Immune checkpoint inhibitors: immune-related adverse events, healthcare utilization, and costs among commercial and Medicare Advantage patients.

BACKGROUND: Immune checkpoint inhibitors (ICI) are increasingly used across multiple cancer types and stages and little is known about real-world outcomes. This study sought to determine healthcare utilization, costs, immune-related adverse events (irAEs), and all-cause mortality of single-agent versus combination ICI in the USA. MATERIALS AND METHODS: This is a retrospective study conducted with 2016-2018 data from the HealthCore Integrated Research Database, consisting of commercial and Medicare-insured adult patients with a cancer diagnosis using ICI in the USA. Outcomes were healthcare utilization, costs, and irAEs (FDA-recognized and others) up to 1-year post-index between patients using ICI monotherapy (mono, PD-1/PD-L1 inhibitor) and combination therapy (combo, PD-1/PD-L1 with CTLA-4 inhibitors). RESULTS: In total, 9084 patients received monotherapy and 904 patients received combo therapy. Mean age 65 years for mono and 58 years for combo. Overall, the combo arm had higher rates of FDA-recognized irAEs (67.4% vs. 45.9%), especially endocrinopathies (27.7% vs 14.7%) and dermatitis (25.9% vs. 12.4%). All-cause mortality over 1-year follow-up was similar, 30.7% in mono vs 30.8% in combo arms. The combo group had higher rates of all-cause inpatient hospitalizations (55.4% mono vs 65.6% combo) and emergency department (ED) visits (33.7% mono vs 41.4% combo). IrAE-related hospitalizations were higher in combo (55.2% vs 42.1%). IrAE-related ED visits were 15.7% mono vs 22.7% combo. This increased toxicity and health care utilization was reflected in significant differences in healthcare costs. Stark differences were seen in all-cause medical costs as well as costs related to inpatient and ED utilization and costs attributed to irAEs. CONCLUSIONS: Higher rates of irAEs, healthcare utilization, and costs occur with combination immunotherapy. As further indications are approved for combination ICI, our study highlights the real-world tradeoffs involved with combination therapy regarding burdens of toxicity and increased healthcare utilization.

The Association Between Mammography Screening Frequency and Breast Cancer Treatment and Outcomes: A Retrospective Cohort Study.

OBJECTIVE: Guidelines for optimal frequency of screening mammography vary by professional society. Sparse evidence exists on the association between screening frequency and breast cancer treatment options. The main objective was to examine differences in cancer treatment rendered for U.S. women with different numbers of screenings prior to breast cancer diagnosis. Cancer stage at diagnosis and health care cost were assessed in secondary analyses. METHODS: This IRB-exempt retrospective study used administrative claims data to identify women aged 44 or older with various numbers of mammographic screenings ≥11 months apart, during the four years prior to incident breast cancer diagnosis from January 2010 to December 2018. Outcomes were assessed over the six months following diagnosis. Generalized linear regression models were used to compare women with differing numbers of mammograms, adjusting for patient characteristics. RESULTS: Claims data review identified 25 492 women who met inclusion criteria. There was a stepwise improvement in each of these screening categories such that women with four screenings, compared to women with only one screening, experienced higher rates of lumpectomy (70% vs 55%) and radiation therapy (48% vs 36%), lower rates of mastectomy (27% vs 34%) and chemotherapy (28% vs 36%), less stage 3 or 4 cancer at diagnosis (15% vs 29%), and lower health care costs within six months postdiagnosis (P < 0.001). Results were similar in a subgroup limited to women aged 44 to 49 at diagnosis. CONCLUSION: Potential benefits of more frequent screening include less aggressive treatment and lower health care costs among women who develop breast cancer.

Trends in Medically Integrated Dispensing Among Oncology Practices.

PURPOSE: The integration of pharmacies with oncology practices-known as medically integrated dispensing or in-office dispensing-could improve care coordination but may incentivize overprescribing or inappropriate prescribing. Because little is known about this emerging phenomenon, we analyzed historical trends in medically integrated dispensing. METHODS: Annual IQVIA data on oncologists were linked to 2010-2019 National Council for Prescription Drug Programs pharmacy data; data on commercially insured patients diagnosed with any of six common cancer types; and summary data on providers' Medicare billing. We calculated the national prevalence of medically integrated dispensing among community and hospital-based oncologists. We also analyzed the characteristics of the oncologists and patients affected by this care model. RESULTS: Between 2010 and 2019, the percentage of oncologists in practices with medically integrated dispensing increased from 12.8% to 32.1%. The share of community oncologists in dispensing practices increased from 7.6% to 28.3%, whereas the share of hospital-based oncologists in dispensing practices increased from 18.3% to 33.4%. Rates of medically integrated dispensing varied considerably across states. Oncologists who dispensed had higher patient volumes (P < .001) and a smaller share of Medicare beneficiaries (P < .001) than physicians who did not dispense. Patients treated by dispensing oncologists had higher risk and comorbidity scores (P < .001) and lived in areas with a higher % Black population (P < .001) than patients treated by nondispensing oncologists. CONCLUSION: Medically integrated dispensing has increased significantly among oncology practices over the past 10 years. The reach, clinical impact, and economic implications of medically integrated dispensing should be evaluated on an ongoing basis.

Clopidogrel use and clinical events after drug-eluting stent implantation: findings from the HealthCore Integrated Research Database.

BACKGROUND: Relationships between long-term use and level of dual antiplatelet therapy and outcomes after drug-eluting stent implantation are not well established. METHODS: This is a retrospective cohort study of 9,256 patients receiving drug-eluting stents between January 2003 and August 2006. We classified patients according to tertiles of clopidogrel use during the 12 months after stent implantation. We used inverse probability weighting to account for differential selection into levels of clopidogrel use and logistic regression to estimate propensity scores for levels of clopidogrel use. We used Cox proportional hazards models to estimate effects of level of clopidogrel use on risk of bleeding events, death, and death or nonfatal myocardial infarction. RESULTS: There were 3,102 patients in the high-use group, 3,069 in the medium-use group, and 3,085 in the low-use group. Compared with the high-use group, risk of death or nonfatal myocardial infarction was greater in the medium-use group (hazard ratio [HR] 1.46, 95% CI 1.09-1.99, P = .01) and the low-use group (HR 1.59, 95% CI 1.18-2.14, P = .002). The risk of bleeding events was lower in the medium-use group (HR 0.84, 95% CI 0.71-0.98, P = .03) and the low-use group (HR 0.77, 95% CI 0.65-0.90, P = .002). CONCLUSIONS: Higher clopidogrel use 12 months after drug-eluting stent implantation was associated with a greater risk of subsequent bleeding events. Lower use was associated with a greater risk of death or nonfatal myocardial infarction.

Use of Optimal Evidence-Based Anticancer Drug Regimens in Physician Offices Versus Hospital Outpatient Facilities.

PURPOSE: Cancer care has increasingly shifted from physician offices (MDOs) to hospital-based outpatient departments (HOPDs). This study compared the proportion of patients receiving optimal, evidence-based anticancer drug regimens and the cost of care when administered in these sites. METHODS: Patients with breast, lung, or colorectal cancer were identified from a large health insurance database. Anticancer drug regimens were considered on pathway when they were on the payer's program list of optimal regimens when administered. Anticancer drug-related costs included all patient- and plan-paid costs on claims for anticancer drugs over the 6-month postindex period; total per-patient costs were summed over all claims in that period. RESULTS: A total of 38,140 patients (MDO, n = 18,998; HOPD, n = 19,142) were included. On-pathway status was similar in HOPDs (59.5%; 95% CI, 58.6% to 60.4%) versus MDOs (60.8%; 95% CI, 59.8% to 61.8%; P = .069). HOPDs had substantially higher costs. Adjusted cancer drug-related costs were $63,763 (95% CI, $62,301 to $65,224) for HOPDs versus $36,500 (95% CI, $35,729 to $37,271) for MDOs (P < .001); adjusted total costs were $115,843 (95% CI, $113,642 to $118,044) for HOPDs versus $77,346 (95% CI, $76,072 to $78,620) for MDOs (P < .001). For Medicare Advantage, adjusted total costs were $61,812 for HOPDs compared with $62,769 for MDOs; adjusted drug-related costs were $31,610 for HOPDs compared with $33,168 for MDOs. For commercial insurance, total costs were $119,288 for HOPDs compared with $77,613 for MDOs; drug-related costs were $65,930 for HOPDs compared with $36,366 for MDOs. CONCLUSION: Total and cancer drug-related per-patient costs were higher in HOPDs versus MDOs, but on-pathway status was similar. The cost differential between HOPDs and MDOs was driven by commercially insured members rather than Medicare Advantage members.

Association of Utilization Management Policy With Uptake of Hypofractionated Radiotherapy Among Patients With Early-Stage Breast Cancer.

Importance: Breast cancer accounts for the largest portion of cancer-related spending in the United States. Although hypofractionated radiotherapy after breast-conserving surgery is a cost-effective and convenient treatment strategy for patients with early-stage breast cancer, less than 40% of eligible women received hypofractionated radiotherapy in 2013. Objective: To assess the association of a large commercial payer's utilization management policy with the use of hypofractionated radiotherapy among women with early-stage breast cancer and its associated cost. Design, Setting, and Participants: A retrospective, adjusted difference-in-differences economic analysis was conducted using administrative claims data from January 1, 2012, to June 1, 2018, of women 18 years or older with early-stage breast cancer who were eligible for hypofractionated radiotherapy according to 2011 guidelines from the American Society for Radiation Oncology and were continuously enrolled in 14 geographically diverse commercial health plans covering 6.9% of US adult women. Women who received mastectomy, brachytherapy, or less than 11 or more than 40 external beam fractions of radiotherapy were excluded. A utilization management policy was used to encourage the use of hypofractionated radiotherapy among women in fully insured and Medicare Advantage (fully insured) plans. Under the new policy, claims for extended-course radiotherapy were not reimbursed for fully insured women who were eligible for hypofractionated radiotherapy. This policy did not apply to women in self-insured or Medicare supplemental insurance (self-insured) plans, allowing these groups to serve as a comparison group. Main Outcomes and Measures: The primary outcome was use of hypofractionated radiotherapy, and the secondary outcome was the cost of this type of radiotherapy. Results: Of 10 540 eligible women, 3619 (34.3%) were in fully insured plans and thus subject to the policy. There were no meaningful differences between the fully insured and self-insured groups in mean (SD) age at the start of radiotherapy (63.8 [8.6] vs 65.0 [8.9] years), mean (SD) Charlson Comorbidity Index score (3.0 [1.5] vs 3.2 [1.6]), or practice setting (outpatient hospital setting, 2982 of 3619 [82.4%] vs 5600 of 6921 [80.9%]). The policy was associated with an increase in use of hypofractionated radiotherapy among fully insured patients subject to the policy (adjusted percentage point difference-in-difference, 4.2%; 95% CI, 0.0%-8.4%; P = .05) and a nonsignificant decrease in radiotherapy-associated expenditures (-$2275 relative to self-insured patients; P = .09). Spillover analyses revealed a significantly higher uptake of hypofractionated radiotherapy among self-insured patients who were indirectly exposed to the policy (adjusted percentage point difference-in-difference, 8.5%; 95% CI, 3.6%-13.5%; P < .001) compared with those who were not exposed. Conclusions and Relevance: This study suggests that a payer's utilization management policy was associated with direct and spillover increases in the use of hypofractionated radiotherapy, even after accounting for a long-term secular trend in the uptake of hypofractionated radiotherapy in the control groups. Utilization management may promote evidence-based cancer care.

HER2 testing and subsequent trastuzumab treatment for breast cancer in a managed care environment.

BACKGROUND: Degree of physician adherence to 2001 guidelines recommending routine testing of human epidermal growth factor receptor 2 (HER2) status among newly diagnosed, recurrent, and metastatic breast cancer (BC) cases, and frequency of trastuzumab use in HER2-positive patients are not well documented. METHODS: Patients newly diagnosed with BC managed by an identifiable hematologist/oncologist between June 1, 2005 and June 30, 2006 were identified from an administrative claims database of three health plans (n = 3,521). From these, a subset of 380 patients was identified for medical chart review. HER2 testing (occurrence, type of test used), HER2 status (positive, negative, unknown), and trastuzumab usage were evaluated. RESULTS: HER2 testing occurred in 88% of all newly diagnosed patients with BC and in 98.1% of those with stage 1 or higher breast cancer (n = 322), for whom testing is recommended. Among those with HER2 testing performed (n = 335), 21.5% were positive (HER2(+)), 77.3% were negative (HER2(-)), and 1.2% were unknown. Of the 52 patients who used trastuzumab, only one patient did not have documented HER2 overexpression. Of the 45 HER2(+) women who had stage 2 or higher BC, 13% did not receive trastuzumab. CONCLUSIONS: HER2 testing status was extremely high among newly diagnosed BC patients treated by hematologists/oncologists in a managed care environment. There was almost no evidence of inappropriate prescribing of trastuzumab, but 1 of every 7.5 patients with HER2-overexpressing stage 2 or higher breast cancer did not receive the agent.

Length of hospitalization and mortality for bleeding during treatment with warfarin, dabigatran, or rivaroxaban.

BACKGROUND: Different outcomes among patients hospitalized for bleeding after starting anticoagulation could influence choice of anticoagulant. We compared length of hospitalization, proportion of Intensive Care Unit (ICU) admissions, ICU length of stay, and 30- and 90-day mortality for adults with atrial fibrillation hospitalized for bleeding after starting warfarin, dabigatran, or rivaroxaban. METHODS: An US commercial database of 38 million members from 1 November 2010 to 31 March 2014 was used to examine adults with atrial fibrillation hospitalized for bleeding after starting warfarin (2,446), dabigatran (442), or rivaroxaban (256). Outcomes included difference in mean total length of hospitalization, proportion of ICU admissions, mean length of ICU stay, and all-cause 30- and 90-day mortality. RESULTS: Warfarin users were older and had more comorbidities. Multivariable regression modeling with propensity score weighting showed warfarin users were hospitalized 2.0 days longer (95% CI 1.8-2.3; p < 0.001) than dabigatran users and 2.6 days longer (95% CI 2.4-2.9; p < 0.001) than rivaroxaban users. Dabigatran users were hospitalized 0.6 days longer (95% CI 0.2-1.0; p = 0.001) than rivaroxaban users. There were no differences in the proportion of ICU admissions. Among ICU admissions, warfarin users stayed 3.0 days (95% CI 1.9-3.9; p < 0.001) longer than dabigatran users and 2.4 days longer (95% CI 0.9-3.7; p = 0.003) than rivaroxaban users. There was no difference in ICU stay between dabigatran and rivaroxaban users. There were no differences in 30- and 90-day all-cause mortality. CONCLUSIONS: Rivaroxaban and dabigatran were associated with shorter hospitalizations; however, there were no differences in 30- and 90-day mortality. These findings suggest bleeding associated with the newer agents is not more dangerous than bleeding associated with warfarin.

Clinical characteristics, patterns of lipid-lowering medication use, and health care resource utilization and costs among patients with atherosclerotic cardiovascular disease.

PURPOSE: The aim of this study was to investigate real-world patient characteristics, medication use, and health care resource utilization (HCRU) and costs among patients with clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, to examine burden of disease and unmet needs, such as potential undertreatment. PATIENTS AND METHODS: This retrospective cohort study utilized a nationally representative managed care database to identify newly diagnosed ASCVD patients between January 1, 2007, and November 30, 2012 (index = first ASCVD diagnosis date) in the USA. Patients had ≥12-month pre-index (baseline) and ≥12-month post-index (follow-up) health plan enrollment and no baseline lipid-lowering medication (LLM). Patient characteristics, LLM utilization patterns, HCRU, and costs were examined for all patients and by subgroups based on LLM use pattern and/or follow-up low-density lipoprotein cholesterol (LDL-C) levels. RESULTS: A total of 128,017 ASCVD patients were identified with a mean (SD) age of 59 (13) years, 43.1% female, and 48.8% with ≥36-month follow-up. Within 12-month follow-up, 10.6% had high-intensity statins and 56.9% had no LLM fills. Baseline mean (SD) all-cause costs were $8,852 ($25,608). At 12-month follow-up, mean (SD) all-cause and ASCVD-related costs were $31,443 ($54,040) and $20,289 ($45,159), respectively. The 36-month analyses showed similar distributions. Multivariable analyses showed that age, gender, region, health insurance type, baseline comorbidities, baseline use of specific medications, baseline lipid profiles, and index ASCVD type were significantly associated with all-cause and ASCVD-related health care costs. CONCLUSION: Patients have nonoptimal treatment for ASCVD and substantial HCRU and costs associated with residual risk. Unmet needs and cost burdens of ASCVD patients merit additional investigation.

Proton pump inhibitor utilization patterns in infants.

OBJECTIVE: Practice patterns regarding pediatric gastroesophageal reflux disease include acid suppression for infants meeting certain clinical criteria. This study aimed to examine the use of proton pump inhibitors (PPI) in infants and neonates. PATIENTS AND METHODS: This retrospective observational study used data from 1999 to 2004 from 4 health care plans in the United States. Infants age <12 months with at least 1 pharmacy claim for a PPI were identified. Demographic information and PPI utilization patterns were assessed. Medical charts were reviewed in a subset of patients to gather dosing information. RESULTS: Identified infants (N = 2469) were 58% male. PPI use rose 4-fold from 2000 to 2003; lansoprazole and omeprazole were almost exclusively used. Treatment for almost half of the patients was initiated by their fourth month of life. The most common diagnoses identified through medical claims included gastroesophageal reflux (59%), problems feeding (23%), upper respiratory infections (23%), esophagitis (21%), and pain from gas (20%). Preindex H2 blockade was evident in 58% of the patients; preindex metoclopramide was used in 38% of the patients. Longer duration of PPI therapy was associated with patients who had more comorbidities. Through chart review of 388 patients, a subset of 272 patients with dosing information revealed that a median daily dosage in patients receiving lansoprazole was 1.74 mg . kg . day compared with 1.21 mg . kg . day for omeprazole. CONCLUSIONS: PPI use in the study population increased steadily from 1999 to 2004. These data offer valuable information on current PPI dosing patterns that may be used to design future clinical trials for assessment of gastroesophageal reflux disease regimens and clinical outcomes in the infant population.

Major Bleeding Risk During Anticoagulation with Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients with Nonvalvular Atrial Fibrillation.

BACKGROUND: The use of non-vitamin K oral anticoagulants (NOACs) has increased steadily following marketing approval; however, their relative safety in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice remains unclear. OBJECTIVE: To compare the risk of major bleeding during anticoagulation therapy between warfarin and NOACs. METHODS: This retrospective cohort study analyzed administrative claims data on new NVAF users of warfarin, dabigatran, apixaban, or rivaroxaban in routine clinical care from November 2010 to February 2015 in a commercially insured population in the United States. The primary outcome was time to first major bleeding event requiring hospitalization. Patients were followed until discontinuation or switch of anticoagulants, health plan disenrollment, death, or end of study. All patient characteristics were balanced after propensity score inverse probability of treatment (IPT) weighting. Event rates by type of anticoagulant exposure were compared using IPT-weighted Cox proportional hazards models. RESULTS: The study cohort comprised 44,057 patients who used warfarin (n = 23,431), dabigatran (n = 8,539), apixaban (n = 3,689), and rivaroxaban (n = 8,398). Overall mean (SD) age was 70 (12) years, and 41% of the patients were women. A total of 2,337 major bleeding events occurred during 36,636.2 person-years of follow-up. The unadjusted rate of major bleeding with warfarin was 6.0 per 100 person-years versus 2.8 with dabigatran, 3.3 with apixban, and 5.0 with rivaroxaban. Relative to warfarin, major bleeding risk was lower with dabigatran (HR = 0.67, 95% CI = 0.60-0.76) and apixaban (HR = 0.52, 95% CI = 0.41-0.67). Compared with rivaroxaban, major bleeding risk was also lower with dabigatran (HR = 0.67, 95% CI = 0.58-0.78) and apixaban (HR = 0.52, 95% CI = 0.40-0.68). Major bleeding risk was similar for rivaroxaban and warfarin. Relative to apixaban, dabigatran was associated with a significantly higher risk of major gastrointestinal bleeding (HR = 1.43, 95% CI = 1.09-1.88). CONCLUSIONS: Study results were consistent with safety findings from pivotal clinical trials comparing NOACs with warfarin and added the perspective of a large real-world observational study that compared bleeding risks associated with NOACs during anticoagulation therapy. Apixaban and dabigatran were associated with lower major bleeding risk compared with warfarin or rivaroxaban; however, apixaban had a lower risk of major gastrointestinal bleeding than dabigatran. These findings can help inform the choice of an optimal agent, which must balance effectiveness and bleeding risk in complex patients. DISCLOSURES: This study was funded by Anthem. Adeboyeje, Sylwestrzak, and Barron are employees of HealthCore, a wholly owned and independently operated subsidiary of Anthem. White, Rosenberg, Abarca, and Crawford are employees of Anthem. Study concept and design were primarily contributed by Adeboyeje and Sylwestrzak, along with the other authors. Adeboyeje took the lead in data collection, along with Sylwestrzak and Barron. Data interpretation was performed primarily by Rosenberg, Crawford, and Redberg, with assistance from the other authors. The manuscript was written by all the authors and revised primarily by White, Abarca, and Redberg, along with the other authors.

A validation of clinical data captured from a novel Cancer Care Quality Program directly integrated with administrative claims data.

BACKGROUND: Data from a Cancer Care Quality Program are directly integrated with administrative claims data to provide a level of clinical detail not available in claims-based studies, and referred to as the HealthCore Integrated Research Environment (HIRE)-Oncology data. This study evaluated the validity of the HIRE-Oncology data compared with medical records of breast, lung, and colorectal cancer patients. METHODS: Data elements included cancer type, stage, histology (lung only), and biomarkers. A sample of 300 breast, 200 lung, and 200 colorectal cancer patients within the HIRE-Oncology data were identified for medical record review. Statistical measures of validity (agreement, positive predictive value [PPV], negative predictive value [NPV], sensitivity, specificity) were used to compare clinical information between data sources, with medical record data considered the gold standard. RESULTS: All 300 breast cancer records reviewed were confirmed breast cancer, while 197 lung and 197 colorectal records were confirmed (PPV =0.99 for each). The agreement of disease stage was 85% for breast, 90% for lung, and 94% for colorectal cancer. The agreement of lung cancer histology (small cell vs non-small cell) was 97%. Agreement of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2 status biomarkers in breast cancer was 92%, 97%, and 92%, respectively; epidermal growth factor receptor and anaplastic lymphoma kinase agreement in lung was 97% and 92%, respectively; and agreement of KRAS status in colorectal cancer was 95%. Measures of PPV, NPV, sensitivity, and specificity showed similarly strong evidence of validity. CONCLUSION: Good agreement between the HIRE-Oncology data and medical records supports the validity of these data for research.

Risk of Neutropenia-Related Hospitalization in Patients Who Received Colony-Stimulating Factors With Chemotherapy for Breast Cancer.

Purpose To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization. Patients and Methods We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used. Results A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated. Conclusion Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.

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.

Analysis of healthcare utilization patterns and adherence in patients receiving typical and atypical antipsychotic medications.

OBJECTIVE: To examine the effects of typical and atypical antipsychotics on medication adherence and healthcare resource utilization. RESEARCH DESIGN AND METHODS: This was a retrospective observational cohort analysis of pharmacy and medical health insurance reimbursement data of patients from a southeastern United States health plan. Pharmacy data of subjects between 6 and 65 years of age were identified. Inclusion criteria included initiation of a single antipsychotic agent between July 1, 1999 and September 30, 2000; no antipsychotic medication usage 6 months prior to the index prescription date; and continuous health plan enrollment for the 18-month study period. Multivariable methods were utilized to analyze healthcare resource utilizations between groups. OUTCOME MEASURES: Primary outcome measures included: (1) adherence and persistence with antipsychotic therapy; (2) healthcare utilization for outpatient office and hospital visits, inpatient hospital visits, and emergency room visits; and (3) therapy modifications and concomitant medications. RESULTS: A total of 469 patients met initial study criteria. Atypical and typical antipsychotics were prescribed to 384 and 85 patients, respectively. Length of therapy (days) for the atypical cohort was significantly longer (136 vs 80; p < 0.001). As defined using medication possession ratio (MPR), the atypical cohort was significantly more adherent to therapy than the typical cohort (mean MPR, 0.53 vs 0.24; p < 0.001). After adjusting for differences in demographics, baseline utilization, MPR, and length of therapy (n = 377), the atypical cohort experienced significantly fewer office visits (2,635 vs 4,249 per 1000 patients per month [P1000PPM]; p = 0.005), fewer inpatient admissions (197 vs 511 P1000PPM; p = 0.032), and fewer emergency room visits (125 vs 354 P1000PPM; p = 0.002). CONCLUSIONS: Atypical antipsychotic users were significantly more adherent to therapy, and had lower rates of office, hospital and emergency room utilization. Within the context of inherent limitations associated with health insurance claims databases, this study suggests that a relationship exists across cohorts between medication adherence and use of healthcare resources.

Quality of care and attributable healthcare costs in diabetic hypertensive patients initiated on calcium antagonist therapy.

BACKGROUND AND OBJECTIVE: Calcium antagonists (CAs) from two classes - dihydropyridine and non-dihydropyridine (DCAs and NDCAs, respectively) - are important add-on agents in goal blood pressure (BP) attainment. This study compared drug regimens to which DCAs or NDCAs had been added; for each class, BP reduction and healthcare costs were evaluated in a diabetic hypertensive population. DESIGN, SETTING AND PATIENTS: This was a retrospective observational study using administrative claims data within two US health plans. Patients with diabetes mellitus (DM) and hypertension initiated on CA therapy between 1 January 2000 through 30 June 2002 were identified; the date the first CA prescription (CA-Rx) was filled in this period was labelled the index date. Inclusion required plan enrolment for 6 months pre- and 1 year post-index, no CA-Rx 6 months pre-index, and medication possession ratio >50% for 1 year post-index. Patients fell into either dihydropyridine or non-dihydropyridine study groups. MAIN OUTCOME MEASURES AND RESULTS: For each group, costs (amounts allowed by plans, in US dollars; actual costs for 2000-2002) were calculated for resources attributable to DM/hypertension. A total of 5551 patients met eligibility criteria (NDCA = 1515; DCA = 4036). Most had been taking other antihypertensive medications: 86% and 76% in the DCA and NDCA groups, respectively. The NDCA group had lower annual attributable costs than the DCA group ($US1637 [95% CI $US1479, $US1813] vs $US1989 [95% CI $US1823, $US2170]; p < 0.004). A total of 313 medical charts were reviewed (DCA = 242, NDCA = 71). Both groups had similar pre-and post-index BP values; mean changes in systolic and diastolic BP were not statistically significant between groups. Only 22% of all patients attained the recommended systolic/diastolic BP goal of <130/80mm Hg, and <45% of patients were tested for proteinuria during the study period. CONCLUSIONS: Patients initiated on an NDCA attained similar BP reductions compared with DCA at lower total healthcare costs. Opportunities exist for more aggressive management of BP and testing for proteinuria in DM patients with hypertension.

Impact of medical homes on quality, healthcare utilization, and costs.

OBJECTIVES: To assess baseline quality metrics, healthcare utilization, and costs of commercially insured patients treated at practices participating in a patient-centered medical home (PCMH) pilot. STUDY DESIGN: Observational cohort study utilizing claims data for patients treated at PCMH and non-PCMH practices. METHODS: Data from Empire Blue Cross and Blue Shield, 1 of 14 plans in the HealthCore Integrated Research Database, were queried for patients identified based on visits to PCMH and non-PCMH practices during 2007-2008; outcome metrics were formulated from the baseline calendar year, 2009. Differences in healthcare utilization were determined with x(2) and 2-sample t tests. Regression models were used to test differences in adjusted emergency department (ED) use, inpatient services, and costs. RESULTS: The study included 31,032 PCMH and 350,015 non-PCMH patients. Among PCMH-treated patients, diabetics had higher rates of glycated hemoglobin testing; cardiovascular disease patients had higher rates of testing and better low-density lipoprotein cholesterol control; imaging rates for low back pain were lower; among pediatric patients, inappropriate antibiotic use for nonspecific or viral respiratory infections was lower. PCMH-treated adults and children had 12% and 23% lower odds of hospitalization, and required 11% and 17% fewer ED services, respectively, than non-PCMH patients. Risk-adjusted total per member per month costs were 8.6% and 14.5% lower for PCMH-treated pediatric and adult patients, respectively (P <.01). CONCLUSIONS: PCMH practices in this pilot were associated with better preventive health, higher levels of disease management, and lower resource utilization and costs in 2009 compared with practices not pursuing PCMH status.

Assessing the economic burden of breast cancer in a US managed care population.

BACKGROUND: Breast cancer is the most commonly diagnosed non-skin cancer and second leading cause of cancer deaths among women in the US. This study compared healthcare resource utilization and costs in women with breast cancer to a control group in a managed care population. MATERIAL AND METHODS: Women >or= 18 years with breast cancer were identified using ICD-9 codes from claims databases of five US health plans during 2004. A randomly matched control group of women without cancer served as a comparator group. Healthcare costs included all medical and pharmacy costs during the year. Comparisons were made using per patient per month (PPPM) costs (total costs per patient within 2004 calendar year/months of eligibility). RESULTS: 10,697 women (mean age 55 years) with breast cancer were identified (prevalence of 250 per 100,000) in 2004, with prevalence increasing with age. Mean attributable PPPM costs associated with breast cancer were $2,896 (median = $1,940) with hospitalization contributing most of the costs ($1,340), followed by pharmacotherapy ($537), and surgical intervention ($470). Mean unadjusted all-cause PPPM total costs were $4,421 (median = $2,964) compared to $3,352 (median = $665) p < 0.0001) for cases and controls respectively. Multivariate analyses controlling for differences in comorbidities showed mean adjusted PPPM costs to be 2.28 times (p < 0.0001) higher than non-breast cancer controls. DISCUSSION: This study demonstrated that breast cancer treatment was associated with substantial healthcare costs, driven mainly by hospitalizations. Projected annual costs for a breast cancer patient would be at least $12,828 higher than that for women without breast cancer based upon unadjusted cost differences.