Economic Impact of Adherence to Pain Treatment Guidelines in Chronic Pain Patients.

OBJECTIVES: This research compared health care resource use (HCRU) and costs for pharmacotherapy prescribing that was adherent vs nonadherent to published pain management guidelines. Conditions included osteoarthritis (OA) and gout (GT) for nociceptive/inflammatory pain, painful diabetic peripheral neuropathy (pDPN) and post-herpetic neuralgia (PHN) for neuropathic pain, and fibromyalgia (FM) for sensory hypersensitivity pain. METHODS: This retrospective cohort study used claims from MarketScan Commercial and Medicare Databases identifying adults newly diagnosed with OA, GT, pDPN, PHN, or FM during July 1, 2006, to June 30, 2013, with 12-month continuous coverage before and after initial (index) diagnosis. Patients were grouped according to their pharmacotherapy pattern as adherent, nonadherent, or "unsure" according to published pain management guidelines using a claims-based algorithm. Adherent and nonadherent populations were compared descriptively and using multivariate statistical analyses for controlling bias. RESULTS: Final cohort sizes were 441,465 OA, 76,361 GT, 10,645 pDPN, 4,010 PHN, and 150,321 FM, with adherence to guidelines found in 51.1% of OA, 25% of GT, 59.5% of pDPN, 54.9% of PHN, and 33.5% of FM. Adherent cohorts had significantly (P < 0.05) fewer emergency department (ED) visits and lower proportions with hospitalizations or ED visits. Mean health care costs increased following diagnosis across all conditions; however, adherent cohorts had significantly lower increases in adjusted costs pre-index to postindex (OA $5,286 vs $9,532; GT $3,631 vs $7,873; pDPN $9,578 vs $16,337; PHN $2,975 vs $5,146; FM $2,911 vs $3,708; all P < 0.001; adherent vs nonadherent, respectively). CONCLUSIONS: Adherence to pain management guidelines was associated with significantly lower HCRU and costs compared with nonadherence to guidelines.

Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography.

BACKGROUND: Little data exist on real-world patterns and associated costs of downstream breast diagnostic procedures following an abnormal screening mammography or clinical exam. OBJECTIVES: To analyze the utilization patterns in real-world clinical settings for breast imaging and diagnostic procedures, including the frequency and volume of patients and procedures, procedure sequencing, and associated health care expenditures. MATERIALS AND METHODS: Using medical claims from 2011 to 2015 MarketScan Commercial and Medicare Databases, adult females with breast imaging/diagnostic procedures (diagnostic mammography, ultrasound, molecular breast imaging, tomosynthesis, magnetic resonance imaging, or biopsy) other than screening mammography were selected. Continuous health plan coverage without breast diagnostic procedures was required for ≥13 months before the first found breast diagnostic procedure (index event), with a 13-month post-index follow-up period. Key outcomes included diagnostic procedure volumes, sequences, and payments. Results reported descriptively were projected to provide US national patient and procedure volumes. RESULTS: The final sample of 875,526 patients was nationally projected to 12,394,432 patients annually receiving 8,732,909 diagnostic mammograms (53.3% of patients), 6,987,399 breast ultrasounds (42.4% of patients), and 1,585,856 biopsies (10.3% of patients). Following initial diagnostic procedures, 49.4% had second procedures, 20.1% followed with third procedures, and 10.0% had a fourth procedure. Mean (SD) costs for diagnostic mammograms of US$349 ($493), ultrasounds US$132 ($134), and biopsies US$1,938 ($2,343) contributed US$3.05 billion, US$0.92 billion, and US$3.07 billion, respectively, to annual diagnostic breast expenditures estimated at US$7.91 billion. CONCLUSION: The volume and expense of additional breast diagnostic testing, estimated at US$7.91 billion annually, underscores the need for technological improvements in the breast diagnostic landscape.

Development of a novel algorithm to determine adherence to chronic pain treatment guidelines using administrative claims.

OBJECTIVE: To develop a claims-based algorithm for identifying patients who are adherent versus nonadherent to published guidelines for chronic pain management. METHODS: Using medical and pharmacy health care claims from the MarketScan® Commercial and Medicare Supplemental Databases, patients were selected during July 1, 2010, to June 30, 2012, with the following chronic pain conditions: osteoarthritis (OA), gout (GT), painful diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM). Patients newly diagnosed with 12 months of continuous medical and pharmacy benefits both before and after initial diagnosis (index date) were categorized as adherent, nonadherent, or unsure according to the guidelines-based algorithm using disease-specific pain medication classes grouped as first-line, later-line, or not recommended. Descriptive and multivariate analyses compared patient outcomes with algorithm-derived categorization endpoints. RESULTS: A total of 441,465 OA patients, 76,361 GT patients, 10,645 pDPN, 4,010 PHN patients, and 150,321 FM patients were included in the development of the algorithm. Patients found adherent to guidelines included 51.1% for OA, 25% for GT, 59.5% for pDPN, 54.9% for PHN, and 33.5% for FM. The majority (~90%) of patients adherent to the guidelines initiated therapy with prescriptions for first-line pain medications written for a minimum of 30 days. Patients found nonadherent to guidelines included 30.7% for OA, 6.8% for GT, 34.9% for pDPN, 23.1% for PHN, and 34.7% for FM. CONCLUSION: This novel algorithm used real-world pharmacotherapy treatment patterns to evaluate adherence to pain management guidelines in five chronic pain conditions. Findings suggest that one-third to one-half of patients are managed according to guidelines. This method may have valuable applications for health care payers and providers analyzing treatment guideline adherence.

Evaluating increased resource use in fibromyalgia using electronic health records.

OBJECTIVE: The management of fibromyalgia (FM), a chronic musculoskeletal disease, remains challenging, and patients with FM are often characterized by high health care resource utilization. This study sought to explore potential drivers of all-cause health care resource utilization and other factors associated with high resource use, using a large electronic health records (EHR) database to explore data from patients diagnosed with FM. METHODS: This was a retrospective analysis of de-identified EHR data from the Humedica database. Adults (≥18 years) with FM were identified based on ≥2 International Classification of Diseases, Ninth Revision codes for FM (729.1) ≥30 days apart between January 1, 2008 and December 31, 2012 and were required to have evidence of ≥12 months continuous care pre- and post-index; first FM diagnosis was the index event; 12-month pre- and post-index reporting periods. Multivariable analysis evaluated relationships between variables and resource utilization. RESULTS: Patients were predominantly female (81.4%), Caucasian (87.7%), with a mean (standard deviation) age of 54.4 (14.8) years. The highest health care resource utilization was observed for the categories of "medication orders" and "physician office visits," with 12-month post-index means of 21.2 (21.5) drug orders/patient and 15.1 (18.1) office visits/patient; the latter accounted for 73.3% of all health care visits. Opioids were the most common prescription medication, 44.3% of all patients. The chance of high resource use was significantly increased (P<0.001) 26% among African-Americans vs Caucasians and for patients with specific comorbid conditions ranging from 6% (musculoskeletal pain or depression/bipolar disorder) to 21% (congestive heart failure). Factors significantly associated with increased medications ordered included being female (P<0.001) and specific comorbid conditions (P<0.05). CONCLUSION: Physician office visits and pharmacotherapy orders were key drivers of all-cause health care utilization, with demographic factors, opioid use, and specific comorbidities associated with resource intensity. Health systems and providers may find their EHRs to be a useful tool for identifying and managing resource-intensive FM patients.

Shorter Hospital Stays and Lower Costs for Rivaroxaban Compared With Warfarin for Venous Thrombosis Admissions.

BACKGROUND: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, results in a substantial healthcare system burden. This retrospective observational study compared hospital length of stay (LOS) and hospitalization costs for patients with venous thromboembolism treated with rivaroxaban versus those treated with warfarin. METHODS AND RESULTS: Hospitalizations for adult patients with a primary diagnosis of deep vein thrombosis or pulmonary embolism who were initiated on rivaroxaban or warfarin were selected from MarketScan's Hospital Drug Database between November 1, 2012, and December 31, 2013. Patients treated with warfarin were matched 1:1 to patients treated with rivaroxaban using exact and propensity score matching. Hospital LOS, time from first dose to discharge, and hospitalization costs were reported descriptively and with generalized linear models (GLMs). The final study cohorts each included 1223 patients (751 with pulmonary embolism and 472 with deep vein thrombosis). Cohorts were well matched for demographic and clinical characteristics. Mean (±SD) LOS was 3.7±3.1 days for patients taking rivaroxaban and 5.2±3.7 days for patients taking warfarin, confirmed by GLM-adjusted results (rivaroxaban 3.7 days, warfarin 5.3 days, P<0.001). Patients with provoked venous thromboembolism admissions showed longer LOSs (rivaroxaban 5.1±4.5 days, warfarin 6.5±5.6 days, P<0.001) than those with unprovoked venous thromboembolism (rivaroxaban 3.3±2.4 days, warfarin 4.8±2.8 days, P<0.001). Days from first dose to discharge were 2.4±1.7 for patients treated with rivaroxaban and 3.9±3.7 for patients treated with warfarin when initiated with parenteral anticoagulants (P<0.001), and 2.7±1.7 and 3.7±2.1, respectively, when initiated without parenteral anticoagulants (P<0.001). Patients initiated on rivaroxaban incurred significantly lower mean total hospitalization costs ($8688±$9927 versus $9823±$9319, P=0.004), confirmed by modeling (rivaroxaban $8387 [95% confidence interval, $8035-$8739]; warfarin $10 275 [95% confidence interval, $9842-$10 708]). CONCLUSIONS: Rivaroxaban was associated with significantly shorter hospital LOS and lower hospitalization costs compared with warfarin.

Pulmonary Embolism Inpatients Treated With Rivaroxaban Had Shorter Hospital Stays and Lower Costs Compared With Warfarin.

PURPOSE: Using real-world data, this study compares inpatient length of stay (LOS) and costs for patients with a primary diagnosis of pulmonary embolism (PE) initiating treatment with oral anticoagulation with rivaroxaban versus warfarin. METHODS: Hospitalizations from MarketScan's Hospital Drug Database were selected from November 1, 2012, through December 31, 2013, for adults with a primary diagnosis of PE initiating treatment with rivaroxaban or warfarin. Warfarin patients were matched 1:1 to rivaroxaban patients using exact and propensity score matching. Hospital LOS, treatment patterns, and hospitalization costs were evaluated. FINDINGS: Matched cohorts included 751 rivaroxaban-treated patients and 751 warfarin-treated patients. Adjusted mean LOS was 3.77 days for rivaroxaban patients (95% CI, 3.66-3.87 days) and 5.48 days for warfarin patients (95% CI, 5.33-5.63 days; P < .001). Mean (SD) LOS was shorter for patients taking rivaroxaban whether admission was for provoked PE (rivaroxaban: 5.2 [5.1] days; warfarin: 7.0 [6.5] days; P < .001) or unprovoked PE (rivaroxaban: 3.4 [2.3] days; warfarin: 5.1 [2.7] days; P < .001). Mean (SD) days from first dose to discharge were 2.5 (1.7) (rivaroxaban) and 4.0 (2.9) (warfarin) when initiated with parenteral anticoagulants (P < .001) and 2.7 (1.7) (rivaroxaban) and 4.0 (2.2) (warfarin) without parenteral anticoagulants (P < .001). The rivaroxaban cohort incurred significantly lower unadjusted mean (SD) hospitalization costs (rivaroxaban: $8473 [$9105]; warfarin: $10,291 [$9185]; P < .001), confirmed by covariate adjustment with generalized linear modeling estimating predicted mean hospitalization costs of $8266 for rivaroxaban patients (95% CI, $7851-$8681) and $10,511 for warfarin patients (95% CI, $10,031-$10,992; P < .001). IMPLICATIONS: patients with PE treated with rivaroxaban incurred significantly lower hospitalization costs by $2245 per admission compared with patients treated with warfarin, which was attributable to cost offsets from 1.71 fewer days of stay in the hospital.

Health care resource utilization and medical costs of spinal cord injury with neuropathic pain in a commercially insured population in the United States.

OBJECTIVE: To evaluate health care resource use, costs, and cost drivers among patients with neuropathic pain (NeP) after spinal cord injury (SCI) in a commercially insured population. DESIGN: Retrospective longitudinal cohort study comparing SCI patients with and without NeP. SETTING: Truven Health MarketScan commercial claims database from 2005 through 2012. PARTICIPANTS: Commercially insured SCI patients with NeP (n=3524) propensity score matched to SCI patients without NeP (n=3524). INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: Health care resource utilization and expenditures for the 12 months after NeP onset (index event; identified through International Classification of Diseases, 9th Revision, Clinical Modification diagnosis 338.0x or use of NeP-specific antiepileptic drugs or NeP-specific antidepressants) in patients with SCI compared with matched patients without NeP. RESULTS: Utilization over 12 months postindex among patients with SCI-associated NeP was higher than among SCI-only patients for inpatient admissions (27.4% vs 22.1%), emergency department visits (36.7% vs 26.4%), and office visits per patient (mean ± SD: 13.0±9.5 vs 9.5±8.3); all P values were <.001. All-cause expenditures showed adjusted incremental costs of $22,545 (95% confidence interval, $19,010-$26,168) per patient with SCI-associated NeP during the 12-month postindex period. CONCLUSIONS: Patients with evidence of NeP secondary to SCI have significantly higher health care utilization and total costs compared with SCI patients without evidence of NeP. Factors contributing to NeP in patients with SCI need to be clinically assessed to determine the optimal approach for treating these individuals.

Health care utilization and expenditures among Medicaid beneficiaries with neuropathic pain following spinal cord injury.

BACKGROUND: The study aimed to evaluate health care resource utilization (HRU) and costs for neuropathic pain (NeP) secondary to spinal cord injury (SCI) among Medicaid beneficiaries. METHODS: The retrospective longitudinal cohort study used Medicaid beneficiary claims with SCI and evidence of NeP (SCI-NeP cohort) matched with a cohort without NeP (SCI-only cohort). Patients had continuous Medicaid eligibility 6 months pre- and 12 months postindex, defined by either a diagnosis of central NeP (ICD-9-CM code 338.0x) or a pharmacy claim for an NeP-related antiepileptic or antidepressant drug within 12 months following first SCI diagnosis. Demographics, clinical characteristics, HRU, and expenditures were compared between cohorts. RESULTS: Propensity score-matched cohorts each consisted of 546 patients. Postindex percentages of patients with physician office visits, emergency department visits, SCI- and pain-related procedures, and outpatient prescription utilization were all significantly higher for SCI-NeP (P<0.001). Using regression models to account for covariates, adjusted mean expenditures were US$47,518 for SCI-NeP and US$30,150 for SCI only, yielding incremental costs of US$17,369 (95% confidence interval US$9,753 to US$26,555) for SCI-NeP. Factors significantly associated with increased cost included SCI type, trauma-related SCI, and comorbidity burden. CONCLUSION: Significantly higher HRU and total costs were incurred by Medicaid patients with NeP secondary to SCI compared with matched SCI-only patients.

Direct medical costs and resource use for treating central and branch retinal vein occlusion in commercially insured working-age and Medicare populations.

PURPOSE: To quantify the burden of illness for incident branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) in a commercially insured working-age (commercial) and Medicare US population. METHODS: Retrospective cohort analysis of health care claims from 2003 through 2008 from commercial and Medicare patients with ≥2 outpatient diagnoses for BRVO or CRVO. The index date was the first retinal vein occlusion diagnosis. Patients with medical and pharmacy benefits were followed ≥1 year preindex and then between 1 year and 3 years postindex. Incidence and prevalence of retinal vein occlusion was determined. Burden of illness was compared with matched control subjects without retinal vein occlusion. RESULTS: The commercial sample comprised 1,188 CRVO and 2,252 BRVO cases, whereas the Medicare sample had 2,739 CRVO and 4,573 BRVO cases. Adjusted ratio of case-to-control, all-cause expenditures for commercial patients at 1 year and 3 years postindex were 1.88 and 1.68, respectively, for BRVO and 1.42 and 1.36, respectively, for CRVO. For Medicare patients, these were 1.29 and 1.13, respectively, for BRVO and 1.23 and 1.14, respectively, for CRVO. All comparisons were significant (P < 0.001). CONCLUSION: Health care utilization and expenditures for commercially insured working-age and Medicare patients with BRVO or CRVO were significantly greater than those for control subjects. Retinal vein occlusion development may be a marker for the increased severity of systemic vascular disease.

Effectiveness of antiepileptic drug combination therapy for partial-onset seizures based on mechanisms of action.

IMPORTANCE: To our knowledge, the current study is the first to describe antiepileptic drug (AED) combination therapy patterns according to their mechanism of action (MOA) in a real-world setting and to evaluate the differences in outcomes comparing different-MOA combination therapy with same-MOA combination therapy for patients with partial-onset seizure. OBJECTIVE: To compare treatment persistence and health care use with AED combinations categorized by MOA in patients with partial-onset seizures. DESIGN, SETTING, AND PARTICIPANTS: Using the Truven Health MarketScan Commercial Claims Database containing 96 million covered lives from July 1, 2004, through March 31, 2011, adults with concomitant use of 2 different AEDs and a recent partial-onset seizure diagnosis were selected. Antiepileptic drugs were categorized by MOA: sodium channel blockers (SC), gamma-aminobutyric acid analogs (G), synaptic vesicle protein 2A binding (SV2), and multiple mechanisms (M). Patients were assigned a combination category based on their concomitant AED use. MAIN OUTCOMES AND MEASURES: Treatment persistence was measured from the start of AED combination therapy until the end of the combination. Health care resource use was measured during the combination treatment duration. Multivariate analyses evaluated AED discontinuation risk and health care use according to MOA combinations. RESULTS: Distribution of 8615 selected patients by combination was 3.3% for G+G, 7.5% for G+SV2, 8.6% for G+M, 13.9% for SC+SC, 19.0% for G+SC, 21.5% for SC+M, and 26.3% for SC+SV2. The same-MOA (G+G and SC+SC) combinations had the shortest persistence (mean [SD], 344 [345] days and 513 [530] days, respectively) and greater hazard of discontinuation compared with different-MOA combinations. Patients with different-MOA G combinations had a significantly lower risk for inpatient admission (odds ratio, 0.716; 95% CI, 0.539-0.952; P = .02) compared with G+G combinations. Patients with different-MOA SC combinations had significantly lower risks for emergency department visits (odds ratio, 0.853; 95% CI, 0.742-0.980; P = .03) compared with SC+SC combinations. CONCLUSIONS AND RELEVANCE: The findings suggest that AED combinations with different MOAs have greater effectiveness as measured by treatment persistence and lower risks for hospitalization and emergency department visits. Further research is needed to more fully understand the role of the MOA in achieving optimal outcomes.

Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study.

BACKGROUND: The goal of this research was to compare the demographics, clinical characteristics and treatment patterns for newly diagnosed multiple sclerosis (MS) patients in a commercial managed care population who received disease-modifying drug (DMD) therapy versus those not receiving DMD therapy. METHODS: A retrospective cohort study using US administrative healthcare claims identified individuals newly diagnosed with MS (no prior MS diagnosis 12 months prior using ICD-9-CM 340) and ≥18 years old during 2001-2007 to characterize them based on demographics, clinical characteristics, and pharmacologic therapy for one year prior to and a minimum of one year post-index. The index date was the first MS diagnosis occurring in the study period. Follow-up of subjects was done by ICD-9-CM code identification and not by actual chart review. Multivariate analyses were conducted to adjust for confounding variables. RESULTS: Patients were followed for an average of 35.7±17.5 months after their index diagnosis. Forty-three percent (n=4,462) of incident patients received treatment with at least one of the DMDs during the post-index period. Treated patients were primarily in the younger age categories of 18-44 years of age, with DMD therapy initiated an average of 5.3±9.1 months after the index diagnosis. Once treatment was initiated, 27.7% discontinued DMD therapy after an average of 17.6±14.6 months, and 16.5% had treatment gaps in excess of 60 days. CONCLUSIONS: Nearly 60% of newly-diagnosed MS patients in this commercial managed care population remained untreated while over a quarter of treated patients stopped therapy and one-sixth experienced treatment gaps despite the risk of disease progression or a return of pre-treatment disease activity.

Real-world evaluation of health-care resource utilization and costs in employees with fibromyalgia treated with pregabalin or duloxetine.

OBJECTIVE: To evaluate changes in health-care resource use and costs after initiating pregabalin or duloxetine in employees with fibromyalgia (FM). METHODS: Employees (18 to 64 years old) with at least one claim for an FM-attributable medication within 60 days following an FM diagnosis were identified using the Thomson Reuters MarketScan(®) Commercial Database (2006 to 2008). Patients newly initiated on pregabalin were propensity score matched to patients newly initiated on duloxetine. These treatment cohorts were evaluated for changes between the 6-month pre- and post-initiation periods in health-care utilization including prescriptions, imputed medically related work loss and expenditures. Pre- to post-initiation changes were compared between pregabalin and duloxetine using a difference-in-difference approach based on univariate statistics and multivariable models. RESULTS: A total of 731 employees with FM initiated on pregabalin (89.9% female, mean age 47.1±9.7 years) were matched with 731 employees initiated on duloxetine (89.5% female, mean age 47.1±9.8 years); other demographic and clinical characteristics were also comparable between cohorts. The adjusted marginal effects were not statistically significant for pre- to post-changes in opioid utilization (P=0.856), number of FM-attributable (P=0.151) or FM-related medications (P=0.462), and all-cause (P=0.323) or FM-attributable (P=0.991) expenditures. Pregabalin was associated with a significantly lower probability of any medically related work loss of 3.2 percentage points (P=0.030) compared with duloxetine, but changes in indirect costs were not significantly different (P=0.600). CONCLUSIONS: The changes in health resource utilization and costs after initiation of pregabalin were not significantly different than the changes observed after initiation of duloxetine. These results not only demonstrate an overall similarity of resource utilization, but also suggest cost neutrality between pregabalin and duloxetine.

Evaluation of healthcare resource utilization and costs in employees with pain associated with diabetic peripheral neuropathy treated with pregabalin or duloxetine.

OBJECTIVE: To evaluate changes in healthcare resource use and costs after initiating pregabalin or duloxetine in employees with pain associated with diabetic peripheral neuropathy (pDPN). METHODS: Employees (18-64 years old) with a DPN diagnosis and at least one pDPN-related pain medication claim were identified using the MarketScan Commercial Database (2005-2008). Propensity scored matched pregabalin and duloxetine new starts were evaluated in the 6-month pre- and 6-month post-initiation periods. Study outcomes including imputed medically-related work loss, prescription and healthcare utilization, and associated expenditures were analyzed using univariate statistics and multivariate models in a difference-in-difference approach. RESULTS: A total of 473 employees in each treatment group were identified. Mean age was 53.6 (SD 7.0) years for pregabalin and 53.5 (SD 7.4) years for duloxetine. There were no pre-index differences between groups. Adjusted marginal effects were not statistically significant for pre-to-post changes in opioid utilization (p = 0.328), number of pDPN-related analgesic medications (p = 0.506), all-cause healthcare costs (p = 0.895), indirect costs (p = 0.324), or pDPN-attributable expenditures (p = 0.359). LIMITATIONS: Claims analysis is limited in accounting for all patient and plan differences, and by the reliability of medical claims for diagnosis coding. The sample size of the matched cohorts may have limited the power of the analysis to detect differences. CONCLUSIONS: There were no significant pre-to-post differences between pregabalin and duloxetine treatment groups in pDPN-related analgesic medication use, or pDPN-attributable, all-cause, and indirect expenditures.

Adherence to aldosterone-blocking agents in patients with heart failure.

The use of aldosterone blockers in the pharmacologic therapy for heart failure (HF) in patients with left ventricular systolic dysfunction has been shown to significantly reduce overall mortality, sudden cardiac death, and hospitalization. Patient adherence to polypharmaceutical regimens including aldosterone blockade and other key medication components is a concern for clinicians and their patients. A retrospective cohort study was conducted using integrated US pharmacy/medical claims covering 44.5 million lives. Inclusion criteria included the following: age at least 50 years, newly prescribed spironolactone or eplerenone from 2002 to 2006, with HF diagnosis within 12 months of prescription initiation and follow-up of at least 6 months to assess outcomes (12 months for adherence). Compliance was measured as the proportion of days covered (prescription days supply in the first year postindex for 365 days), and persistence was measured as days from the first to the last prescription. Of 388,523 patients with HF, 60,183 patients (15.5%) received an aldosterone blocker (n = 2024 for eplerenone, n = 58,159 for spironolactone), from which a newly treated subset was studied (n = 568 eplerenone, n = 11,982 spironolactone). Proportion of days covered was significantly greater for eplerenone (79% ± 42%) than for spironolactone (66% ± 42%, P < 0.01). Persistence was significantly higher for eplerenone than for spironolactone (P < 0.01) with discontinuation before 1 year at 49.5% and 73.7%, respectively. This analysis shows that a majority of patients did not receive an aldosterone blocker after HF diagnosis despite cardiovascular event risks and raises the hypothesis that eplerenone is associated with higher compliance and persistence as compared with spironolactone.

Healthcare utilization and cost effects of prior authorization for pregabalin in commercial health plans.

OBJECTIVES: To compare changes in medication use and costs over time for management of painful diabetic peripheral neuropathy (pDPN) or postherpetic neuralgia (PHN) among patients in commercial health plans requiring prior authorization (PA) for pregabalin versus patients in plans without pregabalin PA policies. STUDY DESIGN: Retrospective claims data were obtained for 2005 to 2007 from 6 health plans with pregabalin PA and 6 health plans without pregabalin PA. Differences in resource utilization and costs were compared between baseline and 1-year follow-up periods using a pre-post parallel-group design. METHODS: Adults diagnosed as having pDPN or PHN with at least 1 claim for pDPN- or PHN-specific pain medication were selected. Pharmacologic therapy, healthcare utilization, and expenditures were analyzed using bivariate statistics and generalized linear models via a difference-in-differences approach comparing cohorts year over year. RESULTS: The 2 cohorts included 2084 patients in PA plans and 1320 patients in non-PA plans. Compared with non-PA plans, plans requiring PA experienced a 5.0-percentage point lower increase in patients using pregabalin year over year (P <.001). Utilization in PA plans of other anticonvulsants was 3.7 percentage points higher (P = .03), while nonopioid analgesic use was 5.2 percentage points lower (P = .01). There were no significant differences in opioid, antidepressant, or other pDPN or PHN medication use or pDPNor PHN-related total healthcare costs. CONCLUSION: A PA policy for pregabalin was associated with lower pregabalin utilization, but there was no statistically significant effect on pDPN- or PHN-specific medication or healthcare expenditures.

Effects of a Medicaid prior authorization policy for pregabalin.

OBJECTIVE: To explore the effect of a prior authorization (PA) policy restricting access to pregabalin for the management of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) on the overall utilization of pharmacologic therapy and healthcare services among fee-for-service Medicaid plan beneficiaries. STUDY DESIGN: Retrospective claims data were obtained for 2005 and 2006 from 6 state Medicaid programs. Two states that had implemented pregabalin PAs beginning in 2006 were compared in terms of drug utilization and costs with 4 states having no such restrictions. METHODS: Patients at least 18 years old in a Medicaid fee-for-service program having a diagnosis of DPN or PHN and at least 1 claim for DPN- or PHN-specific pain medication were selected. Pharmacologic therapy, healthcare utilization, and expenditures were analyzed using bivariate statistics and generalized linear models in a difference-in-difference approach for comparing outcomes between cohorts year over year. RESULTS: The 2 cohorts included 424 patients in the restricted states and 5153 patients in the unrestricted states. Compared with the use in the unrestricted states, the probability of pregabalin use in the restricted states decreased by 4.0 percentage points (P = .02) from 2005 to 2006, while the probability of opioid use increased by 6.5 percentage points (P <.01).The DPN- or PHN-related total healthcare costs were $418 higher for the restricted states versus the unrestricted states (P <.001). CONCLUSION: Although the PA was shown to effectively control access to pregabalin, the overall effect was an increase in the use of opioids and alternative pain management therapies associated with increased disease-related healthcare costs.

Using pharmacy claims data to study adherence to glaucoma medications: methodology and findings of the Glaucoma Adherence and Persistency Study (GAPS).

PURPOSE: To develop methods for investigating adherence to glaucoma medications by using a modified claims data-based measure of adherence, validation by chart review, and patient and physician interviews. METHODS: Data from administrative claims of 13,956 subjects receiving an initial glaucoma medication, and data from overlapping samples of 300 patients' charts, 300 interviews of patients, and 103 interviews of physicians were analyzed and compared. RESULTS: The mean medication possession ratio (MPR) was 0.64 (median 0.57) for the 13,956 subjects. Although 59% potentially had an ocular hypotensive agent at 12 months, only 10% had such medication available continuously. Chart review revealed that 31% of subjects "new to therapy" in claims data had actually been previously treated; and that 90% of the 17% who had medication added to initial monotherapy were misclassified by claims-based algorithms as medication switches or no change. Twenty percent of surveyed patients received samples on a regular basis and had lower MPR than those who did not (P < 0.05). CONCLUSIONS: Large pharmacy databases offer insight into medication usage but are vulnerable to errors from sampling (since patients who receive samples will be considered to have poor adherence), misidentification of newly treated patients, and misclassification of added versus switched medications. That a large proportion of patients stop and restart medications makes MPR a robust measure of adherence over time that reflects the resumption of medication after a gap in adherence. The data confirm that adherence to treatment with glaucoma medications is poor, similar to adherence in patients with other chronic diseases.

Health care resources and costs for treating peripheral artery disease in a managed care population: results from analysis of administrative claims data.

OBJECTIVE: Peripheral arterial disease (PAD) is associated with high rates of morbidity and mortality and serves as an important marker for advanced systemic atherosclerosis accompanied by symptomatic or asymptomatic ischemia of the coronary, cerebral, and visceral vasculature. There are little published data on the use of health care resources and costs attributable to PAD. The objectives of this study were to evaluate, from a societal perspective, PAD-related health care resource utilization and to determine the total annualized costs and cost components for patients with PAD, with particular attention to the key outcomes of myocardial infarction (MI), transient ischemic attacks (TIA), stroke, and amputations. METHODS: This study examined medical, hospital and outpatient, and pharmacy claims from a large managed care database with dates of service from January 1, 1999, through August 31, 2003. Patients with PAD were identified from claims using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes (primary or secondary codes), ICD-9-CM procedure codes, current procedural terminology (CPT) codes, or by a pharmacy claim for cilostazol or pentoxifylline. The index date for each patient was the first occurrence of either a medical claim for PAD or a pharmacy claim for 1 of the 2 drugs. Patients were required to be a minimum of 18 years old with continuous plan eligibility. The prevalence of PAD in adults in a managed care setting was also determined, as were annual rates for the key outcomes of MI, TIA, stroke, and amputations. Health care resource utilization and costs were calculated for PAD patients after the index date for a period of at least 12 months per patient for medications, outpatient/physician office visits, laboratory/diagnostic procedures, emergency department visits, and hospitalization. Cost was defined as the allowed charge on each administrative claim, including the amount paid by the insurer plus the amount paid by the health plan members (copay, deductible, and coinsurance). RESULTS: Prior to application of exclusion criteria for patients aged 18 years or older and the minimum period of continuous eligibility, the overall prevalence of PAD was 1.18% of the total managed care organization population.s 6.67 million members. The PAD study cohort consisted of 30,561 patients with a mean age of 70.7 years at index. The most common comorbidities identified in the preindex period for these PAD patients included hypertension (67% of patients); metabolic disorders/hypercholesterolemia (57%); heart disease including cardiomyopathy, dysrhythmias, and heart failure (55%); and ischemic heart disease (47%). Over a mean postindex period of 25.2 months (median 23.4 months), the total mean annualized PAD-related cost was $5,955 per patient per year (PPPY). Hospitalizations accounted for the largest component cost category, averaging $4,442 PPPY or 75% of the total annualized PAD-related cost per PAD patient. PAD-related noncoronary procedures averaged $729 PPPY (12.2% of total annual PAD-related costs), and PAD-related medications (including antihypertensives and lipid-lowering therapy) totaled $610 (10.2% of total annual costs), including $313 PPPY for antihypertensives and $207 for lipid-lowering therapy. For the subgroup of 24,075 newly identified PAD patients, 8,479 (35.2%) were hospitalized during an average 25.2 months of follow-up, with the mean time to first hospitalization of 8.9 months. CONCLUSIONS: Approximately 75% of the total PAD-related patient cost in an average of 25 months of follow-up is contributed by hospital costs, and 35% of patients newly diagnosed with PAD experienced a hospitalization in a mean of 8.9 months after the index diagnosis. Based upon mean annual health and member costs of only $313 PPPY for antihypertensives and $207 for lipid-lowering therapy, drug therapy in PAD patients may be underutilized.