Health care resource utilization and costs among patients with spasticity or cervical dystonia.

BACKGROUND: Spasticity and cervical dystonia (CD) are movement disorders with considerable direct and indirect health care cost implications. Although several studies have discussed their clinical impact, few have calculated the economic burden of these disorders. OBJECTIVE: To assess the all-cause health care resource utilization (HCRU) and costs in adults and children with spasticity or CD. METHODS: This retrospective, observational cohort-based study was conducted using administrative insurance claims from the IQVIA PharMetrics Plus database from October 1, 2015, to December 31, 2019. Patients were selected based on International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes for first evidence of spasticity (associated with a spasticity etiology) or CD (index date) during the selection window, from April 1, 2016, through December 31, 2018. Cases were stratified into 3 mutually exclusive cohorts: adult patients with spasticity, pediatric patients with spasticity, and patients with CD; those with spasticity who had a history of stroke or cerebral palsy were also evaluated in subcohorts. Patients without evidence of spasticity or CD during the study period were identified as a matched comparator group and were randomly assigned an index date. Patients with spasticity were matched 1:1 to the comparator group based on age, sex, index year, and payer type using descriptive analyses. RESULTS: 215,739 adult patients with spasticity, 29,644 pediatric patients with spasticity, and 9,035 adult patients with CD were identified after matching. Adult patients with spasticity and CD had mean (SD) ages of 48.4 (15.6) years and 48.0 (13.1) years, respectively. Stroke was identified in 31.9% (n = 68,928) of adult patients with spasticity, and cerebral palsy was identified in 11.3% (n = 3,364) of pediatric patients with spasticity. Adult and pediatric patients with spasticity and patients with CD had significantly higher HCRU (including mean number of outpatient, emergency department, and inpatient visits and proportions of patients with prescription fills) and higher mean total health care costs per patient (adult patients with spasticity $29,912 vs $7,464; pediatric patients with spasticity $16,089 vs $2,963; and patients with CD $20,168 vs $7,141) than matched comparators (all P<0.0001). CONCLUSIONS: The management of patients with spasticity or CD results in considerably higher health care expenses. Within managed health care systems, more effective management of spasticity and CD in adult and pediatric patients represents a significant opportunity for cost savings.

Payer approval and rejection of oral anticoagulant prescriptions and prescription abandonment patterns among patients with venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) is a major public health condition that renders patients at risk of recurrent events, which significantly increases their morbidity, mortality, and health care costs. Apart from warfarin, direct oral anticoagulants, such as apixaban, dabigatran, or rivaroxaban, are approved for VTE treatment. Cardiovascular drugs are largely impacted by formulary restrictions; however, the impact on oral anticoagulants (including warfarin and direct oral anticoagulants) in VTE has not been well studied. OBJECTIVE: To describe the extent of payer-rejected claims for oral anticoagulants for VTE and the factors associated with rejected claims. Prescription abandonment of oral anticoagulants and the time to an eventual fill for oral anticoagulant after rejection or abandonment were also evaluated. METHODS: A retrospective cohort study was conducted among patients with VTE newly prescribed an oral anticoagulant (first claim was the index) between October 2016 and October 2021. Descriptive statistics were used to describe the proportion of patients with paid (ie, filled), rejected, or abandoned index oral anticoagulant prescription and journey to paid prescription among those with initial rejection. Multivariable logistic regression was used to identify factors associated with initial rejection. RESULTS: Among the overall sample (N = 297,312), 74.3% had initial oral anticoagulant prescriptions approved, 9.1% had them rejected, and 16.7% abandoned them. Of the patients with initial rejection, 82.1% eventually filled their oral anticoagulant prescriptions; however, for 14.2% of these patients, the first fill was for an oral anticoagulant other than that initially prescribed. The mean time to a first fill for an oral anticoagulant after an initial rejection was 18.3 days. More than half of the patients with an initial rejected oral anticoagulant claim had at least 1 additional rejection during the follow-up period. Of the patients who abandoned their initial oral anticoagulant prescription, 83.9% filled an oral anticoagulant prescription during follow-up; the mean time to fill for the index oral anticoagulant was 15.6 days. Oral anticoagulant type, Medicare payer coverage, prescribing physician specialty, and VTE diagnosis setting of care were significantly associated with index oral anticoagulant claim rejection (P < 0.05). CONCLUSIONS: Rejection and abandonment may delay access to oral anticoagulant treatment. Factors contributing to these scenarios should be understood and addressed for proper VTE management.

Background incidence rates of health outcomes in populations at risk for Lyme disease using US administrative claims data.

BACKGROUND: Background incidence rates (IRs) of health outcomes in Lyme disease endemic regions are useful to contextualize events reported during Lyme disease vaccine clinical trials or post-marketing. The objective of this study was to estimate and compare IRs of health outcomes in Lyme disease endemic versus non-endemic regions in the US during pre-COVID and COVID era timeframes. METHODS: IQVIA PharMetrics® Plus commercial claims database was used to estimate IRs of 64 outcomes relevant to vaccine safety monitoring in the US during January 1, 2017-December 31, 2019 and January 1, 2020-December 31, 2021. Analyses included all individuals aged ≥ 2 years with ≥ 1 year of continuous enrollment. Outcomes were defined by International Classification of Diseases Clinical Modification, 10th Revision (ICD-10-CM) diagnosis codes. IRs and 95 % confidence intervals (CIs) were calculated for each outcome and compared between endemic vs. non-endemic regions, and pre-COVID vs. COVID era using IR ratios (IRR). RESULTS: The study population included 8.7 million (M) in endemic and 27.8 M in non-endemic regions. Mean age and sex were similar in endemic and non-endemic regions. In both study periods, the IRs were statistically higher in endemic regions for anaphylaxis, meningoencephalitis, myocarditis/pericarditis, and rash (including erythema migrans) as compared with non-endemic regions. Conversely, significantly lower IRs were observed in endemic regions for acute kidney injury, disseminated intravascular coagulation, heart failure, myelitis, myopathies, and systemic lupus erythematosus in both study periods. Most outcomes were statistically less frequent during the COVID-era. CONCLUSION: This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions during pre-COVID and COVID era timeframes to inform Lyme disease vaccine safety monitoring. These regional and temporal differences in background IRs should be considered when contextualizing possible safety signals in clinical trials and post-marketing of a vaccine targeted at Lyme disease prevention.

Botulinum Toxin Utilization, Treatment Patterns, and Healthcare Costs Among Patients with Spasticity or Cervical Dystonia in the US.

INTRODUCTION: Spasticity and cervical dystonia (CD) are movement disorders with considerable direct and indirect healthcare cost implications. Although several studies have discussed their clinical impact, few have calculated the economic burden of these disorders. This study aimed to understand treatment/injection patterns of botulinum toxins type A (BoNT-As) and the characteristics, healthcare resource utilization (HCRU), and costs among patients with spasticity or CD. METHODS: Retrospective analyses were conducted using administrative healthcare claims from the IQVIA PharMetrics® Plus database, from October 1, 2015 to December 31, 2019. Eligible patients were selected based on Healthcare Common Procedure Coding System codes for BoNT-A (index date) and ICD-10 diagnosis codes for spasticity or CD with 6 months of continuous enrollment pre-index and 12 months post-index. Patients were stratified into adult spasticity, pediatric spasticity, and CD cohorts, and were evaluated for injection patterns, HCRU, and costs in the post-index period. RESULTS: Overall, 2452 adults with spasticity, 1364 pediatric patients with spasticity, and 1529 adults with CD were included. Total mean all-cause healthcare costs were US$42,562 (adult spasticity), $54,167 (pediatric spasticity), and $25,318 (CD). Differences were observed in the cost of BoNT-A injection visits between toxins, with abobotulinumtoxinA (aboBoNT-A) having the lowest injection cost across all indications. CONCLUSIONS: AboBoNT-A had the lowest injection visit costs across indications. These results are suggestive of real-world resource utilization patterns and costs, and, while helpful in informing insurers' BoNT-A management strategies, further research into cost differences is warranted.

Spasticity is an abnormal, involuntary muscle tightness due to extended muscle contraction. This resistance in movement can be caused by stroke, multiple sclerosis, or traumatic injuries to the brain or spinal cord. Cervical dystonia is a form of sustained involuntary muscle contractions that result in abnormal or repetitive muscle movements in the neck and upper shoulders. Spasticity and cervical dystonia are both associated with significant decrease in quality of life and work productivity as well as significant economic burden. It is therefore important to understand how disease management impacts these patients. Many studies have shown that botulinum toxins type A (BoNT-As) are safe and effective in reducing muscle tightness and improving normal range of motion. This study was conducted to better understand BoNT-A injection patterns, use of healthcare services, and the resulting costs in patients with spasticity or cervical dystonia.

Improved medication adherence in COPD patients using tiotropium or tiotropium olodaterol with the HealthPrize digital behavior change program.

OBJECTIVE: To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD). METHODS: In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs. RESULTS: Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs. CONCLUSIONS: Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

Risk factors for severe infections in secondary immunodeficiency: a retrospective US administrative claims study in patients with hematological malignancies.

Real-world data are lacking to identify patients with secondary immunodeficiency (SID) who may benefit most from anti-infective interventions. This retrospective analysis used the IQVIA PharMetrics® Plus database to assess baseline characteristics associated with risk of severe infections post-SID diagnosis in patients with hematological malignancies. In 4066 patients included, the mean number of any and severe infections per patient in the one-year pre-SID diagnosis period was 9.5 and 0.7, respectively. Post-SID diagnosis, the mean annualized number of any and severe infections was 19.1 and 1.5, respectively. Receiver operating characteristic curve analysis identified a threshold (cutoff) of three bacterial infections at baseline as optimally predictive of severe infections post-SID diagnosis. Multivariate analysis indicated that hospitalizations, infections (≥3), or antibiotic use pre-SID diagnosis were predictive of severe infections post-SID diagnosis. Evaluation of these risk factors could inform clinical decisions regarding which patients may benefit from prophylactic anti-infective treatment, including immunoglobulin replacement if warranted.

Comparative economic outcomes in patients with focal seizures initiating eslicarbazepine acetate versus brivaracetam in the long-term care setting in the USA.

Aim: To compare all-cause and epilepsy-specific pharmacy and total costs associated with initiation of eslicarbazepine acetate (ESL) or brivaracetam (BRV) among patients with focal seizures in long-term care (LTC) in the US. Methods: This retrospective analysis used data from IQVIA's New Data Warehouse. Results: 298 patients initiated ESL and 282 patients initiated BRV. Initiation of ESL versus BRV was associated with 33.3% lower all-cause pharmacy costs, 34.4% lower epilepsy-specific pharmacy costs, 21.3% lower all-cause total costs and 30.9% lower epilepsy-specific total costs (all p < 0.0001). Conclusion: Among patients with focal seizures in LTC in the US, initiation of ESL versus BRV was associated with significant reductions in all-cause and epilepsy-specific pharmacy and total costs compared with initiation of BRV.

Infections in secondary immunodeficiency patients treated with Privigen® or Hizentra®: a retrospective US administrative claims study in patients with hematological malignancies.

B cell-derived lymphoproliferative disorders are associated with secondary immunodeficiency (SID); some patients require immunoglobulin replacement therapy (IgRT) to mitigate infections. Using IQVIA's PharMetrics® Plus database, patients with SID who received IgPro10/IgPro20 in the 12 months post-diagnosis (IgRT users) were matched to patients with SID not receiving IgRT (non-IgRT users). The risk of severe infection was compared using within-patient change from baseline to follow-up as well as between cohorts. Overall, 277 IgRT users were matched to 1019 non-IgRT users. Before IgRT, more IgRT users experienced any bacterial infection (88.4% vs. 72.9%; p<.0001) or ≥1 severe bacterial infection (SBI) (42.2% vs. 31.8%; p=.0011) vs. non-IgRT users. During follow-up, risk of SBI among IgRT users (21.7%) reached parity with non-IgRT users (21.2%). IgRT was associated with a reduction in SBIs to levels comparable with the lower 'baseline infection risk' of non-IgRT users. These criteria help define SID patients who may benefit from IgRT.

Economic benefits of BIS-aided assessment of post-BC lymphedema in the United States.

OBJECTIVES: To estimate the economic outcomes associated with routine use of bioimpedance spectroscopy (BIS) to aid in the assessment of lymphedema following breast cancer (BC) treatment. STUDY DESIGN: Budget impact analysis for a hypothetical payer, comparing a "current standard assessment methods" scenario with a hypothetical scenario in which BIS is used routinely. METHODS: A payer-perspective decision model was built to calculate the 1-year budget impact of using either current standard methods or BISaided assessments for lymphedema in post-BC patients among a hypothetical payer population. Parameter values were obtained from the medical literature, including population characteristics, lymphedema incidence, resource utilization, and costs associated with assessments and treatment. Alternate scenario analysis incorporated incidence and associated costs of downstream infections and excess mental health care. RESULTS: With 627 BC patients in a payer of 1M covered lives, base-case analysis shows cost savings of $315,711, or $0.03 per enrolled member per month (from the payer perspective), from implementation of BIS-aided assessments for lymphedema. Savings improved with consideration of sequelae (eg, infection, hospitalization). However, savings are reduced if specificity of current standard assessments improves by 25% (fewer unnecessary expensive treatments), or if cost of complex decongestive therapy falls by 25%. Sensitivity analysis showed that cost savings results were robust to changes in other model parameters. CONCLUSIONS: Over 1 year, BIS-aided assessment of lymphedema for patients following treatment for BC results in cost savings, even without considering potential cost savings associated with averted downstream sequelae.

Hospital providers: the day after FDA approval.

Hospitals have a lot at stake when new biologic drugs and devices hit the market. Cooperation among medical and administrative leaders can help providers avoid some harrowing financial pitfalls - while improving patient satisfaction.