The Elephant in the Pharmacy: Patient Choice Is the Big Challenge That No One Talks About in Affordability of Prescription Drugs

In May 2004, 66-year-old retired electrician Raymond Lindell was arrested in Mexico a few minutes after filling a prescription for 270 tablets of Valium 10 mg at a pharmacy in Nogales, Sonora. Lindell, an Arizona resident, was charged with failing to obtain a duplicate prescription for the controlled substance from a Mexican physician as required by Mexican law. He was further charged with obtaining the medication for another person, his 73-year-old chronically ill wife, and with obtaining more than the legally permissible 30-day supply. Lindell was released after 8 weeks in a Mexican prison, but not before triggering a highly publicized political fracas that included a citizens’ petition drive on his behalf, a boycott of Mexican border town pharmacies by frightened senior citizens, a media campaign by Nogales business leaders to restore customer confidence, and high-level discussions among government officials from the states of Arizona and Sonora. When asked why he had chosen to travel to Nogales, a driving distance of nearly 4 hours, to purchase brand-name Valium rather than fill his wife’s prescription for a much less expensive generic medication in the United States, Lindell answered that their insurance company had stopped paying for brand-name Valium and his wife was dissatisfied with generic alternatives because they “didn’t seem to work.” When health care professionals speak of prescription drug affordability, they typically refer to several important factors: rising medication cost, escalating copayments, and increasing health insurance premiums, to cite a few. But the problem that we too often fail to acknowledge openly—perhaps because it is so much more difficult to address than the others—is the ubiquitous and sometimes counterproductive effects of the choices made by patients and family members. Human beings do not always make wise decisions, and there is much about consumers’ health care decision making that we do not know. How many of the uninsured could afford health insurance premiums but are simply taking the gamble that they are young and healthy now and do not need coverage? Among non-elderly adults in the United States, the likelihood of being uninsured peaks in the 18to 24-year-old age group at 50%, compared with 33% for those aged 25 to 44 years and 17%-20% for those aged 45 to 64 years. How many of those who report that they have foregone medical insurance coverage because of its cost choose to spend the money on leisure activities or consumer goods? Lower income is clearly associated with lack of medical coverage; of those with annual incomes below 200% of poverty level ($37,320 for a family of 4), 57% are uninsured. Yet of 81.8 million Americans under age 65 without health insurance in 2002-2003, 13.5 million, about 16%, had incomes exceeding 400% of poverty level ($74,040 annually for a family of 4), and 22.6 million, about 28%, had incomes exceeding 300% of poverty level ($55,980 annually for a family of 4). Editorial


nn The Elephant in the Pharmacy: Patient Choice Is the Big Challenge That No One Talks About in Affordability of Prescription Drugs
In May 2004, 66-year-old retired electrician Raymond Lindell was arrested in Mexico afew minutes after filling aprescription for 270 tablets of Valium 10 mg at ap harmacy in Nogales, Sonora. Lindell, an Arizona resident, was charged with failing to obtain aduplicate prescription for the controlled substance from aMexican physician as required by Mexican law.Hewas further charged with obtaining the medication for another person, his 73-year-old chronically ill wife, and with obtaining moret han the legally permissible 30-day supply.Lindell was released after 8weeks in aMexican prison, but not beforetriggering ahighly publicized political fracas that included acitizens' petition drive on his behalf, ab oycott of Mexican border town pharmacies by frightened senior citizens, am edia campaign by Nogales business leaders to restorecustomer confidence, and high-level discussions among government officials from the states of Arizona and Sonora. When asked why he had chosen to travel to Nogales, ad riving distance of nearly 4h ours, to purchase brand-name Valium rather than fill his wife' sp rescription for a much less expensive generic medication in the United States, Lindell answered that their insurance company had stopped paying for brand-name Valium and his wife was dissatisfied with generic alternatives because they "didn'tseem to work." 1,2 When health carep rofessionals speak of prescription drug affordability,t hey typically refer to several important factors: rising medication cost, escalating copayments, and increasing health insurance premiums, to cite af ew.B ut the problem that we too often fail to acknowledge openly-perhaps because it is so much mored ifficult to address than the others-is the ubiquitous and sometimes counterproductive effects of the choices made by patients and family members.
Human beings do not always make wise decisions, and there is much about consumers' health cared ecision making that we do not know.H ow many of the uninsured could affordh ealth insurance premiums but aresimply taking the gamble that they arey oung and healthy now and do not need coverage? Among non-elderly adults in the United States, the likelihood of being uninsured peaks in the 18-to 24-year-old age group at 50%, compared with 33% for those aged 25 to 44 years and 17%-20% for those aged 45 to 64 years. 3 How many of those who report that they have foregone medical insurance coverage because of its cost choose to spend the money on leisureactivities or consumer goods? Lower income is clearly associated with lack of medical coverage; of those with annual incomes below 200% of poverty level ($37,320 for afamily of 4), 57% areuninsured. 3

Editorial
Medication choices arenot always made wisely either,asthe Lindell case illustrated with nearly tragic results. How often do patients seek an expensive brand drug out of ignorance of the benefits and therapeutic or chemical equivalence of generic medications, with the unfortunate consequence that they find full compliance too expensive and curb or even terminate their treatment? In as tudy of medication-taking behavior following the initiation of chronic therapy,p atients initially treated with generic medication werel ess likely (13.6%) than those treated with preferred brands (19.9%) or nonpreferred brands (28.3%) to switch to aproduct in adifferent tier. 4 The percentage of days covered (PDC) was 6.6 percentage points higher for generic users (58.8%) than for users of nonpreferred brands (52.2%), and the odds of adherence (defined as PDC >8 0%) were6 2% higher for generic users than for nonpreferred brand users.
National Medical ExpenditurePanel Survey data suggest that only 61% of U.S. multisource drug sales from 1997 to 2000 wered ispensed as generic; an estimated 11% savings would have resulted from generic conversions on the basis of chemical equivalence alone. 5 An unpublished pharmacy benefits manager study estimated unrealized potential savings from combined therapeutic and chemically equivalent substitution in 6therapy classes (antidepressants, antihyperlipidemics, antihypertensives, calcium channel blockers, gastrointestinals, and nonsteroidal anti-inflammatoryd rugs) at $21.7 billion for commercially insured members in 48 states during 2005 . 6 Yet, in surveys, about 20%-40% of health carec onsumers express the belief that generic medications arelower in quality or effectiveness than brand medications. 7-10 Moreover,t he perceived risk of using ag eneric instead of ab rand medication varies with seriousness of illness, with the percentage increasing for the chronic illnesses most often targeted by generic substitution programs. In aw illingness-to-pay survey assessing the likelihood of generic use by health condition, the percentage of consumers rating ageneric drug as riskier than abrand drug to treat ah eart condition (53.8%) was higher than comparable ratings for hypertension (44.0%), strep throat (22.0%), pain (18.9%), or cough (14.2%). 8 In addressing the question of health carec hoices, including patients' decisions about whether to comply with treatment, policy analysts too often limit their focus to out-of-pocket cost, sometimes ignoring human idiosyncrasy.The willingness-to-pay survey results suggest that as ingle-minded focus on out-ofpocket cost is likely to yield limited results; when rating how much of ag eneric versus brand cost differential would be necessarytoencourage the acceptance of generic medication to treat ah eart condition, 27.2% of respondents said that they would not use ageneric at any cost saving. 8 Given the reality that evidence does not always support the choices that human beings make, how can we do abetter job of promoting good choices?
Put 20 health caree conomists in ar oom, and you might get 20 different opinions about the crucial question of aligning consumer and provider behavior with desired outcomes. Critics of tiered copayment structures or other cost-sharing schemes point out that an insured worker' sa verage out-of-pocket cost for abrand drug has increased considerably in recent years, by 84% for preferred brand medications (from $13 in 2000 to $24 in 2006) according to recent estimates, 11 but rarely mention that the average out-of-pocket cost per prescription for ag eneric medication-$11-is much lower than the brand cost. Nor do these critics typically put the problem into context by pointing out that the shareoftotal pharmaceutical spending paid by consumers has dramatically declined over time. In 1990, consumers paid 56% of prescription drug expenditures out of pocket. Just 10 years later,t he consumer shareo fp rescription drug cost declined to 28%. In 2005 it was 25%, and in 2006 it is projected to decline even further to 19% in large part because of the MedicareP art Dp rogram. 11 Aref urther declines in the sharep aid by consumers the solution to the (as yet not completely understood) problem of prescription drug affordability? Would such declines be sustainable over the long term, or even the short term, in any third-party coverage system? Some have argued that the solution to aligning consumer behavior with desired outcomes lies in value-based insurance design in which out-of-pocket cost would be highly targeted based on the presumed value of the medication in ap atient' s particular clinical situation. For example, averylow copayment would be charged for beta-blocker therapy in congestive heart failurep atients. 12 As imilar proposal in England would require the National Health Service to pay for branded medication based on value, with higher payments for moree ffective drugs and lower payments for "me too" and less effective drugs. 13 While the value-based approach is promising, it is also untested; the industryawaits comparative studies of its merit, much as it implemented 3-tier copayment designs some 15 years ago, before their outcomes had been assessed. And when long-held assumptions aret ested using strong research designs, they aren ot always supported. For example, in the run-up to passage of MedicareP art Dc overage, assertions that better access to prescription drugs would reduce medical expenses were common. Yetinawell-controlled study of the effect of providing prescription coverage to seniors, Briesacher and colleagues found that acquiring prescription drug coverage resulted in increased expense for prescription medications without any observable consistent effect on medical service costs. 14 While we await evidence, payers, providers, and patients seek solutions to the problem of prescription drug affordability as they understand it. This issue of JMCP has 2 commentaries regarding the value versus cost of prescription assistance or patient (medication) assistance programs (PAPs). In ap revious article in JMCP,C lay et al. found that am edical clinic incurred administrative costs of $10.42 per patient for a brand drug that requires 1application per year and up to $46.30 per patient for ad rug in aP AP that requires 4( re)applications per year. 15 Chen and Summers assert in their follow-up commentaryinthis issue of JMCP that PAPs areanessential part of the frayed fabric that supports health cares ervices for lowincome persons who don'tqualify for Medicaid or other public programs. 16 Carroll, in as econd follow-up commentaryi nt his issue, presents an alternative view,that PAPs may incent providers to adopt as hort-term solution-providing a" free" brand-name drug to alower-income patient instead of ageneric medication that might be less expensive and equally effective. 17 Examples of potentially perverse incentives associated with PAPs abound. Paroxetine (Paxil) CR costs approximately $107 per month of therapy in mid-2007 compared with generic paroxetine at $21 per month of therapy,b oth dosed once per day.P axil CR has no generic equivalent but is the same molecule as generic paroxetine, with no evidence of therapeutic inequivalence to paroxetine, meaning that 5p atients can be treated with generic paroxetine for the same cost as 1p atient treated with brand paroxetine CR. 18 Or consider the cost of generic simvastatin at $26 per month of therapy in mid-2007 versus $100 per month of therapy with therapeutically equivalent atorvastatin (Lipitor). All of this leaves us with another fundamental question: Is subsidizing poor decisions necessaryoreven prudent?
These ared ifficult questions, perhaps even offensive questions to some, but they aree ssential questions if we aret o define accurately the problem of affordability of prescription medications and to face head on and realistically the challenge of healthcarereform.To findevidence-basedsolutions,weneedmore answers-specifically,m orea nswers to questions about why some patients comply with treatment, including prescribed medication, and why some do not. We need better information about the degree to which out-of-pocket cost reductions and cost differentials influence patient behavior and how pharmacistdirected intervention such as that described previously by Stebbins et al. 19 and suggested by Chen and Summers might affect the actual realized value of pharmacotherapy.Clay et al. helped define the administrative cost incurred by am edical clinic in assisting patients with PAPs but did not address pharmacist intervention or other systematic education of patients in how to use the drugs. 15 However,Clay et al. opened the door alittle wider for others to measurew hat patients do with these brand drugs obtained via PAPs and how these outcomes compare with am orec omprehensive pharmacist-directed intervention in which PAPs arear elatively small part of attaining affordable drug therapy.
Finally,t ob ase decision making on evidence instead of presupposition, we need rigorous studies to determine which interventions effectively influence patient choice and which do not. Much of the research in benefit design policy is plagued by weak cross-sectional and pre-post analyses, which areprone to confounding even after appropriate statistical controls are used. We call for studies employing stronger quasi-experimental