Randomized trial of four financial-incentive programs for smoking cessation.

BACKGROUND: Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. METHODS: We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. RESULTS: Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P=0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program. CONCLUSIONS: Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs. (Funded by the National Institutes of Health and CVS Caremark; ClinicalTrials.gov number, NCT01526265.).

Partners and Alerts in Medication Adherence: A Randomized Clinical Trial.

BACKGROUND: Poor medication adherence is common and limits the effectiveness of treatment. OBJECTIVE: To investigate how social supports, automated alerts, and their combination improve medication adherence. DESIGN: Four-arm, randomized clinical trial with a 6-month intervention. PARTICIPANTS: A total of 179 CVS health employees or adult dependents with CVS Caremark prescription coverage, a current daily statin prescription, a medication possession ratio less than 80%, and Internet access. INTERVENTIONS: Participants were randomly assigned to control, social support (partner), automated adherence alert messages (alert), or both social support and alerts (partner + alert). Participants in the social support arms were asked to name a medication adherence partner (MAP) to help them take their medication. Participants in the alert arms were sent emails, text messages, or automated phone calls if they had failed to adhere on the previous day and on one or both of the 2 days before that. In partner + alert, both participants and fully enrolled MAPs received alerts. MAIN MEASURES: Adherence measured by wireless pill bottle opening. KEY RESULTS: Compared to 36.0% adherence in control, adherence was significantly greater in the alert arm (52.9%, difference vs. control of 17.0%, 95% CI for difference 6.3 to 27.6%, P = 0.002) and the partner + alert arm (54.5%, difference vs. control of 18.6%, 95% CI for difference 6.6 to 30.5%, P = 0.003). Adherence in the partner arm was not statistically significantly greater than control (43.2%, difference vs. control of 7.2%, 95% CI of difference - 5.2% to 19.5%, P = 0.25). There were no statistically significant differences among the three treatment arms. Fewer participants invited a MAP in the partner + alert arm than the partner arm (P = 0.02). CONCLUSIONS: Automated alerts were effective at improving medication adherence. Assigning a medication adherence partner did not statistically significantly affect adherence rates. TRIAL REGISTRATION: ClinicalTrials.gov Number NCT01890018 [ https://clinicaltrials.gov /].

Does Insulin Price Reduction Suggest a Path Forward for Lowering Drug Costs?

This Viewpoint investigates whether political pressure such as that used to decrease insulin pricing is a feasible method of lowering the cost of other drugs.

Longitudinal Patterns of Spending Enhance the Ability to Predict Costly Patients: A Novel Approach to Identify Patients for Cost Containment.

BACKGROUND: With rising health spending, predicting costs is essential to identify patients for interventions. Many of the existing approaches have moderate predictive ability, which may result, in part, from not considering potentially meaningful changes in spending over time. Group-based trajectory modeling could be used to classify patients into dynamic long-term spending patterns. OBJECTIVES: To classify patients by their spending patterns over a 1-year period and to assess the ability of models to predict patients in the highest spending trajectory and the top 5% of annual spending using prior-year predictors. SUBJECTS: We identified all fully insured adult members enrolled in a large US nationwide insurer and used medical and prescription data from 2009 to 2011. RESEARCH DESIGN: Group-based trajectory modeling was used to classify patients by their spending patterns over a 1-year period. We assessed the predictive ability of models that categorized patients in the top fifth percentile of annual spending and in the highest spending trajectory, using logistic regression and split-sample validation. Models were estimated using investigator-specified variables and a proprietary risk-adjustment method. RESULTS: Among 998,651 patients, in the best-performing model, prediction was strong for patients in the highest trajectory group (C-statistic: 0.86; R: 0.47). The C-statistic of being in the top fifth percentile of spending in the best-performing model was 0.82 (R: 0.26). Approaches using nonproprietary investigator-specified methods performed almost as well as other risk-adjustment methods (C-statistic: 0.81 vs. 0.82). CONCLUSIONS: Trajectory modeling may be a useful way to predict costly patients that could be implementable by payers to improve cost-containment efforts.

Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014).

OBJECTIVES: To assess the impact of CVS Health's discontinuation of tobacco sales on cigarette purchasing. METHODS: We used households' purchasing data to assess rates at which households stopped cigarette purchasing for at least 6 months during September 2014 to August 2015 among 3 baseline groups: CVS-exclusive cigarette purchasers, CVS+ (CVS and other retailers), and other-exclusive (only non-CVS retailers). In state-level analyses using retailers' point-of-sale purchase data, an interrupted time series compared cigarette purchasing before (January 2012 to August 2014) and after (September 2014 to April 2015) tobacco removal in 13 intervention states with CVS market share of at least 15% versus 3 control states with no CVS stores. RESULTS: Compared with other-exclusive purchasers, CVS-exclusive purchasers were 38% likelier (95% confidence interval = 1.06, 1.81) to stop cigarette purchasing after tobacco removal. Compared with control states, intervention states had a significant mean decrease of 0.14 (95% confidence interval = 0.06, 0.22) in packs per smoker per month. CONCLUSIONS: After CVS's tobacco removal, household- and population-level cigarette purchasing declined significantly. Private retailers can play a meaningful role in restricting access to tobacco. This highlights one approach to reducing tobacco use and improving public health.

Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing.

IMPORTANCE: In an effort to regulate physician conflicts of interest, some US academic medical centers (AMCs) enacted policies restricting pharmaceutical representative sales visits to physicians (known as detailing) between 2006 and 2012. Little is known about the effect of these policies on physician prescribing. OBJECTIVE: To analyze the association between detailing policies enacted at AMCs and physician prescribing of actively detailed and not detailed drugs. DESIGN, SETTING, AND PARTICIPANTS: The study used a difference-in-differences multivariable regression analysis to compare changes in prescribing by physicians before and after implementation of detailing policies at AMCs in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) that made up the intervention group with changes in prescribing by a matched control group of similar physicians not subject to a detailing policy. EXPOSURES: Academic medical center implementation of policies regulating pharmaceutical salesperson visits to attending physicians. MAIN OUTCOMES AND MEASURES: The monthly within-drug class market share of prescriptions written by an individual physician for detailed and nondetailed drugs in 8 drug classes (lipid-lowering drugs, gastroesophageal reflux disease drugs, diabetes drugs, antihypertensive drugs, hypnotic drugs approved for the treatment of insomnia [sleep aids], attention-deficit/hyperactivity disorder drugs, antidepressant drugs, and antipsychotic drugs) comparing the 10- to 36-month period before implementation of the detailing policies with the 12- to 36-month period after implementation, depending on data availability. RESULTS: The analysis included 16 121 483 prescriptions written between January 2006 and June 2012 by 2126 attending physicians at the 19 intervention group AMCs and by 24 593 matched control group physicians. The sample mean market share at the physician-drug-month level for detailed and nondetailed drugs prior to enactment of policies was 19.3% and 14.2%, respectively. Exposure to an AMC detailing policy was associated with a decrease in the market share of detailed drugs of 1.67 percentage points (95% CI, -2.18 to -1.18 percentage points; P < .001) and an increase in the market share of nondetailed drugs of 0.84 percentage points (95% CI, 0.54 to 1.14 percentage points; P < .001). Associations were statistically significant for 6 of 8 study drug classes for detailed drugs (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressant drugs) and for 9 of the 19 AMCs that implemented policies. Eleven of the 19 AMCs regulated salesperson gifts to physicians, restricted salesperson access to facilities, and incorporated explicit enforcement mechanisms. For 8 of these 11 AMCs, there was a significant change in prescribing. In contrast, there was a significant change at only 1 of 8 AMCs that did not enact policies in all 3 areas. CONCLUSIONS AND RELEVANCE: Implementation of policies at AMCs that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across 6 of 8 major drug classes; however, changes were not seen in all of the AMCs that enacted policies.

Patients' Satisfaction with and Preference for Telehealth Visits.

BACKGROUND: One-quarter of U.S. patients do not have a primary care provider or do not have complete access to one. Work and personal responsibilities also compete with finding convenient, accessible care. Telehealth services facilitate patients' access to care, but whether patients are satisfied with telehealth is unclear. OBJECTIVE: We assessed patients' satisfaction with and preference for telehealth visits in a telehealth program at CVS MinuteClinics. DESIGN: Cross-sectional patient satisfaction survey. PARTICIPANTS: Patients were aged ≥18 years, presented at a MinuteClinic offering telehealth in January-September 2014, had symptoms suitable for telehealth consultation, and agreed to a telehealth visit when the on-site practitioner was busy. MAIN MEASURES: Patients reported their age, gender, and whether they had health insurance and/or a primary care provider. Patients rated their satisfaction with seeing diagnostic images, hearing and seeing the remote practitioner, the assisting on-site nurse's capability, quality of care, convenience, and overall understanding. Patients ranked telehealth visits compared to traditional ones: better (defined as preferring telehealth), just as good (defined as liking telehealth), or worse. Predictors of preferring or liking telehealth were assessed via multivariate logistic regression. KEY RESULTS: In total, 1734 (54 %) of 3303 patients completed the survey: 70 % were women, and 41 % had no usual place of care. Between 94 and 99 % reported being "very satisfied" with all telehealth attributes. One-third preferred a telehealth visit to a traditional in-person visit. An additional 57 % liked telehealth. Lack of medical insurance increased the odds of preferring telehealth (OR = 0.83, 95 % CI, 0.72-0.97). Predictors of liking telehealth were female gender (OR = 1.68, 1.04-2.72) and being very satisfied with their overall understanding of telehealth (OR = 2.76, 1.84-4.15), quality of care received (OR = 2.34, 1.42-3.87), and telehealth's convenience (OR = 2.87, 1.09-7.94) CONCLUSIONS: Patients reported high satisfaction with their telehealth experience. Convenience and perceived quality of care were important to patients, suggesting that telehealth may facilitate access to care.

Patient Use of Email, Facebook, and Physician Websites to Communicate with Physicians: A National Online Survey of Retail Pharmacy Users.

BACKGROUND: Patient-physician communication often occurs outside the clinic setting; many institutions discourage electronic communication outside of established electronic health record systems. Little empirical data are available on patient interest in electronic communication and Web-based health tools that are technically feasible but not widely available. RESEARCH OBJECTIVE: To explore patient behavior and interest in using the Internet to contact physicians. DESIGN: National cross-sectional online survey. PARTICIPANTS: A sample of 4,510 CVS customers with at least one chronic condition in the household was used to target patients with chronic conditions and their caregivers. Subjects were identified from a national panel of over 100,000 retail pharmacy customers. Of those sampled, 2,252 responded (50.0 % response rate). MAIN MEASURES: Survey measures included demographic and health information, patient use of email and Facebook to contact physicians, and patient interest in and use of Web-based tools for health. KEY RESULTS: A total of 37 % of patients reported contacting their physicians via email within the last six months, and 18 % via Facebook. Older age was negatively associated with contacting physicians using email (OR 0.57 [95 % CI 0.41-0.78]) or Facebook (OR 0.28 [0.17-0.45]). Non-white race (OR 1.61 [1.18-2.18] and OR 1.82 [1.24-2.67]) and caregiver status (OR 1.58 [1.27-1.96] and OR 1.71 [1.31- 2.23]) were positively associated with using email and Facebook, respectively. Patients were interested in using Web-based tools to fill prescriptions, track their own health, and access health information (37-57 %), but few were currently doing so (4-8 %). CONCLUSIONS: In this population of retail pharmacy users, there is strong interest among patients in the use of email and Facebook to communicate with their physicians. The findings highlight the gap between patient interest for online communication and what physicians may currently provide. Improving and accelerating the adoption of secure Web messaging systems is a possible solution that addresses both institutional concerns and patient demand.

Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.

BACKGROUND: The incidence of opioid-related death in women has increased 5-fold over the past decade. For many women, their initial opioid exposure will occur in the setting of routine medical care. Approximately 1 in 3 deliveries in the United States is by cesarean, and opioids are commonly prescribed for postsurgical pain management. OBJECTIVE: The objective of this study was to determine the risk that opioid-naïve women prescribed opioids after cesarean delivery will subsequently become consistent prescription opioid users in the year following delivery and to identify predictors for this behavior. STUDY DESIGN: We identified women in a database of commercial insurance beneficiaries who underwent cesarean delivery and who were opioid naïve in the year prior to delivery. To identify persistent users of opioids, we used trajectory models, which group together patients with similar patterns of medication filling during follow-up, based on patterns of opioid dispensing in the year following cesarean delivery. We then constructed a multivariable logistic regression model to identify independent risk factors for membership in the persistent user group. RESULTS: A total of 285 of 80,127 (0.36%, 95% confidence interval, 0.32-0.40), opioid-naïve women became persistent opioid users (identified using trajectory models based on monthly patterns of opioid dispensing) following cesarean delivery. Demographics and baseline comorbidity predicted such use with moderate discrimination (c statistic = 0.73). Significant predictors included a history of cocaine abuse (risk, 7.41%; adjusted odds ratio, 6.11, 95% confidence interval, 1.03-36.31) and other illicit substance abuse (2.36%; adjusted odds ratio, 2.78, 95% confidence interval, 1.12-6.91), tobacco use (1.45%; adjusted odds ratio, 3.04, 95% confidence interval, 2.03-4.55), back pain (0.69%; adjusted odds ratio, 1.74, 95% confidence interval, 1.33-2.29), migraines (0.91%; adjusted odds ratio, 2.14, 95% confidence interval, 1.58-2.90), antidepressant use (1.34%; adjusted odds ratio, 3.19, 95% confidence interval, 2.41-4.23), and benzodiazepine use (1.99%; adjusted odds ratio, 3.72, 95% confidence interval, 2.64-5.26) in the year prior to the cesarean delivery. CONCLUSION: A very small proportion of opioid-naïve women (approximately 1 in 300) become persistent prescription opioid users following cesarean delivery. Preexisting psychiatric comorbidity, certain pain conditions, and substance use/abuse conditions identifiable at the time of initial opioid prescribing were predictors of persistent use.

Prescriber and pharmacy variation in patient adherence to five medication classes measured using implementation during persistent episodes.

PURPOSE: The objective of this study was to determine the fraction of variance in patient-level medication adherence accounted for by prescribers and pharmacies. METHODS: We used prescription drug claims paid between January 2010 and July 2011 to a national pharmacy benefits manager to define implementation during persistent episodes. Patients in Massachusetts or Rhode Island covered by Blue Cross Blue Shield of Rhode Island and their prescribers were included. Five drug classes were analyzed: angiotensin converting enzyme (ACE) inhibitors, antihyperglycemics (ANHGs), drugs for prostatic hyperplasia (PH), statins, and levothyroxine (THYR). We performed mixed models with random intercepts (drug, patient, prescriber, and pharmacy) and examined the fraction of variance explained at each level using intraclass correlations. RESULTS: Overall implementation ranged from 87 to 91%. The fraction of the explained variance in implementation to ACEs, ANHG, PH, statins, and THYR accounted for by prescribers was 16.4%, 12.6%, 14.6%, 15.6%, and 15% respectively; and for pharmacies 20.4%, 20%, 15.2%, 10.6%, and 9.4%, respectively. CONCLUSIONS: Prescriber and pharmacy effects accounted for a substantial amount of the explained variance in implementation across all five drug classes. Adherence interventions for chronic conditions that target prescribers and pharmacies, in addition to patients, could be effective and efficient. Copyright © 2016 John Wiley & Sons, Ltd.

Cost-effectiveness of novel regimens for the treatment of hepatitis C virus.

BACKGROUND: New regimens for hepatitis C virus (HCV) have shorter treatment durations and increased rates of sustained virologic response compared with existing therapies but are extremely expensive. OBJECTIVE: To evaluate the cost-effectiveness of these treatments under different assumptions about their price and efficacy. DESIGN: Discrete-event simulation. DATA SOURCES: Published literature. TARGET POPULATION: Treatment-naive patients infected with chronic HCV genotype 1, 2, or 3. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Usual care (boceprevir-ribavirin-pegylated interferon [PEG]) was compared with sofosbuvir-ribavirin-PEG and 3 PEG-free regimens: sofosbuvir-simeprevir, sofosbuvir-daclatasvir, and sofosbuvir-ledipasvir. For genotypes 2 and 3, usual care (ribavirin-PEG) was compared with sofosbuvir-ribavirin, sofosbuvir-daclatasvir, and sofosbuvir-ledipasvir-ribavirin (genotype 3 only). OUTCOME MEASURES: Discounted costs (in 2014 U.S. dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: Assuming sofosbuvir, simeprevir, daclatasvir, and ledipasvir cost $7000, $5500, $5500, and $875 per week, respectively, sofosbuvir-ledipasvir was cost-effective for genotype 1 and cost $12 825 more per QALY than usual care. For genotype 2, sofosbuvir-ribavirin and sofosbuvir-daclatasvir cost $110 000 and $691 000 per QALY, respectively. For genotype 3, sofosbuvir-ledipasvir-ribavirin cost $73 000 per QALY, sofosbuvir-ribavirin was more costly and less effective than usual care, and sofosbuvir-daclatasvir cost more than $396 000 per QALY at assumed prices. RESULTS OF SENSITIVITY ANALYSIS: Sofosbuvir-ledipasvir was the optimal strategy in most simulations for genotype 1 and would be cost-saving if sofosbuvir cost less than $5500. For genotype 2, sofosbuvir-ribavirin-PEG would be cost-saving if sofosbuvir cost less than $2250 per week. For genotype 3, sofosbuvir-ledipasvir-ribavirin would be cost-saving if sofosbuvir cost less than $1500 per week. LIMITATION: Data are lacking on real-world effectiveness of new treatments and some prices. CONCLUSION: From a societal perspective, novel treatments for HCV are cost-effective compared with usual care for genotype 1 and probably genotype 3 but not for genotype 2. PRIMARY FUNDING SOURCE: CVS Health.

The adherence impact of a program offering specialty pharmacy services to patients using retail pharmacies.

BACKGROUND: A new service model integrates the specialty pharmacy's comprehensive service with the retail pharmacy's patient contact, giving patients options for medication delivery to home, pharmacy, or doctor's office. OBJECTIVE: Evaluate the impact of the new service model on medication adherence. DESIGN: Retrospective cohort study SETTINGS: One hundred fifteen CVS retail stores in Philadelphia participated in a pilot from May 2012 to October 2013, and 115 matched CVS retail stores from around the nation served as controls. PATIENTS: All eligible patients from the intervention and control stores received specialty medications through CVS retail pharmacies prior to implementation of the new service model. INTERVENTION: The intervention patients were transitioned from retail pharmacy service to the specialty pharmacy with delivery options. The control patients received standard retail pharmacy services. MAIN OUTCOME MEASURES: Proportion of days covered and first fill persistence were tracked for 12 months before and after program implementation. RESULTS: Under the new service model, 228 patients new to therapy in the post period had a 17.5% increase in the rate of obtaining a second fill as compared to matched controls. Patients on therapy in both the pre- and the post-periods had a pre-post increase of 6.6% in average adherence rates and a pre-post increase of 10.8% in optimal adherence rates as compared to 326 matched controls. CONCLUSION: The study demonstrated significant improvement in both adherence to therapy and first-fill persistence among patients in the new service model integrating specialty pharmacy's comprehensive services with the retail pharmacy's patient contact and medication delivery choices.

Prescription drug insurance coverage and patient health outcomes: a systematic review.

Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies demonstrating that broader prescription drug insurance reduces use of other health care services and has a positive impact on patient outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the Affordable Care Act expansions in drug coverage to improve the health of low-income patients receiving state-based health insurance.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

OBJECTIVE: The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. METHODS: We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. RESULTS: We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. SIGNIFICANCE: Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions.

Association between trajectories of statin adherence and subsequent cardiovascular events.

PURPOSE: Trajectory models have been shown to (1) identify groups of patients with similar patterns of medication filling behavior and (2) summarize the trajectory, the average adherence in each group over time. However, the association between adherence trajectories and clinical outcomes remains unclear. This study investigated the association between 12-month statin trajectories and subsequent cardiovascular events. METHODS: We identified patients with insurance coverage from a large national insurer who initiated a statin during January 1, 2007 to December 31, 2010. We assessed medication adherence during the 360 days following initiation and grouped patients based on the proportion of days covered (PDC) and trajectory models. We then measured cardiovascular events during the year after adherence assessment. Cox proportional hazards models were used to evaluate the association between adherence measures and cardiovascular outcomes; strength of association was quantified by the hazard ratio, the increase in model C-statistic, and the net reclassification index (NRI). RESULTS: Among 519 842 statin initiators, 8777 (1.7%) had a cardiovascular event during follow-up. More consistent medication use was associated with a lower likelihood of clinical events, whether adherence was measured through trajectory groups or PDC. When evaluating the prediction of future cardiovascular events by including a measure of adherence in the model, the best model reclassification was observed when adherence was measured using three or four trajectory groups (NRI = 0.189; 95% confidence interval: [0.171, 0.210]). CONCLUSIONS: Statin adherence trajectory predicted future cardiovascular events better than measures categorizing PDC. Thus, adherence trajectories may be useful for targeting adherence interventions.

Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study.

BACKGROUND: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. OBJECTIVE: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes. DESIGN: Observational, propensity score-matched, new-user cohort study. SETTING: Linked electronic data from medical and pharmacy claims. PARTICIPANTS: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008. INTERVENTION: Initiation of a generic or brand-name statin. MEASUREMENTS: Adherence to statin therapy (measured as the proportion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated. RESULTS: A total of 90,111 patients who initiated a statin during the study was identified; 83,731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P<0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was -1.53 events per 100 person-years (CI, -2.69 to -0.19 events per 100 person-years). LIMITATION: Results may not be generalizable to other populations with different incomes or drug benefit structures. CONCLUSION: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome. PRIMARY FUNDING SOURCE: Teva Pharmaceuticals.

Full prescription coverage versus usual prescription coverage after coronary artery bypass graft surgery: analysis from the post-myocardial infarction free Rx event and economic evaluation (FREEE) randomized trial.

BACKGROUND: Eliminating out-of-pocket costs for patients after myocardial infarction (MI) improves adherence to preventive therapies and reduces clinical events. Because adherence to medical therapy is low among patients treated with coronary artery bypass graft surgery (CABG), we evaluated the impact of providing full prescription coverage to this patient subgroup. METHODS AND RESULTS: The MI Free Rx Event and Economic Evaluation (FREEE) trial randomly assigned 5855 patients with MI to full prescription coverage or usual formulary coverage for all statins, ß-blockers, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers. We assessed the impact of full prescription coverage on adherence, clinical outcomes, and healthcare costs using adjusted models among the 1052 patients who underwent CABG at the index hospitalization and 4803 who did not. CABG patients were older and had more comorbid illness (P<0.01). After MI, CABG patients were significantly more likely to receive ß-blockers and statins but were less likely to receive angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy (P<0.01). Receiving full drug coverage increased rates of adherence to all preventative medications after CABG (all P<0.05). Full coverage was also associated with nonsignificant reductions in the rate of major vascular events or revascularization for patients treated with CABG (hazard ratio, 0.91; 95% confidence interval, 0.66-1.25) or without CABG (hazard ratio, 0.93; 95% confidence interval, 0.82-1.06), with no interaction noted (Pint=NS). After CABG, full prescription coverage significantly reduced patient out-of-pocket spending for drugs (P=0.001) without increasing overall health expenditures (P=NS). CONCLUSIONS: Eliminating drug copayments after MI provides consistent benefits to patients treated with or without CABG, leading to increased medication adherence, trends toward improved clinical outcomes, and reduced patient out-of-pocket expenses.

Full coverage for preventive medications after myocardial infarction.

BACKGROUND: Adherence to medications that are prescribed after myocardial infarction is poor. Eliminating out-of-pocket costs may increase adherence and improve outcomes. METHODS: We enrolled patients discharged after myocardial infarction and randomly assigned their insurance-plan sponsors to full prescription coverage (1494 plan sponsors with 2845 patients) or usual prescription coverage (1486 plan sponsors with 3010 patients) for all statins, beta-blockers, angiotensin-converting-enzyme inhibitors, or angiotensin-receptor blockers. The primary outcome was the first major vascular event or revascularization. Secondary outcomes were rates of medication adherence, total major vascular events or revascularization, the first major vascular event, and health expenditures. RESULTS: Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group (P<0.001 for all comparisons). There was no significant between-group difference in the primary outcome (17.6 per 100 person-years in the full-coverage group vs. 18.8 in the usual-coverage group; hazard ratio, 0.93; 95% confidence interval [CI], 0.82 to 1.04; P=0.21). The rates of total major vascular events or revascularization were significantly reduced in the full-coverage group (21.5 vs. 23.3; hazard ratio, 0.89; 95% CI, 0.90 to 0.99; P=0.03), as was the rate of the first major vascular event (11.0 vs. 12.8; hazard ratio, 0.86; 95% CI, 0.74 to 0.99; P=0.03). The elimination of copayments did not increase total spending ($66,008 for the full-coverage group and $71,778 for the usual-coverage group; relative spending, 0.89; 95% CI, 0.50 to 1.56; P=0.68). Patient costs were reduced for drugs and other services (relative spending, 0.74; 95% CI, 0.68 to 0.80; P<0.001). CONCLUSIONS: The elimination of copayments for drugs prescribed after myocardial infarction did not significantly reduce rates of the trial's primary outcome. Enhanced prescription coverage improved medication adherence and rates of first major vascular events and decreased patient spending without increasing overall health costs. (Funded by Aetna and the Commonwealth Fund; MI FREEE ClinicalTrials.gov number, NCT00566774.).

Untangling the relationship between medication adherence and post-myocardial infarction outcomes: medication adherence and clinical outcomes.

BACKGROUND: Patients who adhere to medications experience better outcomes than their nonadherent counterparts. However, these observations may be confounded by patient behaviors. The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear. This study quantifies the relationship between medication adherence and post-myocardial infarction (MI) adverse coronary events. METHODS: This is a secondary analysis of the randomized MI FREEE trial. Patients who received full prescription coverage were classified as adherent (proportion of days covered ≥80%) or not based upon achieved adherence in the 6 months after randomization. First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior. RESULTS: Compared with patients randomized to usual care, full coverage patients adherent to statin, ß-blocker, or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study's primary outcome (hazard ratio [HR] range 0.64-0.81). In contrast, nonadherent patients derived no benefit (HR range 0.98-1.04, P ≤ .01 for the difference in HRs between adherent and nonadherent patients). Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated, although their achieved adherence was higher than that among controls. CONCLUSION: Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival. Lower levels of adherence appear less protective.