Post-index Period Research Articles

Disease Burden and Treatment Patterns Among US Patients with Hidradenitis Suppurativa: A Retrospective Cohort Study.

Hidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval. This non-interventional, retrospective cohort study involved adult (≥18 years) and adolescent (12-17 years) patients diagnosed with HS in the United States (US) using Optum's de-identified Clinformatics® Data Mart Database during the period 1 January 2016 to 31 December 2018. Of 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patientsaged <12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6%; adolescents: 39.6%) or dermatologist (adults: 22.1%; adolescents: 30.6%). Commonly reported Charlson comorbidities at pre-index in adult patients were diabetes without complications (20.4%), chronic pulmonary disease (16.4%) and diabetes with complications (9.0%), and the most frequent Elixhauser comorbidities were uncomplicated hypertension (38.3%), obesity (22.5%), uncomplicated diabetes (19.0%) and depression (17.4%). The burden of comorbidities generally increased over time after diagnosis in both adults and adolescents. HS-related surgical procedures were uncommon in the 2-yearspost-index period: an incision and drainage procedure was reported in 7.6% of adults and 6.4% of adolescents. Patients were predominantly treated with both topical and systemic antibiotic treatments (adults: 25.0% and 65.1%, respectively; adolescents: 41.7% and 74.5%, respectively). Biologic prescription was higher in adults than adolescents (3.5% vs. 1.8%). Total healthcare costs for adult and adolescent patients in the 2-years post-index period were US$42,143 and US$16,057, respectively, with outpatient costs accounting for the majority of these costs (US$20,980 and US$8408, respectively). In adult and adolescent patients with HS, comorbidity burden continues to increase after diagnosis. All-cause and HS-specific HCRU and costs are high in adults and adolescents with HS. These findings support the need for a multidisciplinary comprehensive care strategy for patients with HS.

Factors influencing prescribing the first add-on disease-modifying antirheumatic drugs in patients initiating methotrexate for rheumatoid arthritis

BackgroundAdvances in Disease-Modifying Antirheumatic Drugs (DMARDs) have expanded the treatment landscape for Rheumatoid Arthritis (RA). Guidelines recommend adding either conventional synthetic (cs), biologic (b), or targeted synthetic (ts) DMARDs to methotrexate (MTX) for managing RA. Limited evidence exists regarding the factors that contribute to adding a DMARD agent to the MTX regimen. This study examined the factors associated with adding the first DMARD in RA patients initiating MTX. MethodsThis retrospective cohort study utilized the MarketScan data (2012–2014) involving adults (aged ≥18) with RA initiating an MTX (index date) between Jul 1, 2012 and Dec 30, 2013, and with continuous enrollment for the 6-month pre-index period. The combination therapy users received the first treatment addition of DMARD starting from day 30 after the index MTX over one year period. The study focused on the addition of csDMARDs, Tumor Necrosis Factor Inhibitors (TNFi) bDMARDs, non-TNFi bDMARDs, or tsDMARDs. Baseline covariates were measured in the 6-month pre-index and grouped into predisposing, enabling, and need factors, as per the Andersen Behavior Model. Multivariable logistic regression examined the factors associated with the addition of TNFi compared to adding a csDMARD. An additional regression model evaluated the factors associated with adding any biologic (combining TNFi and non-TNFi biologics). ResultsAmong 8350 RA patients starting MTX, 31.92% (n = 2665) initiated any DMARD within the 1-year post-index period. Among RA patients initiating a DMARD prescription after starting MTX, 945 (11.32%) received combination therapy with treatment addition of a DMARD to MTX regimen; majority added TNFi (550, 58%), followed by csDMARD (352, 37%); non-TNF biologic (40, 4%), or tsDMARD (3, 0.3%). The tsDMARD group was limited and was not included for further analysis. The multivariable model found Preferred Provider Organization insurance coverage (odds ratio [OR], 1.43; 95% confidence interval (CI), 1.06–1.93), chronic pulmonary disease (OR, 1.98; 95% CI, 1.14–3.44), liver disease (OR, 5.24; 95% CI, 1.77–15.49), and Elixhauser score (OR, 0.91; 95% CI, 0.86–0.97) were significantly associated with the addition of TNF-α inhibitors. The separate multivariable model additionally found that patients from metropolitan areas (OR, 1.50; 95% CI, 1.04–2.16) were positively associated with adding any biological agent. ConclusionsTNFi are often added to MTX for managing RA. Enabling and need factors contribute to the prescribing of a TNFi add-on therapy in RA. Future research should examine the impact of these combination therapies on RA management.

A Real-World Evaluation of Primary Medication Nonadherence in Patients with Nonvalvular Atrial Fibrillation Prescribed Oral Anticoagulants in the United States.

Nonadherence to oral anticoagulants (OACs) is a challenge to stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data on primary medication nonadherence (PMN) in NVAF are lacking. Our aim was to assess the rates and predictors of PMN among NVAF patients who were newly prescribed an OAC. This was a retrospective database analysis of linked healthcare claims and electronic health record data. Adult NVAF patients with a prescription order for an OAC (apixaban, rivaroxaban, dabigatran, or warfarin) between January 2016 and June 2019 were identified (date of first prescription order = index date). Patients had a 1-year baseline and a 6-month post-index period to assess the rates of PMN, defined as having a prescription order but no paid claim for any OAC on or within 30 days after the index date. Sensitivity analyses explored 60-, 90- and 180-day PMN thresholds. Logistic regression models were used to examine the predictors of PMN. Among 20,393 patients, the overall 30-day PMN rate was 28.4%; PMN rates decreased to 17% with a 180-day threshold. PMN was numerically lowest for warfarin among OACs and numerically lowest for apixaban among direct OACs. A CHA2DS2-VASc score of ≥ 3, commercial insurance, and African American race were associated with higher odds of PMN. More than one-quarter of patients experienced PMN within 30 days of their initial prescription order. This rate decreased over a longer period, suggesting a delay in fills. Understanding the factors associated with PMN is warranted to develop effective interventions for improving OAC treatment rates in NVAF.

Healthcare utilization and direct medical costs of Huntington’s disease among Medicaid beneficiaries in the United States

AimsTo provide more recent estimates of healthcare utilization and costs in Huntington’s disease (HD) in the Medicaid population.Materials and MethodsThis retrospective analysis used administrative claims data for HD beneficiaries (≥1 HD claim; ICD-9-CM 333.4) from Medicaid Analytic eXtract data files from 1 January 2010–31 December 2014. The date of the first HD claim during the identification period (1 January 2011–31 December 2013) was assigned as the index date. If a beneficiary had multiple HD claims during the identification period, one was randomly chosen as the index date. Beneficiaries were required to be continuously enrolled in fee-for-service plans during the 1-year pre-index and post-index periods. Medicaid beneficiaries without HD were drawn from a 100% random sample and matched (3:1) to those with HD. Beneficiaries were classified by disease stage (early/middle/late). All-cause and HD-related (any utilization related to HD diagnosis or symptoms associated with HD) healthcare utilization and costs were reported.ResultsA total of 1,785 beneficiaries without HD were matched to 595 beneficiaries with HD (139 early-, 78 middle-, and 378 late-stage). The mean (SD) annual total costs were higher for beneficiaries with HD than beneficiaries without HD ($73,087 [$75,140] vs. $26,834 [$47,659], p <.001) and driven by inpatient costs ($45,190 [$48,185] vs. $13,808 [$39,596], p <.001). Total healthcare costs were highest among beneficiaries with late-stage HD (mean [SD] cost: $22,797 [$31,683] for early-stage HD vs. $55,294 [$129,290] for middle-stage HD vs. $95,251 [$60,197] for late-stage HD; p <.001).LimitationsAdministrative claims are intended for billing purposes and subject to coding errors. This study did not address functional status, which may provide further insight to late-stage and end-of-life burden of HD, and indirect costs.ConclusionsMedicaid beneficiaries with HD have higher acute healthcare utilization and costs compared to beneficiaries without HD, which tend to increase with disease progression, indicating that HD beneficiaries at later disease stages have greater burden.

Real-world healthcare resource utilization amongst non-small cell lung cancer (NSCLC) patients tested with a host immune classifier (HIC).

e21210 Background: The HIC is a blood-based proteomic test that measures immune response in patients with NSCLC. The test stratifies patients into two groups, HIC-H and HIC-C which helps evaluate patient prognosis and response to treatment. While clinical validity of the HIC test has been published, no real-world studies have described healthcare resource utilization (HCRU) amongst patients who have been tested with the HIC. This claims analysis describes HCRU amongst patients with NSCLC tested with the HIC. Methods: MarketScan Commercial and Medicare Supplemental Databases linked to Biodesix data files of HIC test results were retrospectively queried to identify patients who were age 18 and older on index date (date of HIC testing), underwent a HIC proteomic test, were continuously enrolled in the MarketScan database for the 6-months before index (pre-index period) and one month post-index, and had at least one non-diagnostic medical claim of lung cancer during the pre-index period. Data utilized was between January 1, 2016 to June 30, 2021. HCRU was measured per patient per month (PPPM) during the pre-index and post-index period and compared between HIC-H and HIC-C cohorts. Results: Of the 328 included patients, 260 patients were HIC-H and 68 were HIC-C. On index, 178 patients had non-metastatic lung cancer and 150 patients had metastatic lung cancer. When examining HCRU in all patients prior to the HIC test, significantly more HIC-C patients had an outpatient visit with an oncologist (40% vs 27%, P &lt; 0.05) or a primary care physician (71% vs 56%, P &lt; 0.05). When assessing only patients with metastatic lung cancer prior to index, significantly more HIC-C patients had inpatient admissions (57% vs 37%, P &lt; 0.05) and more outpatient visits with a primary care physician (73% vs 50%, P &lt; 0.05). When examining HCRU in patients after the HIC test, metastatic patients had significantly more prescriptions (4.6 vs 3.6, P &lt; 0.05). Metastatic HIC-H patients also had significantly more visits to the emergency room (64% vs 43%, P &lt; 0.05). Conclusions: Patients who are identified as HIC-C tend to have higher HCRU earlier in their lung cancer diagnosis and treatment course (prior to HIC testing). In the post-index period, metastatic HIC-H patients had higher HCRU with respect to prescriptions and emergency visits. Other post-index HCRU metrics such as primary care utilization and inpatient admissions were similar among HIC-C and HIC-H patients. Earlier identification of HIC-C and HIC-H patients may help identify those most likely to benefit from additional health system navigation support.

Real-world healthcare costs amongst non-small cell lung cancer (NSCLC) patients tested with a host immune classifier (HIC).

e21187 Background: The HIC is a proteomic test that measures immune response in patients diagnosed with NSCLC. The blood based HIC stratifies patients into two groups, HIC-H and HIC-C which helps evaluate the patient’s prognosis and response to treatment. Currently, no real-world studies have described healthcare costs amongst patients tested with the HIC. This subset analysis of HIC claims examined costs among patients with NSCLC prior to and after using the HIC proteomic test. Methods: HIC test results were retrospectively queried using MarketScan Commercial and Medicare Supplemental Databases using data between January 1, 2016 to June 30, 2021 linked to Biodesix data files. Patients were included if they were age 18 and older on index date (date of HIC testing), underwent a HIC proteomic test, were continuously enrolled in the MarketScan database for the 6-months before index (pre-index period) and one month post-index, and had at least one non-diagnostic medical claim of lung cancer during the pre-index period. Healthcare costs were measured per patient per month (PPPM) during the pre-index and post-index period and compared between HIC-H and HIC-C cohorts. All-cause healthcare costs analyzed included inpatient costs, outpatient costs, outpatient pharmacy costs, total medical costs (inpatient + outpatient), and total costs (total medical + outpatient pharmacy). Results: Of the 328 included patients, 260 patients were HIC-H and 68 were HIC-C. On index, 178 patients had non-metastatic lung cancer and 150 patients had metastatic lung cancer. When examining healthcare costs prior to HIC testing, total costs and inpatient costs were higher amongst HIC-C patients ($10,299 vs $9,689 and $4,032 vs $3,218, respectively) although not statistically significant. HIC-C patients had significantly higher biopsy costs compared to HIC-H patients ($1,285 vs $400, P &lt; 0.05) even though less HIC-C patients underwent a lung biopsy (41% vs 53%, P = 0.091). When assessing healthcare costs post HIC testing, total medical costs were significantly higher in the HIC-C patients ($25,255 vs $17,210, P &lt; 0.05). Although not statistically significant, HIC-C patients had higher inpatient costs and total costs ($9,903 vs $5,583 and $26,237 vs $18,652, respectively). Amongst the patients had significantly higher inpatient costs ($18,580 vs $4,278, P &lt; 0.05), total medical costs ($29,574 vs $12,446, P &lt; 0.05) and total costs ($31,316 vs $13,500, P &lt; 0.05). Conclusions: Patients with NSCLC who are identified as HIC-C have higher healthcare costs, including lung cancer diagnostic and total costs, prior to and post HIC testing. Utilization of the HIC test may help to identify patients who may benefit from additional health system navigation support to mitigate their anticipated increased health care costs.

Healthcare resource use for pediatric low-grade glioma care: A cohort of linked electronic health records and claims data.

10038 Background: Pediatric low-grade glioma (pLGG) is the most common brain tumor in children and is associated with persistent long-term tumor- and treatment-related morbidities. This study aims to characterize the costs associated with the treatment of pLGG. Methods: A retrospective study using the Optum de-identified Market Clarity Dataset linked claims (commercial, Medicare Advantage and Managed Medicaid beneficiaries) and electronic health records (EHRs) of cases ≤18 years of age, with an ICD-10 code for brain neoplasm and ≥1 physician notes between January 2017 and June 2018 was performed. Index date was the first claim or EHR with an ICD-10 code for brain neoplasm. Natural language processing was used to identify pLGG-relevant data from physician notes. The observation period included 3 months prior to index date and 6-month segments from index date for 36 months. Cases had either continuous insurance coverage or continuous EHR activity during this period. Results for procedures and medication use were reported as averages throughout the 36-month post-index follow-up period. Results: A total of 154 patients with pLGG were identified. Median age was 11 years (range 2–18). Among the cohort, 49% (n=76) were female; 75% (n=116) were non-Hispanic white, 13% (n=20) Hispanic, 5% (n=7) African American, 1% (n=1) Asian and 6% (n=10) other/unknown. Of benefits, 56% had commercial and 44% Medicaid. Brain imaging and neuropsychological evaluations were performed at least once in 85% and 57% of the cohort, respectively. Among pLGG relevant medications, 57% of the cohort used analgesics, 45% anti-emetics, 32% anxiolytics, and 29% anticonvulsants. A total of 100 patients received ≥1 pLGG disease control treatments: Of these, 53% underwent emergency brain surgery, 24% had planned brain surgery, 14% received chemotherapy, and 6% received targeted therapy. Of the 100 patients who received disease control treatments, 57% relapsed after first-line treatment; 37% of patients received 2 lines of therapy, and 20% of patients received ≥3 lines of therapy. Conclusions: Our findings show that patients with pLGG often require long-term medical care and high levels of healthcare resources to treat their disease and its sequalae. Additionally, a majority will relapse and face a higher burden of disease. Further studies using integrated data sources are warranted to help us understand the burden of pLGG and inform evidence-based health care planning for these patients.

EE213 Long COVID-19 Associated with 5-Fold Increase in Total Medical Costs and Greater Use of Inpatient and Outpatient Services Compared to Non-Long COVID-19: An Analysis of Real-World Data

Assess real-world evidence data on the prevalence and impact of long COVID (LC) to establish a baseline for the value of potential therapeutic interventions. This study was a retrospective, longitudinal analysis of administrative claims from multiple payer channels spanning 4/1/2020-6/30/2022. Inclusion criteria: 1) ICD-10-CM diagnosis code of COVID-19 (U07.1) on or after 4/1/2020 (COVID-19 diagnosis date=index date), 2) 18+ years of age on index, and 3) at least -365/+30 days of continuous plan enrollment surrounding index. Employing a conservative LC definition, patients were classified as LC if they presented at least 1 claim ≥ 28 days following the index date which included both a COVID-19 diagnosis and ≥1 of 8 LC-related symptoms. LC and non-LC patients were compared on demographics, COVID-19 symptoms, healthcare utilization, and medical costs. Descriptive statistics were presented for outcomes, and bivariate tests of significance were used to assess differences between cohorts. Of 4,938,801 medically attended COVID-19 patients meeting inclusion criteria, 386,153 (7.8%) qualified as LC. The LC patients were older (Mean(SD) = 67.0(19.0) vs. 51.0(20.7)), were more likely to be female (65.1% vs. 60.4%), were in poorer health (Deyo-Charlson Comorbidity Index=3.51(3.24) vs. 1.47(2.45)), and presented greater baseline total medical expenditures ($39,769($60,401) vs. $15,275($35,640); p < 0.0001). On index, LC patients had a higher rate of LC-related symptoms, and in the 180-day post-index period, LC patients incurred increased total medical costs ($38,874($54,098) vs. $7,319($18,439); p < 0.001) and greater use of inpatient and outpatient medical services. Patients with LC presented elevated rates of symptoms and incurred 5-fold greater medical costs post-index compared to non-LC patients. This study is one of the first to longitudinally quantify the cost and symptom burden of LC in a real-world setting and helps to establish a baseline for the value of potential therapeutic interventions.

Real-world treatment modalities, health care resource utilization, and costs among commercially insured patients with newly diagnosed major depressive disorder in the United States.

BACKGROUND: In the United States, major depressive disorder (MDD) is one of the most prevalent mental health disorders. Treatment guidelines for MDD recommend pharmacologic and nonpharmacologic therapies tailored to the patient's disease severity, level of function, and comorbid health conditions. While previous studies examined real-world pharmacologic treatment patterns and costs among patients with MDD, few have examined the use of nonpharmacologic treatments and their association with health care resource utilization (HCRU) and cost. OBJECTIVE: To describe prevalence and associations between patient/provider characteristics and treatment modality and characterize HCRU and cost by treatment modality for patients with newly diagnosed MDD. METHODS: Commercially insured US patients, aged 18-62 years with newly diagnosed MDD between January 1, 2017, and September 30, 2019, were retrospectively identified from the Healthcare Integrated Research Database. Eligible patients were continuously enrolled in the health plan for 1 year before and 2 years after the first MDD diagnosis (index date). Those with co-occurring schizophrenia, bipolar disorder, postpartum depression, substance use disorder, and any prior MDD treatments were excluded. Treatment modalities assessed in the 2-year post-index period included antidepressant only (Rx-only), nonpharmacologic only (non-Rx-only), both antidepressant and nonpharmacologic (combination), and no treatment. HCRU and costs were assessed in the 2-year post-index period by treatment modality. Regression models identified associations between patient/provider characteristics and treatment modality, and the relationship between treatment modality and MDD severity changes. RESULTS: In total, 12,657 patients were included (mean age: 36 years; 60% female). During follow-up, 34% of patients received Rx-only, 25% received non-Rx-only, 28% received combination, and 13% received no treatment. MDD severity at diagnosis (26% mild, 54% moderate, 20% severe) was available for 51% of patients. Post-index inpatient hospitalizations were 11% for those with Rx-only, 10% for non-Rx-only, 16% for combination, and 29% for no treatment, whereas all-cause mean monthly total costs were $792, $633, $786, and $1,292, respectively. In multinomial logistic regression, age, sex, geographic region and urbanicity of patient residence, socioeconomic status, diagnosing provider specialty, and initial diagnosis location were significantly associated (P < 0.05) with treatment modality. In multivariable logistic regression, recipients of Rx-only (odds ratio = 2.03, P < 0.01) or combination (odds ratio = 3.26, P < 0.01) had higher odds of improving MDD severity than patients who received no treatment. CONCLUSIONS: In this real-world sample of commercially insured patients, we observed variations in outcomes by treatment modality and an association between treatment modality and disease severity. Further research is needed to explore the underlying causal relationships between treatment modality and patient outcomes. Study Registration: https://doi.org/10.17605/OSF.IO/YQ6B3 DISCLOSURES: Dr Grabner is an employee of Carelon Research, which received funding from the Innovation and Value Initiative for the conduct of the study on which this manuscript is based. Ms Pizzicato and Mr Yang were employees of Carelon Research at the time the study was conducted. Dr Grabner is a shareholder of Elevance Health. Drs Xie and Chapman are employees of the Innovation and Value Initiative.

Atypical Hemolytic Uremic Syndrome Treated With Ravulizumab or Eculizumab: A Claims-Based Evaluation of Health Care Resource Utilization and Clinical Outcomes in the United States

Ravulizumab and eculizumab have shown efficacy for the treatment of atypical hemolytic uremic syndrome (aHUS), but real-world evidence for ravulizumab is limited owing to its more recent approval. This real-world database study examined outcomes for adult patients switching to ravulizumab from eculizumab and patients treated with individual treatments. A retrospective, observational study using the Clarivate Real World Database. US health-insurance billing data (January 2012 to March 2021) of patients aged 18 years or older with≥1 diagnosis relevant to aHUS,≥1 claim for treatment with eculizumab or ravulizumab, and no evidence of other indicated conditions. Treatment-switch (to ravulizumab after eculizumab), ravulizumab-only, and eculizumab-only cohorts were examined. Clinical procedures, facility visits, health care costs, and clinical manifestations. Paired-sample statistical testing compared the mean numbers of claims for each group 0-3 months before (preindex period) and 0-3 months and 3-6 months after (postindex period) the index date (point of initiation with a single treatment or treatment switch). In total, 322 patients met the eligibility criteria at 3-6 months postindex in the treatment-switch (n=65), ravulizumab-only (n=9), and eculizumab-only (n=248) cohorts. The proportions of patients with claims for key clinical procedures continued to be small after treatment switch and were small (0%-11%) across all cohorts at 3-6 months postindex. Inpatient visits were reduced in the postindex period across all cohorts. At 3-6 months after treatment switch, patients reported fewer claims for outpatient, private practice, and home visits and lower median health care costs. The proportions of patients with claims for clinical manifestations of aHUS were generally reduced in the postindex period compared with those of the preindex period. Low patient numbers receiving ravulizumab only. The health-insurance claims data showed a reduced health care burden for US adult patients after treatment with ravulizumab or eculizumab for treatment of aHUS.

0337 24-Month Patterns of Sleep Medication Use with a Prescription Digital Therapeutic for Chronic Insomnia – A Retrospective Analysis

Abstract Introduction Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment, but sedative-hypnotic medications are often used first, despite contraindications and risk of misuse. This study assessed change in sedative/hypnotic use/dosage in patients with chronic insomnia treated with Somryst® (tested as SHUTi), a prescription digital therapeutic (PDT) delivering CBT-I. Methods A retrospective claims data analysis was conducted with chronic use of prescribed sedatives/hypnotics (days’ supply: 8-200; units dispensed: &amp;gt;12) in patients with self-identified sleep problems who initiated the PDT (index) between June 2016 and December 2018, and who had available closed claims data 24 months pre- and post-index. Eligible medications were used at least once in the year prior to initiation of the PDT, or 90 days after PDT initiation. Outcomes evaluated: dose change, stoppage/initiation, or medication switch, using nearest pre-index medication and furthest post-index medication. Dose change was evaluated using total strength per day: medication dose quantity dispensed/day's supply. Medication switch was evaluated as post-index cessation of a pre-index medication, accompanied by a post-index initiation of a different sedative/hypnotic. Results Of the 248 individuals observed, 131 (52.8%) utilized an eligible sedative/hypnotic medication. On average, individuals were on 1.5 (median of 2, range 1-6) sedative/hypnotic medications. In 59 individuals (45% of the cohort), there was either a decrease in dosage (13 patients, 9.9%), a full stopping of a medication (52 patients, 39.7%), or a stopping of all medications (41 patients, 31.3%). In 32 individuals (24% of the cohort), there was either an increase in dosage (8 patients, 6.1%) or an initiation of a new medication (28 patients, 21.3%). Twenty-two patients (16.7%) switched to a different medication in the post-index period. Forty-three patients (32%) experienced no changes in a specific medication and its dosage, including 25 (19%) patients who had another medication already counted in the groups described above, and 18 (13.7%) patients not counted elsewhere. Conclusion Real-world evidence from a PDT delivering digital CBT-I demonstrated dose reduction and/or stoppage of sedative/hypnotic medications in almost half of the population, with almost a third of patients stopping all such medications. Support (if any) This study was funded by Pear Therapeutics (US), Inc.

Clinical and Economic Burden in Patients With Systemic Lupus Erythematosus During the First Year After Initiating Oral Corticosteroids: A Retrospective US Database Study.

To characterize health care resource utilization (HCRU), health care costs, and adverse events (AEs) among patients with systemic lupus erythematosus (SLE) initiating oral corticosteroids (OCS) versus patients without OCS use. In this retrospective cohort study (GSK Study 213061), eligible patients (aged ≥5 years at first OCS claim) with SLE from the IQVIA Real-World Data Adjudicated Claims-US database (January 2006 to July 2019) had continuous enrollment during the 6-month preindex (baseline) and 12-month postindex (observation) periods and one or more inpatient or emergency department SLE diagnosis codes or two or more outpatient SLE diagnosis codes during baseline. The "OCS-initiator cohort" comprised patients with one or more OCS pharmacy claims during the study period and no evidence of preindex OCS use and was classified into three exposure categories based on the number of 6-month periods of more than 5 mg/day of OCS use (0, 1, 2). The "no-OCS-use cohort" comprised patients without OCS claims, although patients may have received OCS prior to the study period. Clinical and economic outcomes were reported over the observation period. Adjusted health care costs differed significantly ($6542 [95% confidence interval (CI): $5761-$7368], $19,149 [95% CI: $16,954-$21,471], $28,985 [95% CI: $25,546-$32,885]). HCRU incidence rates were significantly greater for all OCS-initiator exposure categories (n=16,216) versus the no-OCS-use cohort (n=11,137; adjusted incidence rate ratios [95% CI]: 1.22 [1.19-1.24], 1.39 [1.34-1.43], 1.66 [1.60-1.73]). OCS-related AEs were experienced by 67.1% to 74.1% of patients with OCS initiation, most commonly affecting the immune system. Within 12 months of OCS initiation, patients with SLE experienced substantial clinical and economic burden, which may imply a need to minimize OCS use.

Understanding the Effect of Osteoarthritis on Surgical Treatment Patterns, Healthcare Resource Utilization, and Costs Among Patients With Tenosynovial Giant Cell Tumors.

Tenosynovial giant cell tumor (TGCT) may be misdiagnosed as osteoarthritis (OA), or the chronic course of TGCT may lead to development of secondary OA. However, little is known about the effect of comorbid OA on long-term surgical patterns and costs among TGCT patients. This cohort study used claims data from the Merative MarketScan Research Databases. The study included adults diagnosed with TGCT from January 1, 2014, to June 30, 2019, who have at least 3 years of continuous enrollment before and after the first TGCT diagnosis (date of the first TGCT diagnosis = index date) and no other cancer diagnosis during the study period. Patients were stratified by the presence of an OA diagnosis relative to the index date. Outcomes included surgical procedure patterns, healthcare resource utilization, and costs in the 3-year pre- and postindex periods. Multivariable models were used to assess the effect of OA on the study outcomes, controlling for baseline characteristics. The study included 2856 TGCT patients: 1153 (40%) had no OA before or after index (OA[-/-]), 207 (7%) had OA before index but not after (OA[+/-]), 644 (23%) had OA after index but not before (OA[-/+]), and 852 (30%) had OA before and after index (OA[+/+]). The mean age was 51.6 years, and 61.7% were female. During the postperiod, joint surgery was more common among OA(-/+) and OA(+/+) patients compared with OA(-/-) and OA(+/-) patients (55.7% vs 33.2%). The mean all-cause total costs in the 3-year postperiod were $19,476 per patient per year. Compared with OA(-/-) patients, OA(-/+) and OA(+/+) patients had a higher risk of undergoing recurrent surgery and higher total healthcare costs postindex. Higher rates of surgery and increased healthcare cost observed in TGCT patients with postindex OA underscore the need for effective treatment options to reduce joint damage, especially among patients with comorbid OA.

Burden of lipoprotein(a) for patients with atherosclerotic cardiovascular disease: A retrospective analysis from the United States.

BACKGROUND: Lipoprotein(a) (Lp(a)) is an inherited, independent, and causal risk factor for atherosclerotic cardiovascular disease (ASCVD). OBJECTIVE: To assess the burden of elevated Lp(a) for patients with ASCVD in a real-world setting in the United States. METHODS: This retrospective cohort study assessed US patients with available Lp(a) measurement and established ASCVD using Optum's Clinformatics Data Mart database (2007-2020). Index date was defined as the first diagnosis of an ASCVD event. Patient demographics, medications, health care resource utilization (HCRU), and occurrence of cardiovascular events were assessed for patients with elevated (≥150 nmol/L) vs normal (≥65 nmol/L) Lp(a) levels, within the first year of index date. HCRU was characterized by inpatient hospitalization, inpatient length of stay (LOS), outpatient visits, and emergency department (ED) visits. All comparative analyses of patients with elevated (≥150 nmol/L) vs normal (≥65 nmol/L) Lp(a) levels within the first year of index date were adjusted for age, sex, baseline statin use, and diabetes. RESULTS: 8,372 patients with ASCVD and Lp(a) measurement in nmol/L were included in this study. Patient demographics and baseline clinical characteristics were similar among those with normal and elevated Lp(a). However, the proportion of patients receiving statins and β-blockers at baseline were significantly higher in the elevated vs normal Lp(a) group (54.76% vs 42.91%, P < 0.0001, and 30.92% vs 27.32%, P = 0.0183, respectively). At 1 year of follow-up, the rates per 100 person-years for ASCVD-related inpatient hospitalizations, outpatient hospitalizations, and ED visits were higher among patients with elevated Lp(a) compared with normal Lp(a) (13.33 vs 9.46, 89.08 vs 85.10, and 2.89 vs 2.29, respectively). The mean LOS per ASCVD-related hospitalization was 7.21 days in the elevated and 6.26 days in the normal Lp(a) group (P = 0.3462). During the 1-year post-index follow-up period, 15% of patients in the elevated Lp(a) group required revascularization compared with 10% of patients in the normal Lp(a) group (P = 0.0002). The odds of composite myocardial infarction, ischemic stroke, and revascularization occurrence of events within the first year of index was significantly higher in the elevated Lp(a) group compared with the normal Lp(a) group (1.46; 95% CI = 1.20-1.77; P < 0.05). CONCLUSIONS: HCRU within the first year of ASCVD diagnosis is substantial among patients with ASCVD and elevated Lp(a). Relatively higher rates of inpatient hospitalizations, increased LOS per hospitalization, and requirement of revascularization procedures within the first year of ASCVD index diagnosis were observed in patients with elevated Lp(a) compared with normal Lp(a) levels. Lp(a) testing in routine clinical practice could help in identification of high-risk patients with ASCVD and play an important role in the overall cardiovascular risk management, aiming to reduce the HCRU associated with ASCVD. DISCLOSURES: Ms Fonseca, Dr Laguna, Dr Itani, Dr Rachel Studer, and Dr Ferber are employees of Novartis Pharma AG, Basel, Switzerland. Ms Byrne is an employee of Novartis AG, Dublin, Ireland. Dr Costa-Scharplatz is an employee of Novartis Sweden AB, Stockholm, Sweden. Dr Heo and Ms Dillon are employees of Genesis Research. Genesis Research was commissioned to conduct the study (data extraction and analysis) on behalf of Novartis Pharma AG.

Adherence and Persistence among Patients with Migraine Initiating Concomitant Use of Self-Injectable Calcitonin Gene-related Peptide Monoclonal Antibody and Novel Acute Migraine Medications (P10-12.007)

<h3>Objective:</h3> To describe demographics, clinical characteristics, and treatment patterns (adherence and persistence) among patients with migraine who concomitantly initiated self-injectable CGRP mAbs and novel acute migraine medications. <h3>Background:</h3> Limited evidence is available on real-world treatment patterns of patients initiating concomitant use of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) and novel acute migraine medications. <h3>Design/Methods:</h3> This retrospective observational study utilized de-identified patient claims data from Merative MarketScan® Research Databases. Included patients initiated self-injectable CGRP mAbs (galcanezumab/erenumab/fremanezumab) and novel acute migraine medications (lasmiditan/rimegepant/ubrogepant) between May 2018 and February 2021, with an overlap between the two. Overlap was defined as ≥2 fills of the index drug (CGRP mAb or novel acute medication, whichever started first), 2 fills of the second drug (novel acute medication if CGRP mAb was the index drug or vice versa), or ≥1 fill each of the index and second drugs within 3 months of index drug initiation. Index date was the date of CGRP mAb initiation. Adherence to CGRP mAbs was assessed as proportion of days covered (PDC) and medication possession ratio (MPR) over a 12-month post-index period. Persistence was defined as the number of days of continuous preventive therapy from index until the end of post-index period, allowing for a maximum gap between fills of 60 days. <h3>Results:</h3> Of the 4,167 patients identified (mean [SD] age: 43.7 [11.2] years; 89.2% females), 59.7% had chronic migraine and 85.0% had CGRP mAbs as their index drug. Anxiety was the most common comorbidity (41.3%). Mean (SD) PDC was 0.7 (0.3) and 47.1% of patients achieved PDC≥0.8. Mean (SD) MPR was 0.9 (0.1) and 80.1% patients achieved MPR≥0.8. Mean (SD) days of persistence for index drug was 273.4 (115.3). <h3>Conclusions:</h3> Understanding treatment patterns among patients initiating concomitant use of CGRP mAbs and novel acute medications may provide valuable insight to providers when evaluating migraine treatment regimens. <b>Disclosure:</b> Miss Varnado has received personal compensation for serving as an employee of Eli Lilly and Company. Miss Varnado has stock in Eli Lilly and Company. Ms. Gulati has nothing to disclose. Dr. Hoyt has received personal compensation for serving as an employee of Eli Lilly and Co.. Dr. Hoyt has stock in Eli Lilly and Co.. Dr. Wheeler has received personal compensation for serving as an employee of Eli Lilly. Dr. Wheeler has stock in Eli Lilly. Jerry Hall has received personal compensation for serving as an employee of Eli Lilly &amp; Co.. Jerry Hall has stock in Eli Lilly &amp; Co..

Longer Milestone-Free Time in Patients With Amyotrophic Lateral Sclerosis Treated With IV Edaravone vs Not Treated With IV Edaravone: Results From a US Administrative Claims Analysis (S14.007)

<h3>Objective:</h3> To estimate time-to-progression milestones in IV edaravone–treated vs non–IV edaravone-treated patients with ALS in a real-world setting. <h3>Background:</h3> Intravenous (IV) edaravone was US Food and Drug Administration-approved in May 2017 based on a slowing of functional decline in patients with amyotrophic lateral sclerosis (ALS). Information on real-world outcomes in patients with ALS treated with IV edaravone is limited. <h3>Design/Methods:</h3> This retrospective observational analysis included patients with ALS who were continuously enrolled in Optum’s de-identified Clinformatics® Data Mart database between August 8, 2017, and September 30, 2021. Propensity score matching (1:1) identified IV edaravone–treated patients (cases) and non–IV edaravone-treated patients (controls) matched for covariates: age, race, geographic region, gender, pre-index disease duration (period between the first claim for ALS diagnosis and the first claim for IV edaravone [cases] or August 2017 [controls]), insurance, cardiovascular disease history, riluzole prescription, gastrostomy tube placement, artificial nutrition, noninvasive ventilation, and all-cause hospitalization. Milestones were defined according to the Healthcare Common Procedure Coding System and included the use of canes/walkers/wheelchairs (M1); artificial nutrition (M2); noninvasive ventilation (M3); invasive ventilation/speech-generating devices (M4); and hospice (M5). Difference between cases and controls in cause-specific restricted mean time lost (RMTL) was estimated to examine IV edaravone benefit. <h3>Results:</h3> Cases (n=360) were matched to controls (n=360); mean age in years (SD) was 62.9 (10.2) and 62.8 (10.2) in cases and controls, respectively. In the post-index period, differences in RMTL (95% CI) in months indicate longer milestone-free time in cases than controls: 2.50 (0.93–4.07), 4.30 (2.88–5.72), 2.92 (1.56–4.28), 4.12 (3.00–5.23), and 2.33 (1.31–3.34) for M1, M2, M3, M4, and M5, respectively. <h3>Conclusions:</h3> This analysis describes the time to milestones in patients with ALS treated with IV edaravone in a real-world setting. This information may be useful to payers and clinicians in evaluating use of IV edaravone. <b>Disclosure:</b> Malgorzata Ciepielewska has received personal compensation for serving as an employee of Mitsubishi Tanable Pharma America . Jeffrey Zhang has received personal compensation for serving as an employee of Princeton Pharmatech. Jeffrey Zhang has received stock or an ownership interest from CalciMedica. Ying Liu has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for MPTA. Dr. Hagan has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America.

Adherence and Persistence of Calcitonin Gene-Related Peptide Monoclonal Antibodies in Patients with Migraine: A Real-World Study (P12-12.007)

<h3>Objective:</h3> This study compared real-world adherence and persistence in adult patients with migraine initiating CGRP mAbs– galcanezumab versus fremanezumab or erenumab. <h3>Background:</h3> Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are approved for migraine prevention. However, real-world studies comparing their treatment patterns in the US are limited. <h3>Design/Methods:</h3> This retrospective cohort study utilized administrative claims data from the Merative Marketscan® Commercial and Medicare Supplemental Databases. Included patients had ≥1 claim for an approved self-injectable CGRP mAb between May 2018 and September 2021 and had continuous enrollment in medical and pharmacy benefits (12 months pre- and 12 months post-index). Index date was defined as date of first prescription fill for a CGRP mAb (index medication). Adherence and persistence were compared for 6- and 12-months post index. Adherence to index medication was assessed as proportion of days covered (PDC) and medication possession ratio (MPR). Persistence was defined as continuous therapy from index until the end of the 12-month post-index period, allowing for a maximum gap between fills of 60 days. <h3>Results:</h3> At 12-months follow-up, 26,176 patients (&gt;85% female) were grouped into galcanezumab (n=9,121), fremanezumab (n=5,003), erenumab (n=12,052) groups based on their index medication. The mean (SD) age was 43.8 (11.3), 44.4 (11.1) and 44.7 (11.2) years, respectively. Mean (SD) PDC and MPR were 0.6 (0.3) for all three groups. More patients in the galcanezumab (45.9%) group achieved PDC ≥ 0.8 followed by fremanezumab (42.8%) and erenumab (41.8%,) groups. Similarly, 46.4%, 43.4%, 42.4% achieved MPR ≥ 0.8 in the respective groups. More patients in the galcanezumab group (52.2%) were persistent through the end of the study period, followed by fremanezumab (47.5%) and erenumab (47.8%) groups. Similar trends were observed for the 6-months follow-up cohort. <h3>Conclusions:</h3> Our findings suggest that patients treated with galcanezumab were more adherent and persistent followed by patients treated with fremanezumab and erenumab. <b>Disclosure:</b> Miss Varnado has received personal compensation for serving as an employee of Eli Lilly and Company. Miss Varnado has stock in Eli Lilly and Company. Dr. Brady has received personal compensation for serving as an employee of Merative. Anthony J Zagar has received personal compensation for serving as an employee of Eli Lilly. Miss Robles has nothing to disclose. Dr. Hoyt has received personal compensation for serving as an employee of Eli Lilly and Co.. Dr. Hoyt has stock in Eli Lilly and Co.. Jerry Hall has received personal compensation for serving as an employee of Eli Lilly &amp; Co.. Jerry Hall has stock in Eli Lilly &amp; Co..

The Burden of Neuropsychiatric Disorders in Medicaid Patients Living With HIV-1 Treated With Integrase Inhibitor or Protease Inhibitor Antiretroviral Therapies.

Objective: Data are scarce regarding the incidence of neuropsychiatric events (NPEs) in people living with human immunodeficiency virus (HIV)-1 taking integrase inhibitor (INI)- or protease inhibitor (PI)-based regimens. This study evaluated the prevalence, incidence, and economic burden of NPEs among people living with HIV-1 who were newly treated with INI- or PI-based regimens in a Medicaid population.Methods: A retrospective cohort study was conducted using administrative claims from the IBM MarketScan Multi-State Medicaid Database (January 1, 2014-December 31, 2018). Treatment-naive and treatment-experienced adults with HIV-1 newly treated with an INI- or PI-based regimen were included. Outcomes included NPE prevalence during the 12-month baseline period, prevalence of existing and incidence of new-onset NPEs during the 6-month post-index period, and total all-cause and NPE-related costs between treatment cohorts. Baseline characteristics between the 2 cohorts were balanced using inverse probability treatment weighting.Results: In the INI (n = 3,929) and PI (n = 3,916) cohorts, mean (SD) ages were 44.87 (12.81) and 44.36 (11.85) years, and 41.7% and 41.3% were female, respectively. High proportions of patients in both cohorts had NPEs during the 12-month baseline period. Among patients with no baseline NPEs, adjusted NPE incident rate ratios (95% CIs) during the post-index period were as follows: any, 1.15 (1.00-1.33); chronic, 1.18 (0.98-1.42); and acute, 1.16 (0.96-1.39). Mean all-cause and NPE-related costs were similar between cohorts.Conclusions: In this study of the Medicaid population, the prevalence and incidence of NPEs, as well as health care costs, were similar among people living with HIV-1 newly treated with an INI- or PI-based regimen.

Rates of Inpatient Hospitalizations Across a 2-Year Time Horizon Between reSET-O and Control Patients: A Difference in Differences Approach

AbstractIntroductionreSET-O® is an FDA-authorized prescription digital therapeutic (PDT) for opioid use disorder (OUD) providing cognitive behavioral therapy as an adjunct to buprenorphine therapy. This analysis describes differences in inpatient hospitalization rates over a 2-year period between patients treated with the PDT and those who were not.MethodsA real-world claims analysis using the HealthVerity Private Source 20 database compared inpatient hospitalization rates (including intensive care unit stays and rehospitalizations) in patients who filled a reSET-O prescription (“cases”) to patients not filling their prescription (“controls”). Index date was date of reSET-O initiation for cases, and prescription date for controls, from January 1, 2019 to June 30, 2020. Pre- and post-index incidence rates of HCRU were compared with the incidence rate ratio (IRR) using a repeated-measures negative binomial model, adjusted for age, sex, region, payer type, Charlson comorbidity index (CCI) score, and number of similar services in the 12 months pre-index with an offset for number of days in the 12-month post-index period. Adjusted differences in inpatient hospitalizations in cases vs. controls were evaluated at 3-month intervals beginning at 12 months pre-index through 12 months post-index, using a difference in differences (DID) approach.ResultsIn this analysis, 901 cases (median age 36 years, 62.4% female, 73.9% Medicaid recipients, 95% treated with buprenorphine in the post-index period) were compared with 978 controls (median age 38 years, 55.1% female, 65.4% Medicaid recipients, 95% treated with buprenorphine in the post-index period). Incidence rate ratios of inpatient stays trended lower in later pre-post comparison periods among cases (IRRs 0.80, 0.95, 0.87, and 0.75 at 3-, 6-, 9-, and 12 months pre-post, respectively), and trended higher in later pre-post periods in controls (IRRs 0.93, 0.83, 0.86, 0.88 at 3-, 6-, 9-, and 12-month intervals respectively). The DID for controls vs. cases during the 12-month post interval compared to the 12-month pre-index rates, represented a 44% lower incidence of inpatient hospitalizations vs. controls between the first and last quarters of observation.ConclusionsThis difference in difference analysis showed a lower 12-month pre-post incidence rate ratio of inpatient hospitalizations for patients using reSET-O vs. controls, and a 24-month change in quarterly inpatient hospitalizations in reSET-O patients that was almost half that of controls.FundingPear Therapeutics (US), Inc.

Treatment patterns, healthcare utilization, and costs of patients with treatment-resistant depression initiated on esketamine intranasal spray and covered by US commercial health plans

AimsTo describe real-world use of esketamine (ESK) intranasal spray and healthcare outcomes among patients with treatment-resistant depression (TRD) in the United States (US).MethodsAdults with TRD initiated on ESK (index date) between 5 March 2019 (US approval date for TRD) and 31 October 2020 were sampled from IBM MarketScan Research Databases. TRD was defined as claims for ≥2 unique antidepressants during the same major depressive episode. Subgroups of the TRD cohort with comorbid cardiometabolic conditions, pain, anxiety disorder, and substance use disorder (SUD) were identified. Patients had ≥6 months of continuous health plan eligibility pre- and post-index.ResultsThe TRD cohort comprised 269 patients; comorbidity subgroups included 123 (cardiometabolic), 144 (pain), 189 (anxiety disorder), and 58 (SUD) patients. Proportion of patients completing ≥8 ESK sessions (number of sessions in induction phase) was 61.3% in the TRD cohort and ranged from 60.2% (cardiometabolic subgroup) to 72.4% (SUD subgroup) in subgroups. Median frequency of induction sessions was every 5–8 days among the TRD cohort and subgroups. Mean mental health–related inpatient costs reduced from pre- to post-index periods in the TRD cohort (mean ± standard deviation [median] costs per-patient-per-6-months: $3,480 ± $13,328 [$0] pre-ESK initiation; $3,262 ± $16,666 [$0] post-ESK initiation; mean difference: –$218) and subgroups (largest decrease in cardiometabolic subgroup: $4,864 ± $14,271 [$0]; $2,792 ± $15,757 [$0]; –$2,072). Mean mental health–related emergency department (ED) costs decreased in the TRD cohort ($608 ± $2,525 [$0]; $269 ± $1,143 [$0]; –$339) and subgroups (largest decrease in the SUD subgroup: $1,403 ± $3,752 [$0]; $351 ± $868 [$0]; –$1,052).LimitationsThis is a descriptive analysis; sample size for some comorbidity subgroups is small.ConclusionsThe majority of patients completed ESK induction phase, and most dosing intervals were longer than the label recommendation. In this descriptive analysis, mental health–related inpatient and ED costs trended lower post-ESK initiation.