Cytomegalovirus related hospitalization costs among hematopoietic stem cell and solid organ transplant recipients treated with maribavir versus investigator-assigned therapy: A US-based study.

BACKGROUND: Cytomegalovirus (CMV) infections among hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients impose a significant health care resource utilization (HCRU)-related economic burden. Maribavir (MBV), a novel anti-viral therapy (AVT), approved by the United States Food and Drug Administration for post-transplant CMV infections refractory (with/without resistance) to conventional AVTs has demonstrated lower hospital length of stay (LOS) versus investigator-assigned therapy (IAT; valgancilovir, ganciclovir, foscarnet, or cidofovir) in a phase 3 trial (SOLSTICE). This study estimated the HCRU costs of MBV versus IAT. METHODS: An economic model was developed to estimate HCRU costs for patients treated with MBV or IAT. Mean per-patient-per-year (PPPY) HCRU costs were calculated using (i) annualized mean hospital LOS in SOLSTICE, and (ii) CMV-related direct costs from published literature. Probabilistic sensitivity analysis with Monte-Carlo simulations assessed model robustness. RESULTS: Of 352 randomized patients receiving MBV (n = 235) or IAT (n = 117) for 8 weeks in SOLSTICE, 40% had HSCT and 60% had SOT. Mean overall PPPY HCRU costs of overall hospital-LOS were $67,205 (95% confidence interval [CI]: $33,767, $231,275) versus $145,501 (95% CI: $62,064, $589,505) for MBV and IAT groups, respectively. Mean PPPY ICU and non-ICU stay costs were: $32,231 (95% CI: $5,248, $184,524) versus $45,307 (95% CI: $3,957, $481,740) for MBV and IAT groups, and $82,237 (95% CI: $40,397, $156,945) MBV versus $228,329 (95% CI: $94,442, $517,476) for MBV and IAT groups, respectively. MBV demonstrated cost savings in over 99.99% of simulations. CONCLUSIONS: This analysis suggests that Mean PPPY HCRU costs were 29%-64% lower with MBV versus other-AVTs.

Healthcare costs among hemophilia A patients in the United States treated with rurioctocog alfa pegol (FVIII-PEG) or antihemophilic factor (recombinant), FC fusion protein (rFVIIIFc) using real-world data.

AIMS: To compare healthcare costs in patients with non-inhibitor hemophilia A treated with Rurioctocog Alfa Pegol (FVIII-PEG) versus Antihemophilic Factor (Recombinant), FC Fusion Protein (rFVIIIFc). MATERIALS AND METHODS: Administrative claims data from the Merative MarketScan Commercial (Commerical) and Medicaid (Medicaid) databases were used for these analyses. Males with non-inhibitor hemophilia A treated with FVIII-PEG or rFVIIIFc from 1 January 2016 to 31 March 2021 were identified (earliest treatment = index). Patients were required to have continuous database enrollment for six months before and after the index date. Follow-up was variable in length until disenrollment or study end. All-cause and hemophilia-related healthcare costs were reported per-patient per month [PPPM] and the average weekly dose during follow-up was compared between treatment groups. Generalized linear regressions were used to estimate multivariable-adjusted differences in total costs and weekly dosage in the two treatment groups. RESULTS: A total of 131 FVIII-PEG (66 Commercial; 65 Medicaid) and 204 rFVIIIFc (111 Commercial; 93 Medicaid) patients were eligible. Mean age was 20.5 and 24.4 for FVIII-PEG and rFVIIIFc in Commercial and 14.9 and 17.5 for FVIII-PEG and rFVIIIFc in Medicaid. PPPM mean (standard deviations [SD]) total healthcare costs in Commercially insured patients were $35,868 [$21,717] for FVIII-PEG vs $40,424 [$25,882] for rFVIIIFc. Costs in Medicaid were $27,495 [$23,243] for FVIII-PEG vs $30,237 [$28,430] for rFVIIIFc. After adjusting for baseline characteristics, the costs for rFVIIIFc (vs FVIII-PEG) were higher by $5,215 in Commercial and $3,895 in Medicaid, but the differences were not statistically significant (p > 0.05). Similar findings were observed for hemophilia-specific healthcare costs. The adjusted mean weekly dose was 6,047 vs 4,892 IU, p = 0.21 for FVIII-PEG vs rFVIIIFc in Commercial and 5,549 vs 7,228 IU, p = 0.07 for FVIII-PEG vs rFVIIIFc in Medicaid. CONCLUSIONS: Healthcare costs and treatment dosing were similar (p > 0.05) for non-inhibitor hemophilia A patients treated with FVIII-PEG and rFVIIIFc.

Evaluation of clinical characteristics, health care resource utilization, and cost outcomes of hemophilia A carriers and noncarriers in the United States: A real-world comparative analysis.

BACKGROUND: Hemophilia A is often viewed as a male disease; females are usually considered asymptomatic hemophilia A carriers. However, hemophilia A carriers may experience mild-to-severe bleeding events. OBJECTIVE: To compare clinical characteristics, health care resource utilization, and costs incurred by hemophilia A carriers compared with a non-hemophilia A carrier female control population in the United States. METHODS: This retrospective observational cohort study used data from IBM MarketScan Commercial Claims and Encounters and Multi-State Medicaid Databases from January 1, 2016, to September 30, 2019. Patients with a hemophilia A carrier diagnosis were matched to a non-hemophilia A carrier female control group in a 1:2 ratio based on sociodemographic characteristics, pregnancy status, and insurance type. Billed annualized bleed rates, health care resource utilization, and annualized costs were evaluated. Generalized linear models compared annualized total costs in the hemophilia A carrier and control groups. RESULTS: After matching, the hemophilia A carrier group included 121 (Commercial) and 55 (Medicaid) patients, matched 1:2 in the control group. Patients in the hemophilia A carrier group (compared with the control group) had numerically higher joint-related health issues (Commercial: 11.6% vs 7.9%; Medicaid: 7.3% vs 4.5%) and lower soft-tissue disorders (Commercial: 13.2% vs 17.4%; Medicaid: 12.7% vs 14.5%). Musculoskeletal pain was higher (33.1% vs 31.0%) and lower (21.8% vs 25.5%) in the Commercial and Medicaid databases, respectively. Billed annualized bleed rates were higher in the hemophilia A carrier group (Commercial: 0.49 vs 0.33; Medicaid: 0.50 vs 0.29). Significantly more patients in the hemophilia A carrier group had minor bleeds (Commercial: 34.7% vs 22.3% [P = 0.001]; Medicaid: 43.6% vs 20.0% [P < 0.001]) and spontaneous bleeds (Commercial: 35.5% vs 21.5%; Medicaid: 47.3% vs 23.6% [P < 0.001 for both]). Outpatient visits represented the majority of health care resource utilization and were higher in the hemophilia A carrier group for all-cause and bleed-related claims; although less frequent, emergency department and inpatient visits followed a similar trend. In the Commercial and Medicaid databases, hemophilia A carriers incurred approximately 2 times higher mean (SD) all-cause health care total costs than patients in the control group (Commercial: $15,345 [21,871] vs $8,358 [11,939] per patient per year [PPPY]; Medicaid: $9,022 [19,461] vs $4,533 [9,532] PPPY). CONCLUSIONS: Hemophilia A carriers experienced more complications and incurred higher costs (resulting from more outpatient, emergency department, and inpatient visits) compared with patients in the control group. These data suggest that hemophilia A carriers have a high disease and economic burden and may benefit from early diagnosis and management to prevent long-term complications. DISCLOSURES: Dr Xing, Dr Bullano, Dr Caicedo, and Mr Farahbakhshian are employees of Takeda Pharmaceuticals U.S.A., Inc., hold Takeda stocks, and have been granted restricted stock shares; Drs Xing and Caicedo received support from Takeda Pharmaceuticals U.S.A., Inc., for travel to THSNA 2022, where the data included in this manuscript were presented. Dr Batt received consulting fees from Complete HEOR Solutions (CHEORS) LLC for the protocol development, data analysis, and interpretation of this study; she also holds stocks from Merck and Sanofi. Ms Kuharic is an employee of the University of Illinois at Chicago and has been supported by a Takeda fellowship during the execution of the study. Ms Chakladar and Ms Markan were employees of CHEORS LLC at the time of the study. CHEORS has received funding from Takeda Pharmaceuticals U.S.A., Inc., for conducting the analysis of this study. This study was funded by Takeda Pharmaceuticals U.S.A., Inc. The sponsor was involved in the study design; collection, analysis, and interpretation of data; development and review of the manuscript; and decision to submit manuscript to publication.

Real-world analysis of patients with haemophilia A and haemophilia A carriers in the United States: Demographics, clinical characteristics and costs.

INTRODUCTION: Females with haemophilia A (HA [FHAs]) and HA carriers (HACs) have an increased risk of bleeding and complications compared to the general population. AIM: To examine the characteristics, billed annualised bleed rates (ABRb ), costs and healthcare resource utilisation for males with HA (MHAs), FHAs and HACs in the United States. METHODS: Data were extracted from the IBM® MarketScan® Research Databases (Commercial and Medicaid) for claims during the index period (July 2016 to September 2018) and analysed across MHAs, FHAs and HACs. RESULTS: Dual diagnosis females (DDFs; both HA and HAC claims) were grouped as a separate cohort. MHAs were generally younger than females (all cohorts) by up to 19 years (Commercial) and 23 years (Medicaid). ABRb  >0 was more frequent in females. Factor VIII claims were higher for MHAs versus female cohorts. Joint-related health issues were reported for 24.4 and 25.6% (Commercial) and 29.3 and 26.6% (Medicaid) of MHAs and FHAs, respectively; lower rates were reported in the other two cohorts. Heavy menstrual bleeding claims occurred for approximately a fifth (Commercial) to a quarter (Medicaid) of female cohorts. All-cause emergency department and inpatient visits in FHAs and DDFs were similar to, or more frequent than, those in MHAs; bleed-related inpatient visits were infrequent. In MHAs (Commercial), mean all-cause total costs ($214,083) were higher than in FHAs ($40,388), HACs ($15,647) and DDFs ($28,320) with similar trends for Medicaid patients. CONCLUSIONS: FHAs and HACs may be undermanaged and undertreated. Further research is needed to fully understand these cohorts' bleeding rates, long-term complications and costs.

Evaluating the financial impact of utilizing recombinant porcine factor VIII or recombinant FVIIa for patients with acquired hemophilia A.

OBJECTIVE: To evaluate the financial impact of utilizing rpFVIII or rFVIIa during a hospital admission for the diagnosis of acquired hemophilia A (AHA) by reviewing the margin between the cost to the hospital for providing care and the amount the hospital is reimbursed by the Centers for Medicare & Medicaid Services (CMS) in the US. METHODS: Data source was the Medicare Limited Data Set, which contains claims for hospitalizations, charges, and amounts reimbursed by CMS. Study patients were hospitalized with AHA and treated with rpFVIII and/or rFVIIa between 1/1/2015 and 12/31/2019. CMS Fiscal Year 2020 Impact Files, with hospital-level cost-to-charge ratios (CCRs), were used to estimate hospital costs. Sensitivity analyses were conducted to estimate margins at different CCRs. RESULTS: Hospital margins were, on average, positive with use of either rpFVIII or rFVIIa (rpFVIII: $51,548.89; rFVIIa: $35,943.80). Sensitivity analysis results suggest that the use of rpFVIII is similiar, compared with rFVIIa for a large majority of hospitals. CONCLUSIONS: While there may be higher reimbursement for rpFVIII hospitalizations, this analysis suggests that the use of rpFVIII, compared to rFVIIa, may have no impact on hospital finances for the majority of hospitals, despite rpFVIII's higher per unit cost.

A real-world study comparing pre-post billed annualized bleed rates and total cost of care among non-inhibitor patients with hemophilia A switching from FVIII prophylaxis to emicizumab.

OBJECTIVE: Factor VIII (FVIII) replacement and emicizumab have demonstrated efficacy for prevention of bleeds among patients with hemophilia A (PwHA) compared to on-demand (OD) use. Evidence investigating clinical outcomes and healthcare costs of non-inhibitor PwHA switching from prophylaxis with FVIII concentrates to emicizumab has not been well-established within large real-world datasets. This study aimed to investigate billed annualized bleed rates (ABRb) and total cost of care (TCC) among non-inhibitor PwHA switching from FVIII-prophylaxis to emicizumab-prophylaxis. METHODS: This retrospective, observational study was conducted using IQVIA PharMetrics Plus, a US administrative claims database. The date of first claim for emicizumab was defined as the index date. OD patients and inhibitor patients were excluded. Bleeds were identified using a list of 535 diagnosis codes. Bayesian models were developed to estimate the probability ABRb worsens and TCC increases after switching to emicizumab. Wilcoxon rank-sum tests were used to test statistical significance of changes in ABRb and TCC after switch. RESULTS: Among the 121 identified patients, the difference in mean ABRb between FVIII-prophylaxis (0.68 [SD = 1.28]) and emicizumab (0.55 [SD = 1.48]) was insignificant (p = .142). The mean annual TCC significantly increased for patients switching from FVIII-prophylaxis ($518,151 [SD = $289,934]) to emicizumab ($652,679 [SD = $340,126]; p < .0001). The Bayesian models estimated a 21.0% probability of the ABRb worsening and a 99.9% probability of increasing TCC after switch. CONCLUSIONS: This study found that in male non-inhibitor PwHA, switching from FVIII prophylaxis to emicizumab incurs substantial cost increase with no significant benefit in ABRb. This evidence may help guide providers, payers, and patients in shared decision-making conversations around best treatment options.

The budget impact of enzyme replacement therapy in type 1 Gaucher disease in the United States.

AIM: Gaucher disease (GD) is a rare autosomal recessive condition. Type 1 GD (GD1) is the most prevalent form of GD in Western countries; enzyme replacement therapy (ERT) is a treatment option for patients with GD1. To understand the economic value of the GD1 ERT velaglucerase alfa, a budget impact model (BIM) was developed from a United States (US) payer perspective. METHODS: We estimated the budget impact of velaglucerase alfa for a 10-million-member US health plan by comparing the annual total costs of therapy between a scenario using current velaglucerase alfa uptake to a projected scenario with increased velaglucerase alfa uptake. Total drug costs for both scenarios were estimated as the sum of the product of the number of eligible patients on each treatment and the annual per-patient cost of each medication. Average per-patient costs for ERTs were calculated by adding the yearly drug acquisition, drug administration, and site-of-care markup costs. The budget impact was measured over years 1-3. RESULTS: An estimated 65 patients would receive velaglucerase alfa treatment in year 1, increasing to 90 patients by year 3. Across analyses, cost savings were realized with velaglucerase alfa compared with imiglucerase ($115,909) and taliglucerase alfa ($80,401). An annual total budget savings of $8.67 million could be realized for a hypothetical 10-million-member US health plan with increased velaglucerase alfa uptake. The per-member per-month costs decreased by $0.0241 across years 1-3. CONCLUSIONS: BIM results show that increased velaglucerase alfa uptake for GD1 treatment is cost-saving for US health plans.

Type 1 Gaucher disease (GD1) is a rare inherited condition. Long-term enzyme replacement therapy (ERT) can reverse and prevent complications. Imiglucerase, taliglucerase alfa, and velaglucerase alfa are 3 ERTs used to treat GD1. In this study, we estimated how increasing uptake of velaglucerase alfa vs. the other ERTs would impact the budget of a hypothetical US healthcare plan. The results show that increased uptake of velaglucerase alfa is cost-saving for US health plans.

Medical and cost burden of atherosclerosis among patients treated in routine clinical practice.

OBJECTIVE: This investigation estimated medical costs attributable to treatment of patients diagnosed with atherosclerosis in routine US clinical practice. METHODS: Using Medstat MarketScan claims data, direct costs of care and rates of cardiovascular (CV) events (i.e., myocardial infarction, stroke, revascularization) were examined for patients≥18 years of age with and without a diagnostic code for atherosclerosis from 1/1/2002 through 12/31/2004. Patients with an atherosclerosis ICD-9 code who had no history of CV events in the preceding 12 months (n=75,469) were evaluated. A comparison cohort (n=238,702) was matched on age, gender, geographic region, enrollment time period, and Charlson comorbidity index to estimate incremental costs attributable to atherosclerosis. Differences between patient groups were tested for CV event rates per 1,000 patients and monthly costs for 6 and 12 months before and after diagnosis. RESULTS: Patients had a mean age of 58 years, 52% men, and a comorbidity index of 0.49. Patients diagnosed with atherosclerosis had significantly higher (p<0.001) rates of CV events (240/1000) after diagnosis, compared with patients without atherosclerosis (32/1000). Mean direct cost of care for patients diagnosed with atherosclerosis was $579/month for 12 months before and $1,074/month for 12 months after diagnosis, an 85% increase. Change in mean annual costs pre/post-index date was $5,232 ($436/month) higher among patients with than those without atherosclerosis (p<0.001). LIMITATIONS: The study population was restricted to patients with diagnosed clinical atherosclerosis based on specific ICD-9 codes. Matching of the patient cohorts was based on observed characteristics and other unobserved differences may exist. CONCLUSIONS: Patients with diagnosed atherosclerosis incur significant clinical and economic burden, indicating a need for earlier diagnosis and treatment of atherosclerosis to help in reducing this burden.

Prevalence and humanistic impact of potential misdiagnosis of bipolar disorder among patients with major depressive disorder in a commercially insured population.

BACKGROUND: Patients with bipolar disorder typically present to physicians in the depressed rather than the manic or hypomanic phase of illness. Because the depressive episodes in bipolar disorder may be indistinguishable from those in major depressive disorder (MDD), misdiagnosis may occur. OBJECTIVES: To estimate from administrative claims data and a telephone survey the prevalence of potential misdiagnosis of bipolar disorder among patients with MDD and the humanistic (health-related quality of life [HRQOL] and disability) effects associated with misdiagnosis in a managed care setting. METHODS: Administrative claims data were used to identify patients with medical claims for MDD from a database of 9 million members of commercial health plans from 3 U.S. regions. The inclusion criteria were as follows: (a) adults aged 18 years or older; (b) at least 2 medical claims, including a primary or secondary diagnosis of MDD: ICD-9-CM codes 296.2x (MDD, single episode), 296.3x (MDD, recurrent episode), or 311 (depressive disorder, not classified elsewhere) during an identification period from January 1, 2000, through March 31, 2004 (study intake period); (c) at least 12 months of pre-index and 12 months of post-index plan eligibility; and (d) active enrollment through March 31, 2005. The index date was defined as the date of the first claim for MDD during the identification period. Patients with ICD-9-CM codes for bipolar disorder at any time throughout the study period (January 1, 2000, through March 31, 2005) were excluded from this cohort. This cohort was targeted for a telephone survey that was conducted from August 1 through October 30, 2006. From the telephone survey sampling frame of 5,777, a total of 1,360 interviews were completed for a response rate of 23.5%. Respondents were screened for potential bipolar disorder using the Mood Disorder Questionnaire (MDQ). The Medical Outcomes 12-Item Short Form Survey (SF-12), Version 2, a widely used and validated instrument that assesses health-related functioning, and the Sheehan Disability Scale (SDS), which measures depression-related disability, were administered to a convenience subsample of 112 survey respondents to collect HRQOL and disability information, respectively. RESULTS: Of 1,360 adult patients aged 18 years or older with a diagnosis of MDD but without a medical claim for diagnosis of bipolar disorder, 94 (6.9%) screened positive for bipolar disorder on the MDQ. More patients with a positive screen for bipolar disorder reported lifetime histories of obsessive compulsive disorder (24.5% vs. 8.2%, P<0.001), psychotic disorders or hallucinations (9.6% vs. 2.4%, P<0.001), suicidal ideation (61.7% vs. 29.4%, P<0.001), and drug abuse (34.0% vs. 11.1%, P<0.001) than did patients with a negative screen for bipolar disorder. In the subgroup of patients who completed the SF-12 and SDS, patients with a positive screen for bipolar disorder (n=33) had lower scores (i.e., greater impairment) on the social functioning, role emotional, and overall mental component summary scales of the SF-12 than did patients with a negative screen for bipolar disorder (n=79, P<0.001), but did not significantly differ on the physical component summary scale. Patients with a positive screen for bipolar disorder on the MDQ were more likely than patients who screened MDQ-negative to report severe depression-related impairment (scores of 7 and higher on the SDS scale) with work life (54.5% vs. 24.1%, respectively, P=0.002), social life (66.7% vs. 39.2%, P=0.008), and family life (66.7% vs. 34.2%, P=0.002) on the SDS. CONCLUSIONS: In this study of patients carrying medical claims for a diagnosis of MDD in their administrative claims data, approximately 7% screened positive for bipolar disorder on a validated self-report assessment instrument. Patients with MDD who screened positive for bipolar disorder reported poorer HRQOL and disability scores than did patients with MDD who screened MDQ-negative. These findings may encourage interventions for appropriate screening, diagnosis, and management of potentially misdiagnosed bipolar disorder patients.

LDL-C goal attainment among patients newly diagnosed with coronary heart disease or diabetes in a commercial HMO.

BACKGROUND: Patients beginning treatment with lipid-modifying drugs should have their serum lipid levels monitored and, if necessary, their drug therapy adjusted to reach and maintain their treatment goals. Patients with coronary heart disease or diabetes are at high risk of coronary events and are particularly important target groups for monitoring and dose adjustment of lipid-modifying drug therapy. OBJECTIVE: to determine from administrative claims the rates of lipid testing, treatment with low-density lipoprotein cholesterol (LDL-C)-lowering drug therapy, and LDL-C goal attainment defined as LDL-C < 100 mg per DL in the time period after a new diagnosis of coronary heart disease or diabetes among patients who had not previously received lipid-modifying drug therapy. METHODS: an index date was defined by a new diagnosis of coronary heart disease or diabetes between January 1, 1999 and December 31, 2000, preceded by a 12-month pre-index period without lipid-modifying drug treatment in a commercial health maintenance organization (HMO) database for the southeastern united states. coronary heart disease (CHD) was defined by a diagnosis code for myocardial infarction (International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] code 410.xx) or angina/ischemic heart disease (411.xx), or a procedural code for angioplasty (icd-9-cM 36.1x-36.3x; Current Procedural Terminology [CPT] 92980-92984, 92995-92996) or coronary artery bypass graft (icd-9-cM 36.01, 36.02, 36.05, 36.09; CPT 33510-33545). diabetes was identified either by an icd-9-cM diagnosis code 250.xx or a pharmacy claim for an antihyperglycemic medication. Patients were followed in the post-index period until loss of eligibility or a maximum of 42 months (mean = 26 months, range=12-42 months). We calculated the proportion of patients with lipids treated and at LDL-C goal (defined as V < 100 mg per DL) in months 1-6 after the index date. among those not at goal in months 1-6, we estimated the proportion treated to goal in months 7-12 and in month 7 to the end of the post-index period. Logistic regression was used to estimate the odds of goal attainment in months 7-12 and in month 7 to the end of the post-index period among patients who were not at goal in months 1-6. RESULTS: Laboratory lipid values were available for 4,676 (40.4%) of 11,552 patients who had not previously received lipid-modifying drug therapy in months 1-6 after the index date, of whom 72.7% (n = 3,400) had an LDL-C > or =100 mg per DL (63.5% for CHD and 76.7% for diabetes). Of 1,245 patients tested and treated with lipid-modifying therapy in months 1-6, 485 (39.0%) were at LDL-C goal in months 1-6 (48.2% of CHD and 28.8% of diabetes patients), and 760 (61.0%) were not at LDL-C goal (51.8% of those with CHD and 71.2% of those with diabetes). Goal attainment (cumulative) among those treated improved to 50.1% in months 7-12 and 58.4% in month 7 to the end of the post-index period. Patients not attaining goal in months 1-6, and who continued treatment in months 7-12 and month 13 to the end of the post-index period, had a 48.8% (95% confidence interval [CI], 44.0%-53.6%) predicted probability of attaining their goals. The odds of goal attainment in month 7 to the end of post-index period (among those not at goal in months 1-6) were greater for (a) age e 65 years (odds ratio [or] = 2.45, 95% CI, 1.62-3.72), (b) history of hypertension (or = 1.91, 95% CI, 1.20-3.03), (c) greater number of distinct medications (or = 1.07, 95% CI, 1.01-1.14 per additional medication), (d) months of observation post-index (or = 1.04, 95% CI = 1.01-1.08 per additional month), and (e) months supply of lipid-modifying medication (or = 1.04, 95% CI, 1.01-1.07 per additional month), and were lower for LDL-C > or = 130 mg per DL in months 1-6 (or = 0.53, 95% CI, 0.35-0.82) and a history of dyslipidemia (or = 0.54, 95% CI, 0.35-0.83). The odds of LDL-C goal attainment were not affected by diagnosis (CHD vs. diabetes), gender, statin titration (34% of patients), lipid-modifying drug switching (39% of patients), or treatment with a high-potency LDL-C-lowering drug dosage (one of sufficient strength to reduce LDL-C by > 40%). CONCLUSION: of patients receiving lipid testing and lipid drug treatment in the 6 months after an initial diagnosis of CHD or diabetes, 61% were not at the LDL-C goal of < 100 mg per DL. Among those not at LDL-C goal in the first 6 months of treatment, only about half who continued treatment subsequently attained their LDL-C goal, despite statin titration or switching of their lipid-modifying drug therapy.

Hypoglycemic events and glycosylated hemoglobin values in patients with type 2 diabetes mellitus newly initiated on insulin glargine or premixed insulin combination products.

PURPOSE: Rates of hypoglycemic events and their associated costs were compared among patients with type 2 diabetes mellitus newly initiated on insulin glargine or a premixed insulin fixed-combination product. METHODS: Patients newly initiated on insulin glargine or premixed insulin fixed-combination products (including pen delivery systems) between June 1, 2001, and February 29, 2004, were identified using an administrative claims database. Hypoglycemic events were identified from International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate analyses were performed. RESULTS: A total of 2315 patients met the inclusion criteria. Of those, 1212 received insulin glargine and 1103 received a premixed fixed-combination insulin product. The mean +/- S.D. treatment duration was 13.7 +/- 8.1 months. Patients treated with premixed insulin had a higher hypoglycemic event rate than glargine patients (13.8 versus 7.0/100 patients/year; p = 0.027), which yielded a number needed to treat of 15 patients. The mean cost per hypoglycemic event was $1049 (95% confidence interval, $426-1672). The mean annual cost of all insulin use was $46 more for the insulin glargine cohort than for those who received premixed insulin ($534 versus $488, respectively) (p < 0.05). Mean postindex insulin use was higher in patients receiving premixed insulin than in those treated with insulin glargine (48.1 versus 43.8 units per day) (p < 0.05). CONCLUSION: Patients with type 2 diabetes mellitus who were newly initiated on insulin glargine had a lower rate of hypoglycemic events compared with patients newly initiated on a premixed fixed-combination insulin product. Treatment of 15 patients with insulin glargine instead of premixed insulin for one year would avoid one hypoglycemic event per year.

Comparison of costs associated with the use of etanercept, infliximab, and adalimumab for the treatment of rheumatoid arthritis.

A retrospective study of health plan costs related to rheumatoid arthritis (RA) revealed that etanercept was associated with the lowest drug and outpatient costs to the health plan than infliximab and adalimumab. Compared with etanercept, infliximab was related to 55% higher postindex RA-related monthly total health care costs paid by the health plan, based on adjusted analyses (95% confidence interval, 1.47-1.64). Patients receiving adalimumab had 12% higher costs (95% confidence interval, 1.04-1.21). The study showed the average dispensing dose increase was greatest for infliximab (17.4%) and least for etanercept (4.1%).

Agreement between administrative claims and the medical record in identifying patients with a diagnosis of hypertension.

OBJECTIVE: This study evaluated the accuracy of 2 administrative claims-based selection rules to identify patients with hypertension (HTN) using medical records as the gold standard. RESEARCH DESIGN: The claims database consisted of inpatient, outpatient, pharmacy, and eligibility claims for members of a single insurance company from January 2000 through March 2003. Medical records were abstracted for 258 matched patient pairs selected by Rule A (at least 1 HTN-related International Classification of Diseases, 9th Revision [ICD-9] claim) and 138 pairs selected by Rule B (at least 1 HTN-related ICD-9 and at least 1 HTN prescription claim) from 31 provider sites. Sensitivity and specificity of the 2 selection rules were computed using medical chart review as the gold standard for a diagnosis of HTN. SUBJECTS: Of patients selected by Rule A, chart review identified 281 patients with and 235 patients without HTN. Of patients selected by Rule B, chart review identified 172 patients with and 104 patients without HTN. RESULTS: The sensitivity and specificity was 70.8% and 74.9% for Rule A and 76.2% and 93.3% for Rule B. The kappa score was 0.45 for Rule A and 0.65 for Rule B. CONCLUSION: To identify patients with HTN, a selection rule using both a diagnosis and prescription claim has greater sensitivity and specificity than a rule using a diagnosis claim only.

Longitudinal evaluation of health plan cost per venous thromboembolism or bleed event in patients with a prior venous thromboembolism event during hospitalization.

OBJECTIVE: To measure the per-event health plan costs for acute and follow-up treatment not directed by a clinical study protocol in a group of commercially insured patients in 2 managed care organizations following an incident hospitalization that included a diagnosis for a venous thromboembolism (VTE) event. METHODS: A cohort of patients with an incident in-hospital VTE event, consisting of deep vein thrombosis (DVT), or pulmonary embolism (PE), or both DVT + PE, was retrospectively identified from the administrative claims databases of 2 large U.S. health care plans. Inclusion criteria were (a) an inpatient VTE event between January 1, 1998, and December 31, 2000, (b) no VTE diagnosis or anticoagulation therapy 3 months prior to the incident VTE in-hospital event, (c) at least 1 anticoagulation pharmacy fill following the incident hospital VTE, and (d) continuous health plan enrollment 3 months prior to and 6 months following the incident hospital VTE event. Total costs were reported on a per-event basis and consisted of the aggregated amount paid by the health plan to the provider after subtraction of member cost-share. Costs were collected separately, first for the incident VTE event for all patients identified and second for patients who had at least 1 of the following events in the follow-up period: bleed requiring or not requiring hospitalization, a recurrent VTE event requiring hospitalization, or a recurrent VTE and bleed (VTE + bleed) event requiring hospitalization. Costs were compared between incident diagnosis groups using multivariate generalized linear model techniques. RESULTS: A total of 2,147 patients (DVT=1,499 [69.8%], PE=373 [17.4%], DVT+PE= 275 [12.8%]) were identified (mean age=61.6standard deviation [SD] 16 years; 46.3% male) and were followed for an average of 21.3 (median, 19.2) months. Disease severity was high in these patients, including 59.2% with a history of or active malignancy. The prevalence of VTE was 2.04 per 100,000 study-eligible health plan members. For the incident VTE events, average costs were 7,712+/-18,339 US dollars (median, 3,131 US dollars) per incident DVT event; 9,566+/-13,512 US dollars (median, 6,424 US dollars) per PE incident event; and 12,200+/-24,038 US dollars (median, 6,678 US dollars) per incident DVT+PE event. Warfarin treatment following the incident VTE event was administered to 97.3% of patients for an average of 6.7 (median, 5.0) months at an average cost of 19.40 US dollars per patient per month. During the average period of 21.3 months, 534 patients (24.9%) experienced an average of 1.24 bleed or recurrent VTE events per patient that required hospitalization at a mean cost of 14,975 US dollars per event or 2,101 US dollars per patient per year. For patients with a bleed in the follow-up period that required hospitalization, average costs were 12,326+/-24,448 US dollars (median, 5,736 US dollars) per recurrent VTE; 15,339+/-52,029 US dollars (median, 4,999 US dollars) per bleed; or 24,085+/-65,411 US dollars (median, 10,185 US dollars) per recurrent VTE + bleed event. During the follow-up period, a total of 612 patients (28.5%) experienced 1,489 recurrent bleed events that did not require hospitalization, at an average cost of 239+/-386 US dollars (median, 95 US dollars) per event. There were no significant differences in mean total costs for all pair-wise comparisons between the 3 incident diagnosis groups. CONCLUSIONS: Of patients who experienced a VTE event during the incident hospital stay for any diagnosis, 1 in 4 experienced an average of 1.24 bleed or recurrent VTE events that required hospitalization in the 21 months of follow-up and incurred an average health plan cost of 14,957 US dollars per event. These data may be of interest to managed care decision makers when evaluating the cost impact of new therapies or providing more comprehensive anticoagulation management services for existing therapies.

Differences in hypoglycemia event rates and associated cost-consequence in patients initiated on long-acting and intermediate-acting insulin products.

OBJECTIVE: To compare hypoglycemia event rates in patients initiated on long-acting insulin analog (glargine) or intermediate-acting insulin (NPH) and to analyze the associated cost-consequence from a managed care perspective. STUDY DESIGN: A retrospective analysis of pharmacy and medical claims and electronic laboratory result data using a southeastern United States managed care health plan. METHODS: Patients newly initiated on glargine or NPH between July 1, 2000 and August 31, 2002 were included. Hypoglycemia events were identified from medical claims by their ICD-9CM codes. Multivariable techniques were used to compare hypoglycemia event rates between cohorts. RESULTS: A total of 1434 patients were eligible (glargine = 310, NPH = 1124). The mean age was 53 years +/- 17 years and 51% of patients were male. The mean treatment duration was 8.6 months +/- 4.5 months. Multivariate analyses showed that patients in the NPH group had a higher hypoglycemia event rate than the glargine group (18.3 versus 7.3 per 100 patients per year; p = 0.009). The number needed to treat (glargine versus NPH) to avoid one hypoglycemia event per patient per year was nine patients at an A1C of 7%. The mean annual index medication cost was $47 more for glargine ($390) than for NPH ($343) per patient per year (p = 0.042). The mean cost per hypoglycemia event was $1087 (95% CI: $764-$1409). CONCLUSIONS: Patients treated with glargine had significantly lower hypoglycemia event rates compared to the NPH group. The risk difference indicated that one hypoglycemia event would be avoided for every nine patients treated with glargine instead of NPH. The cost increase associated with treating nine patients with glargine rather than NPH is less than the cost of treating one hypoglycemia event. In this population, the savings associated with reduced hypoglycemic events more than offset the increased acquisition cost associated with glargine.

Gender bias in lipid assessment and treatment following percutaneous coronary intervention.

OBJECTIVE: To identify a possible gender bias in lipid assessment and treatment of patients following percutaneous coronary intervention (PCI). METHODS: Following PCI, patients were identified from a cardiology practice database, with retrospective follow-up achieved through medical record review in a private cardiology practice and in primary care physician practices. Patients were assessed for lipid measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, and for changes in these measures. RESULTS: A total of 356 patients were identified for analysis: 221 men (62%) and 135 women (38%). Mean post-PCI follow-up was 2.2 +/- 1.6 years. Among females, 80% had lipids measured, as compared with 87% of males (P = 0.07). At pre- and post-PCI, all fractions were significantly higher (P < 0.05) in women, except pre-PCI triglycerides, which were significantly lower in women. From pre- to post-PCI, HDL-C and triglycerides improved significantly more in males, while LDL-C improved significantly more in females. Target LDL-C levels (< 100 mg/dL) were achieved in 46.4% of the overall group. There were no significant gender-related differences in the number of patients treated with dyslipidemic medications or in patients achieving an LDL-C of < 100 mg/dL (P = 0.081). CONCLUSION: Following PCI, a gender bias did not exist for lipid assessment, number of patients treated with pharmacotherapy, or achievement of target LDL-C (< 100 mg/dL). However, in terms of absolute levels achieved, women were treated less aggressively than men for all lipid fractions.

Rates of discontinuation and change of glaucoma therapy in a managed care setting.

BACKGROUND: Comparing discontinuation and change rates of glaucoma pharmacotherapies provides insight as to which agents perform more effectively. OBJECTIVE: To quantify the rates of discontinuation and change of different glaucoma therapies. METHODS: This retrospective, observational study using managed care administrative claims data included patients who were between 20 and 64 years of age and received at least 1 prescription for 1 of the following glaucoma agents as monotherapy: betaxolol, brimonidine, latanoprost, or timolol. Patients receiving any glaucoma medication during the 180 days prior to their index prescription were excluded, as were those who did not have continuous plan enrollment during this period. The primary outcome measures were the discontinuation and change (switching/adding on) of the index glaucoma medication. Rates of discontinuation and change were compared using a proportional hazard model. RESULTS: A total of 1006 patients comprised the final study population. Approximately 62% of patients discontinued their index glaucoma medication, and 18% of patients changed to a different therapy within 18 months of starting therapy. Among those discontinuing therapy, latanoprost patients remained on therapy the longest (mean: 217 days) compared to other study cohorts (range: 182 to 184 days). Compared with latanoprost, patients initiated on any of the other agents were more likely to discontinue or change therapy. CONCLUSIONS: This study indicates that latanoprost therapy results in a lower rate of discontinuation or change compared to patients started on betaxolol, brimonidine, or timolol.