Real-world evidence of improved healthcare utilization in patients with schizophrenia or schizoaffective disorder after early treatment of paliperidone palmitate once-monthly treatment in Hong Kong

Background: Very few data are available to demonstrate the economic benefit of early paliperidone palmitate once-monthly long-acting injectable (PP1M) treatment in patients with schizophrenia or schizoaffective disorder.

Methods and materials: This study has retrospectively compared the healthcare utilization and associated costs of pre- and post-PPIM treatment in 413 patients with schizophrenia or schizoaffective disorder recruited from three major public hospitals providing psychiatric services in Hong Kong. Patients were categorized into early treatment (≤3 years since diagnosis) and chronic (>3 years) groups, and also whether they were receiving polypharmacy (POP).

Results: It was found that patients who were started on early therapy with no POP had the most favourable outcomes. Overall results of the entire cohort, including both early and late treatments, indicate that there was a slight increase in annual in-patient days (IP) per patient and outpatient visit (OP) by 3.18 and 1.87, respectively, and a decrease in emergency room visit (ER) of 0.9 (p?p?p?p?Conclusions: From the 413 patients studied, potential annual savings is higher by early administration of PPIM in patients with NP. Analysis using multivariate linear regression based on generalized estimating equations and sensitivity analysis using a linear mixed model supported the findings.     

Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers

Aims: To compare economic and clinical outcomes between patients undergoing laparoscopic Roux-en-Y gastric bypass (LRY) or laparoscopic sleeve gastrectomy (LSG) with use of powered vs manual endoscopic surgical staplers.

Materials and methods: Patients (aged ≥21 years) who underwent LRY or LSG during a hospital admission (January 1, 2012–September 30, 2015) were identified from the Premier Perspective Hospital Database. Use of powered vs manual staplers was identified from hospital administrative billing records. Multivariable analyses were used to compare the following outcomes between the powered and manual stapler groups, adjusting for patient and hospital characteristics and hospital-level clustering: hospital length of stay (LOS), total hospital costs, medical/surgical supply costs, room and board costs, operating room costs, operating room time, discharge status, bleeding/transfusion during the hospital admission, and 30, 60, and 90-day all-cause readmissions.

Results: The powered and manual stapler groups comprised 9,851 patients (mean age?=?44.6 years; 79.3% female) and 21,558 patients (mean age?=?45.0 years; 78.0% female), respectively. In the multivariable analyses, adjusted mean hospital LOS was 2.1 days for both the powered and manual stapler groups (p?=?.981). Adjusted mean total hospital costs ($12,415 vs $13,547, p?=?.003), adjusted mean supply costs ($4,629 vs $5,217, p?=?.011), and adjusted mean operating room costs ($4,126 vs $4,413, p?=?.009) were significantly lower in the powered vs manual stapler group. The adjusted rate of bleeding and/or transfusion during the hospital admission (2.46% vs 3.22%, p?=?.025) was significantly lower in the powered vs manual stapler group. The adjusted rates of 30, 60, and 90-day all-cause readmissions were similar between the groups (all p?>?.05). Sub-analysis by manufacturer showed similar results.

Limitations: This observational study cannot establish causal linkages.

Conclusions: In this analysis of patients who underwent LRY or LSG, the use of powered staplers was associated with better economic outcomes, and a lower rate of bleeding/transfusion vs manual staplers in the real-world setting.     

Perioperative outcomes and hospital costs associated with flowable gelatin hemostatic matrix for lumbar surgeries in real world hospital setting

Abstract

Background: Efficient hemostasis during lumbar surgery (LS) is associated with better perioperative outcomes. Flowable gelatin hemostatic matrix (FGHM) is a new type of absorbable hemostatic agent, which is effective to control bleeding during spinal surgery. This study aimed to assess the impact of FGHM on perioperative outcomes and hospital costs associated with LS.

Methods: This study retrospectively analyzed medical and billing records of patients who underwent LS for spinal degenerative disease in a Chinese tertiary care hospital from 2014 to 2016. The identified patients were further stratified into a FGHM group (n?=?108) (using the combination of FGHM and gelatin sponge) and a historical control group (using oxidized cellulose and/or collagen, n?=?82) for the adjusted comparisons of the perioperative outcomes using a propensity score matching method. Multiple generalized linear regression was conducted to assess the impact of using FGHM on total hospitalization costs.

Results: Comparisons of 64 propensity score matched pairs showed a significantly lower blood transfusion rate (34.4% vs 64.1%, p?=?0.005), lower blood transfusion volume (182.7?±?312.4 vs 301.3?±?281.0?mL, p?=?0.045), reduced post-surgery drainage tube placement rate (82.8% vs 93.8%, p?=?0.046), and shorter post-operative days on antibiotics (6.0?±?2.6 vs 7.1?±?2.4 days, p?=?0.010) in the FGHM group. Although with a relatively high acquisition price, the use of FGHM for hemostasis in LS did not increase the total hospitalization costs (coefficient = ?0.001, p?=?0.972).

Conclusions: The use of FGHM in LS improved perioperative outcomes related to hemostatic effects without increasing overall hospital costs in a real-world hospital setting.     

Treatment patterns and healthcare costs among newly-diagnosed patients with chronic myeloid leukemia receiving dasatinib or nilotinib as first-line therapy in the United States

Objective: To compare treatment patterns and economic outcomes of dasatinib and nilotinib as 1st-line therapies for chronic myeloid leukemia (CML).

Methods: Adult CML patients initiated on first-line dasatinib or nilotinib in 2010–2014 were identified from two large US administrative claims databases. Treatment patterns, tyrosine kinase inhibitor (TKI) adherence and healthcare resource utilization (HRU) and costs were measured from the 1st-line TKI initiation (index date) to the end of follow-up.

Results: A total of 604 and 418 patients were included in the dasatinib and nilotinib cohorts (mean ages = 50.9 and 52.5 years, 46.4% and 45.7% female), respectively. Among the dasatinib patients, 91% started with 100?mg/day, 3% with <100?mg/day, and 6% with >100?mg/day. Among the nilotinib patients, 76% started with 600?mg/day, 16% with >600?mg/day, and 8% <600?mg/day. The dasatinib cohort had a higher hazard of dose decrease (hazard ratio [HR]?=?1.66; p?=?.002) and of switching to another TKI (HR =1.62; p?=?.019) compared to the nilotinib cohort. The hazard of dose increase (HR =0.76; p?=?.423) and treatment discontinuation (HR =1.10; p?=?.372) were not significantly different between cohorts. There was also no significant difference in TKI adherence levels (mean proportion of days covered [PDC] difference over first 6 months = ?0.0003, p?=?.981; mean PDC difference over first 12 months = ?0.0022, p?=?.880) and HRU (inpatient day incidence rate ratio [IRR]?=?1.03, p?=?.930; emergency room IRR =1.26, p?=?.197; and days with outpatient services IRR = 1.01, p?=?.842). The dasatinib cohort incurred higher healthcare costs by $749 per patient per month (p?=?.044) compared to the nilotinib cohort.

Limitation: Information on CML phase and Sokal score was not available.

Conclusions: Dasatinib was associated with an increased hazard of dose decrease and switching to another TKI and higher healthcare costs, vs nilotinib.     

Cost minimization analysis of capecitabine versus 5-fluorouracil-based treatment for gastric cancer patients in Hong Kong

Background: EOX (epirubicin, oxaliplatin, Xeloda; capecitabine) and FOLFOX4 (5-fluorouracil (5-FU), leucovorin, oxaliplatin) are the common chemotherapy regimens used in the treatment of advanced gastric cancer (aGC) in Hong Kong. This study aimed to compare the costs of these therapies for aGC patients from both the healthcare and societal perspectives. It should be noted that, while FOLFOX4 is routinely administered in an outpatient setting in North America and Europe, inpatient setting is adopted in Hong Kong instead, incurring hospitalization cost as a result.

Methods: Fifty-eight patients were identified from the electronic records in two public tertiary hospitals, with 45 and 13 receiving EOX and FOLFOX4 regimens, respectively. Healthcare cost was direct medical costs including drugs, clinic follow-up, hospitalization, diagnostic laboratories, and radiographs. Societal cost refers to indirect costs such as patient time and travel costs. Cost items were further classified as “expected” or “unexpected”. All cost data was expressed in US dollars.

Results: Patients in the EOX and FOLFOX4 arm received an average of 5.3 and 7.8 cycles of treatment, respectively. The capecitabine-based regimen group had a higher expected medication cost per cycle when compared to the 5-FU-based treatment group (US$290.3 vs US$66.9, p?p?p?p?=?.001), respectively, in the capecitabine-based regimen group. Sensitivity analyses based on full cycle regimen costs and net capecitabine or 5-FU/leucovorin costs still showed EOX to be less costly than FOLFOX4.

Conclusion: The capecitabine-based regimen, EOX, was found to generate significant cost saving from both the healthcare and societal perspectives in regions in which FOLFOX4 is given in an inpatient setting.     

Brain metastases in non-small cell lung cancer patients on epidermal growth factor receptor tyrosine kinase inhibitors: symptom and economic burden

Objective: This study describes the symptom and economic burden associated with brain metastases (BM) in patients with non-small cell lung cancer (NSCLC) receiving epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (EGFR-TKIs).

Methods: This retrospective study included adults with ≥2 medical claims, within 90 days, for lung cancer and ≥1 administration of EGFR-TKIs. Based on ICD-9 codes, patients were stratified into cohorts by type of metastases (BM, other metastases [OM], or no metastases [NM]), and by when the metastasis diagnosis occurred (synchronous or asynchronous).

Results: The population (synchronous BM [SBM]?=?24, synchronous OM [SOM]?=?23, asynchronous BM [ASBM]?=?15, asynchronous OM [ASOM]?=?49, NM?=?85) was mostly female (57%), average age 69 years (SD?=?11). SBM patients experienced more fatigue and nausea/vomiting compared with SOM and NM patients and more headaches and loss of appetite than NM patients. ASBM was associated with more fatigue, nausea/vomiting, headaches, pain/numbness, altered mental status, and seizures than NM, and more headaches and pain/numbness than ASOM. SBM patients experienced a greater increase in per-member-per-month all-cause total healthcare costs after diagnosis ($20,301) vs SOM ($9,131, p?=?.001) and NM ($2,493, p?=?.001). ASBM’s cost increase between baseline and follow-up ($7,867) did not differ from ASOM’s ($4,947, p?=?.195); both were larger than NM ($2,493, p?=?.001 and p?=?.009, respectively).

Limitations: EGFR mutation status was inferred based on EGFR-TKI treatment, not by molecular testing. Patients were from US commercial insurance plans; results may not be generalizable to other populations.

Conclusions: Among patients with EGFR-TKI-treated NSCLC, patients with BM experienced more symptoms and, when diagnosed synchronously, had significant increases in total medical costs vs patients with OM and NM. Therapeutic options with central nervous system activity may offer advantages in symptomatology and costs in EGFR-mutated patients with BM.     

Major bleeding risk and healthcare economic outcomes of non-valvular atrial fibrillation patients newly-initiated with oral anticoagulant therapy in the real-world setting

Aims: This study compared the risk for major bleeding (MB) and healthcare economic outcomes of patients with non-valvular atrial fibrillation (NVAF) after initiating treatment with apixaban vs rivaroxaban, dabigatran, or warfarin.

Methods: NVAF patients who initiated apixaban, rivaroxaban, dabigatran, or warfarin were identified from the IMS Pharmetrics Plus database (January 1, 2013–September 30, 2015). Propensity score matching (PSM) was used to balance differences in patient characteristics between study cohorts: patients treated with apixaban vs rivaroxaban, apixaban vs dabigatran, and apixaban vs warfarin. Risk of hospitalization and healthcare costs (all-cause and MB-related) were compared between matched cohorts during the follow-up.

Results: During the follow-up, risks for all-cause (hazard ratio [HR]?=?1.44, 95% confidence interval [CI]?=?1.2–1.7) and MB-related (HR?=?1.57, 95% CI?=?1.0–2.4) hospitalizations were significantly greater for patients treated with rivaroxaban vs apixaban. Adjusted total all-cause healthcare costs were significantly lower for patients treated with apixaban vs rivaroxaban ($3,950 vs $4,333 per patient per month [PPPM], p?=?.002) and MB-related medical costs were not statistically significantly different ($100 vs $233 PPPM, p?=?.096). Risk for all-cause hospitalization (HR?=?1.98, 95% CI?=?1.6–2.4) was significantly greater for patients treated with dabigatran vs apixaban, although total all-cause healthcare costs were not statistically different. Risks for all-cause (HR?=?2.22, 95% CI?=?1.9–2.5) and MB-related (HR?=?2.05, 95% CI?=?1.4–3.0) hospitalizations were significantly greater for patients treated with warfarin vs apixaban. Total all-cause healthcare costs ($3,919 vs $4,177 PPPM, p?=?.025) and MB-related medical costs ($96 vs $212 PPPM, p?=?.026) were significantly lower for patients treated with apixaban vs warfarin.

Limitations: This retrospective database analysis does not establish causation.

Conclusions: In the real-world setting, compared with rivaroxaban and warfarin, apixaban is associated with reduced risk of hospitalization and lower healthcare costs. Compared with dabigatran, apixaban is associated with lower risk of hospitalizations.     

Comparative evaluation of treatment patterns and healthcare utilization of newly-diagnosed rheumatoid arthritis patients by anti-cyclic citrullinated peptide antibody status

Background: Anti-cyclic citrullinated peptide (CCP) antibody positivity is an established diagnostic factor for severe disease activity and joint damage and a prognostic factor for aggressive disease in rheumatoid arthritis (RA).

Objective: To compare RA-related treatment, healthcare utilization, and joint erosion between anti-CCP-positive and anti-CCP-negative RA patients.

Methods: Newly-diagnosed RA patients were identified from the Henry Ford Health System database between January 1, 2009 and December 31, 2014; the date of the first RA diagnosis within the study period was the index date. Baseline anti-CCP test was used to categorize patients as anti-CCP-positive or anti-CCP-negative, and outcomes were evaluated in the 6 months post-index.

Results: There were 217 anti-CCP-positive and 191 anti-CCP-negative RA patients included in the study. A higher proportion of anti-CCP-positive patients were initiated on RA treatment than anti-CCP-negative patients (70.5% vs 23.0%; p?<?.0001). More anti-CCP-positive patients received methotrexate (73.2% vs 56.8%; p?=?.0374), while more anti-CCP-negative patients received hydroxychloroquine (31.8% vs 13.1%; p?=?.0037) in first-line therapy. A higher proportion of anti-CCP-negative patients were tested for rheumatoid factor (RF) and erythrocyte sedimentation rate (ESR). Of those tested, there were more positive test results in the anti-CCP-positive cohort compared to the anti-CCP-negative cohort (RF: 84.4% vs 18.2%, p?<?.0001; C-reactive protein [CRP]: 69.7% vs 48.3%, p?=?.0008; and ESR: 89.5% vs 53.9%, p?<?.0001). Outpatient utilization predominated, with more anti-CCP-positive patients having any outpatient physician office visit (96.3% vs 77.5%, p?<?.0001) and a higher mean number of visits (5.3 vs 2.5, p?<?.0001) than anti-CCP-negative patients. Among anti-CCP-positive (n?=?113) and anti-CCP-negative (n?=?58) patients with imaging results, more anti-CCP-positive patients had joint erosion compared to anti-CCP-negative patients (18.6% vs 8.6%; p?=?.0858); however, statistical significance was not reached.

Conclusion: RA patients with positive anti-CCP antibodies had higher degrees of inflammation and disease activity as indicated by laboratory results, which likely contributed to their higher rates of healthcare utilization, joint erosion, and proportions of RA treatment.     

The economic burden of switching targeted disease-modifying anti-rheumatic drugs among rheumatoid arthritis patients

Aims: To estimate real world healthcare costs and resource utilization of rheumatoid arthritis (RA) patients associated with targeted disease modifying anti-rheumatic drugs (tDMARD) switching in general and switching to abatacept specifically.

Materials and methods: RA patients initiating a tDMARD were identified in IMS PharMetrics Plus health insurance claims data (2010–2016), and outcomes measured included monthly healthcare costs per patient (all-cause, RA-related) and resource utilization (inpatient stays, outpatient visits, emergency department [ED] visits). Generalized linear models were used to assess (i) average monthly costs per patient associated with tDMARD switching, and (ii) among switchers only, costs of switching to abatacept vs tumor necrosis factor inhibitors (TNFi) or other non-TNFi. Negative binomial regressions were used to determine incident rate ratios of resource utilization associated with switching to abatacept.

Results: Among 11,856 RA patients who initiated a tDMARD, 2,708 switched tDMARDs once and 814 switched twice (to a third tDMARD). Adjusted average monthly costs were higher among patients who switched to a second tDMARD vs non-switchers (all-cause: $4,785 vs $3,491, p?p?p?p?=?.021), and numerically lower all-cause costs ($4,444 vs $4,741, p?=?0.188). Switchers to TNFi relative to abatacept had more frequent inpatient stays after switch (incidence rate ratio (IRR) = 1.85, p?=?.031), and numerically higher ED visits (IRR = 1.32, p?=?.093). Outpatient visits were less frequent for TNFi switchers (IRR = 0.83, p?Limitations and conclusions: Switching to another tDMARD was associated with higher healthcare costs. Switching to abatacept, however, was associated with lower RA-related costs, fewer inpatient stays, but more frequent outpatient visits compared to switching to a TNFi.     

Healthcare resource utilization and direct costs associated with frequent nausea in episodic migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study

Abstract

Background:

Nausea is a common migraine symptom that is associated with impaired quality-of-life and functional disability. In this study, population-based data were used to elucidate the relationship between nausea frequency and headache-related healthcare utilization and costs in persons with migraine.

Research design and methods:

Participants with episodic migraine who completed the 2009 American Migraine Prevalence and Prevention (AMPP) Study survey rated their headache-related nausea as occurring never, rarely, <half the time, or ≥half the time with their headaches, and completed questions on symptom frequency and healthcare resource utilization.

Main outcomes measures:

Ordinal logistic regression models were used to assess the association between nausea frequency and headache-related healthcare utilization. Healthcare cost equivalents were calculated.

Results:

Among the 6488 respondents with episodic migraine, the number of respondents observed across headache-related nausea frequency strata were 6.9% for never, 14.5% for rarely, 29.1% for <half the time, and 49.5% for ≥half the time. In unadjusted models, the odds of having ≥1 healthcare encounter for headache in the preceding year increased with frequency of nausea for primary care/obstetrics-gynecology visits (OR?=?1.41; 95% CI?=?1.30–1.52, p?<?0.001), nurse practitioner/physician assistant visits (OR?=?1.52; 95% CI?=?1.25–1.85, p?<?0.001), neurology/headache clinic visits (OR?=?1.33, 95% CI?=?1.18–1.51, p?<?0.001), pain clinic visits (OR?=?1.31, 95% CI?=?1.01–1.71, p?<?0.05), emergency department visits (OR?=?1.85; 95% CI?=?1.56–2.19, p?<?0.01), and overnight hospital stays (OR?=?1.50, 92% CI?=?1.12–2.00, p?<?0.01). The odds of having ≥1 lifetime CT scan or MRI also increased with the frequency of nausea (p?<?0.001 for both). Results remained significant in these analyses when controlling for sociodemographics and overall symptom severity except in the case of pain clinic visits (p?<?0.107). Visits for Mental Health and visits for Chiropractic/Alternative care did not differ significantly by nausea group in unadjusted or adjusted models. Mean estimated direct headache-related healthcare cost equivalents per person per year generally increased with increasing headache-related nausea frequency across categories of healthcare utilization. Average per person healthcare cost for nausea ≥half the time vs nausea never was $179 and $49 yearly for outpatient services, $183 vs $20 yearly for overnight hospital stays, and $314 vs $257 for lifetime diagnostic services/imaging.

Conclusions:

Direct costs of migraine increase with increasing frequency of migraine-associated nausea. Both frequency and severity of headache-related nausea should be monitored as part of ongoing care of persons with migraine. Headache-related nausea, like headache pain, should be considered an area of central concern during clinical, diagnostic, and treatment optimization assessments.

Study limitations:

This study relied on self-reported headache frequency and healthcare costs which are subject to recall bias and under-reporting; however, reporting bias is unlikely to be different as a function of nausea frequency. In addition, medication use costs and indirect costs (which may be higher than direct costs for migraine) were not assessed.     

Healthcare costs of urinary tract infections and genital mycotic infections among patients with type 2 diabetes mellitus initiated on canagliflozin: a retrospective cohort study

Objective: To assess the economic impact of urinary tract infections (UTIs) and genital mycotic infections (GMIs) among patients with type 2 diabetes mellitus (T2DM) initiated on canagliflozin.

Methods: Administrative claims data from April 2013 through June 2014 MarketScan^® databases were extracted. Adults with ≥1 claim for canagliflozin, T2DM diagnosis, and ≥90 days enrollment before and after canagliflozin initiation were propensity score matched to controls with T2DM initiated on other anti-hyperglycemic agents (AHAs). UTI and GMI healthcare costs were evaluated 90-days post-index and reported as cohort means.

Results: Rates of UTI claims 90 days post-index were similar in patients receiving canagliflozin for T2DM (n?=?31,257) and matched controls (2.7% vs 2.8%, p?=?.677). More canagliflozin than control patients had GMI claims (1.2% vs 0.6%, p?p?p?=?.150). GMI treatment costs were higher for the canagliflozin cohort ($3.68 vs $2.44, p?=?.041). Combined costs to treat either UTI and/or GMI averaged $31.29 per patient for the canagliflozin cohort v $39.77 for controls (p?=?.211). Rates and costs of UTIs and GMIs were higher for females than males, but the canagliflozin vs control trends observed for the overall sample were similar for both sexes. There were no significant cost differences between the canagliflozin and control cohorts among patients aged 18–64. Among patients aged 65 and above, GMI treatment costs were not significantly different, but costs to treat UTIs and either UTI and/or GMI were significantly lower for canagliflozin patients vs controls.

Conclusions: In a real-world setting, the costs to payers of treating UTIs and GMIs are generally similar for patients with T2DM initiated on canagliflozin vs other AHAs.     

Bronchodilator reliever use and its association with the economic and humanistic burden of COPD: a propensity-matched study

Background and aims: Short-acting bronchodilators are normally used as supplemental relief medication for breakthrough symptoms in COPD patients. The objective of this cross-sectional study was to assess if more frequent vs infrequent use of relief medication in maintenance-treated COPD patients, split by the severity dyspnea, was associated with an increase in the overall disease burden.

Methods: A population-based cross-sectional survey (Adelphi DSP) was conducted among patients with COPD in five European countries. Information was collected on demographic and clinical characteristics, reliever inhaler use, dyspnea (mMRC), health status (CAT, EQ-5D), sleep quality (JSEQ) and healthcare resource use including moderate–severe COPD exacerbations, physician visits, COPD medications and other COPD related resources. The humanistic and economic burden was compared between patients with infrequent reliever use (<1 occasion/week) and more frequent use (≥ 1 occasion/week). The association between increased reliever use and economic burden was also examined after matching patients based on propensity-scores balancing demographic and disease burden characteristics.

Results: Among the 1373 COPD patients prescribed a reliever inhaler, 29% reported using reliever medication ≥1 occasion/week. In the unmatched cohort, more frequent reliever use (n?=?377) compared to infrequent use (n?=?996) was linked to poorer health status (CAT: 25.7 vs 20.0; p?p?p?p?p?=?.0001). In the propensity-score matched population, more frequent reliever use was also associated with significantly higher annual costs for COPD management (€5,034 vs €3,705, p?=?.0327) compared to patients with infrequent reliever use.

Conclusion: In moderate-to-severe COPD, more frequent reliever use is associated with increased exacerbation risk and increased management costs.     

Healthcare utilization and costs with fixed-source versus variable-source tacrolimus in patients receiving a kidney transplant

Abstract

Aims: Switching drug manufacturers in transplant patients may require an increased intensity of therapeutic monitoring, leading to additional healthcare visits, associated laboratory tests, and perhaps hospitalizations. As real-world studies examining the interchangeability of tacrolimus from different manufacturers are limited, the purpose of this study was to examine the healthcare resource utilization (HRU) and economic impact of tacrolimus-switching in kidney transplantation.

Materials and methods: This cross-sectional, retrospective study examined HRU and healthcare costs (HCCs) among patients with a kidney transplant who were prescribed tacrolimus from fixed-source (FS) vs variable-source (VS) manufacturers using claims data from the large US health plan Humana from October 1, 2012, to December 31, 2013.

Results: Overall, 1,024 patients were identified (FS: n?=?674, 66%; VS: n?=?350, 34%). The number of therapeutic drug monitoring (TDM) events for the VS group was 13% greater than for the FS group after controlling for demographics, comorbidity score, and number of medications (incidence rate ratio?=?1.13, p?=?.033). Adjusted total HCCs were 9% lower for VS (US$28,054 vs US$30,823, p?=?.045). In the unadjusted analysis, VS had greater emergency department (ED) utilization (45% vs 35%, p?<?.002). In the VS group, the mean (standard deviation [SD]) number of days from manufacturer switch to first outpatient visit was 23.8 (33.6), and the number of days (SD) to first TDM event was 43.6 (56.2).

Limitations: Study limitations include the lack of availability of many transplant-specific variables within the Humana database, potential errors/omissions in claims coding, and restriction of cross-sectional data examination to a 1-year period.

Conclusions: VS patients had greater TDM and lower total HCCs. Further research is warranted to understand the drivers of ED use among the VS group, and to determine factors associated with delayed TDM after regimen modification. Opportunities may exist to improve the quality of care for patients receiving immunosuppressant treatment with tacrolimus.     

Cost-effectiveness analysis of disease modifiying drugs (interferons and glatiramer acetate) as first line treatments in remitting-relapsing multiple sclerosis patients

Abstract

Objective:

The aim of this study was to assess cost-effectiveness of the different Disease Modifying Drugs (DMD) used as first-line treatments (interferons IM IFNβ-1a, SC IFNβ-1a, SC IFNβ-1b, and glatiramer acetate, GA) in Remitting-Relapsing Multiple Sclerosis (RRMS) in Spain.

Methods:

A Markov model was developed to simulate the progression of a cohort of patients with RRMS, during a period of 10 years. Seven health states, defined by the Expanded Disability Status Scale (EDSS), were considered in the model. Patients with an EDSS score less than 6.0 were assumed to be treated with one of the DMD. In addition, all patients were assumed to receive symptomatic treatment. The monthly transition probabilities of the model were obtained from the literature. The analysis was performed from the societal perspective, in which both direct and indirect (losses in productivity) healthcare costs (€, 2010) were included. A discount rate of 3% was applied to both costs and efficacy results.

Results:

GA was the less costly strategy (€322,510), followed by IM IFNβ-1a (€329,595), SC IFNβ-1b (€ 333,925), and SC IFNβ-1a (€348,208). IM IFNβ-1a has shown the best efficacy results, with 4.176 quality-adjusted life years (QALY), followed by SC IFNβ-1a (4.158 QALY), SC IFNβ-1b (4.157 QALY), and GA (4.117 QALY). Incremental costs per QALY gained with IM IFNβ-1a were €?1,005,194/QALY, €?223,397/QALY, and €117,914/QALY in comparison to SC IFNβ-1a, SC IFNβ-1b, and GA, respectively.

Conclusions:

First-line treatment with GA is the less costly strategy for the treatment of patients with RRMS. Treatment with IM IFNβ-1a is a dominant strategy (lower cost and higher QALY) compared with SC IFNβ-1a and SC IFNβ-1b. However, IM IFNβ-1a is not a cost-effective strategy vs GA, because incremental cost per QALY gained with IM IFNβ-1a exceeds the €30,000 per QALY threshold commonly used in Spain.

Limitations:

The highly-restrictive inclusion criteria of clinical trials limits generalization of the results on efficacy to all patients with multiple sclerosis. Availability of data for head-to-head comparisons is associated with the use of information from clinical trials.     

Outcomes of tumor necrosis factor inhibitor cycling versus switching to a disease-modifying anti-rheumatic drug with a new mechanism of action among patients with rheumatoid arthritis

Objectives: To examine treatment patterns, treatment effectiveness, and treatment costs for 1 year after patients with rheumatoid arthritis switched from a tumor necrosis factor inhibitor (TNFi) (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab), either cycling to another TNFi (“TNFi cyclers”) or switching to a new mechanism of action (abatacept, tocilizumab, or tofacitinib) (“new MOA switchers”).

Methods: This retrospective cohort study used administrative claims data for a national insurer. Treatment persistence (without switching again, restarting, or discontinuing), treatment effectiveness (defined below), and costs were assessed for the 12-month post-switch period. Patients were “effectively treated” if they satisfied all six criteria for a treatment effectiveness algorithm (high adherence, no dose increase, no new conventional synthetic disease-modifying anti-rheumatic drug, no subsequent switch in therapy, no new/increased oral glucocorticoids, and <2 glucocorticoid injections). Multivariable logistic models were used to adjust for baseline factors.

Results: The database included 581 new MOA switchers and 935 TNFi cyclers. New MOA switchers were 39% more likely than TNFi cyclers to persist after the switch (odds ratio [OR]?=?1.39; 95% confidence interval [CI]?=?1.12–1.74; p?=?.003) and 36% less likely to switch therapy again (OR?=?0.64; 95% CI?=?0.51–0.81; p?p?=?.006). New MOA switchers had 16% lower drug costs than TNFi cyclers (cost ratio?=?0.84; 95% CI?=?0.79–0.88; p?p?Limitations: Claims payments may not reflect rebates or other cost offsets. Medical and pharmacy claims do not include clinical end-points or reasons that lead to new MOA switching vs TNFi cycling.

Conclusions: These results support switching to a new MOA after a patient fails treatment with a TNFi, which is consistent with recent guidelines for the pharmacologic management of established rheumatoid arthritis.     

Cost comparison of four revascularisation procedures for the treatment of multivessel coronary artery disease

Objective: An economic evaluation was performed, using modelling techniques, to compare 1-year total costs of four revascularisation procedures in patients with multivessel disease: on-pump coronary artery bypass grafting (CABG); off-pump CABG; percutaneous coronary intervention (PCI) with bare-metal stents (BMS); and PCI with drug-eluting stents (DES).

Methods: Clinical data were derived from four randomised clinical trials comparing CABG versus PCI, as well as from literature reviews. Resource use and unit cost estimates were modelled to reflect current Canadian practice.

Results: This study demonstrated that 1 year after the initial revascularisation, PCI with BMS is the least costly procedure, followed by off-pump CABG, PCI with DES and on-pump CABG. DES became the most costly procedure if 3.5 or more DES were used or if staged PCI was performed.