions or comments? You can share you thoughts with our audience in the comments section below, alternatively you can email the author directly at marya@researchpartnership.com.

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Brands Cannot be Patient-Centric Simply by Adopting the Catchphrase

Dr Pamela Walker — Mon, 02 Sep 2013 10:34:06 +0000

Précis:

Patient-centricity is gaining traction in pharma and companies have gone in to overdrive trying to implement this into planning and strategy. But what does it actually mean to be patient centric, and how close are we as an industry to achieving this?

Brands can’t ‘be’ patient-centric by simply repeating the mantra. In order to put the patient at the heart of drug research, development, and marketing, a company must probe deep into what patients want from a treatment. They should be considered more like the consumers ordinary brands aim to please and less like patients who benefit from pharmaceutical treatments.

Although it seems intuitive, this approach is borne out of multiple factors colliding. The move toward more personalised care, the need to communicate a product’s value proposition in a competitive market, and an increasingly engaged consumer base have forced pharma companies to review their marketing strategy.

The industry needs a fundamental change; a seismic shift in behaviour in order to conquer patient-centricity

So just how close are we to being patient-centric? Recognising the need to re-focus marketing efforts is a start, but collectively the industry still falls short of the mark when it comes to execution.

The industry needs a fundamental change; a seismic shift in behaviour in order to conquer patient-centricity. Through our work at Incite in both consumer and pharmaceutical research, it’s clear that three critical areas need attention in order to drive patient centricity forward. Patient support services, market research, and social media are all important pieces in the patient-centric puzzle. Fine-tuning our approach to each area will ensure that this omnipresent industry term doesn’t become just another marketing catchphrase.

Support Services Revolution

Where do we stand in terms of the support programmes we offer our patients, carers and HCPs? Companies are enjoying mixed success creating relevant and helpful support programmes, and while success stories are few and far between, some are already reaping the benefits.

Abbvie’s Humira is one such success story. The company has rolled out a number of patient support programmes in recent years that are relevant to local markets and can inspire sufferers with Rheumatoid Arthritis or Psoriasis. These campaigns include ‘Let’s Cook!’ and a multitude of online support programs for patients which have had a huge influence on turning the company in to a market-leader.

Asking probing questions about the support service programmes offered at present will lead to marked improvements

For the majority of companies, however, it is undoubtedly a work in progress. Nevertheless, asking probing questions about the support service programmes offered at present will lead to marked improvements.

Consider a review of current programmes at a national and local level:

Are there any particular programmes that have worked well?
Are there specific programmes in local markets that have seen great success?
Have we received feedback that certain services are missing or are in need?
What are our competitors offering in this space and how successful have they been?

With this insight to hand, it will become clear where gaps in our services exist. Prioritising potential services will be the next step – something which requires extensive patient insight.

Market Research Overhaul

Pharma brands have a comprehensive understanding of the HCP, but insight into the patient’s mind-set is not yet as complete. One of the first steps to becoming more patient-centric is to delve deeper into the patient experience. Walk in their shoes. Understand how they live life and cope on a daily basis.

For years, a lengthy and expensive ethnography process has been the go-to methodology for pharma market research. A more engaged and knowledgeable patient base, however, requires a fresh approach and deviating from ethnography will not only save precious marketing budget, but offer insight into the patient experience that’s relevant in 2013.

To help understand the modern ethnography programme, we need look no further than the work of consumer brands. When the likes of large beer brands are incorporating smart phone film, interactive tasks and ‘consumer journalism’ all reporting into an online forum, there is nothing holding us back in pharma from doing something similar. Not only is this a cost-effective longitudinal option, but it is empowers the patient and offers an opportunity to engage with others via online focus groups.

Similar to ethnography, being able to develop truly patient-focussed campaigns is also something our consumer colleagues have been doing for some time. Collaborating with the consumer on everything from chocolate bar flavours to washing powder campaigns, means that the end user is intimately involved in the campaign development process. The result: a campaign created in association with the consumer which consequently places them at the heart of all communications.

Social Media Insight

While not always 100% relevant or reflective, social media can be an incredibly valuable tool for gaining deeper patient understanding. The social phenomenon has meant that across pharma companies worldwide, teams have started to track social media platforms and are actively reviewing product feedback.

Taking advantage of the fresh insight digital channels deliver means pharma companies can better understand the end-consumers’ brand experience

This is a positive step for the industry and its value can be increased if this approach continues to be adapted to better understand patients. Monitoring feedback will in turn deliver key competitive intelligence. Taking advantage of the fresh insight digital channels deliver means pharma companies can better understand the end-consumers’ brand experience, measure it against competitor activity and even adapt products, packaging and support accordingly.

Future Pharma Strategy

Armed with brilliant support programmes, deep consumer knowledge and understanding, the next step is to adapt our sales force to a more patient-centric way of thinking and selling. A refined selling strategy should mirror this new lens with a focus on benefits to the patient, outcomes for the patient, and offering the best and most complete support for the patient.

Patient-centricity is certainly on the rise in pharma, but as our consumer counterparts have shown we still have a lot to learn in order to truly excel. By taking advantage of social media insight, changing our approach to market research and scrutinising support services the industry will undoubtedly be a lot closer to achieving the real meaning of this term – ensuring that it isn’t just another buzzword in the process.

Questions or comments? You can share you thoughts with our audience in the comments section below, alternatively you can email the author directly at Pamela.walker@incite.ws.

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