Prescription Drug Benefit Research Articles

Medication Access in America and Medicare Part D: Prescription Shopping Saves but May Be Costly.

This article is a reflection of some of the changes we have witnessed in pharmacy over the years, including the rise in medication use and prices and the transformation of how medicines are paid for in the United States, with growing concern over pricing transparency. We discuss the complex Medicare Part D prescription drug benefit, how enrollees can save by comparing plans annually, and the influence of preferred pharmacies. We review options for medication assistance other than Part D and share our belief that, although Medicare Part D has dramatically improved access to medicines, more needs to be done to decrease Medicare's and individuals' out-of-pocket spending and, as importantly, to ensure that medicines are doing more good than harm.

Association of high cost sharing and targeted therapy initiation among elderly Medicare patients with metastatic renal cell carcinoma.

High out‐of‐pocket costs may limit access to oral therapies covered by patients’ prescription drug benefits. We explored financial barriers to treatment initiation in patients newly diagnosed with metastatic renal cell carcinoma (mRCC) by comparing Medicare Part D patients with low out‐of‐pocket costs due to receipt of full low‐income subsidies (LIS beneficiaries) to their counterparts who were responsible for more than 25% cost sharing during Medicare's initial coverage phase (non‐LIS beneficiaries). We used 2011–2013 100% Medicare claims for non‐LIS and LIS beneficiaries newly diagnosed with metastases in the liver, lung, or bone to examine targeted therapy treatment initiation rates and time to initiation for (1) oral medications (sorafenib, sunitinib, everolimus, pazopanib, or axitinib) covered under Medicare's prescription drug benefit (Part D); (2) injected or infused medications (temsirolimus or bevacizumab) covered by Medicare's medical benefit (Part B); and (3) any (Part D or Part B) targeted therapy. The final sample included 1721 patients. On average, non‐LIS patients were responsible for out‐of‐pocket costs of ≥$2,800 for their initial oral prescription, as compared to ≤$6.60 for LIS patients. Compared to LIS patients, a lower percentage of non‐LIS patients initiated oral therapies (risk‐adjusted rates, 20.7% vs. 33.9%; odds ratio [OR] = 0.49, 95% CI: 0.36–0.67, P < 0.001) and any targeted therapies (26.7% vs. 40.4%, OR = 0.52, 95% CI: 0.38–0.71, P < 0.001). Non‐LIS patients were also slower to access therapy. High cost sharing was associated with reduced and/or delayed access to targeted therapies under Medicare Part D, suggesting that financial barriers play a role in treatment decisions.

The impact of Medicare Part D on cognitive functioning at older ages

Research has shown that the establishment of Medicare prescription drug benefit in 2006 leads to improvement in medication adherence and mortality outcomes. Despite a clear connection between physical/mental health and the risk of dementia, little is known about the extent to which this reform has affected the cognitive functioning of the elderly. Using data from the Health and Retirement Study and difference-in-differences approach, this study provides the first evidence on the cognition-enhancing effects of Medicare Part D. Our estimates show that Part D implementation is associated with 1.6% increase in cognitive functioning or 1.1-year delay of cognitive aging among benefit-eligible persons. Further analyses indicate that most of the cognitive benefits accrue to the vulnerable populations who previously lacked prescription drug coverage, and that a reduction in cardiovascular mortality is the most likely pathway through which the expansion improved cognitive functioning.

Renin-angiotensin system blockers and residual kidney function loss in patients initiating peritoneal dialysis: an observational cohort study

BackgroundAlthough angiotensin-converting enzyme inhibitors (ACEI) and angiotensin-II receptor blockers (ARB) have been shown to preserve residual kidney function in a select group of Asian patients undergoing continuous ambulatory peritoneal dialysis (PD) in two small randomized clinical trials, the effectiveness of these drugs has yet to be demonstrated in a more diverse population of patients with multiple comorbid conditions. We investigated the association between ACEI/ARB use and development of recorded anuria in a cohort of patients initiating PD in the U.S.MethodsWe conducted a retrospective observational cohort study using the US Renal Data System and electronic health records data from a large national dialysis provider. We identified adult patients who initiated PD from 2007 to 2011. Only patients who participated in the federal prescription drug benefit program, Medicare Part D, for the first 90 days of dialysis were included. Patients who filled a prescription for an ACEI or ARB during those 90 days were considered users. We applied Cox proportional hazards models to an inverse probability of treatment-weighted (IPTW) cohort to estimate the hazard ratio (HR) for anuria (24-h urine volume < 200 ml) in ACEI/ARB users vs. non-users.ResultsAmong 886 patients, 389 (44%) used an ACEI/ARB. Almost a third of these patients were black or Hispanic, and more than a quarter had comorbidities that would have excluded them from the randomized clinical trials of ACEI/ARB. Two hundred eighty patients reached anuria over 840 person-years of follow-up, for a composite event rate of 33 events per 100 person-years. We found no clear association between ACEI/ARB use and progression to anuria [HR: 0.86, 95% CI: 0.73–1.02].ConclusionsACEI/ARB use is common in patients initiating PD in the U.S. but was not associated with a lower risk of anuria. Residual confounding by unmeasured variables is an important limitation of this observational study. Still, these findings suggest that pragmatic clinical trials are warranted to test the effectiveness of ACEI/ARB in slowing the decline of residual kidney function in a diverse population of peritoneal dialysis patients with multiple comorbid conditions.

Real-world health care utilization in asthma patients using albuterol sulfate inhalation aerosol (ProAir ® HFA) with and without integrated dose counters.

BackgroundAccurate tracking of the administered dose of asthma rescue inhalers is critical for optimal disease management and is related to reductions in rates of unscheduled health care utilization in asthma patients. There are few published data on the real-world impact of rescue inhalers with integrated dose counters (IDCs) on health care resource utilization (HRU) for asthma patients. This study evaluates HRU among users of ProAir® hydrofluoroalkane (HFA) (albuterol sulfate inhalation aerosol), with IDC versus without IDC, in asthma patients.MethodsThis was a retrospective administrative claims study of asthma patients receiving a new prescription for albuterol inhalation aerosol without IDC during 2 years (January 2011–December 2012) or with IDC during the first full year after IDC implementation in the USA (July 2013–July 2014). Six months of continuous enrollment with medical and prescription drug benefits were required before and after the first prescription during the study period. Data on respiratory-related hospitalizations and emergency department (ED) visits were collected during the follow-up period.ResultsA total of 135,305 (32%) patients used albuterol inhalation aerosol with IDC, and 287,243 (68%) patients received albuterol inhalation aerosol without IDC. After adjusting for baseline confounding factors, the odds ratio (OR) for experiencing a respiratory-related hospitalization (OR=0.92; 95% confidence interval [CI] 0.88–0.96) or ED visit (OR=0.92; 95% CI 0.90–0.94) was significantly lower among patients using albuterol inhalation aerosol with IDC versus without IDC.ConclusionIn a real-world setting, asthma patients using ProAir HFA with IDC experienced significantly fewer hospitalizations and ED visits compared with patients using ProAir HFA without IDC. Dosage information provided by IDCs may allow providers to better understand patients’ disease severity and aid in titrating controller medications and also decrease the likelihood that the canister will be empty when needed, thereby enhancing disease management and reducing HRU.

Did Medicare Part D Reduce Mortality?

We investigate the implementation of Medicare Part D and estimate that this prescription drug benefit program reduced elderly mortality by 2.2 percent annually. This was driven primarily by a reduction in cardiovascular mortality, the leading cause of death for the elderly. There was no effect on cancer mortality, the second leading cause. We validate these results by demonstrating that the changes in drug utilization following the implementation of Medicare Part D match the mortality patterns we observe. We calculate that the value of the mortality reduction is equal to $5 billion per year.

Did Medicare Part D reduce mortality?

We investigate the implementation of Medicare Part D and estimate that this prescription drug benefit program reduced elderly mortality by 2.2% annually. This was driven primarily by a reduction in cardiovascular mortality, the leading cause of death for the elderly. There was no effect on deaths due to cancer, a condition whose drug treatments are covered under Medicare Part B. We validate these results by demonstrating that the changes in drug utilization following the implementation of Medicare Part D match the mortality patterns we observe. We calculate that the value of the mortality reduction is equal to $5 billion per year.

Does a One-Size-Fits-All Cost-Sharing Approach Incentivize Appropriate Medication Use? A Roundtable on the Fairness and Ethics Associated with Variable Cost Sharing.

Tiered formularies, in which patients pay copays or coinsurance out-of-pocket (OOP), are used to manage costs and encourage more efficient health care resource use. Formulary tiers are typically based on the cost of treatment rather than the medical appropriateness for the patient. Cost sharing may have unintended consequences on treatment adherence and health outcomes. Use of higher-cost, higher-tier medications can be due to a variety of factors, including unsuccessful treatment because of lack of efficacy or side effects, patient clinical or genetic characteristics, patient preferences to avoid potential side effects, or patient preferences based on the route of administration. For example, patients with rheumatoid arthritis may be required to fail low-cost generic treatments before obtaining coverage for a higher-tier tumor necrosis factor alpha inhibitor for which they would have a larger financial burden. Little is known about stakeholders' views on the acceptability of greater patient cost sharing if the individual patient characteristics lead to the higher-cost treatments. To identify and discuss the trade-offs associated with variable cost sharing in pharmacy benefits. To discuss the trade-offs associated with variable cost sharing in pharmacy benefits, we convened an expert roundtable of patient, payer, and employer representatives (panelists). Panelists reviewed background white papers, including an ethics framework; actuarial analysis; legal review; and stakeholder perspectives representing health plan, employer, and patient views. Using case studies, panelists were asked to consider (a) when it would be more (or less) acceptable to require higher cost sharing; (b) the optimal distribution of financial burdens across patients, all plan members, and employers; and (c) the existing barriers and potential solutions to align OOP costs with medically appropriate treatments. Panelists felt it was least acceptable for patients to have greater OOP costs if the use of the higher-cost treatment was due to biological reasons such as step therapy (6 = unacceptable, 9 = neutral, 2 = acceptable) or diagnostic results (5 = unacceptable, 10 = neutral, and 2 = acceptable). In contrast, panelists felt it was more acceptable for patients to pay greater OOP costs when treatment choice was based on preferences to avoid a side-effect risk (1 = unacceptable, 3 = neutral, and 13 = acceptable) or the route/frequency of administration (1 = unacceptable, 1 = neutral, and 15 = acceptable). Five guiding principles emerged from the discussion: When patients have tried lower-cost therapies unsuccessfully, the benefits of higher-cost treatments were certain and significant, the cost difference between treatments was aligned with improved benefits, and penalties due to bad luck were mitigated, then cost-sharing differences should be minimized but not eliminated. Patient OOP costs can affect the use of both inappropriate and appropriate medications. This study identified 5 guiding principles to determine when it was more (or less) acceptable for patients with the same or similar conditions to have different OOP costs. Barriers that hinder the alignment of care and patient cost sharing exist. Policies that facilitate the alignment of patient cost sharing with appropriate care are needed. Funding for this roundtable was provided by the National Pharmaceutical Council (NPC). Graff and Dubois are employed by the NPC. Shih was employed by the NPC at the time of this study. Barker, Dieguez, Sherman, and Larson received consulting fees for participation in this study. Larson also reports receiving grants and other payment from multiple major pharmaceutical manufacturers outside of this study. The NPC employees developed the study design and chose the case studies in collaboration with the white paper authors. The roundtable was facilitated by Dubois, and the meeting summary and manuscript were written by Graff and Shih, with revisions by all roundtable participants. The abstract for this article was previously presented as a poster at the following meetings: Stakeholder perspectives on balancing patient-centeredness and drug costs in the design of pharmacy benefits. Presented at: Academy of Managed Care Pharmacy 27th Annual Meeting & Expo; San Diego, California; April 8, 2015. Considering efficiency and fairness in the design of prescription drug benefits: seeking a balanced approach to improve patient access to medically appropriate medication and manage drug costs. Presented at: AcademyHealth Annual Research Meeting; Minneapolis, Minnesota; June 15, 2015. Study concept and design were contributed by Shih, Dubois, and Graff, along with Barker and Dieguez. Barker and Dieguez took the lead in data collection, assisted by Graff, Shih, and Dubois. Data interpretation was performed by Shih, Larson, Sherman, and Graff, with assistance from Dubois. The manuscript was written and revised by Graff and Shih, with assistance from the other authors.

Management of Medicare Part D Prescription Drug Plans and Medication Adherence: A Conceptual Framework and Empirical Analysis.

Although contractors that offer prescription drug plans through the Medicare Part D program are evaluated in part on enrollees' medication adherence scores, little evidence addresses contractors' ability to influence these scores. We used data from the Centers for Medicare and Medicaid Services and US Census to investigate contractors' ability to influence their medication adherence scores. In accordance with a conceptual model, we hypothesized that contractors can directly and indirectly influence their medication adherence scores based on how effectively they manage prescription drug benefits for enrollees. We focused on 4 plan management variables: service reliability, stability/accuracy of drug prices, accessibility of prescription drugs, and availability of drug information. We examined indirect effects via enrollees' satisfaction with the plan. We conducted a cross-sectional study based on 2012 data for which the contractor was the unit of analysis. We conducted path regression models that accounted for plan type (ie, Medicare Advantage vs. stand alone) and enrollee characteristics. Among contractors, enrollee satisfaction scores were positively and significantly associated with medication adherence scores. Two of the 4 plan management variables were observed to have both direct and indirect effects on medication adherence scores: accessibility of prescription drugs and service reliability. Our study indicates that Part D contractors do appear to have some level of influence over their medication adherence scores based on how effectively they manage prescription drug benefits for enrollees. Accessibility to prescriptions and better service delivery appear important in this regard and should be explored further in future research.

How Intensive are Patients’ Behavior in Cost-Related Medication Non- Adherence?

The cost barrier to medications is a persistent and serious problem among the U.S. elderly population. Twenty-six percent of the elderly do not take medication as prescribed due to a cost barrier [1]. This is not surprising as many elderly patients depend on a small amount of fixed income from social security and struggle on a day-to-day basis to make difficult choices between meeting the basic needs of daily life and filling prescriptions. The Medicare Part D program, a subsidized drug program, aims to significantly improve access to outpatient prescription drug benefits for millions of elderly Americans [2]. While overall utilization increased after the institution of Part D, [3] costrelated medication non-adherence (CRN) has not deceased or has even worsened among the sickest patients, including those with multiple chronic conditions, depression, and stroke survivors [4-6].

Racial and ethnic disparities in meeting MTM eligibility criteria among patients with asthma

ABSTRACTBackground: Asthma is one of the most frequently targeted chronic diseases in the medication therapy management (MTM) programs of the Medicare prescription drug (Part D) benefits. Although racial and ethnic disparities in meeting eligibility criteria for MTM services have been reported, little is known about whether there would be similar disparities among adults with asthma in the United States. Methods: Adult patients with asthma (age ≥ 18) from Medical Expenditure Panel Survey (2011–2012) were analyzed. Bivariate analyses were conducted to compare the proportions of patients who would meet Medicare MTM eligibility criteria between non-Hispanic Blacks (Blacks), Hispanics and non-Hispanic Whites (Whites). Survey-weighted logistic regression was performed to adjust for patient characteristics. Main and sensitivity analyses were conducted to cover the entire range of the eligibility thresholds used by Part D plans in 2011–2012. Results: The sample included 4,455 patients with asthma, including 2,294 Whites, 1,218 Blacks, and 943 Hispanics. Blacks and Hispanics had lower proportions of meeting MTM eligibility criteria than did Whites (P < 0.001). According to the main analysis, Blacks and Hispanics had 36% and 32% lower, respectively, likelihood of MTM eligibility than Whites (odds ratio [OR]: 0.64, 95% confidence interval [CI]: 0.45–0.90; OR: 0.68, 95% CI: 0.47–0.98, respectively). Similar results were obtained in sensitivity analyses. Conclusions: There are racial and ethnic disparities in meeting Medicare Part D MTM eligibility criteria among adult patients with asthma. Future studies should examine the implications of such disparities on health outcomes of patients with asthma and explore alternative MTM eligibility criteria.

The anticipatory effects of Medicare Part D on drug utilization

While health care policies are frequently signed into law well before they are implemented, such lags are ignored in most empirical work. This paper demonstrates the importance of implementation lags in the context of Medicare Part D, the prescription drug benefit that took effect two years after it was signed into law. Exploiting the differential responses of chronic and acute drugs to anticipated future prices, I show that individuals reduced drug utilization for chronic but not acute drugs in anticipation of Part D's implementation. Accounting for this anticipatory response substantially reduces the estimated total treatment effect of Part D.

Myopic and Forward Looking Behavior in Branded Oral Anti-Diabetic Medication Consumption: An Example from Medicare Part D.

We evaluate consumption responses to the non-linear Medicare Part D prescription drug benefit. We compare propensity-matched older patients with diabetes and Part D Standard or low-income-subsidy (LIS) coverage. We evaluate monthly adherence to branded oral anti-diabetics, with high end-of-year donut hole prices (>$200) for Standard patients and consistent, low (≤$6) prices for LIS. As an additional control, we examine adherence to generic anti-diabetics, with relatively low, consistent prices for Standard patients. If Standard patients are forward looking, they will reduce branded adherence in January, and LIS-Standard differences will be constant through the year. Contrary to this expectation, branded adherence is lower for Standard patients in January and diverges from LIS as the coverage year progresses. Standard-LIS generic adherence differences are minimal. Our findings suggest that seniors with chronic conditions respond myopically to the nonlinear Part D benefit, reducing consumption in response to high deductible, initial coverage and gap prices. Thus, when the gap is fully phased out in 2020, cost-related nonadherence will likely remain in the face of higher spot prices for more costly branded medications. These results contribute to studies of Part D plan choice and medication adherence that suggest that seniors may not make optimal healthcare decisions. Copyright © 2016 John Wiley & Sons, Ltd.

Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use and cardiovascular outcomes in patients initiating peritoneal dialysis.

Data on the effectiveness of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) in reducing cardiovascular (CV) risk in patients undergoing peritoneal dialysis (PD) are limited. We investigated the association between ACEI/ARB use and CV outcomes in patients initiating PD. In this observational cohort study, we identified from the United States Renal Data System all adult patients who initiated PD from 2007 to 2011 and participated in Medicare Part D, a federal prescription drug benefits program, for the first 90 days of dialysis. Patients who filled a prescription for an ACEI or ARB in those 90 days were considered users. We applied Cox regression to an inverse probability of treatment weighted cohort to estimate the hazard ratios (HRs) for the combined outcome of death, ischemic stroke or myocardial infarction (MI) and each outcome individually. Among 4879 patients, 2063 (42%) used an ACEI/ARB. Patients were followed up for a median of 1.2 years. We recorded 1771 events, for a composite rate of 25 events per 100 person-years. ACEI/ARB use (versus nonuse) was associated with a reduced risk of the composite outcome {HR 0.84 [95% confidence interval (CI) 0.76-0.93]}, all-cause mortality [HR 0.83 (95% CI 0.75-0.92)] and CV death [HR 0.74 (95% CI 0.63-0.87)], but not MI [HR 0.88 (95% CI 0.69-1.12)] or ischemic stroke [HR 1.06 (95% CI 0.79-1.43)]. Results were similar in as-treated analyses. In a subgroup analysis, we did not find any effect modification by residual renal function. ACEI/ARB use is common in patients initiating PD and is associated with a lower risk of fatal CV outcomes.

Evidence selection for a prescription drug's benefit-harm assessment: challenges and recommendations

ObjectivesTo describe challenges and make recommendations for researchers in how they select evidence to quantitatively assess a prescription drug's benefits and harms. Study Design and SettingThese challenges and recommendations are based on our recent experience conducting a benefit-harm assessment for the prescription drug roflumilast. We considered the selection of evidence to quantify (1) the drug's treatment effects in patients, (2) the patient population's baseline risks for beneficial and harmful outcomes without treatment, and (3) the patient population's preferences for these beneficial effects and harms. These are fundamental steps for most benefit-harm assessment methods. ResultsWe identify critical issues in selecting evidence for each of these steps. We justify in particular the need to incorporate (1) clinical trials for the drug's specific treatment effect; (2) observational studies with the most valid, precise, and applicable effect estimates for the baseline risk; and (3) flexible weighting approaches for balancing the drug benefits and harms. ConclusionWe identify challenges and make recommendations for selecting evidence at the critical steps in a prescription drug's benefit-harm assessment. Our findings should assist other researchers conducting these assessments for prescription drugs, which could help regulators, medical professionals, and patients make better decisions about prescription drug use.

How Increasing Medical Access to Opioids Contributes to the Opioid Epidemic: Evidence from Medicare Part D

Drug overdoses involving opioid analgesics have increased dramatically since 1999, representing one of the United States’ top public health crises. Opioids have legitimate medical functions, but improving access may increase abuse rates even among those not prescribed the drugs given that opioids are frequently diverted to nonmedical use. We have little evidence about the causal relationship between increased medical access to opioids and spillovers resulting in abuse. We use the introduction of the Medicare Prescription Drug Benefit Program (Part D) as a large and differential shock to the geographic supply of opioids. We compare growth in opioid supply and abuse rates in states with large 65+ population shares to states with smaller elderly population shares with a focus on abuse among the Medicare-ineligible population. Part D increased opioid utilization for the 65+ population, and we show that this increase in utilization led to significant growth in the overall supply of opioids in high elderly share states relative to low elderly share states. This relative expansion in opioid supply resulted in an escalation in opioid-related substance abuse treatment admissions and opioid-related mortality among the Medicare-ineligible population, implying meaningful spillovers to individuals who did not experience any change in prescription drug benefits. The evidence suggests that increased opioid supply is associated with economically-important levels of diversion for nonmedical purposes. Our estimates imply that a 10% increase in medical opioid distribution leads to a 7.4% increase in opioid-related deaths and a 14.1% increase in substance abuse treatment admission rates for the Medicare-ineligible population.

Functional Limitations, Medication Support, and Responses to Drug Costs among Medicare Beneficiaries.

ObjectiveStandard Medicare Part D prescription drug benefits include substantial and complex cost-sharing. Many beneficiaries also have functional limitations that could affect self-care capabilities, including managing medications, but also have varying levels of social support to help with these activities. We examined the associations between drug cost responses, functional limitations, and social support.Data Sources and Study SettingWe conducted telephone interviews in a stratified random sample of community-dwelling Medicare Advantage beneficiaries (N = 1,201, response rate = 70.0%). Participants reported their functional status (i.e., difficulty with activities of daily living) and social support (i.e., receiving help with medications). Drug cost responses included cost-reducing behaviors, cost-related non-adherence, and financial stress.Study DesignWe used multivariate logistic regression to assess associations among functional status, help with medications, and drug cost responses, adjusting for patient characteristics.Principal FindingsRespondents with multiple limitations who did not receive help with their medications were more likely to report cost-related non-adherence (OR = 3.2, 95% CI: 1.2–8.5) and financial stress (OR = 2.4, 95% CI: 1.3–4.5) compared to subjects with fewer limitations and no help; however, those with multiple limitations and with medication help had similar odds of unfavorable cost responses as those with fewer limitations.ConclusionThe majority of beneficiaries with functional limitations did not receive help with medications. Support with medication management for beneficiaries who have functional limitations could improve adherence and outcomes.

Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety.

We read with great interest the article entitled ‘Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety’ by Simon and colleagues, published in the April 2015 Issue of Therapeutic Advances in Drug Safety [Simon et al. 2015]. We agree with the authors that Federal abuse-deterrent formulation (ADF) policy does not reflect the urgency of the prescription drug abuse epidemic and does not go far enough toward changing the status quo. We also agree with the authors that policies must also require federal prescription drug benefit plans to cover ADFs to ensure consumers have access to such medications. However, we disagree with the statement ‘ADFs have been proven to reduce prescription drug abuse and its consequences, and even an incremental reduction in abuse can have a significant impact on the nation by reducing the costly social, physical, mental, and public health problems resulting from abuse’. The study by Coplan and colleagues [Coplan et al. 2013] was quoted as the main reference to support the argument by Simon and colleagues that ‘ADF have been proven to reduce prescription drug abuse and its consequences…’. However, in the study by Coplan and colleagues, what was additionally reported was a 20% increase in abuse exposure for other single-entity oxycodone, and 42% increase in abuse exposure for heroin, concomitant with the 36% decrease in abuse exposure for reformulated extended-release (ER) oxycodone (ADF). Coplan and colleagues also acknowledged that reformulating one product’s tablets will not treat opioid addiction, and substitution of other available opioids is likely to consequently occur. Michna and colleagues examined the degree of adherence to the ER opioid, following its switching to a reformulated ER opioid (ADF), and found some patients changed to other ER opioids without abuse-deterrent technology or discontinued ER opioids [Michna et al. 2014]. The conclusion of their study was that abusers may seek more easily abusive alternatives. These include prescription opioids without abuse deterrent technology. Preliminary data suggest that the reformulation of opioids to resist tampering may influence media attention, recreational user preferences, and opioid availability in ways that may in turn alter their attractiveness to recreational users [Romach et al. 2013]. ER oxymorphone abuse has been mentioned in popular media only since recreational users began to recognize it as an alternative to the reformulation of ER oxycodone (ADF), which is designed to be tamper-resistant. Increased public awareness of higher potency with oxymorphone ER and the difficulties of tampering with reformulated ER oxycodone may have lessened abuse of ER oxycodone and made ER oxymorphone a preferred choice for some recreational users [Romach et al. 2013]. Indeed, total oxymorphone prescriptions increased sharply from 268,000 in 2007 to 1.22 million in 2012. In the first quarter of 2011, 325,000 oxymorphone prescriptions were dispensed by retail pharmacies [Drug Enforcement Administration, 2013]. According to the Drug Abuse Warning Network (DAWN ED), total estimated emergency department visits associated with oxymorphone increased from 4599 in 2010 to 12,122 in 2011. The American Association of Poison Control Centers reported 1041 total oxymorphone exposures in 2011, an increase from 169 in 2010 [Drug Enforcement Administration, 2013]. To examine the change in prevalence of prescription opioid abuse after introduction of an abuse-deterrent formulation oxycodone ER in August 2010, Cassidy and colleagues conducted a cross-sectional study, and found significantly greater abuse of oxymorphone ER and buprenorphine, coinciding with the introduction of ADF oxycodone ER [Cassidy et al. 2014]. Cassidy and colleagues conclude that replacement of a widely prescribed opioid with ADF formulation may have had little effect on overall prescription opioid abuse as a class. Another issue of great concern is escalating heroin abuse since the introduction of reformulated ER oxycodone (ADF) to the market. There were 119,000 total users in 2003, but 281,000 by 2011. In addition, first-time past-year use nearly doubled between 2005 and 2011. The death rate of heroin overdose from the 28 states (surveyed) doubled, from 2010 to 2012, from 1.0 to 2.1 per 100,000 [Rudd et al. 2014]. Heroin overdose death rates increased significantly for both sexes, all age groups, all census regions, and all racial/ethnic groups other than American Indians/Alaska Natives. In conclusion, at this point, the introduction of ADF opioids has resulted in significantly reduced abuse of those specific ADF opioids after they have fully replaced the original formulations. However, this has resulted in merely a shift away from the ADF opioids to other traditional non-ADF opioids or heroin, and unfortunately, no effect on the overall rates of opioid abuse.

Cost-Related Medication Nonadherence and Cost-Saving Behaviors Among Patients With Glaucoma Before and After the Implementation of Medicare Part D.

Understanding factors that lead to nonadherence to glaucoma treatment is important to diminish glaucoma-related disability. To determine whether the implementation of the Medicare Part D prescription drug benefit affected rates of cost-related nonadherence and cost-reduction strategies in Medicare beneficiaries with and without glaucoma and to evaluate associated risk factors for such nonadherence. Serial cross-sectional study using 2004 to 2009 Medicare Current Beneficiary Survey data linked with Medicare claims. Coding to extract data started in January 2014 and analyses were performed between September and November of 2014. Participants were all Medicare beneficiaries, including those with a glaucoma-related diagnosis in the year prior to the collection of the survey data, those with a nonglaucomatous ophthalmic diagnosis in the year prior to the collection of the survey data, and those without a recent eye care professional claim. Effect of the implementation of the Medicare Part D drug benefit. The change in cost-related nonadherence and the change in cost-reduction strategies. Between 2004 and 2009, the number of Medicare beneficiaries with glaucoma who reported taking smaller doses and skipping doses owing to cost dropped from 9.4% and 8.2% to 2.7% (P < .001) and 2.8%, respectively (P = .001). However, reports of failure to obtain prescriptions owing to cost did not improve in the same period (3.4% in 2004 and 2.1% in 2009; P = .12). After Part D, patients with glaucoma had a decrease in several cost-reduction strategies, namely price shopping (26.2%-15.2%; P < .001), purchasing outside the United States (6.9%-1.3%; P < .001), and spending less money to save for medications (8.0% to 3.5%; P < .001). Using a multivariate analysis, the main independent risk factors common to all cost-related nonadherence measures were female sex, younger age, lower income (<$30 000), self-reported visual disability, and a smaller Lawton index. After the implementation of Part D, there was a decrease in the rate that beneficiaries with glaucoma reported engaging in cost-saving measures. Although there was a decline in the rate of several cost-related nonadherence behaviors, patients reporting failure to fill prescriptions owing to cost remained stable. This suggests that efforts to improve cost-related nonadherence should focus both on financial hardship and medical therapy prioritization, particularly in certain high-risk sociodemographic groups.

The Turbulent History of the Nation’s Largest Voluntary Employees’ Beneficiary Association

The Detroit automakers’ Retiree Medical Benefits Trust is the nation’s largest Voluntary Employees’ Beneficiary Association (VEBA). It is an independent trust with assets of $60 billion that is responsible for providing medical, prescription drug, dental and vision benefits to 720,000 hourly retirees, surviving spouses and dependents of General Motors, Ford and Fiat Chrysler. It was established in 2007 through the joint efforts of the Big Three Detroit automakers and the United Automobile Workers Union primarily to protect the health care benefits of hourly retirees and to provide the companies with financial relief from the burdens of legacy costs that eventually contributed to their bankruptcies. Although it is now viewed as a success, there were times in its history when its inception and future were seriously in doubt. A review of its history will inform HR professionals of the problems and solutions they may encounter in establishing a VEBA.