Medication adherence, hospitalization, and healthcare resource utilization and costs in patients with pulmonary arterial hypertension treated with endothelin receptor antagonists or phosphodiesterase type-5 inhibitors.

Adherence to therapy for pulmonary arterial hypertension is essential to optimize patient outcomes, but data on real-world adherence to different pulmonary arterial hypertension drug classes are limited. This retrospective database analysis evaluated relationships between adherence, hospitalization, and healthcare costs in pulmonary arterial hypertension patients treated with endothelin receptor antagonists or phosphodiesterase type-5 inhibitors. From the IQVIA Adjudicated Health Plan Database, patients with pulmonary arterial hypertension were identified based on diagnostic codes and prescriptions for endothelin receptor antagonists (ambrisentan, bosentan, macitentan) or phosphodiesterase type-5 inhibitors (sildenafil, tadalafil) approved for pulmonary arterial hypertension. Patients were assigned to the class of their most recently initiated (index) pulmonary arterial hypertension therapy between 1 January 2009 and 30 June 2015. Medication adherence was measured by proportion of days covered; patients with proportion of days covered ≥80% were considered adherent. The proportion of adherent patients was higher for endothelin receptor antagonists (571/755; 75.6%) than for phosphodiesterase type-5 inhibitors (970/1578; 61.5%; P < 0.0001). In both groups, hospitalizations declined as proportion of days covered increased. Among adherent patients, those on endothelin receptor antagonists had a significantly lower hospitalization rate than those on phosphodiesterase type-5 inhibitors (23.1% versus 28.5%, P = 0. 0218), fewer hospitalizations (mean (standard deviation) 0.4 (0.8) versus 0.5 (0.9); P = 0.02), and mean hospitalization costs during the six-month post-index ($9510 versus $15,726, P = 0.0318). Increasing adherence reduced hospitalization risk more for endothelin receptor antagonists than for phosphodiesterase type-5 inhibitors (hazard ratio 0.176 versus 0.549, P = 0.001). Rates and numbers of rehospitalizations within 30 days post-discharge were similar between groups. Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs.

Estimation of Missed Statin Prescription Use in an Administrative Claims Dataset.

BACKGROUND: Nonadherence to statin medications is associated with increased risk of cardiovascular disease and poses a challenge to lipid management in patients who are at risk for atherosclerotic cardiovascular disease. Numerous studies have examined statin adherence based on administrative claims data; however, these data may underestimate statin use in patients who participate in generic drug discount programs or who have alternative coverage. OBJECTIVE: To estimate the proportion of patients with missing statin claims in a claims database and determine how missing claims affect commonly used utilization metrics. METHODS: This retrospective cohort study used pharmacy data from the PharMetrics Plus (P+) claims dataset linked to the IMS longitudinal pharmacy point-of-sale prescription database (LRx) from January 1, 2012, through December 31, 2014. Eligible patients were represented in the P+ and LRx datasets, had ≥1 claim for a statin (index claim) in either database, and had ≥ 24 months of continuous enrollment in P+. Patients were linked between P+ and LRx using a deterministic method. Duplicate claims between LRx and P+ were removed to produce a new dataset comprised of P+ claims augmented with LRx claims. Statin use was then compared between P+ and the augmented P+ dataset. Utilization metrics that were evaluated included percentage of patients with ≥ 1 missing statin claim over 12 months in P+; the number of patients misclassified as new users in P+; the number of patients misclassified as nonstatin users in P+; the change in 12-month medication possession ratio (MPR) and proportion of days covered (PDC) in P+; the comparison between P+ and LRx of classifications of statin treatment patterns (statin intensity and patients with treatment modifications); and the payment status for missing statin claims. RESULTS: Data from 965,785 patients with statin claims in P+ were analyzed (mean age 56.6 years; 57% male). In P+, 20.1% had ≥ 1 missing statin claim post-index; 13.7% were misclassified as nonstatin users; and 14.9% were misclassified as new statin users. MPR was higher in the augmented P+ dataset versus the P+ dataset alone for all patients (79.4% vs. 76.7%, P < 0.001) and new users (61.4% vs. 58.7%, P < 0.001). Similarly, mean PDC was higher in the P+ dataset augmented with LRx versus the P+ dataset alone for all patients (76.0% vs. 74.0%, P < 0.001) and new users (58.5% vs. 56.5%, P < 0.001). Most patients received moderate-intensity statins; few changes in dose, intensity, or discontinuation of statins were observed when the P+ dataset was augmented. The most common reasons for missing data were payment by an alternate third-party program (66.3%) and use of cash, coupon, or discount cards (18.7%). CONCLUSIONS: Augmenting commercial claims data with point-of-sale data provides a more accurate assessment of statin use than claims data alone. DISCLOSURES: This study was funded by Amgen, which contributed to data interpretation and manuscript preparation. Wade, Hill, and De are employees of QuintilesIMS, which received funding from Amgen for work on this study. Patel and Harrison are employees of Amgen and own Amgen stock/stock options. Study concept and design were contributed by Wade, Hill, Patel, and Harrison. De took the lead in data collection, along with the other authors, and all authors contributed to data analysis. The manuscript was written and revised by all the authors.

Synchronization of administrations of chemotherapy and erythropoiesis-stimulating agents and frequency of associated healthcare visits.

PURPOSE: The erythropoiesis-stimulating agents (ESAs), darbepoetin alfa (DA), and epoetin alfa (EA) differ with respect to dosing schedule in chemotherapy-induced anemia. DA can be administered less frequently than EA, which may increase synchronicity between chemotherapy and ESA schedules. This study compared DA and EA with respect to frequency of synchronization and frequencies of total and ESA healthcare visits in current clinical practice. METHODS: A retrospective analysis of ESA utilization during ESA episodes of care was conducted on all cancer patients identified in the SDI health oncology electronic medical records database who underwent chemotherapy and received ESA therapy from July 1, 2007 to March 31, 2010 (n = 6522 DA, n = 3,439 EA). RESULTS: The frequency of synchronization (chemotherapy and ESA therapy on the same day) was higher with DA (67 %) than EA (58 %) (p < 0.001). The odds that an ESA administration was synchronized with chemotherapy were higher with DA compared with EA (odds ratio = 1.46, 95 % CI: 1.37, 1.54). Compared with EA, DA patients had 2.3 fewer visits with an ESA administration (p < 0.001) and 3.0 fewer total visits (p < 0.001). CONCLUSIONS: Compared with patients receiving EA, DA patients were more likely to have an ESA administration on the same healthcare visit as chemotherapy and had fewer visits for any cause or for ESA administration. These results suggest that through greater synchronization of ESA and chemotherapy administrations, DA may reduce patient and practice burden and healthcare utilization.

Cost of palliative radiation to the bone for patients with bone metastases secondary to breast or prostate cancer.

BACKGROUND: To estimate the costs (paid amounts) of palliative radiation episodes of care (REOCs) to the bone for patients with bone metastases secondary to breast or prostate cancer. METHODS: Claims-linked medical records from patients at 98 cancer treatment centers in 16 US states were analyzed. Inclusion criteria included a primary neoplasm of breast or prostate cancer with a secondary neoplasm of bone metastases; ≥2 visits to ≥1 radiation center during the study period (1 July 2008 through 31 December 2009) on or after the metastatic cancer diagnosis date; radiation therapy to ≥1 bone site; and ≥1 complete REOC as evidenced by a >30-day gap pre- and post-radiation therapy. RESULTS: The total number of REOCs was 220 for 207 breast cancer patients and 233 for 213 prostate cancer patients. In the main analysis (which excluded records with unpopulated costs) the median number of fractions per a REOC for treatment of metastases was 10. Mean total radiation costs (i.e., radiation direct cost + cost of radiation-related procedures and visits) per REOC were $7457 for patients with breast cancer and $7553 for patients with prostate cancer. Results were consistent in sensitivity analyses excluding patients with unpopulated costs. CONCLUSIONS: In the US, current use of radiation therapy for bone metastases is relatively costly and the use of multi-fraction schedules remains prevalent.

Second-line treatment outcomes after first-line sunitinib therapy in metastatic renal cell carcinoma.

This study was conducted to evaluate the treatment outcomes associated with common second-line targeted therapies given after first-line sunitinib for metastatic renal cell carcinoma (mRCC). The sample comprised patients with mRCC (n = 257) who were receiving second-line everolimus, sorafenib, or temsirolimus between April 1, 2008, and February 29, 2011, after first-line sunitinib treatment. The patients were followed-up from the start of second-line treatment until treatment failure (defined as advancement to a third-line therapy or to mortality) or the last observation in the medical and pharmacy databases. Treatment failure was observed in 38.5% (n = 99) of cases: 20.2% of patients (n = 52) advanced a line of treatment; and 18.3% of patients (n = 47) died. Kaplan-Meier analysis indicated a statistical difference in time to treatment failure among the 3 second-line targeted therapies (log-rank test, P = .045). The estimated 1-year cumulative probabilities of treatment failure were 49.9% for everolimus, 68.4% for sorafenib, and 71.4% for temsirolimus. In a multivariate Cox proportional hazards model, a higher adjusted risk of treatment failure vs. everolimus was observed for both temsirolimus (hazard ratio [HR] 2.05 [95% CI, 1.26-3.35]; P = .004) and sorafenib (HR 1.77 [95% CI, 1.02-3.07]; P = .043). The results of this real-world data analysis suggest that the risk of second-line treatment failure after first-line sunitinib was significantly higher with temsirolimus and sorafenib compared with everolimus.

Clinical burden of illness in patients with neuroendocrine tumors.

OBJECTIVE: The objective of this study was to evaluate the incremental risk of morbidities affecting the cardiovascular, hepatic, gastrointestinal, skeletal, and neuropsychiatric systems in patients with neuroendocrine tumors (NETs) compared with a noncancer cohort. METHODS: In a retrospective, matched-control study using US claims databases, noncancer control subjects (n = 3524) were matched 2:1 with patients with newly diagnosed NET (n = 1762) on age, sex, region, hospital data availability, and index year. Rates of select morbidities were compared between patients with NET and control subjects. Incremental risks were analyzed using logistic regressions adjusting for baseline characteristics. RESULTS: In the first 3 years after diagnosis in patients with NET versus matched control subjects without cancer, (1) the adjusted risk of cardiovascular morbidities was higher (odds ratio [OR], 1.26; P = 0.0206); (2) the adjusted risk of hepatic or gastrointestinal morbidities was higher (OR, 1.95, P < 0.0001); (3) the adjusted risk of osteoporosis/osteopenia was higher among those 50 years or younger (OR, 3.24; P = 0.0081); and (4) the adjusted risk of anxiety/depression was higher among those 65 years or younger (OR, 1.48; P = 0.0210). CONCLUSIONS: Patients with NET have greater clinical burden of disease than matched control subjects with respect to conditions affecting the cardiovascular, hepatic, and gastrointestinal systems. Excess clinical burden of disease with respect to anxiety, depression, osteoporosis, and osteopenia was observed in patients with NET in the younger age groups.

Comparative antibiotic failure rates in the treatment of community-acquired pneumonia: Results from a claims analysis.

INTRODUCTION: Antibiotic treatment failure contributes to the economic and humanistic burdens of community-acquired pneumonia (CAP) by increasing morbidity, mortality, and healthcare costs. This study compared treatment failure rates of levofloxacin with those of other antibiotics in a large US sample. METHODS: Medical and pharmacy claims in the nationally representative SDI database were used to identify adults with a new outpatient diagnosis of CAP receiving a study antibiotic (levofloxacin, amoxicillin/clavulanate, azithromycin, moxifloxacin) between September 1, 2005 and March 31, 2008. Treatment failure was defined as ≥1 of the following events ≤30 days after index date: a refill for the index antibiotic after completed days of therapy, a different antibiotic dispensed >1 day after the index prescription, or hospitalization with a pneumonia diagnosis or emergency department visit >3 days postindex. Cohorts were propensity score matched for demographic and clinical characteristics. Treatment failure rates were compared between pairs of cohorts for the full sample and for high-risk patients (age ≥65 and/or on Medicaid). RESULTS: Among the 3994 study patients, the numbers of dispensed index prescriptions were 268 for amoxicillin/clavulanate, 1609 for azithromycin, 1460 for levofloxacin, and 657 for moxifloxacin. Unadjusted treatment failure rates for the sample were 20.8% for levofloxacin, 23.9% for amoxicillin/clavulanate, 23.9% for azithromycin, and 19.9% for moxifloxacin. For high-risk patients, unadjusted treatment failure rates were 19.1% for levofloxacin, 26.1% for amoxicillin/clavulanate, 26.3% for azithromycin, and 24.3% for moxifloxacin. Propensity score-matched treatment failure rates were significantly lower with levofloxacin than azithromycin (19.8% vs. 24.5%, odds ratio [OR] comparator vs. levofloxacin 1.38; 95% CI: 1.14, 1.67), a difference amplified in high-risk patients (19.0% vs. 26.4%, OR 1.61; 95% CI: 1.22, 2.13). No significant differences were observed for other paired comparisons. CONCLUSION: In a large US sample, treatment failure in CAP appeared to be less likely with quinolones (such as levofloxacin) than azithromycin, an effect particularly marked in high-risk patients (age ≥65 and/or on Medicaid).

Health care utilization and costs of Alzheimer's disease: the role of co-morbid conditions, disease stage, and pharmacotherapy.

BACKGROUND AND OBJECTIVES: Studies on the relationship between Alzheimer's disease (AD) and health care costs have yielded conflicting results. This study analyzed the relationship between co-morbid conditions and health care utilization and costs for patients with AD and estimated costs by stage of disease and receipt of pharmacotherapy. METHODS: We conducted a retrospective analysis of administrative data for 1,366 patients with AD and 13,660 age-gender matched controls enrolled in a large Medicare managed care organization (MCO). Co-morbid conditions were based on the diagnostic classifications from the Charlson co-morbidity index. Health care costs and utilization for MCO-covered services for cases were compared to controls. We used presence of complications of AD associated with later-stage disease to classify patients as having earlier- or later-stage AD. RESULTS: After controlling for co-morbid conditions, age, and gender, annual costs were $3,805 higher for AD patients, resulting in excess costs of $5 million to the MCO. For seven of the 10 most prevalent co-morbidities for AD patients, adjusted costs were higher for AD patients compared with controls with the same condition. Higher costs were attributable to higher inpatient and skilled nursing facility costs. Costs for patients classified as earlier-stage AD were 44% higher than controls and significantly higher for eight of 10 co-morbid conditions when compared with controls with the same conditions. Costs for AD patients receiving treatment by a cholinesterase inhibitor were $2,408 lower than AD patients not receiving therapy. CONCLUSIONS: Utilization and costs for patients with AD were higher compared to controls and were substantially higher for patients with both AD and co-morbid diseases commonly targeted for disease management. Earlier-stage AD and receipt of pharmacotherapy were associated with lower costs. These findings indicate that better treatment and care management of AD could reduce the costs of co-morbid illnesses commonly suffered by AD patients.

The effect of donepezil therapy on health costs in a Medicare managed care plan.

The objective of this study was to estimate the ramifications of donepezil use on the health care costs of a large Medicare managed care plan. Patients with a diagnosis of Alzheimer's disease or related dementia were identified from the claims-and-encounter records of the plan. Costs for 204 patients identified as having Alzheimer's disease and who were receiving donepezil were compared with a control group of 204 patients with Alzheimer's disease who had matching characteristics, but who were not receiving therapy. After controlling for age, gender, pharmacy benefits, comorbid conditions, and complications of dementia, annual costs for medical services and prescription drugs were found to be $3,891 lower for the study group. Costs were $4,192 lower for patients receiving longer-term therapy (> or = 270 day supply of donepezil) and $3,579 lower for patients receiving shorter-term therapy when compared with controls. By improving cognitive and daily functioning, donepezil may lower costs by improving medical management.