The Importance of Patient Services

Exploring the benefits of additional support & education services for pharma and patient adherence

n Insights from senior industry figures

and academic experts

n Discover what its costing you when

talking about non-adherence

n Learn about how support services

geared towards adherence can improve the patient experience and ultimately your bottom line

Author Professor Kevin Dolgin Editor Craig Sharp

Disclaimer
The information and opinions in this report were prepared by eyeforpharma (FC Business Intelligence) and its partners. FC Business Intelligence has no obligation to tell you when opinions or information in this report change. eyeforpharma makes every effort to use reliable, comprehensive information, but we make no representation that it is accurate or complete. In no event shall eyeforpharma (FC Business Intelligence) and its partners be liable for any damages, losses, expenses, loss of data, loss of opportunity or profit caused by the use of the material or contents of this report. No part of this document may be distributed, resold, copied, or adapted without eyeforpharmas prior written permission. FC Business Intelligence Ltd 2013

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Factors affecting patient adherence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 The importance of patient support to the pharmaceutical industry . . . . . . . . 9 Patient support programs, and their impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Patient Support Programs and the Pharmaceutical Industry . . . . . . . . . . . . . . . . . 13 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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Introduction
After many years of lobbying from patients, enlightened segments of the pharma industry have finally recognized that patient services are a worthwhile way to improve adherence, have a positive impact on the patient experience, and can make a difference to their bottom line. But while many firms have begun to do this in earnest; others hesitate and question whether these services are warranted or appropriate. After all, it is the healthcare professionals who decide which treatments to prescribe for patients, and it is perhaps they who are most directly concerned with any types of patient support. However, it is increasingly apparent that the industry has a role to play in patient support, and that much is at stake for the industry itself. Why is this? Because while traditional communication efforts have been focused on gaining prescriptions, the reality is that those prescriptions are not delivering the benefits they should to patients, and in return, the patients are not delivering the value they could to the industry. Consider the following example... An organ transplant is a life-saving, serious operation. Potential recipients often wait for a year or more over three years for a kidney transplant in the UK. Consequences for those who do not receive their transplants are often fatal. And yet, after the operation, roughly one out of four transplant recipients do not properly take the immunosuppresive drugs that prevent rejection, making non-adherence one of the principle causes of transplant rejection1. This is difficult to understand for many. How could someone go through the anxiety of the wait, the trauma of the operation, and the relief upon learning that they will receive the extraordinary gift of life from a brave or unfortunate donor a gift that will not be available for some other fellow-patient and then not follow a simple maintenance regime? And if one out of four transplant patients dont adhere to regular treatment, essentially condemning themselves to serious consequences, often leading to their deaths, how much lower are adherence rates for less striking conditions? The answer is that on average, adherence to long-term chronic treatment is generally less than 50%2. How much of a problem is this? According to the World Health Organization3:
Poor adherence to treatment of chronic diseases is a worldwide problem of striking magnitude. The impact of poor adherence grows as the burden of chronic disease grows Worldwide. The consequences of poor adherence to long-term therapies are poor health outcomes and increased

healthcare costs.
Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the

population than any improvement in specific medical treatments. Over the past several years, stakeholders in the healthcare world have intensified their efforts both to understand this issue and to put into place patient support programs that will help. It is one of the few topics on which everyone is in agreement: patients certainly benefit from increased support and payers would very much like to reduce overall costs by enhancing adherence to those drug treatments which they have decided are beneficial; healthcare professionals would like to ensure that the treatments they prescribe are being followed and the pharmaceutical industry benefits by increased sales of their products. Its a win-win-win-win prospect. How can adherence be affected? Through patient support, and in reality, just about every patient support program, whether initiated by the pharmaceutical industry or by other stakeholders is aimed at helping patients to access and adhere to the treatments that will help them. In this white paper, we will examine patient support programs via the lens of their principle objective: increased adherence. First, well look at the extent of the problem and how it varies across different types of therapies and patients. Then, well examine the reasons for poor adherence and the need for patient support. Following this, well consider the types of patient support programs that have been put into place and their results and how support programs can deliver positive benefits for both patients and program sponsors through increased adherence.

1 Ley, problem of noncompliance affects transplant patients too . 2 RTI InternationalUniversity of North Carolina Evidence-based Practice Center, Medication Adherence Interventions: Comparitive Effectiveness . 3 Sabat and World Health Organization, Adherence to Long-term Therapies.

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The Problem
Do patients need support programs? The need for such initiatives is evident when considering adherence rates. As cited, the WHO has stated that improving adherence would have a greater impact on health than any potential discovery in medicine. After all, even if the pharmaceutical industry one day discovers a much wished-for cure for cancer, its likely that it wont be taken properly (oral anti-cancer therapies currently run about 60% adherence4). How low is adherence? It depends on many things, most importantly the pathology itself. Two interesting sets of figures for different conditions show the extent of the problem and how it varies across pathologies. % adherence to treatment5
80 70 60 Percentage Percentage 50 40 30 20 10 High blood pressure Incontinence Depression Reumatoid arthritis Parkinsons HIV / Aids COPD Cancer GERD 0

% of patients with MPR >80%6

80 70 60 50 40 30 20 10 Hypertension Hypothyroidsm T2 Diabetes Hypercholesterolemia Osteoporosis Seizure disorders Gout 0

Note that these two sets of figures use different measures for adherence, pointing out the difficulty in even discussing the topic. The first set of figures is based on patient-reported adherence rates. There are a number of established methods to gauge self-reported adherence, the most common perhaps being the Morisky scale, which has been proven to correspond to clinical measures7. The second set of data uses the Medical Possession Ratio. This is a widely used measure that takes the sum of the days supply of medication divided by the number of days in the study period. For example, if someone is supposed to be taking one anti-hypertensive pill a day for six months, the MPR of that person will be the number of pills actually in their possession over that period divided by 180 days. Very few people have an MPR equal to or greater than 100%, so the threshold for adherence is often determined according to the therapy (although the graph at right has considered 80% and more to signal adherence in all classes studied). Which measures are best to use? There are pros and cons for all8, but as can be seen above, no matter what the measurement approach, the problem itself is evident. In fact, it is so evident that it is increasingly becoming a focal point for governments. While there may have been a tendency in the past to assume that non-adherence to drug therapy provided some degree of savings, The US Congressional Budget Office (CBO), which serves as the independent, official scorekeeper of the fiscal impact of federal policy and proposed legislation, changed its stance on medication adherence in 2002, recognizing that the evidence of a direct connection between medication use and healthcare spending was sufficient to score a medical cost offset in its budgetary forecasts. The CBOs budget forecasting now assumes that medication adherence can lead to reductions in doctor visits and hospitalizations, and impact the rise of healthcare costs.9 Thomas Forissier from Capgemini Consulting and Katrina Firlik of HealthPrize Technologies, who spoke in Healthcare Packaging Compliance Councils 2013 RxAdherence Conference, provided some interesting statistics:
Adherence only increases 4% to 6% when drugs are given away If all patients with high blood pressure were fully adherent, up to 89,000 deaths could be prevented each year in

the United States

4 5 6 7 8 9 Carolyn Blasdel and Joseph Bebalo, Special Report, Adherence to Oral Cancer Therapies: Meeting the Challenge of New Patient Care Needs . Andre Bates, Ensuring Profitable Patient Adherence Programs: Using Analytics to ... Briesacher and al., Comparison of Drug Adherence Rates Among Patients with Seven Different Medical Conditions . Oliveira-Filho and al., Association between the 8-item Morisky Medication Adherence Scale (MMAS-8) and blood pressure control . Fairman and Matheral, Evaluating medication adherence . Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicares Spending for Medical Services .

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Interview with Ian Talmage

Senior Vice President, Global Marketing, general Medicine, Bayer Pharmaceuticals How has patient support, as a subject, evolved for the pharmaceutical industry? I look at this over a long period of time, starting with my childhood and then over my thirty years in the industry. When I was a child, the GP was god: you were told what was wrong with you, you were given something to take, and you took it. The GP was right at the top of the trust scale. As we moved forward, we became more informed and as we become more informed, we want to become more involved. We also become more demanding: we regard it as our right to go to the gym, have a game of tennis. Even in old age, we are much more active than our parents generation. However, this often requires treatment: we need to take responsibility for our own health, and we need to have the right information. Pharma must feel a responsibility to ensure that the right information is given to patients at the right time. If we dont have the answers to this, we will end up very much just selling drugs. Can pharma afford to do this? If you give the primary beneficiaries of your products the information they need, if you respect them and understand that they need to get well, and you help them to do that then all the other things follow: positive word of mouth, sales, and appropriate returns that we can invest in further R&D. Why not leave it to the healthcare professionals? Because its complex, and we master elements of that complexity already. We understand our products and the diseases through our own research. We also have at our disposal new tools to help adherence. For example, people are beginning to use their smart phones to keep themselves fit, theyre measuring activity, calorie burn, distances run. We can use these tools too to increase the effectivness of our products. You mention effectiveness, how does this differ from efficacy? In clinical trials were looking at efficacy and safety in an artificial, controlled environment. The effectiveness of our drugs should be our main concern, and that happens in the real world. We already do a lot of things: weve made smaller tablets, syrop for children, but we have new communications technologies that we could associate with these therapies and make them more effective. We have so much information within our walls that we are in a position in which we can become more of a solution in a fast-changing world. When I went through chemo myself, I knew what to expect and could prepare for it, my physician asked me afterwards to help other patients understand what to expect. The industry could be doing this as well. I think most of us are exceedingly proud of what were doing. A friend from the States wrote to tell me that his father had been hospitalized and was receiving one of our drugs. He was doing much better. That is far more rewarding for me than hitting some market share figure, and if we can help people feel better by patient support programs, we should do it.
Increased adherence to hypertension and cholesterol medicines would reduce healthcare spending by $4 to $5

for every new dollar spent on medicines

A 10% adherence to asthma medications was associated with a nearly 5% decrease in total annual medical

spending
Patients who take medications as doctors direct may save as much as $7,800 each year10

The problem is dramatically underestimated by many of the key players who are affected by it. Many pharmaceutical companies overestimate the adherence of patients to their drugs by orders of magnitude and physicians are no better. In fact, a 2004 study showed that physicians, even those with long-term relationships to patients, are no better able to predict adherence than is chance11. This is partly because patients have a tendency not to be entirely truthful with their physicians. This is not new, in fact, Hippocrates warned: keep watch also on the faults of the patients which often make them lie about the taking of things prescribed. It is also, however, partly due to a simple tendency of physicians to assume that their instructions will be followed. In other words, they dont ask.

10 Tierney, Liz. Patient non-adherence costs underestimated. Packaging World. 22 Mar 2013. www.packworld.com/package-feature/safety/patientnon-adherence-costs-underestimated 11 Murri and al., Patient-reported and Physician-estimated Adherence to HAART .

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Factors affecting patient adherence

There are many reasons given by patients for not adhering to their prescribed treatment. The most obvious are that they simply forgot to take their medicine. This generally corresponds to only about 30% to 40% of cases12. In other words, up to 70% of non-adherence is voluntary; people decide not to follow their therapy, either discontinuing it altogether (i.e. not being persistent) or not taking it as often as they should (non-compliant). Why? Different studies supply different answers to that question, but they can generally be grouped into the following categories13,14,15,16,17: 1 Concerns about the medication These are generally concerns with respect to side effects. Some studies have shown that 45% of patients have reported not taking their medication out of fears about side effects.18. However, other factors also can come into play, such as the impression that the patient is already taking too many medications, fear of addiction, worries about what others will think about the medication, etc. 2 Impression that the medication is unnecessary In some cases, this is an initial impression that the medication simply isnt needed, in others, this arises once the patient begins to feel better. In certain patients, this can be directly linked to an outright denial of the underlying condition, or of its gravity. 3 Financial worries Even in situations in which medications are fully reimbursed, an initial out-of-pocket expense can be a hindrance to adherence. In cases in which patients directly pay for all or part of the medication, this can be an even more significant factor 4 Forgetfulness As cited, some patients simply forget to take their medication properly, or to renew their prescription in time. 5 Cultural or religious beliefs Certain individuals hold distinct cultural or religious beliefs that make them hesitate or refuse medication. In many cases, the patients avoid making these beliefs known to their physicians and accept the prescription, but do not take the medication, or even fill the prescription. 6 Depression A number of studies show that depressed patients are not as adherent to treatment as those who do not suffer from depression, or other mental health conditions. This has obvious implications for anti-depression treatments, but must also be taken into account for other pathologies, as the incidence of clinical depression is high. 7 Inability to follow treatment Some patients are simply unable to follow their treatment. Reasons for this are many and varied, and range from incomprehension of the treatment to factors such as reduced mobility, unavailability of the medication, or even war. The relative importance of these seven factors vary greatly across different patients, geographies and pathologies. Any effort by the pharmaceutical industry to support patients must first understand what they need, what the specific drivers are for non-adherence in the case of the treatment in question. For example, anti-psychotics in the United States present a different picture from oral diabetic treatments in Western Europe, if only because of the relative importance of patient out of pocket expenses, and both are very different from HIV in Africa. Part of the problem lies with healthcare providers. While many chide the pharmaceutical industry for not paying enough attention to patient support, healthcare professionals are just as derelict in their attention to the problem. For example, US physicians spend on average 16 minutes with a patient, but only 49 seconds explaining new treatment. Of those 49 seconds, 8.5 are spent talking about directions for administration and 4.7 about side effects19, while a clear understanding of side effects before initiating treatment has a positive as opposed to a negative effect on adherence. Likewise, there is the underlying fact that the general population in most countries has a very poor understanding

12 Chewning and al., Does the concodrance concept serve patient medication management? . 13 Gadkari and McHorney, Medication nonfulfillment rates and reasons . 14 RTI InternationalUniversity of North Carolina Evidence-based Practice Center, Medication Adherence Interventions: Comparative Effectiveness . 15 CapGemini, Patient Adherence: The Next Frontier in Patient Care . 16 Elder, Ayala, and Harris, Theories and intervention approaches to health-behavior change in primary care . 17 National Council on Patient Information, Enhancing Prescription Medicine Adherence: A National Action Plan . 18 Ibid. 19 Tarn and al., How Much Time Does It Take to Prescribe a New Medication? .

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of medicine. In a 199520 study, it was revealed that among patients in the United States:
33% 42%

Were unable to read basic healthcare materials Could not comprehend directions for taking medication on an empty stomach 26% Were unable to understand information on an appointment slip 43% Did not understand the rights and responsibilities section of a Medicaid application 60% Did not understand a standard informed consent The ubiquity of the internet since 1995 has undoubtedly modified these figures somewhat, but at the same time, the internet can reinforce confirmation-bias, allowing those with irrational or ill-informed preconceptions about treatment to reinforce the beliefs that lead them to reject the treatment. A 2010 study of patient populations in Northern California found that 62% of patients were health-illiterate.21 It should also be noted that even unintentional non-adherence seems to be linked to patient beliefs and attitudes.22,23 Many studies have noted that fear of side effects in particular and general beliefs about the effectiveness or underlying need for the medication are closely correlated to forgetfulness in taking the medication. Beyond the direct causes of non-adherence lie the psychological constructs of behavior. In other words, why do we do what we do, and why dont we do what we should? A number of different theories exist to address these questions. In adherence research, behavioral models generally cited include the Health belief Model, Learning Theory, and the Theory of Reasoned Action (TORA). Adherence as a topic is often also informed by behavioral modification theories24. These theories help shed light on the often bewildering behavior of patients and they are often used to help build patient support programs. Dr. Gerard Reach has published numerous books and articles on the psychology of non-adherence. He points out two major psychological constructs when considering the issue: the inter-temporal effect and the time horizon effect.25 In the first case, Dr. Reach points out that the desire for a given reward increases as its realization nears. As such, short term benefits become increasingly tempting while long-term benefits remain vague. George Ainslie calls this a surge of preference for the less valued alternative when it looms close26. For example, an obese person might place greater value on losing weight than on eating a piece of pie. Upon waking up in the morning, these relative values are clear for him. However, as the day goes on and dinner approaches, the pie is getting more and more tempting, while an eventual loss of weight offers a reward that remains distant. Eventually, the desire for pie gains the upper hand and the refrigerator is raided.
Value Improved health

Pie

Time

The time horizon effect is linked to the inter-temporal effect. Different people operate with different time horizons, and those who habitually maintain a longer-term vision are more likely to value longer-term rewards, such as better health. This is directly observable in the fact that older populations tend to have higher adherence rates than younger populations (which is often surprising to many healthcare professionals).27 In this case, two factors are responsible: the older populations are nearer to the eventual benefits of increased health and longer life span, and older people naturally tend to have a longer time horizon than do the young. What does all this imply for patient support programs? Study of these phenomena can help those who design
20 Williams and al., Inadequate Functional Health Literacy Among Patients at Two Public Hospitals . 21 Sarkar and al., The Literacy Divide: Health Literacy and the Use of an Internet-Based Patient Portal in an Integrated Health SystemResults from the Diabetes Study of Northern California . 22 Gadkan and McHorney, Unintentional non-adherence to chronic prescription medications: how unintentional is it? . 23 Lowry and al., Intentional and unintentional nonad... [Ann Pharmacother. 2005 Jul-Aug] - PubMed - NCBI . 24 Elder, Ayala, and Harris, Theories and intervention approaches to health-behavior change in primary care . 25 Reach, Pourquoi se soigne-t-on?. 26 Ainslie, A selectionist model of the ego . 27 Briesacher and al., Comparison of Drug Adherence Rates Among Patients with Seven Different Medical Conditions .

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such programs to build approaches that have far greater impact than those built in ignorance of the psychological constructs involved. The two time effects suggest a number of strategies to support patients and motivate them to adhere to treatment. First, the perceived value of the distant reward can be increased. By making the prospect of increased health and longer life more visceral, the entire value curve can be shifted up. Patient testimonies and inter-patient communication can greatly help in this respect. Second, the payoff can be brought forward in time. Many behavioral experts talk about the importance of setting short-term goals for long-term projects. For example, smoking cessation support programs often encourage smokers to give themselves presents periodically, with the money saved by not buying cigarettes. In all cases, a close understanding of the mechanisms of non-adherence is vital for those who design programs to combat it. Different people have very different value constructs and time horizons as well as very different reasons for not adhering to treatment. Support programs must be flexible enough to adapt to individual differences.

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The importance of patient support to the pharmaceutical industry

Non-adherence has obvious costs to the pharmaceutical industry. First, like any industry, pharma thrives by providing value to patients, and that value can be measured by the improvement in patient health afforded by the products and services provided by the industry itself. If patients do not fully enjoy the health benefits that pharma products can offer, then that value is reduced. As Peter Drucker said, Success depends on your contribution to the success of your customers.28 Most pharmaceutical companies include elements in the vision and mission statements that outline their commitment to patient well-being, but that well-being is lessened if patients are not supported and dont adhere to treatment. As stated in the article: Beyond Magic Bullets: True Innovation in Healthcare: the main driver of improved outcomes and meaningful benefits may not be innovative therapeutics alone but an ecosystem comprising the therapeutic and wrap around tools and services. For example, integrated solutions that improve adherence and access to an existing drug could have as much impact on health outcomes as introducing new drugs.29 Secondly, there is a real and enormous impact on revenues. What is the size of that impact? Estimates range from $30 billion a year to $560 billion a year, although it must be pointed out that patients who do not adhere to a given treatment often end up on a different treatment, so the higher figures are undoubtedly not representative of the impact on the industry as a whole. However, for any given treatment, the impact on revenues is fully felt. What happens when a patient doesnt adhere to, for example, an oral treatment for type II diabetes? In most cases, the treating physician will witness a deterioration of the patients clinical state. Since most physicians do not recognize non-adherence, as stated previously, they will switch to a different therapy. If the degradation is serious enough, the patient may be put on insulin, if not, they will probably be switched to a different non-insulin therapy. Either way, the patient is lost to the original drug. As such, although the overall revenue impact of the worlds average 50% adherence rate doesnt necessarily mean that the industry as a whole is losing 50% of its revenues to non-adherence, a 50% adherence rate for any given drug means exactly that for its producer. This is not lost on pharmaceutical executives. In 2011, business intelligence firm Cutting Edge Information (CEI), conducted a survey of 18 drug companies. The study concluded that 25% of overall sales were diminished by lack of patient adherence, while 31% of revenue can be preserved by patient support efforts. 30 Nevertheless, the pharmaceutical industry has focused its promotional efforts overwhelmingly on prescribers, primarily through the sales force. The worldwide pharmaceutical sales army probably reached its peak in 2003, with over 300,000 reps worldwide. Since then, numbers have begun to fall dramatically, as the old strong relationship between detailing pressure and market share has begun to flatten. In other words, the industry has recognized that the commercial model needs changing, that the promotional methods that brought success over the last thirty years are increasingly ineffective. According to Davide Levi, Vice President of consulting at IMS Health: From their peak in the early 2000s rep numbers in mature markets have declined by about 40%, or 120,000 headcount losses worldwide, as pharmaceutical companies have found impact and returns of detailing decrease dramatically. Emerging economies, particularly China, have somewhat mitigated the impact on total headcount, but not completely. In the face of these changes many companies are turning to new channels such as CLM and interactive physician web sites in an attempt to find other ways to continue promoting to prescribers (and to consumers via DTC, in the United States). These efforts are understandable and prescribers will always remain key customers who require new communications means. However, in the face of 50% adherence, there is an enormous reservoir of unrealized potential that is barely being tapped instead of chasing a point of market share with a bunch of $180000 / year reps, why not use some of that resource to increase the value to, and of, the patients already on the treatment by providing them with support? The logic is obvious, and yet while spending on patient support programs has quadrupled over the last five years, it still remains at roughly 3% of what is spent on efforts to increase market share.31 Why? As stated by Paul Mehta, of HIS: Pharmaceutical companies, in the past, viewed adherence as a minor downstream phenomenon within the supply chain. Though it has always been a subject of discussion, adherence rates have
28 Drucker, The five most important questions you will ever ask about your organization. 29 Narayan and al., Beyond magic bullets . 30 Silverman, Ed. What Pharma Is Doing About Patient Adherence.Pharmalot, from the publishers of PharmaLive.com. UBM Canon Pharmaceutical Media, 23 Apr 2012. Web. 11 Sep 2012. www.pharmalot.com/2012/04/what-drugmakers-really-do-about-patient-adherence. 31 Andre Bates, Ensuring Profitable Patient Adherence Programs: Using Analytics to ...

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remained unchanged mainly because of the lack of consensus on this issue within the industry.32 In a report from AccountAbility, in partnership with the UN Global Compact Study, the reasons for the pharmaceutical industrys underinvestment in patient support include:
Economic leakage: programs to improve patient awareness and behaviors may not be specific to one

companys products, they may also benefit competitors. Many pharmaceutical companies have a problem with this. Existing incentives: incentives and KPI structures introduce institutional inertia and foster neglect for patient support. Regulations: existing and potential rigorous regulations regarding direct to consumer (DTC) communications and promotions may make the industry hesitant in aggressively promoting patient support. Reputation risk: related to issues on regulations, the industry has come under criticism and scrutiny for its strategies to influence customer choices. patient support programs could be met with suspicion. Lack of expertise: patient support requires expertise in education and patient behavior. Pharma companies core competencies rest principally in discovering, manufacturing, and distributing drug based medical solutions. Cultural disconnect: the industry remains largely geared to communicate to scientists, physicians, other healthcare providers, and professionals working for payers; and relatively have less experience understanding the kinds of patient audiences that possess low health literacy. Emphasis on treatment rather than prevention, health, and wellness: although pharma company leaders have become more attuned to these needs, their efforts are very new and under-developed.33 Are these good reasons for pharma to continue spending 33 times more on market share promotion than on patient support? Responses to each of these issues are telling. According to Geoffroy Vergez, Managing Director of Observia, a French company providing adherence programs in Europe34: 1 Leakage: This is an often-cited reason for not undertaking patient support programs. The reasoning is that company investments should not benefit competitors. However, this is not a zero-sum game. If all patients on a given type of therapy benefit, all revenues increase. If a support program offers a positive ROI then the fact that a competitor also benefits is entirely beside the point. If a given program will bring 500% ROI, increase patient well-being and boost your reputation are you really going to refuse just because your competitor also sees some benefit? Thats hardly putting the patient first. 2 Existing Incentives: Companies that are driven purely by market share will be less interested in patient support, since it will inevitably entail greater or lesser degrees of leakage. Also, many companies are strongly focused on sales-force related KPIs, such as reach and frequency with prescribers. Obviously, this encourages neglect for patient support but once again, it doesnt make much business sense. 3 Regulations: Most companies overestimate the legislative restrictions around patient support. Most European governments are enthusiastic about support programs designed to increase adherence and are glad to see them initiated. Of course, both pharmaceutical companies and their partners must be fully aware of and compliant with these regulations, but there is a great deal that can be done. 4 Reputation risk: Clearly this is an important concern and one that must be taken into account. The risk is greatest, however, when companies undertake patient support initiatives for the wrong reasons in other words, to try to influence prescribers. Improved adherence in itself is the real point, and for that matter, will provide better ROI than a disguised attempt at market share grab. Those companies that set out truly to increase value to patients through support programs are not risking their reputations. On the contrary. 5 Lack of expertise and cultural disconnect. These can be addressed together, because they stem from the same thing the pharmaceutical industrys lack of experience with services. The industry is scientific by nature, and that scientific expertise has revolutionized human health for the better. The industry is uncomfortable providing value added services; it is much more at ease understanding what happens in a persons cells than in the persons mind. This is why partnerships are crucial to good support programs. 6 Emphasis on treatment. This is natural, given the aforementioned scientific foundation of the industry. However, the industry must recognize that measuring the benefits of its products in a laboratory, or even in the setting of a clinical trial, is not at all the same thing as measuring the benefits in the real world, where half of its patients dont take their drugs properly. Treatment is inadequate without attention to these other factors.
32 Mehta, Praful. Patient Adherence: Can it Shape Market Access in the Pharmaceutical Industry?.IHS Healthcare and Pharma Blog. IHS, 23 Feb 2012. Web. 17 Sep 2012. <http://healthcare.blogs.ihs.com/2012/02/23/patient-adherence-can-it-shape-market-access-in-the-pharmaceutical-industry/>. 33 Duplay, David, Sunil Misser, and and al. Taking Strategic Leadership: An Approach for Pharmaceuticals to Invest in Coordinated Patient Adherence and Access Strategies. AccountAbility. Account Ability, n.d. Web. 21 Sep 2012. 34 Disclosure notice: the author is also an executive in Observia

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Of course, many pharmaceutical companies are already doing much to provide patient support services. Johnson & Johnson, for example, has created an innovation team that focuses strongly on such issues. According to Diego Miralles, M.D., head of Janssen Healthcare Innovation: Janssen Healthcare Innovation is developing products and services to transform the patient experience and promote better health outcomes. We have identified improving medication adherence as one of our key initiatives.35 Petteri Jarkka is the Customer Engagement Manager at Janssen Nordic, a region in which the traditional pharmaceutical promotional model has long been under pressure. He is responsible for a number of patient-focused programs. We want to symbolize a new way of marketing and customer communication, a new way of engaging with our customers. We want to show that were putting the focus on the customer instead of the channels. So, we dont have a digital manager. We dont want to have a channel-based approach because online or offline isnt the point, the point is the customer. With engagement we want to show that its a dialogue, not a traditional you listennow approach. Its about going out there and co-creating services with our customers, for our customers. For example: We look at illnesses and the treatments that are available and we look at cases where support would be needed to enhance the treatment, such as HIV and hep C then we look at things we can do to support and create new services to support. In order to understand the patient journey and therefore create things of value, we have to be as close to the patient as possible, and that means having workshops with them to co-create and develop. What about the issues raised in the AccountAbility article cited above? When asked about the issue of leakage, Jarkka responded: The key thing is to go beyond selling. We have to focus on improving the care, improving the outcome. Quite often that might mean that the service you offer is not even linked to your brand. With respect to regulations and reputation risk: You have to put your sales hat away and put on your patient focus hat to make sure that in the end you deliver something of value. We have our brands but were not there to sell. The customer engagement specialists often dont have a sales background and this is creating an environment in which youre not forced to sell, you dont have to, and thats the right environment. And of course you need to involve regulatory and legal from the start. I actually think theres a greater risk to be non-compliant with sales activities, e.g. off-label promotion. When you leave that selling aside and youre there as a partner to improve healthcare and patient outcomes, you avoid a lot of the risks, which are around the selling part. Lastly, in terms of competency and company culture, the existence of Janssen Healthcare Innovation as a distinct unit is an attempt both to acquire and develop those competencies, and to influence company culture. As Jarkka says, Jannsen healthcare innovation has a few locations across the world. Its quite new, but even before we do I think what it does is that it has a very strong symbolic value for all of us, both internally and externally. Our corporate vision is to be a medical innovator and thats been injected into the corporate culture of Jannsen.

35 Janssen Healthcare Innovation Launches Care4Today(TM) Mobile Adherence Medication Reminder Platform , 4.

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Patient support programs, and their impact

As stated in the introduction, the ultimate goal of almost any patient support program is to increase adherence levels, sometimes by helping with access, usually by providing patients with the information and reminders they need to adhere to treatment, both medicinal and in terms of lifestyle. In order to do this, most patient support programs incorporate elements of the following: 1 Reminding. This focuses on forgetfulness. While this is not the most important of the reasons for not adhering to treatment, it is all the same a significant factor and is often the easiest to address. Regular SMS or voice messages have been proven effective reminders. 2 Simplification. This is aimed at those patients who are unable to follow treatment due to incomprehension or confusion about it. Pillboxes (some including high-tech elements), aids to administration, new forms, etc. have all been put into place to help simplify treatment. 3 Price reductions / coupons. In markets in which financial concerns are important, many programs offer reductions in exchange for compliance with treatment. These programs have generally proven effective. In the United States, programs also often help patients to apply for reimbursement for given treatments from their insurance providers, thereby directly helping with access to treatment. 4 Education / motivation. The first two reasons for non-adherence fundamentally stem from a gap in understanding between the prescriber and the patient. If we assume that the prescriber is correct in his or her treatment choice, then education is key to addressing this major cause of non-adherence, and most programs are built on or at least include educational elements. Likewise, a clear understanding of the behavioral elements of adherence can be used to incorporate motivational elements into any patient support program. Education often incorporates two key facets: the first upon the initial explanation of the treatment, and then an ongoing element over the course of treatment. Do these programs work? The answer is absolutely sometimes. This is not as vague as it seems, a great many programs can be proven to have directly affected adherence and many can be linked to significant positive ROI for the pharma companies sponsoring them, through these increases. Many programs sponsored by payers and managed care organizations are likewise closely linked to positive pharmaconomic results. In almost all cases, patients display satisfaction with support programs. At the same time, a number of programs have been measured as providing little or no benefit. What, then, seems to be the deciding factors, what separates the successful from the unsuccessful programs? According to Petteri Jarkka, of Janssen: The most common reason for failure weve had is that we havent 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 youre able to provide the service, thats pretty much it. When patient needs are understood, programs can have great impact, even relatively simple ones... Dr. Jacques Quilici and colleagues at the Timone hospital of Marseilles carried out a simple text message reminder initiative with patients who had received stents, to increase adherence with anti-platelet drugs and therefore increase overall health benefits. The group found a significant difference in both reported adherence and in clinical endpoints between patients who had participated in the support program and a control group who had not, with non-adherence rates among the SMS group being half that of the control group. Their conclusions: While healthcare providers play a pivotal role in maximizing patient adherence, individually tailored, computer generated reminders can produce positive effects on patients behavior. Such interventions are inexpensive, widely available, and offer the potential to both improve clinical care and impact health outcomes. Pilot studies of mobile health technologies are emerging in a broad range of disorders.36 Likewise, Kaiser Permanente found that patients prescribed statins were 1.6 times more likely to fill their prescriptions when sent automated reminders.37 This simple form of patient support has been increasingly adopted, and a 2012 research paper studying the general impact of such programs concluded that three out of four SMS initiatives studied showed significant increase in adherence. Their conclusions: After providing patients with the electronic reminders, no additional effort is needed from healthcare providers, making this an intervention easy to implement in daily practice. Furthermore, electronic reminders and especially SMS reminders appear to be easily integrated into patients lives. As such, this seems to be a simple intervention for both patient and professional for enhancing medication adherence.
36 Quilici and al., Effect of motivational phone short message service on aspirin adherence after coronary stenting for acute coronary syndrome . 37 Hylas Saunders and Hernandez-Millet, Automated Phone and Mail Notices Increase Medication Adherence | Kaiser Permanente News Center .

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At the same time, other simple texting initiatives have shown little or no impact on either adherence rates or clinical endpoints, and some far more expensive programs fare no better. How can such programs be made effective? Coming back to Mr. Jarkkas comments, it is clearly a question of understanding the patient and designing programs that correspond to the needs of patients on that particular therapy, recognizing that each has his or her own personality, beliefs, and history. Furthermore, each patient has a different experience depending on the healthcare professional with whom they interact, the varying influences of their own entourage and the details of their personal life. This is known as the patient journey. Since, as we have established, non-adherence, even unintentional non-adherence is linked to patient beliefs, these beliefs must be understood in order to have an impact. Just as pharmaceutical companies carry out market research to understand the needs of prescribers, so is research needed to understand the needs and beliefs of patients. Kaiser Permanente, for example, has a research group dedicated to the continuing study of non-adherence. Once these needs and beliefs are understood, programs can be designed to educate patients appropriately, keeping in mind that education does not necessarily mean simply making information available and assuming that it will be assimilated. We must respect the patients intelligence and his choices, according to Dr. Reach.38 By understanding and respecting patients, as well as understanding the reasons behind non-adherence and the psychological constructs that govern behavior, even simple programs can be made effective. For example, the text-messagebased reminder program from the Timone hospital cited above did not simply remind patients, but it gave them varied, light motivational messages as well, as opposed to many less effective simple reminder initiatives. As the pharmaceutical industry inevitably begins investigating more thoroughly the benefits of patient support programs, a clear understanding of patient behavior and the underlying behavioral paradigms will be crucial to ensuring effectiveness.

38 Reach, Notes from 1er Carrefour de lObservance .

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Patient Support Programs and the Pharmaceutical Industry

Although the pharmaceutical industry may still be under spending in patient support, it has been far from absent. While the topic is quite new in some companies, others have long been involved in support programs, with varying results. According to the CEI survey already cited, patient support budgets nearly quadrupled from 2009 to 2012. Forecasts anticipate US brand teams allocating more than $1.5 million towards support efforts this year, more than three times the 2009 estimate of $400,000. European Union and Canadian based companies expect spending up to a $1 million, representing an increase of 566% over the past four years.39 Despite these increases, the survey also found that only 66% of participating companies have dedicated patient support teams, while those without dedicated teams usually house support efforts under marketing or brand teams on an ad hoc basis. Of those that do have patient support teams in place, only 16% have had teams for longer than three years. 40 A different CEI study pointed out that the major hurdle to pharma companies considering patient support programs is the perceived lack of ROI measurement. Part of the challenge facing patient programs lies in separating their goals from the bottom-line focus inherent to many commercial teams, said Michelle Vitko, senior research analyst at Cutting Edge Information.41 And yet, in reality it is no more difficult, and perhaps easier, to measure the ROI of a patient support program than to measure the ROI of a detail aid, or even a sales rep. Consider, for example, a recent program carried out by Medco... In 2003, Medco published the results of a support initiative carried out for patients suffering from depression. Certain patients were enrolled in a program in which they received telephone coaching from nurses, consisting of an initial description of the treatment, followed by three additional telephone-counseling calls and five educational mailings. The communication focused on education, reasons for non-adherence, symptoms and the program itself. The program lasted for eight months. The results were impressive: Program enrollees were significantly more persistent, i.e. likely to remain on therapy over the period (77.8% compared to 49.5%). They were also significantly more compliant with treatment, being far timelier with prescription refills. Likewise, Evive Health, which offers personalized, data-driven patient support programs, won last years Strategic Patient Adherence Awards in the United States, demonstrating increases in adherence ranging from 15% to 28% using direct mail programs driven by principles from behavioral science.42 From the perspective of a pharmaceutical company, the initial ROI calculation is simple: the percentage increases in adherence generated by a patient support program directly correlate to increases in sales. If programs such as these can generate similar results - if even the simple text messaging service described in the Quilici paper can have that much of an impact, at a cost of 3 per patient43 - then ROI calculations become straightforward. Of course, it is always somewhat more complex than that, but no more so than estimates of the impact of promotional spending. These kinds of figures, and a general concern to create value for patients has led to the aforementioned increase in spending and will undoubtedly lead to a considerable further increase in pharmaceutical patient support programs. In the meantime, numerous programs and initiatives have already been undertaken and have been widely discussed. Frost & Sullivan describe, for example, a support program in obesity carried out by an unnamed pharmaceutical company in the United States: The companys contact center functioned as a single point-of-contact. The reimbursement team overcame significant hurdles by working with patients, physicians and healthcare plans to secure statements of medical necessity to ensure access to the drug. To maximize ROI, an enrollment questionnaire was used to stratify the patient population and target those segments with the highest potential with more intensive communication and support. The collected data was used to establish behavioral patterns and refine subsequent interactions... Highly-trained customer service representatives (CSRs) explained program benefits, answered questions, captured patient information, processed enrollments and coordinated reimbursement. Clinicians, including registered nurses and dieticians, provided counseling to patients on
39 Ray, Patient Adherence: Increased Dedication Fuels Bigger Budgets . 40 Ibid. 41 Companies Rank ROI as Leading Operational Challenge to Patient Adherence Efforts | Reuters . 42 William Looney, Strategic Patient Adherence Awards: This Years Winner . 43 Reach, Notes from 1er Carrefour de lObservance .

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medical and diet-related issues.44 The program was estimated by the sponsor to have achieved an ROI of roughly 300% while at the same time encouraging physician adoption of the product.45 According to Pfizers VP of customer engagement, Jim Sage: The value equation has changed. It used to be that having a differentiated medicine was the value. Thats changed. Its still part of the value, but now we also have the obligation and the expectation that were going to make sure we follow through on that and support whoever takes those medicines in an appropriate way.46 His colleague, Adele Gulfo, president and general manager for US primary care, agrees. The days of just selling the pill are over, she says. As the number one player in primary care, we touch millions of patients, and we can take costs out of the overall healthcare system. Its an opportunity and a responsibility.47 Many other broad programs have been initiated and have shown positive results. Three that have statistical proof of their effectiveness include:
Program Name Patient Empowerment Program - Pilot Drug/Pathology Chronic Medications: e.g. Calcium Channel Blockers Anti-ulcerants Antidepressants Administrator Pharmacists Paid by Boehringer Ingelheim Result Identified the need to address non-adherence causes beyond financial and reminders. Increased adherence ratio from 0.73 to 0.89 among enrolled patients. Increased prescription refills by 7.9% per month resulting to an additional Rx of $19.86 per test patient.* The program has been statistically proven to improve quality of life for participating patients across a number of clinical measures.** Among patients enrolled in CuraScript and taking Gleevec (Cancer drug), 63% achieved a drug possession ratio (MPR) of 90% or better compared to 53% who used retail pharmacies. CuraScript patients enrolled in oncology Care program achieved adherence rates 12% higher than those for similar patients who received their medications through retail.

Solutions for Wellness

Psychotropic medications

Healthcare provider / nurses Pharmacists

Eli Lilly

CuraScript Specialty Pharmacy (Service)

Chronic illness such as Cancer Growth Hormone Deficiency Hemophilia Hepatitis C

Various sponsors

* Medical Adherence Pilot Final Report . ** Vreeland and al., Solutions for Wellness: Results of a Manualized Psychoeducational Program for Adults with Psychiatric Disorders .

These examples are only a small sample of the many patient support programs that have been undertaken. Many more are undoubtedly on their way.

44 Frost & Sullivan, The Evolution of Patient Adherence Programs: Moving from mass market Relationships to a Personal Approach . 45 Ibid. 46 Arnold, Thinking Past the Pill . 47 Ibid.

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Conclusions
Most pharmaceutical companies talk about the importance of putting patients first in their vision and mission statements. Most pharmaceutical executives are entirely sincere in this, and share these values. As Ian Talmage has pointed out, hearing that the companys drug has actually benefitted a friend is often one of the most rewarding things the companys executives can hear, and such stories are common conversation topics among industry executives. And yet, as Ian also pointed out, effectiveness is not the same thing as efficacy, and if those same life-saving drugs are not taken properly, then they will not be as effective. If pharmaceutical companies wish to move the patientcentric philosophy in their mission statements into their operations then patient support programs seem to be a good way to do that. From the financial perspective, a drug that costs over a billion dollars to research and that can help millions of people will only help those who have received the information and counseling necessary to take it properly. If not, the drug has less value for the patient, and conversely, the patient will generate less value for the drugs supplier. This is a key point when considering patient support programs: if they are undertaken with the goal of increasing prescriptions then they are fundamentally misaligned, they must be undertaken with the goal of truly supporting patients. Its not through increased prescriptions that they will generate direct returns (although well-considered programs may have a positive effect on prescriptions), but increasing adherence will generate revenues that can cover the costs of the program and more. We have seen a number of examples of programs that did exactly that. In this paper weve examined the extent to which left on their own, patients do not adhere to treatments, even in cases in which the consequences of non-adherence are dire. Weve also considered the underlying reasons for non-adherence and reviewed a number of patient support programs that have had measurable positive results through their impact on adherence. The evidence and testimony, taken together, lead to the following conclusions: Should pharma engage with patient support programs? Yes. It makes sense both in terms of the industrys values and its returns. Can pharma successfully engage in patient support programs? Yes. There are many examples of successes, and the examples of failures can inform new programs. Does pharma invest in patient support programs? Yes. Much has already been done and many companies have instituted dedicated teams at a very high level. Much, though, remains to be done.

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