Drug Codes Research Articles

18410 A retrospective analysis of the duration of long-term oral antibiotic use for the treatment of hidradenitis suppurativa

Hidradenitis suppurativa (HS) is an inflammatory skin condition often treated with oral antibiotics. The duration of use in clinical studies is typically 12-16 weeks, however it is possible that longer durations are used in clinical care. This study aimed to investigate the duration of long-term oral antibiotic use for the treatment of HS. The MarketScan database was queried for patients with a diagnosis of HS from January 1 through December 31, 2005. Antibiotic use and duration was determined using National Drug Codes.

Exploration of PCORnet Data Resources for Assessing Use of Molecular-Guided Cancer Treatment.

Examine the ability of PCORnet data resources to investigate molecular-guided cancer treatment. Patients (N = 86,154) had single primary solid tumors (diagnosed 2013-2017) from hospital oncology registries linked to the PCORnet Common Data Model (CDM) at 11 medical institutions. Molecular and anatomic test procedures and oral and infused therapies were identified with Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, RxNorm Concept Unique Identifier, and National Drug Codes from CDM tables. Chart review (2 institutions, n = 213) for advanced colorectal cancer and Medicare claims linkages (7 institutions, n = 1,731) for breast cancer explored options for increasing electronic data capture. Molecular testing prevalence detected via analyte-specific molecular CPT/HCPCS codes was 5.5% (n = 4,784); for the nonspecific anatomic pathology codes, for which only some testing is performed to guide therapy selection, it was an additional 44.8% (n = 38,610). Molecular-guided therapy prevalence was 5% (n = 4,289). Testing and treatment were most common with stage IV disease and varied across cancer types and study institutions (testing, 0%-10.4%; treatment, 0.8%-8.4%). Therapy-concordant test results were found in charts for all 36 treated patients with colorectal cancer at the 2 institutions, 3 (8.3%) of whom received treatment outside the institution. Breast cancer Medicare claims linkage increased rates of identified testing from 62.7%-98.9% and treatment from 3.9%-8.2%. Although a minority of patients received molecular-guided therapies, the majority had testing that could guide cancer treatment. Claims data extended electronic data capture for therapies and test orders but often was uninformative for types of test ordered. Test results continue to require text data curation from narrative pathology reports.

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018

ObjectiveBuprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions. MethodsWe first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News. ResultsBrand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation. ConclusionsBrand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.

Rapid Epidemiological Analysis of Comorbidities and Treatments as risk factors for COVID-19 in Scotland (REACT-SCOT): A population-based case-control study.

The objectives of this study were to identify risk factors for severe coronavirus disease 2019 (COVID-19) and to lay the basis for risk stratification based on demographic data and health records. The design was a matched case-control study. Severe COVID-19 was defined as either a positive nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the national database followed by entry to a critical care unit or death within 28 days or a death certificate with COVID-19 as underlying cause. Up to 10 controls per case matched for sex, age, and primary care practice were selected from the national population register. For this analysis-based on ascertainment of positive test results up to 6 June 2020, entry to critical care up to 14 June 2020, and deaths registered up to 14 June 2020-there were 36,948 controls and 4,272 cases, of which 1,894 (44%) were care home residents. All diagnostic codes from the past 5 years of hospitalisation records and all drug codes from prescriptions dispensed during the past 240 days were extracted. Rate ratios for severe COVID-19 were estimated by conditional logistic regression. In a logistic regression using the age-sex distribution of the national population, the odds ratios for severe disease were 2.87 for a 10-year increase in age and 1.63 for male sex. In the case-control analysis, the strongest risk factor was residence in a care home, with rate ratio 21.4 (95% CI 19.1-23.9, p = 8 × 10-644). Univariate rate ratios for conditions listed by public health agencies as conferring high risk were 2.75 (95% CI 1.96-3.88, p = 6 × 10-9) for type 1 diabetes, 1.60 (95% CI 1.48-1.74, p = 8 × 10-30) for type 2 diabetes, 1.49 (95% CI 1.37-1.61, p = 3 × 10-21) for ischemic heart disease, 2.23 (95% CI 2.08-2.39, p = 4 × 10-109) for other heart disease, 1.96 (95% CI 1.83-2.10, p = 2 × 10-78) for chronic lower respiratory tract disease, 4.06 (95% CI 3.15-5.23, p = 3 × 10-27) for chronic kidney disease, 5.4 (95% CI 4.9-5.8, p = 1 × 10-354) for neurological disease, 3.61 (95% CI 2.60-5.00, p = 2 × 10-14) for chronic liver disease, and 2.66 (95% CI 1.86-3.79, p = 7 × 10-8) for immune deficiency or suppression. Seventy-eight percent of cases and 52% of controls had at least one listed condition (51% of cases and 11% of controls under age 40). Severe disease was associated with encashment of at least one prescription in the past 9 months and with at least one hospital admission in the past 5 years (rate ratios 3.10 [95% CI 2.59-3.71] and 2.75 [95% CI 2.53-2.99], respectively) even after adjusting for the listed conditions. In those without listed conditions, significant associations with severe disease were seen across many hospital diagnoses and drug categories. Age and sex provided 2.58 bits of information for discrimination. A model based on demographic variables, listed conditions, hospital diagnoses, and prescriptions provided an additional 1.07 bits (C-statistic 0.804). A limitation of this study is that records from primary care were not available. We have shown that, along with older age and male sex, severe COVID-19 is strongly associated with past medical history across all age groups. Many comorbidities beyond the risk conditions designated by public health agencies contribute to this. A risk classifier that uses all the information available in health records, rather than only a limited set of conditions, will more accurately discriminate between low-risk and high-risk individuals who may require shielding until the epidemic is over.

The missed opportunity for real-world evidence to shape our understanding of medical cannabis.

The missed opportunity for real-world evidence to shape our understanding of medical cannabis.

S0415 Eosinophilic Esophagitis in the United States from 2009-2015: Cross-Sectional Analysis of Office Visits From the National Ambulatory Medical Care Survey

INTRODUCTION: Histologically, Eosinophilic Esophagitis (EoE) is defined by an accumulation of eosinophils in the mucosal lining of the esophagus. Leading symptoms are dysphagia, chest pain, and heartburn. Most cases occur in younger, non-Hispanic white males and co-occurrence with asthma is frequent. The incidence of EoE has increased over the last twenty years, partly due to increased recognition. To date, data on EoE is mostly limited to regional demographic studies. Our aim was to conduct a cross-sectional study examining demographics, comorbidities, and medication use of EoE patients in the United States (US) from 2009-2015. METHODS: The CDC’s National Ambulatory Medical Care Survey (NAMCS) uses weighted sampling methods to generate cross-sectional data representative of ambulatory care visits in the US. Using ICD-9 codes, we identified patients with EoE for the period 2009-2015. For these patients, we used visit codes to identify the following: presence of GERD, dysphagia, and asthma. Drug codes were used to investigate PPI and topical steroid use. Weighting of encounters using SPSS were performed to provide population estimates. RESULTS: After weighting, the study group included 710,339 unique outpatient visits for EoE; 63.9% male, mean age 35.5 years. Using corresponding estimated census data for 2013, the year with the greatest number of EoE visits, 70.1/100,000 outpatient visits in the US were for EoE. Race/ethnicity: non-Hispanic white 79.1% (6% higher than general population for 2013); NHB 18.5%; Hispanic 1.7%. Mean BMI was 25.3 ± 5.2 with 23.4% of patients having a BMI >30. Overall, 21.0% of patients had concomitant asthma. Among presenting complaints for an office visit, there were 29.0% with GERD, 15.0% with dysphagia, and 19.8% with an “allergy disorder”. Most patients were on PPI therapy (55.4%) and 29.4% were on topical steroids. CONCLUSION: Our nationwide data confirms that EoE affects younger adults, males, and the non-Hispanic white race out of proportion to the general population. About 1 in 5 EoE patients have asthma which is roughly 3 times higher than the general population supporting the association. GERD was the presenting complaint for nearly twice as many visits compared to dysphagia, a unique finding compared to previous studies. Most patients were on a PPI and nearly one-third were on topical steroids. Additional large scale, unbiased, population-based studies are needed to provide epidemiologic clarity concerning EoE.

EGFR testing and erlotinib use in non-small cell lung cancer patients in Kentucky.

This study determined the frequency and factors associated with EGFR testing rates and erlotinib treatment as well as associated survival outcomes in patients with non small cell lung cancer in Kentucky. Data from the Kentucky Cancer Registry (KCR) linked with health claims from Medicaid, Medicare and private insurance groups were evaluated. EGFR testing and erlotinib prescribing were identified using ICD-9 procedure codes and national drug codes in claims, respectively. Logistic regression analysis was performed to determine factors associated with EGFR testing and erlotinib prescribing. Cox-regression analysis was performed to determine factors associated with survival. EGFR mutation testing rates rose from 0.1% to 10.6% over the evaluated period while erlotinib use ranged from 3.4% to 5.4%. Factors associated with no EGFR testing were older age, male gender, enrollment in Medicaid or Medicare, smoking, and geographic region. Factors associated with not receiving erlotinib included older age, male gender, enrollment in Medicare or Medicaid, and living in moderate to high poverty. Survival analysis demonstrated EGFR testing or erlotinib use was associated with a higher likelihood of survival. EGFR testing and erlotinib prescribing were slow to be implemented in our predominantly rural state. While population-level factors likely contributed, patient factors, including geographic location (areas with high poverty rates and rural regions) and insurance type, were associated with lack of use, highlighting rural disparities in the implementation of cancer precision medicine.

Comparison of Postoperative Opioid Utilization in an ACDF Cohort: Narcotic Naive Patients Versus Preoperative Opioid Users.

A retrospective cohort study. To compare the postoperative opioid utilization rates and costs after anterior cervical discectomy and fusion (ACDF) procedures between groups of patients who were preoperative opioid users versus opioid naive. Opioid medications are frequently prescribed after ACDF procedures. Given the current opioid epidemic, there is increased emphasis on early identification of patients at risk for prolonged postoperative opioid use. Records from patients diagnosed with cervical stenosis who underwent a ≤3-level index ACDF surgery between 2007 and 2017 were collected from a large insurance database. International Classification of Diseases diagnosis/procedure codes, Current Procedural Terminology codes, and generic drug codes were used to search clinical records. Two cohorts were established: a group of patients who utilized opioids preoperatively and a group of patients who were opioid naive at the time of surgery. The 1-year utilization and costs of postoperative therapies were documented for each group. The preoperative opioid use cohort contained 4485 patients (61.6%), whereas the opioid-naive cohort included 2799 patients (38.4%). Postoperatively, 86.6% of the preoperative opioid use group continued to use opioids, whereas 59.0% of the opioid-naive group began using opioids. Patients who utilized opioids preoperatively were 4.48 times more likely (95% confidence interval, 3.99-5.02, P<0.001) to use opioids postoperatively and 4.30 times more likely (95% confidence interval, 3.10-5.94, P<0.001) to become opioid dependent compared with opioid-naive patients. In addition, after normalization, patients in the preoperative opioid use group utilized 3.7 times more opioid units/patient and billed for 5.3 times more dollars/patient than opioid-naive patients. In patients with cervical stenosis who undergo an ACDF procedure, the postoperative utilization and costs of opioids seem to be substantially higher in patients with preoperative opioid use compared with opioid-naive patients. Efforts should be made to avoid opioid use as a component of conservative management before surgery. Level III.

Frequency of Early Refills for Opioids in the United States.

ObjectiveRefilling an opioid prescription early is an important risk factor of prescription opioid abuse and misuse; we aimed to understand the scope of this behavior. This study was conducted to quantify the prevalence and distribution of early refills among patients prescribed opioids.MethodsWe conducted a retrospective cohort study utilizing dispensed prescription records. Patients filling one or more prescription opioids were identified and followed for one year. Early refills were defined as having a second prescription filled ≥15% early relative to the days’ supply of the previous prescription for the same opioid (according to the National Drug Code [NDC]). The distribution of the number of early refills and patient characteristics were assessed.ResultsA total of 60.6 million patients met the study criteria; 28.8% had two or more opioid prescriptions for the same opioid during follow-up. Less than 3% of all patients receiving an opioid had an early refill. Approximately 10% of those with two or more opioid prescriptions for the same drug had an early refill. For patients with multiple fills (N = 1.5 million with extended-release long-acting [ER/LA] opioids; N = 17.1 million with immediate-release short-acting [IR/SA] opioids), early refills were more common among patients with an ER/LA opioid (18.5%) compared with an IR/SA opioid (8.7%). Three-quarters of patients with an early refill had only one (70.9% and 78.4% for ER/LA and IR/SA, respectively).ConclusionRefilling an opioid prescription with the same opioid early is an infrequent behavior within all opioid users, but more common in ER/LA users. Patients who refilled early tended to do so just once.

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.

Increasing generic drug price competition by facilitating abbreviated new drug applications (ANDA) submission may help patients have access to affordable care. This study examined factors associated with first ANDA submission for the brand drug to be copied [the "reference listed drug" (RLD)]. This study used several data sources from 1/1/2011 to 12/31/2017, including FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), internal ANDA submission data, FDA's Product-Specific Guidances (PSGs), National Drug Code, and IQVIA National Sales Perspectives. Two Cox proportional hazard models were separately performed to determine factors associated with first ANDA submissions for groups of ANDAs for RLDs with "new chemical entity" (NCE) exclusivity that were submitted on the first lawfully permissible date NCE ANDAs, and non-NCE ANDA groups. For NCE group, annual market sales were the only factor associated with increased likelihood of first ANDA submission. Specifically, adjusted hazard ratio (HR) for RLDs with annual sales > $250 million was nearly 5 times higher than those with annual sales < $10 million (HR 4.74; Confidence Interval [CI] 1.85-12.13) suggesting RLDs with higher sales are more likely to have ANDA submissions. For the non-NCE group, annual market sales (HR 2.40; CI 1.09-5.25, sales > $100-250 million compared with sales < $10 million) and PSG availability were associated with increased likelihood of first ANDA submission. Being an ANDA for a complex drug product was associated with decreased likelihood of submission for both NCE (HR 0.51; CI 0.26-0.99) and non-NCE groups (HR 0.62; CI 0.39-0.98). Given the impact of regulatory-related factors, particularly PSG availability prior to ANDA submission, the findings provide opportunities to address high drug prices with specific FDA actions. Specifically, timely development of PSGs, including those for complex generics, and research prioritizing complex generics may facilitate ANDA submission; and thus, promote drug price competition.

Impact of flu vaccine on survival after immunotherapy for metastatic castration resistant prostate cancer (mCRPC): Analysis of Medicare claims data.

e17591 Background: Sipuleucel-T (sip-T) is a cellular immunotherapy that activates a patient’s own immune system to target prostate cancer cells. Flu vaccine contains inactivated virus that stimulates the immune system to induce a response. Hypothetically, influenza vaccines may impact sip-T effectiveness by affecting the apheresis procedure, ex vivo production of sip-T, and/or CD 54+ upregulation. We explored the effect of receiving the flu vaccine on outcomes in men who received first line treatment with sip-T. Methods: Claims data from the 2013-2017 CMS Fee for Service 100% Medicare Identifiable Database for Parts A, B and D Data were examined. Among men with dates of first sip-T doses in 2014 and 2015 (ie, index dates), we identified whether or not they received flu vaccine 30 days before or after based on healthcare common procedure coding system (HCPCS) codes and National Drug Codes (NDCs). Kaplan-Meier methodology was used to assess survival with Cox proportional hazards regression model used to calculate hazard ratios (HR). Three years of follow-up (F/U) were available for men with 2014 index dates; 2 years were available for men with 2014 and 2015 index dates. Results: Approximately 8% of men received the flu vaccine (102 of 1279 with 2 years of F/U; 50 of 656 with 3 years of F/U). Overall, mean age was 76 years. Most ( &gt; 86%) were white. Receipt of flu vaccine did not impact the overall survival of men who received sip-T (HR [95% CI], 0.93 [0.64, 1.35] at 2 years and 0.90 [0.60, 1.37] at 3 years). The resultant Kaplan-Meier curves overlapped (not shown). Conclusions: Based on these claims analyses, concomitant use of flu vaccine did not appear to impact survival outcomes after sip-T administration in men with mCRPC. These data have practical application for clinicians and patients given limited prospective data evaluating the role of flu vaccination in patients receiving immunotherapy. [Table: see text]

Immune-checkpoint inhibitors among privately insured cancer patients: Utilization pattern and out-of-pocket cost.

e19252 Background: Immune-checkpoint inhibitors (ICI) is a form of immunotherapy that “releases the brakes” on the immune cells to restore antitumor immunity and promote tumor cell death to treat cancer. In March 2011, the United States Food and Drug Administration (FDA) approved ipilimumab, the 1st ICI, to treat advanced-stage melanoma. Since December 2014, FDA successively approved another six ICIs: nivolumab, pembrolizumab, avelumab, durvalumab, cemiplimab, and atezolizumab. Beside melanoma, the treatment indications for these agents have been expanded to renal cell carcinoma, microsatellite instability (MSI)-high malignancies, small-cell lung cancer, non-small-cell lung cancer, and cutaneous squamous cell carcinoma. No study had examined the patterns and out-of-pocket (OOP) costs of ICI among cancer patients (pts) with private insurance. Methods: We used the IBM MarketScan Commercial Claims and Encounters database to document the uptake of ICI from 2011 to 2017. Using the Healthcare Common Procedure Coding System (HCPCS) codes, and national Drug code, we identified ICI claims among pts 18 to 64 years old. OOP cost for ICI was computed as sum of coinsurance, copayment, and deductible. To determine whether financial burden was higher for pts with high-deductible (HD) plans, we dichotomized pts’ insurance plan as HD vs. non-HD. Summary statistics was used to describe the patterns of ICI use. We used Wilcoxon Rank Sum test to compare the OOP by HD status. Results: The study cohort included 7,855 pts with 62,636 ICI claims of ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, and atezolizumab between 2011 and 2017. The median age was 57 years and about 56.9% pts were male. Approximately 90% of pts used ICI as monotherapy, and the median number of claims per patient was 4. The most commonly used ICI was nivolumab (55.4%), accounting for about 90% of claims after 2014, followed by lpilimumab (24.6%), pembrolizumab (18.5%). Among the ICI pts, 17.2% enrolled in HD plans and 82.8% had non-HD plans. The median OOP for both HD and non-HD groups was $0, whereas the 3rd quartile of OOP was significantly higher for pts in HD plans ($556 vs. $26, P &lt; 0.01). In addition, approximately 18.7% of pts (17.3% of pts in non-HD and 25.6% in HD plans) paid over $500 OOP per patient for ICI. Conclusions: The use of ICI was dramatically increased as more ICI agents were approved since 2015. Although more than 50% of pts had $0 OOP, possibly due to the out-of-pocket max provision in private insurance, pts with HD plans are especially susceptible to high financial burden of ICIs.

Effects of age on outcomes in men receiving treatment for metastatic castration-resistant prostate cancer (mCRPC): Analysis of Medicare fee for service (FFS) claims data.

e17590 Background: Because elderly patients may exhibit differences in immune activation, we evaluated outcomes in men receiving first line treatment for mCRPC with sip-T or oral agents (ie, abiraterone acetate or enzalutamide) by age. Methods: Claims data from the 2013-2017 Centers for Medicare and Medicaid Services Fee for Service 100% Medicare Identifiable Database for Parts A, B and D were examined. We evaluated with index dates in 2014 and 3 years of follow-up. Patients were categorized by age (Table) and agent use as per Healthcare Common Procedure Coding System codes and National Drug Codes. First line use of sip-T vs oral agents was examined as was any line use of sip-T vs oral agents (without sip-T). Kaplan-Meier methodology was used to assess survival with Cox proportional hazards regression modelling used to calculate hazard ratios (HR). Results: Mean ages of men receiving sip-T and orals were 76 and 78 years, respectively. Most (84%) were white. Regardless of line of use, the risk of death among men receiving sip-T was lower than the risk in men receiving orals, except in men over 90 years old (Table). Conclusions: Based on these claims data, benefits of sip-T use were evident across all ages except for the men 90+ years old with decreasing differences between agents with increasing age, as would be expected. While the oral agents may be perceived as more convenient, greater survival with sip-T suggests that clinicians should consider use of sip-T therapy for mCRPC, irrespective of age. [Table: see text]

M125. DISEASE PREVALENCE, COMORBID CONDITIONS, AND MEDICATION UTILIZATION AMONG PATIENTS WITH SCHIZOPHRENIA IN THE UNITED STATES

BackgroundThe comorbid medical and psychiatric burden for individuals with schizophrenia in the United States is substantial compared with the general population. This study sourced the IBM® MarketScan® Research Databases to examine disease prevalence, comorbid conditions, and drug treatments in a large population of commercial- or Medicaid-insured individuals with schizophrenia in the United States to characterize this patient population.MethodsA retrospective cross-sectional claims analysis from the IBM® MarketScan® Commercial and Medicare Supplemental Databases and the Multi-state Medicaid Database from January 1, 2009 to June 30, 2016 was conducted. Individuals with dual coverage for commercial and Medicare Supplemental were included within the commercial analysis. Schizophrenia cases were defined by ≥1 diagnostic claim (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]/ICD-10-CM) for schizophrenia anytime during the study period. Comorbidities were assessed by ≥1 ICD-9-CM/ICD-10-CM diagnosis code, grouped into clinically meaningful categories according to the Clinical Classifications Software (CCS) level 2 categories. For the comorbidity analysis, within each database, schizophrenia cases were matched with controls along several demographic characteristics. Case-control comorbidity comparisons were performed using prevalence rate ratios (PRRs) and 95% confidence intervals. Medication exposure was assessed for cases only within each database and was based on ≥1 National Drug Code (NDC) occurring in the outpatient setting grouped by Redbook classification.ResultsSchizophrenia prevalence was 0.99% in Medicaid-insured patients and 0.11% in those with commercial insurance. In both commercial and Medicaid databases, the prevalence of comorbidities was higher among schizophrenia cases as compared with controls in approximately ≥80% of the CCS level 2 categories assessed. Of the top 5 categories of comorbidities across databases for schizophrenia cases, those in common were mood disorders, anxiety disorders, other connective tissue disease, and cardiovascular disease. The comorbidities with the highest case-control PRR point estimates across databases included personality disorders, suicide and intentional self-inflicted injury, and impulse control disorders. Antipsychotics, antidepressants, and analgesics/antipyretics–opiate agonists were the most commonly prescribed medications for schizophrenia cases across databases. Risperidone, quetiapine, aripiprazole, and olanzapine were the top 4 antipsychotics prescribed across both databases. The fifth most commonly prescribed antipsychotics were ziprasidone and haloperidol in the commercial and Medicaid databases, respectively.DiscussionThis large-scale database analysis confirmed the burden of medical and psychiatric comorbidities in patients with schizophrenia compared with controls and provided additional insight on treatment approaches in these patients. Understanding the comorbidities affecting this patient population in comparison with the general population highlights the importance of integrated medical and psychiatric care.

Quality of reporting of drug exposure in pharmacoepidemiological studies.

PurposeExposure definitions vary across pharmacoepidemiological studies. Therefore, transparent reporting of exposure definitions is important for interpretation of published study results. We aimed to assess the quality of reporting of exposure to identify where improvement may be needed.MethodWe systematically reviewed observational pharmacoepidemiological studies that used routinely collected health data, published in 2017 in six pharmacoepidemiological journals. Reporting of exposure was scored using 11 items of the ISPE‐ISPOR guideline on reporting of pharmacoepidemiological studies.ResultsOf the 91 studies included, all studies reported the type of exposure (100%), while most reported the exposure risk window (85%) and the exposure assessment window (98%). Operationalization of the exposure window was described infrequently: 16% (14/90) of the studies explicitly reported the presence or absence of an induction period if applicable, 11% (5/47), and 35% (17/49) reported how stockpiling and gaps between exposure episodes were handled, respectively, and 35% (17/49) explicitly mentioned the exposure extension. Switching/add‐on was reported in 62% (50/81). How switching between drugs was dealt with and specific drug codes were reported in 52 (57%) and 24 (26%) studies, respectively.ConclusionPublications of pharmacoepidemiological studies frequently reported the type of exposure, the exposure risk window, and the exposure assessment window. However, more details on exposure assessment are needed, especially when it concerns the operationalization of the exposure risk window (eg, the presence or absence of an induction period or exposure extension, handling of stockpiling and gaps, and specific codes), to allow for correct interpretation, reproducibility, and assessment of validity.

Data Quarantine in the Time of the COVID-19 Pandemic.

Our healthcare information is trapped It is trapped in the proprietary data models of the electronic medical record and in our healthcare systems' data warehouses This reality has become strikingly clear as the COVID-19 pandemic has swept across the globe, killing more than 20,000 people in the United States alone We need answers but struggle to address even the simplest questions How many individuals are infected? Who is at highest risk for developing severe infection? What therapies are being used to treat hospitalized patients? This crisis is testing the limits of our public health and healthcare systems in many ways, including a "quarantined" health information system This perspective reviews several deficiencies in healthcare information technology that currently limit our ability to deal with the pandemic and suggests current solutions moving forward

Utilization of the Cancer Medications Enquiry Database (CanMED)-National Drug Codes (NDC): Assessment of Systemic Breast Cancer Treatment Patterns

Cancer Medications Enquiry Database (CanMED) is comprised of two interactive, nomenclature-specific databases within the Observational Research in Oncology Toolbox: CanMED-Healthcare Common Procedure Coding System (HCPCS) and CanMED-National Drug Code (NDC), described through this study. CanMED includes medications with a) a US Food and Drug Administration-approved cancer treatment or treatment-related symptom management indication, b) inclusion in treatment guidelines, or c) an orphan drug designation. To demonstrate the joint utility of CanMED, medication codes associated with female breast cancer treatment were identified and utilization patterns were assessed within Surveillance Epidemiology and End Results-Medicare (SEER) data. CanMED-NDC (11_2018 v.1.2.4) includes 6860 NDC codes: chemotherapy (1870), immunotherapy (164), hormone therapy (3074), and ancillary therapy (1752). Treatment patterns among stage I-IIIA (20701) and stage IIIB-IV (2381) breast cancer patients were accordant with guideline-recommended treatment by stage and molecular subtype. CanMED facilitates identification of medications from observational data (eg, claims and electronic health records), promoting more standardized and efficient treatment-related cancer research.

PND4 REAL-WORLD COSTS OF ADMINISTERING DISEASE MODIFYING DRUG INFUSIONS AMONG PATIENTS WITH MULTIPLE SCLEROSIS: A US RETROSPECTIVE ADMINISTRATIVE CLAIMS DATABASE ANALYSIS

To document, categorize, and quantify real-world costs associated with administering multiple sclerosis (MS) disease-modifying drug (DMD) infusions using medical billing codes occurring on the same day as a DMD infusion. The IQVIA™ RWD Adjudicated Claims–US database was used to identify patients with a diagnosis of MS and ≥1 Healthcare Common Procedure Coding System (HCPCS) billed medical claims for natalizumab, alemtuzumab, or ocrelizumab from 1/1/2017–9/30/2018. Patients with National Drug Code billed claims for a study DMD were excluded. All medical billing codes (i.e., HCPCS, Current Procedural Terminology [CPT] and Revenue) occurring on the same day as a HCPCS-coded claim for natalizumab, alemtuzumab, or ocrelizumab were included. CPT and HCPCS, and Revenue codes were categorized as administration, co-administration (e.g., pre-treatment steroid, antihistamine, pregnancy test, lab tests, etc.), MS-related, potentially MS-related, and not MS-related. The primary outcome was the average non-DMD cost per infusion-day (i.e., per dose) by category and DMD. The unit of analysis was the infusion-day. The 8,812 patients meeting eligibility criteria had 63,389 infusion days. Mean total non-DMD costs for all medical codes billed on infusion-day were $936 for alemtuzumab, $830 for ocrelizumab, and $401 for natalizumab. Most non-DMD costs were categorized as administration costs; costs for administration per infusion-day were $827 for alemtuzumab, $750 for ocrelizumab, and $346 for natalizumab. The next most costly categories were co-administration costs (alemtuzumab $78, ocrelizumab $52, and natalizumab $18 per infusion-day), MS-related costs (alemtuzumab $5, ocrelizumab $18, and natalizumab $25 per infusion-day), potentially MS-related costs (alemtuzumab $18, ocrelizumab $4, and natalizumab $4 per infusion-day), and unrelated costs (alemtuzumab $9, ocrelizumab $5, and natalizumab $6 per infusion-day). The ‘real-world’ costs of administering DMD infusions among patients with MS should be considered. Challenges exist in setting rules for specificity and sensitivity (e.g., time frame, code categorization, etc.) for capturing appropriate costs.

PND83 IDENTIFYING NEUROMYELITIS OPTICA PATIENTS FROM INSURANCE CLAIMS DATA USING NFERX, A NATURAL LANGUAGE PROCESSING-BASED PLATFORM

Neuromyelitis optica spectrum disorder (NMO) is a rare auto-immune disease affecting the central nervous system and has clinical characteristics similar to multiple sclerosis (MS), making clinical diagnosis challenging. This study aims to improve the identification of NMO patients by leveraging nferX, a natural language processing platform, to enable encoding of patient claims that are specific to NMO versus MS. Disease phenotypes associated with NMO or MS were identified from the biomedical literature using the nferX platform. Patients with at least 1 NMO or MS diagnosis code were identified in the IQVIA Pharmetrics Plus database. Accompanying diagnosis, procedure, and drug codes present in greater than 0.1% of patients and at least 2-fold more prevalent in either cohort were mapped to nferX-identified phenotypes. These phenotypes’ relative association with NMO versus MS were quantified using nferX’s adaptation of the pointwise mutual information metric. Associations were aggregated into a summary score for each patient from the number of corresponding claims in the year preceding the initial NMO or MS diagnosis claim. Separation of scores between cohorts of NMO and MS patients identified with existing standard algorithms was assessed. A total of 307,166 patients with at least 1 NMO or MS claim between 2006-2018 were identified. 3,132 NMO patients and 102,611 MS patients were selected using previously published algorithms. The Cohen’s d separation of summary scores between these two cohorts was 1.50, suggesting significant separation. By applying a cutoff of one standard deviation above the mean summary score, 14,822 NMO patients were identified, including 13,150 patients without any claims for NMO. Use of the nferX platform has the potential to improve identification of NMO patients from claims data. Further validation of the approach is needed to support its future use.

Selective serotonin reuptake inhibitor use patterns among commercially insured US pregnancies (2005-2014).

The goal of this study was to describe patterns of selective serotonin reuptake inhibitor (SSRI) use during pregnancy in a US cohort (2005-2014) of > 1 million commercially insured women using administrative claims. We used international classification of disease (ICD-9) diagnosis and procedure and current procedural terminology codes in the OptumLabs® Data Warehouse to identify deliveries (including losses) among US women aged 15-45 (n= 1,061,023). SSRI dispensings that overlapped with the timing of pregnancy were identified using national drug codes in linked pharmacy claims. Demographic characteristics were imputed based on residential location, census data, and consumer information. We investigated patterns by trimester, agent, and demographic subgroups. A total of 46,087 of women (4.34%) were dispensed SSRIs during the estimated pregnancy period. Sertraline was the most common overall and had the highest initial use after trimester 1, including women who switched from another SSRI, although dispensing for > 1 SSRI during pregnancy was uncommon. Use of vilazodone was rare and had the highest discontinuation after trimester 1, followed by paroxetine. SSRI use was more common among women who were older, White, college-educated, higher income (≥ $100,000), or resided in the Midwest. Paroxetine and dispensings for > 1 SSRI were more common in lower education subgroups. White women had the highest proportion of use in all trimesters of pregnancy, whereas Hispanic women had the lowest. Among commercially insured US women, SSRI use during pregnancy differed by agent and demographics. More research is needed to understand whether these differences are due to symptom reporting, cultural beliefs, and/or physician preferences.