Is There a Relationship Between Part D Medication Adherence and Part C Intermediate Outcomes Star Ratings Measures?

BACKGROUND: Improvements in the Centers for Medicare & Medicaid Services (CMS) star ratings Part D medication adherence measures may affect performance in Part C intermediate outcome measures for which the Part D targeted medication classes are prescribed. OBJECTIVE: To determine if Part D medication adherence measures are associated with corresponding Part C intermediate outcome measures. METHODS: This was a cross-sectional analysis using the CMS 2015 star ratings report (based on 2013 benefit year plan data) for Medicare contracts. The measures of interest included the Part D adherence measures for diabetes medications, antihypertensive agents, and statins and the Part C intermediate outcome measures for controlled blood sugar, blood pressure, and cholesterol. All Medicare Advantage Prescription Drug (MAPD) contracts with complete data for all Part C and D measures of interest were included. Contracts with ≥ 25% of total enrollment with MA-only benefit were excluded. Linear and logistic regression models were used to assess the association between 2015 Part D adherence measures and Part C intermediate outcome measures (n = 366). The regression models were adjusted for low-income subsidy (LIS) beneficiary enrollment and log-transformed (natural logarithm) total contract enrollment. RESULTS: Bivariate linear regression models demonstrated moderate positive associations between each of the 2015 Part D adherence scores and related 2015 Part C measures that explained 27%-29% (R(2)) of variance. Including LIS and total contract enrollment in the regression models increased the R2 to 30%-36%. The multivariate logistic regression models showed that each percentage point of improvement in the 2015 Part D adherence measures was associated with a 4.13 to 4.69 greater odds of performing in the top quartile in corresponding 2015 Part C measures. CONCLUSIONS: Moderate positive associations were observed between the Part D and Part C scores in the same benefit year. MAPD plans may observe improved Part C intermediate outcome measures with strategies that improve Part D medication adherence measures. DISCLOSURES: This study was conducted by MedImpact Healthcare Systems, San Diego, California, without external funding. All authors are employees of MedImpact Healthcare Systems. Erickson reports advisory board fees from Sanofi and AstraZeneca. Ta, Erickson, and Patel were responsible for study concept and design and data interpretation, with assistance from Qiu. Qiu and Ta took the lead in data collection, assisted by Erickson. Ta wrote the manuscript, which was revised by Erickson and Patel.

Evaluation of an integrated adherence program aimed to increase Medicare Part D star rating measures.

BACKGROUND: The Centers for Medicare Medicaid Services (CMS) Plan Quality and Performance Program, or Star Ratings Program, allows Medicare beneficiaries to compare quality of care among available Medicare Advantage prescription drug (MA-PD) plans and stand-alone prescription drug plans (PDPs). Health plans have increased intervention efforts and applied existing care management infrastructure as an approach to improving member medication adherence and subsequent Part D star rating performance. Independent Care Health Plan (iCare), an MA-PD plan; MedImpact Healthcare Systems, Inc. (MedImpact), a pharmacy benefits manager; and US MED, a mail order pharmacy, partnered to engage and enroll iCare's dual-eligible special needs population in an intervention designed to improve patient medication adherence and health plan performance for 3 Part D patient safety outcome measures: Medication Adherence for Oral Diabetes Medications (ODM), Medication Adherence for Hypertension (HTN), and Medication Adherence for Cholesterol (CHOL). OBJECTIVES: To (a) assess the effectiveness of a coordinated member-directed medication adherence intervention and (b) determine the overall impact of the intervention on adherence rates and CMS Part D star rating adherence measures.  METHODS: Administrative pharmacy claims and health plan eligibility data from MedImpact's databases were used to identify members using 3 target medication classes. Adherence was estimated by the proportion of days covered (PDC) for all members. Those members considered at high risk for nonadherence were prioritized for care management services. Risk factors were based on members' use of more than 1 target medication class, newly started therapy, and suboptimal adherence (PDC less than 80%) in the most recent 6-month period. Data files listing member adherence rates and contact information were formatted and loaded monthly into iCare's care management system, which triggered an alert for care coordinators to counsel members on the importance of adherence and offer the members an option for monthly 30-day supply medication delivery via US MED. Member adherence rates were calculated 9 months pre- and postimplementation for all members and adjusted by length of member enrollment based on CMS technical specifications. Regression analysis assessed pre-post changes in rates comparing 2 intervention groups: (1) members receiving iCare counseling only (iCare-only) and (2) members receiving counseling and medication delivery (iCare + US MED). To evaluate the overall impact of the intervention, iCare's adherence rates and iCare's measure-specific star ratings for the 2011 and 2012 calendar years (CMS measurement years) were compared with the national MA-PD plan contract average and with a health plan similar in member characteristics but without adherence intervention exposure.  RESULTS: A total of 2,700 members were initially targeted for referral to iCare care management and US MED customer service specialist teams. Between April 2012 (implementation date) and January 2013, 1,302 (48.2%) members enrolled in the US MED component of the intervention. Seventy-six percent of identified members were nonadherent (PDC less than 80%) to 1 of the 3 target medication classes, and 32% of members were nonadherent to more than 1 target medication class. Pre-post absolute average adherence rates increased for the iCare-only group (ODM = 15.1, HTN = 10.1, CHOL = 13.6) and the iCare-US MED group (ODM = 30.9, HTN = 25.5, CHOL = 29.4).  From 2011 to 2012, iCare adherence rates increased by absolute differences of 15.2, 9.2, and 10.1 percentage points for ODM, HTN, and CHOL measures, respectively, compared with the average MA-PD plan contract differences (1.1, 2.1, and 2.5) and the comparator health plan differences (-2.7, -1.4, and -4.1). Increases in iCare's adherence rates were associated with significant increases in iCare's 2014 adherence measure star ratings (1 star to 3 stars for ODM and CHOL, 1 star to 2 stars for HTN), which contributed to increases in the Drug Plan Quality Improvement measure (2 stars to 4 stars) and iCare's overall Part D star rating (3 to 3.5 stars).  CONCLUSIONS: Members in this MA-PD plan dual-eligible population benefited from multiple points of contact to achieve increased adherence. Health plans can use network pharmacies, care management staff, and their pharmacy benefits managers to collaborate and implement interventions aimed to improve members' adherence to targeted maintenance medications and overall health plan quality performance and star ratings.

Is there an association between the high-risk medication star ratings and member experience CMS star ratings measures?

BACKGROUND: Methods to achieve high star ratings for the High-Risk Medication (HRM) measure are thought to result in unintended consequences and to compromise several member experience measures that ultimately put at risk the plan sponsor's Medicare Part D Centers for Medicare Medicaid (CMS) star rating.  OBJECTIVE: To determine if HRM scores are associated with relevant member experience measure scores.  METHODS: This is a cross-sectional analysis utilizing CMS 2013 and 2014 plan star ratings reports (2011 and 2012 benefit year data) for Medicare Advantage prescription drug (MA-PD) plans and prescription drug plans (PDPs). Medicare contracts with complete data for all measures of interest in 2013 and 2014 star ratings reports were included (N = 443). Bivariate linear regressions were performed for each of 2 independent variables: (1) 2014 HRM score and (2) 2013 to 2014 change in HRM score. Dependent variables were the 2014 scores for "Getting Needed Prescription Drugs," "Complaints about Drug Plan," "Rating of Drug Plan," and "Members Choosing to Leave the Plan." RESULTS: The bivariate linear regressions demonstrated weak positive associations between the 2014 HRM score and each of the 2014 member experience measures that explained 0.5% to 4% (R2) of variance of these measures. The bivariate regressions for the 2013 to 2014 change in the HRM score and 2014 member experience measures of interest demonstrated associations accounting for 1% to 8% of variance (R2). The greatest associations were observed between each independent variable and the 2014 "Getting Needed Prescription Drugs" score with correlation coefficients of 0.21 and 0.29.  CONCLUSIONS: HRM star ratings and change in HRM star ratings are weakly correlated with member experience measures in concurrent measurement periods. Plan sponsors may be more aggressive in HRM utilization management, since it is unlikely to negatively impact CMS summary star ratings. 

Prescriber perceptions of a near real-time fax alert program for potential drug-drug interactions.

BACKGROUND: Health systems have developed interventions to reduce harm associated with drug-drug interactions. Pharmacy benefit managers are in an important position to identify the coprescribing of medications known to interact, since they process data on a large portion of prescription claims in the United States. Electronic health records and electronic prescribing also include alerts through their systems' clinical decision support. However, limited data are available that assess prescribers' perceptions of processes that screen for potential drug-drug interactions (PDDIs). OBJECTIVE: To determine prescribers' perceptions of near real-time fax alerts for PDDIs. METHODS: This was a 6-month prospective study where a pharmacy benefit manager distributed evidence-based summaries of 18 different PDDIs that included references and suggested management strategies. Fax alerts were individualized letters sent to the prescriber of the second drug of a PDDI pair for an individual patient. A 16-item questionnaire to assess prescribers' perceptions of the intervention accompanied each individualized PDDI evidence-based summary. RESULTS: A total of 8,075 fax alerts were distributed with 977 returning questionnaires, yielding a 12.1% response rate. There were 848 (86.8%) responses completed by physicians, and 71 (7.3%) completed by nurse practitioners. The most common PDDI fax alerts sent were for warfarin-statin (3,511, 43.5%) and warfarin-thyroid (2,111, 26.1%) interactions. 42.6% of respondents agreed or strongly agreed that fax alerts were a good way to communicate with them. However, 37.5% of respondents either agreed or strongly agreed that the fax alert was a "waste of my time." In contrast, respondents thought notification of carbamazepine-macrolide (mean 1.5 ± 0.71), ciprofloxacin-tizanidine (mean 2.3 ± 1.0), and statin-macrolide (mean 2.3 ± 1.1) was not a waste of time. Also, 59.1% of respondents either disagreed or strongly disagreed that they would prefer to receive a telephone call when interactions like this occur. Half (50.5%) of the respondents indicated their computer systems provided drug interaction alerts. Prescribers who had previously received alerts and specialists were less likely to respond to the questionnaire (OR = 0.685, P ≤ 0.0001 and OR = 0.851, P = 0.0205, respectively). CONCLUSIONS: The positive response to fax alerts by physicians varies by the component drugs of the PDDI alerts.

Benefit restrictions and gout treatment.

BACKGROUND: Gout is a chronic rheumatic disease that can have serious sequelae, including persistent pain, nerve compression, joint destruction and deformities if left untreated. Febuxostat, initially introduced in the United States in 2009, was the first new treatment option for gout in over 40 years. With the introduction of a new drug into a therapeutic class that is composed of generically available options, utilization management will be a common strategy employed in an effort to contain cost; however, the effects of these strategies are not known for chronic gout treatment. OBJECTIVE: To evaluate the effect of utilization management strategies on chronic gout treatment. METHODS: This retrospective analysis examined claims data from a large, national pharmacy benefits manager with a client base that includes commercial HMOs, Medicaid, Medicare Part D, and self-insurers. The study population included patients aged 18 years or older who had at least 1 rejected claim for febuxostat in the 16-month identification period from March 1, 2009, through June 30, 2010. Outcomes of interest were the proportion of patients who filled a febuxostat prescription and proportion of patients who filled a prescription for another chronic gout treatment within 1 month of the febuxostat claim rejection date (the index date). Multivariate logistic regression models were used to assess factors affecting patient response to a rejected febuxostat claim. RESULTS: Of 1,034 patients with rejected febuxostat claims, 95% had claims denied due to utilization management: 36% due to step therapy, 25% due to lack of drug coverage, 18% due to quantity or other limits (i.e., fill limit exceeded, days supply exceeding benefit maximum, or maximum days supply limit exceeded), 16% due to prior authorization requirements, while 5% were due to "other reasons" unrelated to the utilization management strategies of interest. "Other reasons" included over 100 possible rejection reasons such as fill dispensed too soon, missing/invalid days supply, group not having benefit, physician not covered, non-matched group, not a network pharmacy, non-matched member, claim/member birth date not matching, and missing/invalid prescriber identifier. Subsequently, 474 (46%) of these patients filled a febuxostat prescription within 1 month of a rejected claim; 364 (35%) had not filled a prescription for any chronic gout medication within a month of the febuxostat claim rejection. Those filling a febuxostat prescription had higher pre-index total 6-month pharmacy costs than those not filling a chronic gout prescription ($1,718 vs. $988; P < 0.001) . They also had a higher number of pre-index drug claims (25 vs. 18; P < 0.001). The regression model found the following variables to be statistically significant in positively influencing the likelihood of patients filling a febuxostat prescription within a month of a febuxostat claim rejection: (a) self-insured coverage (compared with commercial HMO coverage); (b) pre-index total prescription costs of at least $1,800; (c) claim rejection due to quantity or other limit (compared with lack of drug coverage); (d) claim rejection due to "other reason" (compared with lack of drug coverage); and (e) 1 and ≥1 pre-index colchicine claim. Patients with projected febuxostat copay of $100 to $149 were found to be less likely to fill febuxostat compared with patients with a projected copay of $0 to $19. CONCLUSION: Utilization management strategies likely result in gaps in gout treatment; 35% of patients with a denied febuxostat claim in this study population did not fill a prescription for any chronic gout therapy within a month of the claim denial. These findings are important in the consideration of benefit design in gout treatment.

Effects of coverage gap reform on adherence to diabetes medications.

OBJECTIVES: To investigate the impact of Part D coverage gap reform on diabetes medication adherence. STUDY DESIGN: Retrospective data analysis based on pharmacy claims data from a national pharmacy benefit manager. METHODS: We used a difference-in-difference-indifference method to evaluate the impact of coverage gap reform on adherence to diabetes medications. Two cohorts (2010 and 2011) were constructed to represent the last year before Affordable Care Act (ACA) reform and the first year after reform, respectively. Each patient had 2 observations: 1 before and 1 after entering the coverage gap. Patients in each cohort were divided into groups based on type of gap coverage: no coverage, partial coverage (generics only), and full coverage. RESULTS: Following ACA reform, patients with no gap coverage and patients with partial gap coverage experienced substantial drops in copayments in the coverage gap in 2011. Their adherence to diabetes medications in the gap, measured by percentage of days covered, improved correspondingly (2.99 percentage points, 95% confidence interval [CI] 0.49-5.48, P = .019 for patients with no coverage; 6.46 percentage points, 95% CI 3.34-9.58, P <.0001 for patients with partial coverage). Patients with full coverage also had lower copayments in the gap in 2011. However, their adherence did not increase (-0.13 percentage point, P = .8011). CONCLUSIONS: In the first year of ACA coverage gap reform, copayments in the gap decreased substantially for all patients. Patients with no coverage and patients with partial coverage in the gap had better adherence in the gap in 2011.

Evaluation of a drug-drug interaction: fax alert intervention program.

BACKGROUND: Clinicians often encounter information about drug-drug interactions (DDIs) during clinical practice. This information is found within product information (hardcopy and electronic) and various electronic systems. Prescribers may receive medication-related communications in practice that are distributed by facsimile (fax), mail, or telephone from pharmacies and pharmacy benefit managers (PBMs). The purpose of this study was to determine if near-real time fax alerts for potential drug-drug interactions (PDDIs) would influence prescribing. METHODS: A prospective study, in cooperation with a pharmacy benefit manager (PBM), was conducted targeting 18 clinically important PDDIs. Fax alerts included an individualized letter to the prescriber with a list of the interacting drugs, PDDI evidence summaries with citations, and recommended clinical management strategies. Among the 18 PDDIs, 13 PDDIs could be assessed for prescription therapy changes using pharmacy claims data. A prospective cohort design was used to evaluate changes in prescription dispensing 90-days following a PDDI fax alert. RESULTS: A total of 8,075 fax alerts were sent to prescribers and there were 4,712 alerts for the 13 PDDIs that could be assessed for change using pharmacy claims data. There were 2,019 patients (interventions) for which fax alerts were sent to their prescribers who were matched with a control group consisting of patients with the same PDDIs but for whom no fax alert was sent. Overall, this study found 154 (7.6%) of patients in the fax alert group compared to 132 (6.5%) in the control group had changes in therapy (p = 0.177). CONCLUSIONS: This fax alert intervention program observed no statistically significant differences in prescribing with a fax alert compared to the control group. If PBMs chose to send individualized, evidence-based information to clinicians regarding drug-drug interactions, this study suggests it may not be an effective intervention to mitigate harm.

Failure to intensify hypertension therapy after rejected aliskiren claims.

BACKGROUND: Failure to intensify therapy when indicated is a serious problem in the management of hypertension. Patients having an antihypertensive prescription rejected because of utilization management tools may be at a high risk of failing to intensify their therapy when it is warranted. OBJECTIVE: The goal of this study was to investigate the patterns of therapy change after rejected aliskiren claims because of utilization management tools such as prior authorization, step therapy, and restrictive formulary. METHODS: A retrospective study was conducted using data from a large national pharmacy benefits manager. Patients with a rejected aliskiren claim because of utilization management and who were naive to aliskiren treatment before having a rejected aliskiren claim were included. Patients were followed up for 6 months after the initial rejected aliskiren claim to see whether there was a therapy change. Therapy change was defined as titration of old regimens, fulfillment of aliskiren, or fulfillment of a new antihypertensive medication not used previously. RESULTS: A total of 1955 patients were identified (mean age, 64.5 years; 54.4% female). Six months after having rejected aliskiren claims, 36.8% overcame the utilization management and filled aliskiren; 45.1% filled a new antihypertensive medication not used previously; and 10.8% patients titrated old antihypertensive medications. More than one quarter of patients (28.4%) had no change in their antihypertensive treatment. Logistic regression analysis revealed that patients rejected because of prior authorization (odds ratio = 4.00 [95% CI, 1.89-8.44]) or step therapy (odds ratio = 2.59 [95% CI, 1.26-5.32]) were more likely to have a therapy change compared with patients rejected because of a restrictive formulary. CONCLUSIONS: A significant number of patients had no therapy change 6 months after having rejected aliskiren claims because of utilization management tools, indicating potential clinical inertia or lack of therapy intensification in hypertension management. Patients with restrictive formularies were least likely to have a therapy change. More aggressive follow-up with patients with a rejected claim may be warranted to reduce treatment gaps.

Evolution of postmenopausal hormone therapy between 2002 and 2009.

OBJECTIVE: The results of the Women's Health Initiative led to a sharp decline in postmenopausal hormone therapy use. Subsequently, treatment guidelines were revised to recommend hormone therapy at the lowest effective dose for the shortest possible duration. The objective of this analysis was to assess trends in nationwide hormone therapy prescription claims from 2002 to 2009. METHODS: This study was a retrospective database analyses of pharmacy claims from MedImpact Healthcare Systems Inc. Data from women with claims for oral or transdermal hormone therapy were analyzed to assess trends in hormone therapy claims, including route of administration, dose, and physician specialty. RESULTS: By the end of 2002, the total number of hormone therapy claims dropped approximately 30% from 2002 second quarter claims. This trend continued during the next 7 years, and by 2009, hormone therapy claims were reduced by more than 70%. The proportion of low--dose oral claims rose fourfold, whereas the proportion of standard/high-dose claims decreased 30%. The proportion of claims for transdermal formulations more than doubled, and the proportion of claims for low-dose transdermal hormone therapy increased 10-fold. Although reductions in overall claims, routes of administration, and dose categories were similar between physician specialties, obstetrician/gynecologists prescribed transdermal hormone therapy nearly twice as often as all other types of providers. CONCLUSIONS: Since the publication of the Women's Health Initiative results, there has been a sustained decrease in hormone therapy claims. The proportional use of low-dose oral and transdermal formulations has increased, but as of 2009, claims for these formulations accounted for approximately one in four total hormone therapy claims.

Effects of copayment on initiation of smoking cessation pharmacotherapy: an analysis of varenicline reversed claims.

BACKGROUND: Smoking cessation pharmacotherapy is a critical component of smoking cessation treatment, but most smokers use neither pharmacotherapy nor behavior counseling in attempts to quit smoking. The low rate of smoking cessation medication use is of great concern because it can negatively influence the odds of success in smoking cessation. OBJECTIVE: This study was conducted to analyze how copayment may influence the likelihood of initiating smoking cessation pharmacotherapy following a reversed varenicline claim. METHODS: A retrospective cohort analysis was performed using pharmacy claims data from a large national pharmacy benefits management company. Reversed claims were claims first approved by the health plan and then reversed by the pharmacy. The study population included patients with over-the-counter nicotine replacement therapy coverage and a reversed varenicline claim between January 2007 and April 2008 and who were naive to varenicline before the reversed claim. A multivariate logistic regression analysis was conducted to evaluate the probability of initiating any smoking cessation pharmacotherapy (varenicline, bupropion, and prescribed or over-the-counter nicotine replacement therapy) within 183 days of the reversed claim. RESULTS: A total of 20,451 patients met the inclusion criteria. The mean (SD) age of patients was 47.8 (12.4) years, with 57.41% being female. The majority (87.72%) were covered in commercial managed care plans. A total of 17,028 patients (83.26%) had at least 1 smoking cessation medication filled 6 months after their reversed claim. The odds ratios for patients who had any smoking cessation medication filled and copayments of $31 to $40, $41 to $60, or >$60 were 0.68, 0.48, and 0.35, respectively (all, P < 0.001), compared with patients with copayments of $0 to $5. CONCLUSIONS: The findings suggest that some patients might have been deterred by a high copayment (≥$31) and, ultimately, did not fill any smoking cessation treatments within 183 days of reversed varenicline claims. It is important to address this potential treatment gap to improve the effectiveness of smoking cessation therapy.

Utilization management for smoking cessation pharmacotherapy: varenicline rejected claims analysis.

OBJECTIVE: To evaluate the impact of utilization management methods on use of smoking cessation medication. STUDY DESIGN: Retrospective cohort analysis of pharmacy claims data. METHODS: The study population included patients at least 18 years of age, naive to varenicline, and with a rejected varenicline claim between January 2007 and April 2008 because of 1 of 4 utilization management restrictions: drug not covered, prior authorization, step therapy, or quantity limits. The outcome variable was whether patients used any smoking cessation medication including varenicline, bupropion, and nicotine replacement therapy (prescribed and over-the-counter) within 6 months of the rejected varenicline claim. Multivariable logistic regression was conducted to evaluate the probability of filling a prescription for any smoking cessation medication. RESULTS: A total of 15,597 patients were identified. Within 6 months after the rejected claims, 8393 (53.8%) patients filled at least 1 smoking cessation medication, 7864 (93.7%) of whom filled varenicline. Compared with quantity limits, the odds ratios for filling any smoking cessation medication after the rejected varenicline claim were 0.01 (95% confidence interval [CI], 0.01-0.02) for varenicline not covered, 0.07 (95% CI, 0.06-0.09) for step therapy, and 0.18 (95% CI, 0.16-0.20) for prior authorization. Higher out-of-pocket expense was associated with a lower probability of filling any smoking cessation medication. CONCLUSION: About half of the patients in this study did not fill any smoking cessation medication following a rejected varenicline claim. It is important to address this treatment gap in support of patients seeking smoking cessation therapy.

The impact of value-based benefit design on adherence to diabetes medications: a propensity score-weighted difference in difference evaluation.

OBJECTIVE: To evaluate the impact of value-based benefit design (VBBD) on adherence to diabetes medications. METHODS: Health Alliance Medical Plans piloted VBBD for diabetes medications for a subgroup of 5400 enrollees in January 2007 while keeping drug benefits unchanged for the remaining plan enrollees. A difference in difference method (DID) was used to evaluate the effect of VBBD based on pharmacy claim data. Patients with unchanged benefits in the same plan were used as the control group. Adherence was measured by the proportion of days covered. Propensity score weighting was used to balance characteristics of the case group and the control group. RESULTS: There were 71 patients in the case group and 5037 patients in the control group. The patients in the two groups had comparable characteristics after propensity score weighting. After the implementation of VBBD, the average copayment per 30 days of supply for diabetes medications decreased from $15.3 to $10.1 for the case group and increased from $14.6 to $15.1 for the control group. The probability of being adherent increased from 75.3% to 82.6% for the case group and was roughly unchanged from 79.1% to 78.5% for the control group. Propensity score-weighted DID analysis showed that patients with copayment reduction had greater odds of being adherent: odds ratio=1.56, P=0.03, 95% confidence interval 1.04-2.34. CONCLUSION: A VBBD program that reduced the copayment for diabetes medications by 36.1% reduced the number of nonadherent patients by 30.0%.

Part D coverage gap and adherence to diabetes medications.

OBJECTIVE: To evaluate the impact of Medicare Part D coverage gap (donut hole) on adherence to diabetes medications. STUDY DESIGN: Retrospective cohort analysis based on pharmacy claims data. METHODS: The sample included 12,881 Medicare Part D beneficiaries with diabetes who entered the coverage gap in 2008. Sample patients had 3 different levels of coverage in the donut hole: no coverage, generic drug coverage only, and both generic and brand-name drug coverage. Adherence was measured by the proportion of days covered. We used a difference-in-difference model to evaluate the effect of coverage gap on adherence. RESULTS: In the donut hole, the average copayment for diabetes medications increased substantially for beneficiaries with no coverage and beneficiaries with generic drug coverage only, whereas the average copayment for beneficiaries with both generic and brand-name medication coverage declined slightly. Compared with beneficiaries with full coverage of both generic and brand-name drugs, beneficiaries with no coverage (odds ratio[OR] = 0.617, P <.0001, 95% confidence interval [CI] = 0.523, 0.728) and beneficiaries with generic drug coverage only (OR = 0.702, P <.0001, 95% CI = 0.604, 0.816) were significantly less likely to be adherent after entering the donut hole. The difference between having generic coverage and no coverage was not significant (P = .1586). CONCLUSIONS: The coverage gap in the Medicare Part D program has a significant negative impact on medication adherence among beneficiaries with diabetes. Availability of brand-name drug coverage in the donut hole is critical to adherence to diabetes medications.

The demand for statin: the effect of copay on utilization and compliance.

Increasing drug costs in the US have prompted employers and insurers alike to turn to higher drug copays for cost containment. The effect of rising copays on compliance with statins (HMG-CoA reductase inhibitors) treatment has received surprisingly little attention in the applied literature. This paper uses pharmacy claims data from a commercially insured adult population to determine the effect of copay change on compliance at the individual level. Fixed effect logit and Poisson regressions estimate the effect of copays on monthly likelihood of high compliance and average monthly days of supply respectively. Higher copays reduce compliance among statin users, with less compliant patients responding more strongly to copay change than compliant patients. These results suggest that specific financial incentives given to less compliant patients could improve compliance with statin treatment at a relatively low cost.

Effects of initial antihypertensive drug class on patient persistence and compliance in a usual-care setting in the United States.

Antihypertensive treatment regimen persistence and compliance were measured using a retrospective cohort study of pharmacy claims data. Newly treated patients receiving monotherapy with angiotensin II receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), beta-blockers (BBs), or diuretics were followed for 1 year (N=242,882). A higher proportion of ARB patients (51.9%) were persistent in taking prescribed medication compared with those in the ACEI (48.0%), BB (40.3%), CCB (38.3%), and diuretic groups (29.9%). Compared with patients receiving diuretics, those receiving ARBs (hazard ratio [HR], 0.593; P<.0001), ACEIs (HR, 0.640; P<.0001), CCBs (HR, 0.859; P<.0001), and BBs (HR, 0.819; P<.0001) were all less likely to discontinue therapy. Compliance was similar in ACEI and ARB patients, but patients receiving ARBs and ACEIs had better compliance than those receiving BBs, CCBs, or diuretics. The lesser degree of compliance and persistence observed in patients receiving diuretics compared with other antihypertensive medications may have public health as well as cost implications.

The effect of the Rx-to-OTC switch of loratadine and changes in prescription drug benefits on utilization and cost of therapy.

BACKGROUND: Numerous prescription products have become available over the counter (OTC) in recent years. Previous simulation models have shown the Rx-to-OTC switch of loratadine to be cost effective. OBJECTIVE: To empirically assess the overall effect of the Rx-to-OTC switch of loratadine and the specific effect of different pharmacy benefit structures on prescription drug utilization and cost among different plan sponsors. METHODS: Data from a national pharmacy benefit management organization covering lives throughout the United States were used. The analysis included a comparison of the before and after change in prescription utilization and cost for plan sponsors that instituted 1 of 3 second-generation antihistamine (SGA) benefit responses: made no change, moved SGAs to the third tier, or restricted SGA benefits through a requirement for prior authorization. Multivariate regression analysis was used to control for differences across the study groups. RESULTS: There was a substantial decrease in utilization and cost of all prescription drugs and combinations of drug classes. Patients with allergic rhinitis facing restricted prescription benefits for SGAs did not appear to increase utilization of other allergic rhinitis medications or other medications used to treat comorbid conditions such as asthma, sinusitis, and otitis media. CONCLUSIONS: Utilization and cost decreased substantially for all types of medications and all pharmacy benefit structures. Future studies need to examine the effect of the Rx-to-OTC switch of loratadine and resultant prescription benefit policies on medical utilization and OTC antihistamine utilization.