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Management of many chronic conditions has improved dramatically in the last decade with the advent of novel specialty drugs, which are often both life-changing and costly. This is particularly true for rheumatoid arthritis (RA), a condition affecting 1.3 million people in the United States (1). Prior to the late 1990s, RA was among the most debilitating chronic conditions, with one in three patients permanently disabled within five years (2, 3). In 2014, disease control is possible for many patients with early and aggressive treatment using disease modifying anti-rheumatic drugs (DMARDs), now standard components of guideline-based care (4, 5). However, newer biologic DMARDs can cost over $20,000 annually, and even with insurance, many patients who require them after failing first-line drugs for disease control will face a significant financial burden for treatment (6–9). A national survey of 1,100 adults with RA found that 1 in 6 decreased medication use due to cost, potentially resulting in worse outcomes (10). Because biologic DMARDs are both efficacious and expensive, understanding how to cover and pay for them is an important policy issue. Since RA affects 2.3% of older persons and over 1 in 4 Medicare beneficiaries with RA receive biologic DMARDs, Medicare spending in this area is large, exceeding a billion dollars in 2009 (11, 12). Insurance coverage for biologic DMARDs by Medicare has grown increasingly complex. Biologic DMARDs were historically covered only under Medicare’s medical insurance (Part B) as physician-administered drugs. With the introduction of the Part D pharmacy benefit in 2006, coverage was significantly expanded to include self-administered biologic DMARDs dispensed through a pharmacy. Despite the projected growth in Medicare spending on biologic DMARDs in Part D, no studies have systematically examined how Part D plans nationwide cover biologic DMARDs or the financial implications of current coverage policies. To address this gap, we conducted a nationwide examination of 2013 Part D plans’ coverage of biologic and non-biological DMARDs. We investigate the level of cost sharing for patients and also analyze how Medicare Advantage versus stand-alone drug plans structure cost sharing by using prior authorizations (PA), specialty tiers, and coinsurance versus fixed dollar copayments. Our findings shed light on how Part D currently provides coverage for biologic DMARDs and the potential impact of Part D changes included in the Affordable Care Act.

SUMMARY Background Studies have associated thiazolidinedione (TZD) treatment with cardiovascular disease (CVD) and questioned whether the two available TZDs, rosiglitazone and pioglitazone, have different CVD risks. We compared CVD incidence, cardiovascular (CV), and allcause mortality in type 2 diabetic patients treated with rosiglitazone or pioglitazone as their only TZD. Methods We analyzed survey, medical record, administrative, and National Death Index (NDI) data from 1999 through 2003 from Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Medications, CV procedures, and CVD were determined from health plan (HP) administrative data, and mortality was from NDI. Adjusted hazard rates (AHR) were derived from Cox proportional hazard models adjusted for age, sex, race/ethnicity, income, history of diabetic nephropathy, history of CVD, insulin use, and HP. Results Across TRIAD’s 10 HPs, 1,815 patients (24%) filled prescriptions for a TZD, 773 (10%) for only rosiglitazone, 711 (10%) for only pioglitazone, and 331 (4%) for multiple TZDs. In the seven HPs using both TZDs, 1,159 patients (33%) filled a prescription for a TZD, 564 (16%) for only rosiglitazone, 334 (10%) for only pioglitazone, and 261 (7%) for multiple TZDs. For all CVevents, CV, and all-cause mortality, we found no significant difference between rosiglitazone and pioglitazone. Conclusions In this relatively small, prospective, observational study, we found no statistically significant differences in CV outcomes for rosiglitazone- compared to pioglitazone-treated patients. There does not appear to be a pattern of clinically meaningful differences in CV outcomes for rosiglitazone- versus pioglitazone-treated patients. Copyright # 2010 John Wiley & Sons, Ltd.

Background Medicare Part D beneficiaries with diabetes are at risk of medication non-adherence and forgoing necessities due to cost pressures. Generic drug coverage during the Part D gap may attenuate these potentially adverse behaviors.

Author(s): Ettner, Susan L; Cadwell, Betsy L; Russell, Louise B; Brown, Arleen; Karter, Andrew J; Safford, Monika; Mangione, Carol; Beckles, Gloria; Herman, William H; Thompson, Theodore J; TRIAD Study Group | Abstract: BackgroundResearch on self-care for chronic disease has not examined time requirements. Translating Research into Action for Diabetes (TRIAD), a multi-site study of managed care patients with diabetes, is among the first to assess self-care time.ObjectiveTo examine associations between socioeconomic position and extra time patients spend on foot care, shopping/cooking, and exercise due to diabetes.DataEleven thousand nine hundred and twenty-seven patient surveys from 2000 to 2001.MethodsBayesian two-part models were used to estimate associations of self-reported extra time spent on self-care with race/ethnicity, education, and income, controlling for demographic and clinical characteristics.ResultsProportions of patients spending no extra time on foot care, shopping/cooking, and exercise were, respectively, 37, 52, and 31%. Extra time spent on foot care and shopping/cooking was greater among racial/ethnic minorities, less-educated and lower-income patients. For example, African-Americans were about 10 percentage points more likely to report spending extra time on foot care than whites and extra time spent was about 3 min more per day.DiscussionExtra time spent on self-care was greater for socioeconomically disadvantaged patients than for advantaged patients, perhaps because their perceived opportunity cost of time is lower or they cannot afford substitutes. Our findings suggest that poorly controlled diabetes risk factors among disadvantaged populations may not be attributable to self-care practices.

Author(s): Tseng, Chien-Wen; Dudley, R Adams; Brook, Robert H; Keeler, Emmett; Hixon, Allen L; Manlucu, Luella R; Mangione, Carol M | Abstract: ObjectivesMany elderly persons have drug benefits with coverage gaps, such as in Medicare Part D. Because beneficiaries who have such gaps must pay all drug costs, an accurate knowledge of gap thresholds and communication with providers about exceeding caps is important for elderly persons to manage out-of-pocket drug costs.DesignCross-sectional survey.SettingHealth plan.ParticipantsOne thousand three hundred eight health plan members aged 65 and older. The study was a 2002 cross-sectional survey of elderly persons with capped drug benefits in a managed care plan in one state. Participants were sampled so that half reached coverage caps and half did not.MethodsParticipants reported cap levels, communication with providers about exceeding caps, and decreased medication use due to cost.ResultsOf the 1,308 participants (65.4%response rate), 68.6%did not know their correct cap level. Rates were similar in those who exceeded caps (66.2%), reported difficulty paying for medications (63.9%), or decreased medication use (66%). For participants who exceeded caps, 59.1% did not know beforehand that they were close to exceeding caps and 50.2% did not tell providers afterward. In multivariate analyses accounting for demographics and health, the oldest participants (g or =85 vs 65-74) were at greater risk for not knowing cap levels (odds ratio (OR)=2.0, 95% confidence interval (CI)=1.2-3.4) and not telling providers about exceeding caps (OR=2.2, 95% CI=1.1-4.5).ConclusionsElderly patients often did not know correct cap levels and did not tell providers about exceeding caps. Providers, plans, and policymakers should actively assess and improve Medicare beneficiaries' knowledge of Part D coverage gaps.

Author(s): Tseng, Chien-Wen; Dudley, R Adams; Brook, Robert H; Keeler, Emmett; Steers, W Neil; Alexander, G Caleb; Waitzfelder, Beth E; Mangione, Carol M | Abstract: ObjectivesTo determine whether elderly patients with high drug expenditures want and receive providers' help in managing drug costs.DesignCross-sectional survey.SettingA Medicare managed care plan (g400,000 members) in one state in 2002.ParticipantsOne thousand one hundred six seniors (62% response rate) sampled so that half exceeded caps on their drug benefits the previous year, and all had total drug expenditures in the top quartile of members in their cap level.MeasurementsParticipants' preferences and experiences with providers discussing costs and participation in choosing medications.ResultsTwo-thirds reported difficulty paying for medications, and one-fourth decreased medication use because of cost. Most wanted providers to ask about medication affordability (81%), consider cost (86%), offer choices (70%), and to persuade them or decide for them which medication to use (88%), but few said providers asked about affordability (17%), usually or always discussed prices (19%), or offered choices (45%), although nearly all said providers chose their medications (93%). Sixty-two percent had asked providers for help with drug costs, although 34% who used less medication because of cost or had difficulty paying for medications had not asked for help.ConclusionProviders should be aware that elderly patients want their help in managing drug costs but do not always receive it or ask for help when they need it. Providers could improve communication by initiating conversations about cost and by asking patients about preferences when prescribing.