Sensitivity of Medication Use to Formulary Controls in Medicare Beneficiaries: A Review of the Literature

November/December 2011, Vol4, No7 - Business
Rahul Shenolikar, PhD
Amanda Schofield Bruno, PhD, MPH
Christopher Cantrell, PhD
Michael Eaddy, PharmD, PhD
Vice President
Real-World Evidence
Xcenda
AmerisourceBergen
Frisco, TX
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Abstract

Background: Several studies have examined the impact of formulary management strategies on medication use in the elderly, but little has been done to synthesize the findings to determine whether the results show consistent trends.

Objective: To summarize the effects of formulary controls (ie, tiered copays, step edits, prior authorization, and generic substitution) on medication use in the Medicare population to inform future Medicare Part D and other coverage decisions.

Methods: This systematic review included research articles (found via PubMed, Google Scholar, and specific scientific journals) that evaluated the impact of drug coverage or costsharing on medication use in elderly (aged ?65 years) Medicare beneficiaries. The impact of drug coverage was assessed by comparing patients with some drug coverage to those with no drug coverage or by comparing varying levels of drug coverage (eg, full coverage vs $1000 coverage or capped benefits vs noncapped benefits). Articles that were published before 1995, were not original empirical research, were published in languages other than English, or focused on populations other than Medicare beneficiaries were excluded. All studies selected were classified as positive, negative, or neutral based on the significance of the relationship (P <.05 or as otherwise specified) between the formulary control mech - anism and the medication use, and on the direction of that relationship.

Results: Included were a total of 47 research articles (published between 1995 and 2009) that evaluated the impact of drug coverage or cost-sharing on medication use in Medicare beneficiaries. Overall, 24 studies examined the impact of the level of drug coverage on medication use; of these, 96% (N = 23) supported the association between better drug coverage (ie, branded and generic vs generic-only coverage, capped benefit vs noncapped benefit, supplemental drug insurance vs no supplemental drug insurance) or having some drug coverage and enhanced medication use. Furthermore, 84% (N = 16) of the 19 studies that examined the effect of cost-sharing on medication use demonstrated that decreased costsharing was significantly associated with improved medication use.

Conclusion: Current evidence from the literature suggests that restricting drug coverage or increasing out-of-pocket expenses for Medicare beneficiaries may lead to decreased medication use in the elderly, with all its potential implications.

Am Health Drug Benefits. 2011;4(7):465-474

Patient access to healthcare resources is an important topic of healthcare discussion, research, and reform in the United States.1,2 Access issues are usually framed in the context of patients having health insurance, as the quality of health insurance facilitates patient access to necessary medical and pharmaceutical therapies.2 Although patient access to medications is essential, formulary management strategies may introduce barriers aimed at restricting utilization, including curbing patient demand by increasing the cost borne by the patient or providing incentives to select lower-cost alternatives. Examples of these strategies include tiered copays, coinsurance, and benefit caps.3,4

The advent of Medicare Part D in 2006 made the federal government the single largest payer of medications in the country, providing coverage to Medicare beneficiaries and the disabled. Although Part D is sponsored by the Centers for Medicare & Medicaid Services (CMS), it is administered by health plans that have the ability to implement restrictions on medication use in the form of drug benefit. Evidence generated from previous studies demonstrate that formulary controls can impact patients’ medication-taking be havior and, ultimately, patient outcomes. 4 However, conclusions drawn from these studies were largely based on populations that included nonelderly, commercial, or non-US populations.4 Elderly people could behave differently from younger people in response to formulary controls, given their increased likelihood of comorbidities and greater need for medications to maintain good health.

No study to date has collated existing data to assess the consistency in the findings regarding the impact of formulary controls on medication use—defined in this current study as adherence, change in days supply, medication fills, and number of tablets—in the elderly. Synthesizing evidence from previous studies involving elderly populations may help in assisting Medicare and other health plan benefit design guidelines in the future.

Therefore, the objective of this study was to summarize the effects of formulary controls on the US elderly (ie, Medicare) population based on previously published studies to generate evidence using earlier research that could be used to make future coverage decisions. Formulary controls included all formulary strategies that use mechanisms such as formulary restrictions and benefit design, including tiered copayments, step edits, prior authorization, and generic substitution.

Methods
Study Selection

First, a list of search terms was applied to a database of the medical sciences (PubMed, published by the National Library of Medicine), the search engine Google Scholar, and specific scientific journals. Second, articles from certain journals, such as Health Affairs, Medical Care, the American Journal of Geriatric Pharmacotherapy, and the Journal of the American Geriatrics Society, were individually searched. These journals were selected because of their wide readership and focus on healthcare policy studies and research related to clinical care, and because of recent developments in drug therapy in the elderly.

The list of search terms used in step 1 was designed to address the impact of formulary controls on patient medication use. Formulary controls included in this study encompassed all formulary strategies that use formulary restrictions and benefit design mechanisms, as noted above (ie, tiered copayments, step edits, prior authorization, and generic substitution). Some of these strategies are intended to curb patient demand for drug therapies, by increasing the cost borne by the patient or by providing incentives to select lower-cost alternatives.

The set of search terms, therefore, included: Medicare, elderly, older, compliance, adherence, persistence, outcomes, adverse event, utilization, resource use, prescription drug expenditures, cost, cost share, copayment, out of pocket, coinsurance, deductible, pharmacy coverage, step therapy, benefit change, cap, premium, insurance coverage, insurance type, tiered benefit design, formulary, consumer-driven health plans, prescription drugs, generic drug use, branded drugs, access, capitated, fee for service, and retrospective analysis.

More than 500 research articles were obtained that pertained to these search terms. To make the articles applicable to this literature review, certain exclusion criteria were applied (Figure 1). Articles were excluded if they were published before 1995, were not original empirical research, were published in languages otherthan English, or focused on populations other than Medicare enrollees. These exclusion criteria were used after a review of the title and content of the abstracts. A full article review was conducted in cases where the title and abstract review were inconclusive. There was no restriction on study design.

The third component of the search strategy included an examination of the list of references from all studies selected in steps 1 and 2 to determine whether the studies met the selection criteria.

Table 1
Variables Defined by Studies Included in This Systematic Review

Study Variables
Formulary controls are tools used by payers to restrict the number of medications covered for each patient. Operational definitions of formulary controls evaluated in this study were based on the definitions in the studies that met the selection criteria. Included studies examined a variety of formulary controls—except step therapy and prior authorization—and were classified according to whether the specific control affected either (1) the level of drug coverage or (2) medication cost-sharing (Table 1). The classification of studies into these 2 categories allowed for the assessment of the impact of drug coverage on medication use by comparing, for example, patients with some drug coverage with those with no drug coverage, or by comparing different levels of drug coverage (eg, branded and generic vs genericonly coverage).

The impact of cost-sharing, however, was examined by comparing differences in patient copayment or the coinsurance amount for medications. Medication use the outcome variable included in the study was also defined according to the definitions used in the included studies (Table 1), and together these variables were used to represent the variable medication use.

Study Classification into Positive, Negative, or Neutral Categories
This literature review included 2 types of studies:

  1. Studies that examined the relationship between costsharing/ level of drug coverage and medication use, using hypothesis testing
  2. Descriptive studies. (Some descriptive studies were not categorized and are described separately in the Results section.)
Figure 1
Article Selection and Identification Criteria

All other studies were classified as positive, negative, or neutral based on the following 2 criteria. First, we determined whether the relationship between the impact of the level of drug coverage or medication costsharing on medication use was statistically significant. Second, if the relationship was significant, we determined the direction of relationship, that is, whether it was positive or negative based on a predetermined definition of positive relationship, as illustrated in Figure 2. For example, better drug coverage (eg, branded and generic vs generic-only coverage, capped benefit vs noncapped benefit, supplemental drug insurance vs no supplemental drug insurance) or lower cost-sharing associated with significantly improved medication use was considered a positive relationship, whereas reduced drug coverage or increased cost-sharing associated with significantly reduced medication use was considered a negative relationship. Relationships that were not significant were considered neutral.

In addition, the following decision rule was applied to research articles that examined multiple disease states, outcome measures, therapies, or periods of study. Studies with positive and neutral relationships between the impact of drug coverage level or medication cost-sharing on medication use were classified as positive; studies with negative and neutral relationships were classified as negative; and those with positive and negative relationships were classified as both positive and negative. Studies that assessed the impact of cost-sharing as well as drug coverage were counted as 2 different studies in the results of this systematic review.

Results
A total of 47 research articles met the selection criteria and were included in this systematic review (see Appendix at www.AHDBonline.com/node/868).5-51 Of these studies, 13% (N = 6) were descriptive.46-51

Overall, in the 15-year (1995-2009) time frame, 24 studies examined the impact of level of drug coverage on medication use,5-28 and 19 studies examined the impact of cost-sharing on medication use.8,22,29-45 The majority of these studies were cross-sectional and used the Medicare Current Beneficiary Survey (MCBS, a predesigned survey) or medical and/or pharmacy claims as a data source and were not specific to a particular disease state. Studies that were specific, however, focused on a single disease or on multiple diseases (including cardiovascular conditions, diabetes, arthritis, lung disease, and depression). The studies by Blustein8 and by Steinman22 were counted twice, because they assessed the level of drug coverage as well as the impact of cost-sharing on medication use.

Of the 24 studies that examined the impact of drug coverage,5-27 96% (N = 23) were positive, indicating that better coverage was associated with increased use of medications (Table 2). Similarly, of the 19 studies that examined the effect of cost-sharing on medication use, 84% (N = 16) were positive, demonstrating that decreased cost-sharing improved medication use.8,22,29-42

Findings from Descriptive Studies
All 6 of the descriptive studies were published before the launch of Medicare Part D.46-51 Their findings are described separately, because those studies did not include hypothesis testing to examine the relationship between formulary control and medication use. They simply described the variation in medication use for different levels of cost-sharing or drug coverage.

The study by Davis and colleagues that used the 1995 MCBS showed that elderly persons with drug coverage averaged 20.3 prescriptions annually, whereas those with no drug coverage averaged 5 (25%) fewer prescriptions annually.46 In addition, patients with dual eligibility for Medicare and Medicaid used about twice as many (102% more) prescriptions, on average, as those in fee-for-service plans with no supplemental insurance (25.6 vs 12.7 prescriptions annually, respectively).46

The US Department of Health and Human Services reported similar findings using 1996 MCBS data,47 and another study examining 2 years of data (1995 and 1996) reported that in 1996, on average, Medicare beneficiaries without drug coverage used 5 (24%) fewer prescriptions than those with drug coverage (16.01 vs 21.14 prescriptions, respectively).48

This finding was supported by a follow-up study using 1998 data that showed even greater differences in medication utilization between Medicare beneficiaries with and without drug coverage.49 Those with drug coverage used almost 8 (46%) more prescriptions annually than those without coverage (24.35 vs 16.65 prescriptions, respectively).49

Another study supporting the relationship between drug coverage and medication use based on the 1996 MCBS data reported that Medicare beneficiaries who were always covered during the year filled 22.4 prescriptions compared with 16.7 prescriptions filled by those with no coverage, a 34% difference; beneficiaries with only partial-year coverage fell in between, filling only 21.8 prescriptions for the year.50

The final descriptive study, which examined 4 years (1996-1999) of MCBS data, revealed little difference between Medicare beneficiaries with and without drug coverage in acquiring prescribed medications.51 Less than 3.5% of beneficiaries in each group (those with and without coverage) reported that they did not acquire a prescribed medicine.51

Figure 2
Positive Study Classification,a Based on Relationships of Interest

Selected Study Findings
Impact of drug coverage or cost-sharing on medication use.
Irrespective of formulary control, the majority of the studies included in our analysis supported the hypothesis that more restrictive drug coverage is associated with decreased medication use. From a more granular perspective, studies that empirically examined the relationship between the level of coverage or costsharing and medication use showed that implementing 2 cost-sharing options (ie, full prescription drug coverage vs $1000 maximum annual coverage) increased the overall rates of discontinuation over time.

Table 2
Studiesa with Positive Status: Impact of Coverage Type on Medication Use in the Medicare Population

A study that investigated the use of lipid-lowering agents demonstrated that among elderly patients who were initially prescribed a statin, the 12-month discontinuation rates were 33% for those with full drug benefit coverage and 50% for those with $1000 maximum annual coverage. After 21 months, these rates increased to 60% and 86%, respectively (P = .023).5 In another study, an effective price decrease of 10% for prescription drugs was estimated to increase utilization by 5.4% (P <.05).20

In addition, a separate study showed that the odds of failing to purchase any antihypertensive medications were 40% greater (odds ratio [OR], 1.4; P = .002) for those lacking drug coverage compared with those with drug coverage.8 In the same study, drug coverage significantly increased the number of tablets purchased during the year (from 423 tablets to 460, adjusted for other covariates; P = .02).8 In another study, the risk for delay in filling medications was significantly lower (OR, 0.33; P <.001) among those who had drug coverage compared with those who lacked drug coverage.14

However, in a sample of 310 community-dwelling elderly, those who reported having some drug coverage did not report increased daily use of medications, regardless of their out-of-pocket amount.28 Respondents with Medicaid coverage were 17.24 times more likely (90% confidence interval [CI], 1.24-239) to report using at least 1 medication, and those with a service benefit (2.49; 90% CI, 0.53-11.6) or indemnity coverage (OR, 2.67; 90% CI, 0.58-12.5) were more than twice as likely as those who were uninsured to report using a prescription drug; however, these effects were not significant.28 These neutral findings could have been the result of the small sample size, and warrant additional investigation.

Managed care Medicare beneficiaries who reached their prescription drug capped amount were more likely to engage in behavior to decrease out-of-pocket expenses, including taking fewer medications than prescribed (OR, 2.83; 95% CI, 1.55-5.20) and discontinuing medication use (OR, 3.36; 95% CI, 1.63-6.94).32

A 2004 survey of Medicare+Choice beneficiaries revealed that a higher proportion of patients exceeding their coverage cap reported using fewer prescribed medications than the controls (18% vs 10%, respectively; P <.001), but similar proportions reported stopping their medications completely (8% for both; P = .86), and those with chronic conditions such as asthma, hyperlipidemia, and hypertension were most responsive to benefit caps.27

These results suggest that formulary controls should perhaps be targeted to avoid affecting the elderly at greatest risk for adverse health outcomes. In addition, 2 studies addressed drug benefit generosity. One study showed that Medicare beneficiaries with the most generous drug coverage (defined as the percentage of annual drug expenditures paid by insurance) were twice as likely (OR, 2.22; 95% CI, 1.80-2.75) to receive cy clooxygenase-2 inhibitors as those with no third-party coverage.33

Another study showed that no drug coverage (no retiree drug benefits or no spending covered by an employer) was associated with lower odds of using essential cardiovascular medications, such as statins (OR, 0.34; 95% CI, 0.21-0.56) for coronary artery disease (CAD) or hyperlipidemia, or angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (OR, 0.35; 95% CI, 0.23-0.55) for congestive heart failure CAD.34 Those with no drug coverage (Medicare fee-for-service only and Medigap without drug coverage) were less likely to receive statins than those with some form of drug coverage (OR, 0.16; 95% CI, 0.05-0.49).11

Although certain drug classes were affected more than others, elderly patients who chose 3-tier drug coverage were more likely overall to experience patterns of medication interruption compared with those who remained on 2-tier coverage. In a study that compared four 3-tier formulary intervention plans with two 2-tier plans, the adjusted probability of nonpersistent drug use among one of the 3-tier intervention plans’ ACE inhibitor users (who switched from a 2-tier formulary) was 18.4% compared with 15.3% (P ?.01) for the comparison group that stayed with the 2-tier coverage.37 The adjusted probability of discontinuation among ACE inhibitor users in the intervention plan was 4.7% compared with 3.8% for the comparison group (P = .04).37

Furthermore, beneficiaries with chronic obstructive pulmonary disease who were members of a staff model health maintenance organization with a generic-only benefit (lowest level of coverage) were more likely (OR, 1.70; 95% CI, 1.25-2.31) to report taking less than the prescribed dose and discontinuing regular medications more frequently (OR, 1.77; 95% CI, 1.27- 2.47) than those with 1- or 2-tier coverage.39

Discussion
This study intended to summarize published evidence in an effort to inform policies related to medication use, medication access, and drug benefits in Medicare plans. Based on the available research previously published, this review suggests that more restrictive drug coverage or formulary strategies that are intended to curb patient demand for drug therapies by increasing the cost borne by the patient or by providing incentives to select lowercost alternatives—in the elderly leads to decreased utilization of drug therapies.

Since 1995, 4 studies reported nonsignificant, neutral relationships. Two of these studies had a relatively low sample size (300-800 patients), and therefore, merit consideration in light of other studies conducted in larger Medicare populations.28,43

One of the benefits of implementing formulary controls is that they can be used as a cost-control mechan - ism to limit or reduce prescription spending. However, these benefits could be short-term. There is little evidence documenting their long-term impact on healthcare costs and patient quality of care.52,53

Furthermore, even though such strategies help control prescription drug spending, they can have limitations. Evidence suggests that formulary management controls designed to direct patients toward lower-cost therapies or reduce their overall medication use have unintended consequences, often resulting in the underuse or discontinued use of medications.52-55

The evidence is constant in commercial and in privately insured populations as well. In a study of privately insured individuals aged 18 to 64 years, Goldman and colleagues showed that doubling the patient copayment was associated with a significant reduction in the use of anti-ulcer drugs (33% reduction), anti-asthmatic agents (32%), antidepressants (26%), antihypertensives (26%), antihyperlipidemic drugs (34%), antidiabetic drugs (25%), anti-inflammatory drugs (45%), and antihistamines (44%).54

Although price sensitivity is greatest in therapies used to treat the symptoms of disease, there is a fair degree of price elasticity in patient demand for essential therapies that are taken regularly for the treatment of chronic and/or serious illnesses.54-56 One study compared employersponsored health plans in which one plan simultaneously switched from a 1-tier to a 3-tier formulary and increased all enrollee copayments for medications. The second employer switched from a 2-tier to a 3-tier formulary, changing only the copayments for tier-3 drugs. Enrollees covered by the employer who implemented more dramatic changes experienced slower growth in the probability of the use of a drug than the comparison group.55

Research shows that reduced medication use can lead to worse health outcomes. Inconsistent use of betablockers after a myocardial infarction has been associated with increased rates of mortality,57,58 suboptimal use of antidepressants has been related to decreased productivity59 and quality of life,60 and intermittent use of inhaled corticosteroids in patients with asthma has been linked to exacerbations requiring visits to the emergency de - partment and hospital admission.61

Although these types of unintended effects are undesirable, they support increased efforts by health policymakers to design formulary controls that aim to improve appropriate use of medications to reduce disease burden and improve the overall health of patient populations.

For this reason, it could be argued that formulary controls should be implemented only after considering the potential unintended consequences, such as discontinuation of needed medications, that could further lead to poor health outcomes and inefficient use of medical resources. Broad population-based controls aimed directly at reducing the total pharmacy budget may therefore be less beneficial than more customized approaches that encourage value-based spending.

As formulary controls are becoming more complex, with 86% of Medicare Part D plans utilizing 4- or 5-tier structures,62 consideration of the unintended consequences of restricted coverage in this population will continue to be important. Since the inception of Part D, elderly beneficiaries have faced less restrictive coverage with more drug options on formulary; however, there is evidence that beneficiaries are not reevaluating available coverage options to best meet their needs.13

In addition, drug prices are often not transparent to patients, who can in some cases pay the full price of brand-name medications under reference-based pricing schedules.63 Furthermore, although subsidies are provided to help low-income elderly patients pay for their drug coverage, the most optimal plan is not always selected, because the set of alternatives is difficult to navigate.64

To compound matters, coverage completion and beneficiary selection of a “best plan” is compromised by the highly variable mix of drug therapies needed by patients over time.65 A recent survey conducted by the AARP showed that nearly 17% of all elderly respondents believed they would be unable to afford their medications in the coming year.66

Finally, the recent rise in pharmaceutical drug spending67 and health reform efforts to support the implementation of more comparative effectiveness studies will ensure that increased attention will be paid to the contribution of high-cost drug therapies to healthcare budgets. Payers, in turn, will face greater pressure to implement management strategies that reduce drug costs and drug demand while still providing access to valuable treatments. T

he results of this study may therefore inform payer and other stakeholder decisions that affect treatment access in the elderly through the promotion of customized, value-based approaches to curbing drug and overall medical spending.

Limitations
This study has several limitations. First, the selection criteria might have excluded some studies with useful results. For example, studies that defined older patients as those aged ?50 years were excluded, because not all patients in these studies were Medicare enrollees. In addition, Canadian studies conducted in a population aged ?65 years were excluded, because this review was focused on the US Medicare population.

Second, the internal validity of included studies might have been affected by study design or other components of the methodology, such as the lack of standardized measures to assess patterns of medication use or the use of patient-reported measures of medication use. Very few studies used widely accepted and validated measures, such as the Medication Possession Ratio and Proportion of Days Covered measure, that use patients’ pharmacy claims, partly because these data were unavailable to the researchers.

This literature review evaluated studies that were conducted after, as well as before, the implementation of Medicare Part D. The reason for evaluating these studies together was that there were few published studies conducted after the implementation of Part D. To gain future insights, other researchers should investigate studies conducted only after the implementation of Part D.

Finally, the measurement of long-term outcomes is inadequate, because of the lack of large databases with clinical and/or economic information for elderly patients.68 The number of total studies included was low despite the minimally restrictive selection criteria. This low number could be the result of limited access to appropriate data sources, creating a need for greater efforts to be made to release this information to organizations and individuals conducting health services research.

Conclusion
As additional studies become available, results should continue to be synthesized for policy recommendations. CMS has issued a final ruling that permits the use of claims data collected from Medicare Part D beneficiaries for research by external researchers, including other federal agencies such as the US Food and Drug Administration and the Agency for Healthcare Research and Quality, as well as reputable academic centers and thinktank organizations.69 The release of these data may allow the study of the benefits and risks of different formulary controls, which would, in turn, inform benefit design restrictions and the differential impact of certain management strategies on patient subgroups, such as those with specific chronic conditions.70

With such increased research and an active political environment determined to maximize value in the US healthcare system, the results presented here suggest that medication use among the elderly, along with clinical outcomes and economic efficiency, can potentially be improved through carefully crafted policies and drug coverage decisions that account for unintended consequences.

References

  1. Pear R. At house party on health care, the diagnosis is it’s broken. The New York Times. December 22, 2008. www.nytimes.com/2008/12/23/health/23health.html. Accessed July 28, 2011.
  2. Baicker K. Formula for compromise: expanding coverage and promoting highvalue care. Health Aff (Millwood). 2008;27:658-666.
  3. Chao SH. Introduction: shifting the focus from cost to value. J Manag Care Pharm. 2006;12(suppl S-b):S3-S5.
  4. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost-sharing: associations with medication and medical utilization and spending and health. JAMA. 2007;298:61-69.
  5. Abughosh SM, Kogut SJ, Andrade SE, et al. Persistence with lipid-lowering therapy: influence of the type of lipid-lowering agent and drug benefit plan option in elderly patients. J Manag Care Pharm. 2004;10:404-411.
  6. Andrade SE, Gurwitz JH. Drug benefit plans under managed care: to what extent do older subscribers selecting less drug coverage put themselves at increased financial risk? J Am Geriatr Soc. 2002;50:178-181.
  7. Adams AS, Soumerai SB, Ross-Degnan D. Use of antihypertensive drugs by Medicare enrollees: does type of drug coverage matter? Health Aff (Millwood). 2001;20:276-286.
  8. Blustein J. Drug coverage and drug purchases by Medicare beneficiaries with hypertension. Health Aff (Millwood). 2000;19:219-230.
  9. Christian-Herman J, Emons M, George D. Effects of generic-only drug coverage in a Medicare HMO. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4-455– W4-468.
  10. Coulson N, Stuart B. Insurance choice and the demand for prescription drugs. South Econ J. 1995;61:1146-1157.
  11. Federman AD, Adams AS, Ross-Degnan D, et al. Supplemental insurance and use of effective cardiovascular drugs among elderly medicare beneficiaries with coronary heart disease. JAMA. 2001;286:1732-1739.
  12. Hsu J, Price M, Huang J, et al. Unintended consequences of caps on Medicare drug benefits. N Engl J Med. 2006;354:2349-2359.
  13. Jackson EA, Axelsen KJ. Medicare Part D formulary coverage since program inception: are beneficiaries choosing wisely? Am J Manag Care. 2008;14:SP29-SP35.
  14. Klein D, Turvey C, Wallace R. Elders who delay medication because of cost: health insurance, demographic, health, and financial correlates. Gerontologist. 2004; 44:779-787.
  15. Lillard LA, Rogowski J, Kington R. Insurance coverage for prescription drugs: effects on use and expenditures in the Medicare population. Med Care. 1999;37: 926-936.
  16. Mojtabai R, Olfson M. Medication costs, adherence, and health outcomes among Medicare beneficiaries. Health Aff (Millwood). 2003;22:220-229.
  17. Rogowski J, Lillard LA, Kington R. The financial burden of prescription drug use among elderly persons. Gerontologist. 1997;37:475-482.
  18. Saleh SS, Weller W, Hannan E. The effect of insurance type on prescription drug use and expenditures among elderly Medicare beneficiaries. J Health Hum Serv Adm. 2007;30:50-74.
  19. Saver BG, Doescher MP, Jackson JE, Fishman P. Seniors with chronic health conditions and prescription drugs: benefits, wealth, and health. Value Health. 2004; 7:133-143.
  20. Shea DG, Terza JV, Stuart, BC, Briesacher B. Estimating the effects of prescription drug coverage for Medicare beneficiaries. Health Serv Res. 2007;42:933-949.
  21. Soumerai SB, Pierre-Jacques M, Zhang F, et al. Cost-related medication nonadherence among elderly and disabled medicare beneficiaries: a national survey 1 year before the Medicare drug benefit. Arch Intern Med. 2006;166:1829-1835.
  22. Steinman MA, Sands LP, Covinsky KE. Self-restriction of medications due to cost in seniors without prescription coverage. J Gen Intern Med. 2001;16:793-799.
  23. Stuart B, Grana J. Are prescribed and over-the-counter medicines economic substitutes? A study of the effects of health insurance on medicine choices by the elderly. Med Care. 1995;33:487-501.
  24. Stuart B, Grana J. Ability to pay and the decision to medicate. Med Care. 1998; 36:202-211.
  25. Taira DA, Iwane KA, Chung RS. Prescription drugs: elderly enrollee reports of financial access, receipt of free samples, and discussion of generic equivalents related to type of coverage. Am J Manag Care. 2003;9:305-312.
  26. Tseng CW, Brook RH, Keeler E, et al. Effect of generic-only drug benefits on seniors’ medication use and financial burden. Am J Manag Care. 2006;12:525-532.
  27. Tseng CW, Brook RH, Keeler E, et al. Cost-lowering strategies used by Medicare beneficiaries who exceed drug benefit caps and have a gap in drug coverage. JAMA. 2004;292:952-960.
  28. Mott DA, Schommer JC. Exploring prescription drug coverage and drug use for older Americans. Ann Pharmacother. 2002;36:1704-1711.
  29. Artz MB, Hadsall RS, Schondelmeyer SW. Impact of generosity level of outpatient prescription drug coverage on prescription drug events and expenditure among older persons. Am J Public Health. 2002;92:1257-1263.
  30. Cole JA, Norman H, Weatherby LB, Walker AM. Drug copayment and adherence in chronic heart failure: effect on cost and outcomes. Pharmacotherapy. 2006;26: 1157-1164.
  31. Colombi AM, Yu-Isenberg K, Priest J. The effects of health plan copayments on adherence to oral diabetes medication and health resource utilization. J Occup Environ Med. 2008;50:535-541.
  32. Cox ER, Jernigan C, Coons SJ, Draugalis JL. Medicare beneficiaries’ management of capped prescription benefits. Med Care. 2001;39:296-301.
  33. Doshi JA, Brandt N, Stuart B. The impact of drug coverage on COX-2 inhibitor use in Medicare. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4-94–W4-105.
  34. Doshi JA, Polsky D. Drug benefit generosity and essential medication use among Medicare-eligible retirees. Am J Manag Care. 2007;13:425-431.
  35. Gilman BH, Kautter J. Consumer response to dual incentives under multitiered prescription drug formularies. Am J Manag Care. 2007;13:353-359.
  36. Gilman BH, Kautter J. Impact of multitiered copayments on the use and cost of prescription drugs among Medicare beneficiaries. Health Serv Res. 2008;43:478-495.
  37. Huskamp HA, Deverka PA, Landrum MB, et al. The effect of three-tier formulary adoption on medication continuation and spending among elderly retirees. Health Serv Res. 2007;42:1926-1942.
  38. Rector TS, Venus PJ. Do drug benefits help Medicare beneficiaries afford prescribed drugs? Health Aff (Millwood). 2004;23:213-222.
  39. Spence MM, Hui R, Chan J. Cost reduction strategies used by elderly patients with chronic obstructive pulmonary disease to cope with a generic-only pharmacy benefit. J Manag Care Pharm. 2006;12:377-382.
  40. Stuart B, Zacker C. Who bears the burden of Medicaid drug copayment policies? Health Aff (Millwood). 1999;18:201-212.
  41. Thomas CP, Wallack SS, Lee S, Ritter GA. Impact of health plan design and management on retirees’ prescription drug use and spending. Health Aff (Millwood). 2001;Suppl Web Exclusives:W4-408–W4-419.
  42. Wilson IB, Rogers WH, Chang H, Safran DG. Cost-related skipping of medications and other treatments among Medicare beneficiaries between 1998 and 2000. Results of a national study. J Gen Intern Med. 2005;20:715-720.
  43. Cox ER, Henderson R. Prescription use behavior among medicare beneficiaries with capped prescription benefits. J Manag Care Pharm. 2002;8:360-364.
  44. Johnson RE, Goodman MJ, Hornbrook MC, Eldredge MB. The effect of increased prescription drug cost-sharing on medical care utilization and expenses of elderly health maintenance organization members. Med Care. 1997;35:1119-1131.
  45. Johnson RE, Goodman MJ, Hornbrook MC, Eldredge MB. The impact of increasing patient prescription drug cost-sharing on therapeutic classes of drugs received and on the health status of elderly HMO members. Health Serv Res. 1997; 32:103-121.
  46. Davis M, Poisal J, Chulis G, et al. Prescription drug coverage, utilization, and spending among Medicare beneficiaries. Health Aff (Millwood). 1999;18:231-243.
  47. US Department of Health & Human Services. Report to the president: prescription drug coverage, spending, utilization, and prices. April 2000. http://aspe.hhs. gov/health/reports/drugstudy/index.htm. Accessed July 28, 2011.
  48. Poisal JA, Chulis GS. Medicare beneficiaries and drug coverage. Health Aff (Millwood). 2000;19:248-256.
  49. Poisal JA, Murray L. Growing differences between Medicare beneficiaries with and without drug coverage. Health Aff (Millwood). 2001;20:74-85.
  50. Stuart B, Shea D, Briesacher B. Prescription drug costs for Medicare beneficiaries: coverage and health status matter. The Commonwealth Fund Issue Brief. January 2000. www.commonwealthfund.org/~/media/Files/Publications/Issue%20Brief/2000/ Jan/Prescription%20Drug%20Costs%20for%20Medicare%20Beneficiaries%20%20 Coverage%20and%20Health%20Status%20Matter/Stuart_prescriptiondrug%20pdf. pdf. Accessed July 28, 2011.
  51. Craig BM, Kreling DH, Mott DA. Do seniors get the medicines prescribed for them? Evidence from the 1996-1999 Medicare Current Beneficiary Survey. Health Aff (Millwood). 2003;22:175-182.
  52. Motheral BR, Henderson R, Cox ER. Plan-sponsor savings and member experience with point-of-service prescription step therapy. Am J Manag Care. 2004;10: 457-464.
  53. Ovsag K, Hydery S, Mousa S. Preferred drug lists: potential impact on healthcare economics. Vasc Health Risk Manag. 2008;4:403-413.
  54. Goldman D, Joyce G, Escarce J, et al. Pharmacy benefits and the use of drugs by the chronically ill. JAMA. 2004;291:2344-2350.
  55. Huskamp H, Deverka P, Epstein A, et al. The effect of incentive-based formular - ies on prescription-drug utilization and spending. N Engl J Med. 2003;349:2224-2232.
  56. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353: 487-497.
  57. Ho PM, Spertus JA, Masoudi FA, et al. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006;166:1842-1847.
  58. Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence- based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007;297:177-186.
  59. Mintz J, Mintz LI, Arruda MJ, Hwang SS. Treatments of depression and the functional- capacity to work. Arch Gen Psych. 1992;49:761-768.
  60. Heiligenstein JH, Ware JE, Beusterien KM, et al. Acute effects of fluoxetine versus placebo on functional health and well-being in late-life depression. Int Psychogeriatr. 1995;7(suppl):125-137.
  61. Williams SG, Schmidt DK, Redd, SC, Storms W, for the National Asthma Education and Prevention Program. Key clinical activities for quality asthma care. MMWR Recomm Rep. 2003;52(RR-6):1-8.
  62. Avalere Health. Avalere Health data finds four-tier system growing among Medicare Part D plans. www.avalerehealth.net/wm/show.php?c=&id=777. Accessed July 28, 2011.
  63. Zhang J, Fuhrmans V. Medicare plans draw criticism on drug pricing. The Wall Street Journal. December 16, 2008. http://online.wsj.com/article/SB1229389514 83309103.html#. Accessed July 28, 2011.
  64. Flaer PJ, Dondériz A, Younis MZ. Medicare Part D—the sea of choices meets the donut hole. J Health Care Finance. 2007;34:1-7.
  65. Domino ME, Stearns SC, Norton EC, Yeh WS. Why using current medications to select a medicare Part D plan may lead to higher out of pocket payments. Med Care Res Rev. 2008;65:114-126.
  66. Keenan T. Prescription for the future: medications, Medicare Part D, and managing expenses in a difficult economy—research report. AARP Knowledge Management. December 2008. http://assets.aarp.org/rgcenter/health/rx_future_08.pdf. Accessed July 28, 2011.
  67. Catlin A, Cowan C, Hartman M, et al. National health spending in 2006: a year of change for prescription drugs. Health Aff (Millwood). 2008;27:14-29.
  68. Choudhry NK, Brennan T, Toscano M, et al. Rationale and design of the Post- MI FREEE trial: a randomized evaluation of first-dollar drug coverage for postmyocardial infarction secondary preventive therapies. Am Heart J. 2008;156:31-36.
  69. Centers for Medicare & Medicaid Services (CMS). Medicare program; Medicare Part D claims data [CMS 4119-F]. www.cms.hhs.gov/PrescriptionDrugCovGenIn/ Downloads/PartDDataReg.pdf. Accessed November 5, 2008.
  70. Balfour DC 3rd, Evans S, Januska J, et al. Medicare part D—a roundtable discussion of current issues and trends. J Manag Care Pharm. 2009;15:S3-S9.
Stakeholder Perspective
We Need More Research on True Value-Based Benefit Design that Will Improve Outcomes and Control Costs
Gary M. Owens, MD
President
Gary Owens Associates
Ocean View, DE

MEDICAL/PHARMACY DIRECTORS: Managing the Medicare drug benefit is one of the most challenging aspects of a Pharmacy and Therapeutics (P&T) committee’s duties. One of the major charges of a P&T committee is to provide plan members a wide range of drugs for a broad number of clinical indications. This must be done in the context of the overall pharmacy benefit cost. Keeping the benefit plan affordable, while providing adequate coverage for a broad range of medications, is not an easy task. To do this, we must balance not only the cost of the drugs but also the expected utilization, and one of the drivers of that utilization is plan member cost-sharing.

Dr Shenolikar and his colleagues have performed a systematic review of the literature for their study. They analyzed the 47 articles that evaluated the impact of drug coverage or cost-sharing on medication use in the Medicare population in the past 15 years (1995-2009). Their conclusion is not surprising to those involved in benefit design: “Current evidence from the literature suggests that restricting drug coverage or increasing out-of-pocket expenses for Medicare beneficiaries may lead to decreased medication use in the elderly, with all its potential implications.”

This is an issue that regularly comes up in benefit design discussions, and the P&T committee members are aware that increasing plan member cost may lead to a reduction in the use of essential medications, as well as medications that may not be essential or may even be inappropriate. It is the latter—nonessential and inappropriate medication use—that formularies and benefit designs are intended to address.

We all share the authors’ goal to create benefit designs and formularies that provide access to needed medications, while avoiding the cost associated with inappropriate or more costly medications that have clinically appropriate, lower-cost alternatives.

However, there is no easy solution to this cost versus benefit problem. Although it is tempting to lower member cost-sharing to improve the uptake and use of essential medications, experience tells us that when that is done, the utilization of essential as well as nonessential medications increases. That becomes important, because the result of increased utilization is increased cost to the plan.

We also know that as plan costs increase, the affordability of the plan drops, and some plan members are forced to drop drug coverage or choose less costly alternative plans that are even more restrictive. This may ultimately create the unintended consequence of more individuals having no, or only minimal, coverage because of their inability to afford the plan costs.

POLICYMAKERS/RESEARCHERS: I therefore agree with the authors’ conclusion that more research is needed to better understand the best ways to create affordable drug coverage plans. Such research must address how to motivate Medicare beneficiaries and their prescribers to make clinically and cost-effective medication choices, how to create benefit designs that facilitate these choices, and how benefit design and member cost-sharing impact clinical outcomes.

Our work is just starting in this area, and if we are to develop true value-based benefit designs that simultaneously improve outcomes and control cost, we will need much more research to help drive those decisions.

Gary M. Owens, MD
President, Gary Owens Associates
Philadelphia, PA

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