BACKGROUND:Monitoring prescription medication utilization can serve as a powerful indicator of health system resilience and vulnerabilities during public health emergencies. By examining shifts in medication fills, policymakers and stakeholders can identify both strengths and weaknesses in access to care for vulnerable populations. OBJECTIVE:To evaluate health system responses during the COVID-19 pandemic and inform future preparedness strategies during public health crises using trends in prescription medication utilization. METHODS:Using data from the Colorado All Payer Claims Database (CO APCD), we conducted an interrupted time-series analysis of monthly prescription fills among insured adults from January 2019 to December 2021. Therapeutic categories included opioids, psychotropics, antibiotics, antivirals, cardiometabolic drugs, and oncology medications. Interventional autoregressive integrated moving average models assessed immediate and trend-level changes in utilization following the pandemic onset in March 2020. We separately evaluated prescriptions dispensed by retail pharmacies, including mail order, and physician-administered medications, highlighting differences in how each modality adapted to system-level disruptions. RESULTS:The pandemic led to an immediate decrease in prescription fills, with 3.3 fewer fills per 100 insured adults (95% CI = -0.049 to -0.016; P < 0.001). Retail pharmacy prescriptions rebounded over time, supported by telehealth and mail-order options, whereas physician-administered therapies faced sustained declines. Specific therapeutic classes showed varied responses. Opioid prescriptions decreased by 0.4 fills per 100 adults (95% CI = -0.0058 to -0.0026; P < 0.001), whereas psychotropic medication use increased by 0.8 fills per 100 insured adults (95% CI = 0.0037-0.0123; P < 0.001). Antibiotic and antiviral prescriptions declined significantly. Cardiometabolic and oncology medication utilization remained stable throughout the study period. CONCLUSIONS:The rebound in retail pharmacy prescriptions during the COVID-19 pandemic highlights the role of telehealth and mail-order services in mitigating care disruptions. However, the persistent declines in physician-administered therapies reveal structural vulnerabilities, particularly for populations requiring complex or injectable treatments. Policymakers should build on strengths such as telehealth expansion and existing successful overprescribing management programs for opioids and antibiotics and should also address gaps in access to safe in-person care, particularly for vulnerable populations. Emergency preparedness measures should also prioritize promoting mental health support to ensure comprehensive resilience in future public health crises. By incorporating prescription utilization surveillance into routine health system monitoring, stakeholders can respond proactively to emerging challenges and promote more equitable access to essential therapies during public health emergencies.
PURPOSE:Thiamine doses greater than 200 mg are typically prepared as an IV piggyback (IVPB) and administered over 30 minutes to reduce the risk of adverse events (AE) associated with administration. Administration of high-dose (HD) thiamine as an IV push may reduce cost and clinical burden without increasing risk of AE. METHODS:This was a retrospective, single-center cohort analysis of hospitalized patients over the age of 18 years old admitted to the University of Colorado Hospital and receiving HD thiamine from June 1st, 2024 to October 31st, 2024. In August 2024, the preparation and administration of HD IV thiamine was changed from 500 mg IVPB administered over 30 minutes to 400 mg undiluted IV push over 2 minutes. The primary outcome was the average total cost comparing thiamine 500 mg IVPB versus 400 mg IV push. Secondary outcomes included cumulative dose administrations and AE. RESULTS:A total of 731 patients met inclusion criteria with 339 (46%) receiving thiamine 500 mg IVPB infusion (2,493 doses) and 392 (54%) receiving thiamine 400 mg IV push (3,145 doses). The average total cost of HD thiamine therapy per patient was $91.12 for the 500 mg IVPB cohort and $59.05 for the 400 mg IV push cohort (p < 0.001). Additionally, the mean cumulative dose of thiamine administered was higher in the 500 mg IVPB cohort compared to the 400 mg IV push cohort (P = 0.002). Hypotension (0.5%) and burning sensation (1.0%) were only reported in the thiamine 400mg IV push group and were not statistically significant. CONCLUSIONS:The institutional change from thiamine 500mg IVPB to thiamine 400mg undiluted IV push resulted in significant cost savings with minimal risk for adverse events.
Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) improves survival and health-related quality of life, yet prescribing remains suboptimal in both cardiology and primary care. This study aimed to examine clinicians’ perceptions of safety thresholds and the thresholds at which clinicians hesitate to prescribe GDMT. We conducted a concurrent mixed-methods study using a 24-item survey of cardiologists and primary care providers (PCPs) to assess perceived safe cutoffs (knowledge) and hesitancy thresholds (comfort) for prescribing GDMT across four biometric factors: systolic blood pressure, heart rate, estimated glomerular filtration rate (eGFR), and potassium. Open-ended responses were analyzed thematically, and generalized linear models compared responses by specialty. Among 101 respondents (23 cardiologists, 78 PCPs, from 3 unique health systems), clinicians reported more conservative hesitancy thresholds than safety thresholds, with greater differences among PCPs. PCPs consistently reported more conservative safety and hesitancy thresholds across all biometric categories compared to cardiologists, who pushed thresholds further (lower systolic blood pressure, heart rate, and eGFR; higher potassium). These differences were statistically significant except for potassium and eGFR in two GDMT categories. PCPs cited unfamiliarity with certain medications and concerns about adverse effects as drivers of conservative thresholds, whereas cardiologists emphasized strategies to manage adverse effects. When both potassium and eGFR were relevant, potassium more strongly influenced prescribing decisions. Thresholds at which clinicians hesitate to intensify GDMT for HFrEF are more conservative than their perceived safety thresholds, and variability exists in what is considered an evidence-based safe threshold. Cardiologists push safety and hesitancy thresholds further than PCPs and have smaller differences between these thresholds, which may reflect greater familiarity and less concern about adverse effects. Clinicians reported context is an important determinant of threshold. These findings highlight opportunities for targeted interventions to address knowledge gaps and reduce hesitancy, particularly in primary care.
This study aims to evaluate the financial implications of implementing various payment models, including outcome-based agreements (OBAs), volume-based rebates, and guaranteed rebates, for the newly approved gene therapies, exagamglogene autotemcel (exa-cel) and lovotibeglogene autotemcel (lovo-cel), in the treatment of sickle-cell disease (SCD) from the perspective of Colorado Medicaid. The analysis specifically examines the cost of standard of care (SoC) for severe SCD, the impact of different eligibility criteria based on vaso-occlusive events (VOEs), and the potential financial impacts associated with rebate structures. Data from the Colorado Department of Health Care Policy Financing (HCPF) database was used to estimate the annual costs for Medicaid-enrolled patients with severe SCD from 2018 to 2023. Patients were selected based on various eligibility criteria, including the number of VOEs, acute chest syndrome events, and stroke diagnoses. Three-state Markov models (SCD, stable, and dead) were constructed to compare the costs of SoC and gene therapies. The durability of gene therapy effectiveness and the financial impact of OBAs, volume-based rebates, and guaranteed rebates were evaluated over a 6-year contract period, with scenarios reflecting different VOE criteria and treatment durability. The average annual SoC cost for severe SCD patients (N = 138) was US45,941 (SD US59,653), with higher costs associated with more frequent VOEs. Gene therapies exa-cel and lovo-cel, with one-off list prices of US2.2 million and US3.1 million, respectively, exhibited high upfront costs, resulting in a negative cumulative balance averaging − US2.11 million for exa-cel and − US3.00 million for lovo-cel per patient over 6 years compared with SoC. Outcome-based rebates could potentially save Medicaid approximately US260K (uncertainty interval 88K–772K) per patient on average for exa-cel and US367K (uncertainty interval 122K–1111K) for lovo-cel after they pay the full up-front cost. Volume-based and guaranteed rebates also offered potential savings but varied in impact based on contract duration and effectiveness of gene therapy. The study highlights critical considerations for Medicaid in negotiating OBAs for SCD gene therapies. Achieving budget neutrality over 6 years is unlikely due to low SoC costs. However, payment models can enhance value-based spending by linking high therapy costs and potential rebates to the health gains these treatments may offer. OBAs offer offsets contingent on therapy effectiveness durability and contract terms (such as length and price), while varying eligibility criteria impact budgets and outcomes. Medicaid real-world data is crucial for navigating complexities in defining eligible populations and structuring OBAs.
Background Digital health (patient portals, remote monitoring devices, video visits) is a routine part of health care, though the digital divide may affect access. Objectives To test and validate an electronic health record (EHR) screening tool to identify patients at risk of the digital divide. Materials and Methods We conducted a retrospective EHR data extraction and cross-sectional survey of participants within 1 health care system. We identified 4 potential digital divide markers from the EHR: (1) mobile phone number, (2) email address, (3) active patient portal, and (4) >2 patient portal logins in the last year. We mailed surveys to patients at higher risk (missing all 4 markers), intermediate risk (missing 1-3 markers), or lower risk (missing no markers). Combining EHR and survey data, we summarized the markers into risk scores and evaluated its association with patients' report of lack of Internet access. Then, we assessed the association of EHR markers and eHealth Literacy Scale survey outcomes. Results A total of 249 patients (39.4%) completed the survey (53%>65 years, 51% female, 50% minority race, 55% rural/small town residents, 46% private insurance, 45% Medicare). Individually, the 4 EHR markers had high sensitivity (range 81%-95%) and specificity (range 65%-79%) compared with survey responses. The EHR marker-based score (high risk, intermediate risk, low risk) predicted absence of Internet access (receiver operator characteristics c-statistic=0.77). Mean digital health literacy scores significantly decreased as her marker digital divide risk increased (P <.001). Discussion Each of the four EHR markers (Cell phone, email address, patient portal active, and patient portal actively used) compared with self-report yielded high levels of sensitivity, specificity, and overall accuracy. Conclusion Using these markers, health care systems could target interventions and implementation strategies to support equitable patient access to digital health.
Background: Patients with type 2 diabetes (T2DM) are at risk of developing urinary tract infections (UTIs). Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a common medication associated with UTIs in these patients. However, emerging data show that other medications may be more frequently prescribed prior to UTI diagnosis. Objectives: Explore the correlation of newly prescribed medications in patients with the diagnosis of T2DM prior to an incidence of UTI and compare it to those without a UTI. Design: This observational case-control study aimed to explore the correlation between the incidence of UTIs in patients with T2DM and new prescription medication fills. Methods: Data were retrieved from national prescription and medical claims database IQVIA PharMetric® Plus for Academics between 2018 to 2021. The exposed cohort included patients with T2DM and an encounter for UTI. The comparator cohort was developed using propensity score matching and consisted of patients with T2DM and a health care encounter, but without a diagnosis of UTI. Results: A total of 31,746 patients met study criteria, with 15,873 in both the exposed and matched comparator cohorts. The medications with the largest percentage point difference were opioids at 3.70 ( p -value <0.001), statins at 3.42 ( p -value <0.001), amoxicillin at 2.48 ( p -value <0.001), metformin at 2.45 ( p -value <0.001), and PPIs at 2.19 ( p -value <0.001). SGLT2i were the 19th most prescribed medication class. Conclusion: Opioids, statins, amoxicillin, metformin, and PPIs were the top 5 medications prescribed prior to the UTI event based on percentage point difference. SGLT2i were not in the top 10 medications initiated prior to UTI. This adds to existing literature that other new start medications may be correlated with a higher risk of developing a UTI such as opioids and PPIs than SGLT2 inhibitors in patients with T2DM.
IntroductionHigh-cost gene therapies strain the sustainability of healthcare budgets. Despite the potential long-term savings promised by certain gene therapies, realizing these savings faces challenges due to uncertainties regarding the treatment’s durability and a lesser-discussed factor: the true potential for cost offset. Our study aims to assess the cost-offset uncertainty for US Medicaid regarding recently approved gene therapies in hemophilia A and B.MethodsThe analysis used 2018 to 2022 Colorado Department of Health Care Policy & Financing data to determine direct costs of standard of care (factor replacement therapy or emicizumab). Cost-simulation models over five- and ten-year time horizons estimated Colorado Medicaid costs if patients switched to gene therapy (valoctocogene roxaparvovec or etranacogene dezaparvovec) versus maintaining standard of care. Patients were included if aged 18 and over with ICD-10-CM codes D66 (hemophilia A) and D67 (hemophilia B). In the base case, severe hemophilia A was defined as requiring greater than or equal to six yearly factor VIII or emicizumab claims and moderate/severe hemophilia B requiring greater than or equal to four factor IX replacement therapy claims annually.ResultsAnnual standard-of-care costs were USD426,000 (SD USD353,000) for hemophilia A and USD546,000 (SD USD542,000) for hemophilia B. Valoctocogene roxaparvovec (hemophilia A) had incremental costs of USD880,000 at five years and −USD481,000 at 10 years. Sensitivity analysis revealed a 23 percent chance of break-even within five years and 48 percent within 10 years. Etranacogene dezaparvovec (hemophilia B) showed incremental costs of USD429,000 at five years and −USD2,490,000 at 10 years. Simulation indicated a 32 percent chance of break-even within five years and 59 percent within 10 years. Varying eligibility (≥4 to ≥15 standard-of-care claims) notably affected break-even; for example, valoctocogene roxaparvovec: 40 percent to 77 percent chance of break-even in 10 years.ConclusionsOur study highlights significant cost variation in the standard of care of patients eligible for gene therapies, adding to the uncertainty surrounding cost estimation and highlighting the importance of addressing this factor in risk-sharing agreements. The impact of varying eligibility criteria on cost offsets emphasizes the importance of carefully defining eligibility when using real-world data in the context of health technology assessment.
RationaleLittle is known about the prescribing of medications with potential to cause QTc-prolongation in the ambulatory care settings. Understanding real-world prescribing of QTc-prolonging medications and actions taken to mitigate this risk will help guide strategies to optimize safety and appropriate prescribing among ambulatory patients.ObjectiveTo evaluate the frequency of clinician action taken to monitor and mitigate modifiable risk factors for QTc-prolongation when indicated.MethodsThis retrospective, cross-sectional study evaluated clinician action at the time of prescribing prespecified medications with potential to prolong QTc in adult patients in primary care. The index date was defined as the date the medication was ordered. Electronic health record (EHR) data were evaluated to assess patient, clinician and visit characteristics. Clinician action was determined if baseline or follow-up monitoring was ordered or if action was taken to mitigate modifiable risk factors (laboratory abnormalities or electrocardiogram [ECG] monitoring) within 48 h of prescribing a medication with QTc-prolonging risk. Descriptive statistics were used to describe current practice.ResultsA total of 399 prescriptions were prescribed to 386 patients, with a mean age of 51 +/- 18 years, during March 2021 from a single-centre, multisite health system. Of these, 17 (4%) patients had a known history of QTc-prolongation, 170 (44%) did not have a documented history of QTc-prolongation and 199 (52%) had an unknown history (no ECG documented). Thirty-nine patients (10%) had at least one laboratory-related risk factor at the time of prescribing, specifically hypokalemia (16 patients), hypomagnesemia (8 patients) or hypocalcemia (19 patients). Of these 39 patients with laboratory risk factors, only 6 patients (15%) had their risk acknowledged or addressed by a clinician. Additionally, eight patients' most recent QTc was >= 500 ms and none had an ECG checked at the time the prescription was ordered.ConclusionDespite national recommendations, medication monitoring and risk mitigation is infrequent when prescribing QTc-prolonging medications in the ambulatory care setting. These findings call for additional research to better understand this gap, including reasons for the gap and consequences on patient outcomes.
Rationale: In patients with pneumonia requiring intensive care unit (ICU) admission, alcohol misuse is associated with increased mortality, but the relationship between other commonly misused substances and mortality is unknown. Objectives: We sought to establish whether alcohol misuse, cannabis misuse, opioid misuse, stimulant misuse, or misuse of more than one of these substances was associated with differences in mortality among ICU patients with pneumonia. Methods: This was a retrospective cohort study of hospitals participating in the Premier Healthcare Database between 2010 and 2017. Patients were included if they had a primary or secondary diagnosis of pneumonia and received antibiotics or antivirals within 1 day of admission. Substance misuse related to alcohol, cannabis, stimulants, and opioids, or more than one substance, were identified from the International Classification of Diseases (Ninth and Tenth Editions). The associations between substance misuse and in-hospital mortality were the primary outcomes of interest. Secondary outcomes included the measured associations between substance misuse disorders and mechanical ventilation, as well as vasopressor and continuous paralytic administration. Analyses were conducted with multivariable mixed-effects logistic regression modeling adjusting for age, comorbidities, and hospital characteristics. Results: A total of 167,095 ICU patients met inclusion criteria for pneumonia. Misuse of alcohol was present in 5.0%, cannabis misuse in 0.6%, opioid misuse in 1.5%, stimulant misuse in 0.6%, and misuse of more than one substance in 1.2%. No evidence of substance misuse was found in 91.1% of patients. In unadjusted analyses, alcohol misuse was associated with increased in-hospital mortality (odds ratio [OR], 1.12; 95% confidence interval [CI], 1.06-1.19), whereas opioid misuse was associated with decreased in-hospital mortality (OR, 0.46; 95% CI, 0.39-0.53) compared with no substance misuse. These findings persisted in adjusted analyses. Although cannabis, stimulant, and more than one substance misuse (a majority of which were alcohol in combination with another substance) were associated with lower odds for in-hospital mortality in unadjusted analyses, these relationships were not consistently present after adjustment. Conclusions: In this study of ICU patients hospitalized with severe pneumonia, substance misuse subtypes were associated with different effects on mortality. Although administrative data can provide epidemiologic insight regarding substance misuse and pneumonia outcomes, biases inherent to these data should be considered when interpreting results.
Background: Since the mid-1990s, more than 500,000 deaths have been attributed to the opioid overdose epidemic, which has created a serious national crisis affecting public health and social and economic welfare. To mitigate these opioid-related overdoses and deaths, interventions targeted at both the patient and community level are needed. Objective: This demonstration project sought to determine whether implementation of a provider-to-provider opioid pain teleconsultation service with a pain specialist was correlated with a reduction in inappropriate opioid use and improve health outcomes. Methods: Individual-level claims data for Health First Colorado Medicaid members were collected between March 1, 2017, and September 30, 2021, for individuals who triggered a provider-to-provider pain management teleconsultation based on receipt of a prescription for an opioid where the member was receiving a high-dose opioid (n = 125) or was opioid-naive (n = 819). The primary outcome measures were a patient's opioid dose less than 200 morphine milligram equivalent (MME) by 6 months after the consult if consult was triggered for high-dose use or discontinuation of an opioid by 12 weeks after consult if the consult was triggered for opioid naivety. Secondary opioid-related health outcomes were also assessed. Results: In the high-dose opioid cohort, 87% of the members had their monthly average MME reduced to less than 200 by 180 days after their consult. More than half of the opioid-naive group had discontinued their opioid by 90 days after their consult. Conclusion: Results indicate that provider-to-provider teleconsultation services with a pain specialist can be an effective intervention at reducing total inappropriate opioid use. (c) 2022 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
Introduction: Corticosteroid (CS) treatment reduces the risk of mortality and respiratory failure in patients with human immunodeficiency virus (HIV) and moderate to severe Pneumocystis jirovecii pneumonia (PJP). The role of CS in HIV-negative immunocompromised hosts with PJP remains unclear. Our study aimed to evaluate HIV-negative critically ill patients with PJP and respiratory failure to determine if CS were associated with reduced risk of mortality. Methods: This was a retrospective cohort of HIV-negative critically ill patients with confirmed PJP requiring respiratory support. Patients were identified via the Premier Incorporated database. Inclusion criteria were adult patients requiring respiratory support (supplemental oxygen or non-invasive ventilation [NIV] and mechanical ventilation [MV]) within 48 hours of PJP diagnosis and intensive care unit admission. Exclusion criteria consisted of new or existing HIV diagnosis, death or palliative care within 72 hours, and lack of active PJP treatment. Patients who did not receive CS were compared to those who received prednisone equivalents of at least 40 mg daily (CS). The primary outcome was in-hospital mortality. Results: A total of 807 patients were included (n=176 no CS, n=631 CS) with an average age of 62 years and were 54% male. In the first 48 hours of PJP treatment, 432 patients (54%) required MV and 375 (46%) required NIV. In-hospital mortality occurred in 75 patients (42.6%) who did not receive CS and 237 (37.6%) who received CS (Odds Ratio [OR] 0.81; 95% Confidence Interval [CI] 0.58 to 1.14). There was no difference in ICU free days (11 days [no CS] vs 10.8 days [CS]; p=0.72) or 28-day ventilator free days (13.6 days [no CS] vs 13.3 days [CS]; p=0.55). Furthermore, subgroup analysis of MV patients revealed no significant mortality difference with regard to CS treatment (68% no CS vs 69% CS; OR 0.76; 95% CI 0.51 to 1.14). Conclusions: Corticosteroids are often used for critically ill HIV-negative patients with PJP and respiratory failure. However, CS administration to these patients was not clearly associated with significant reduction in mortality or other clinical outcomes. Further determination of patient selection and risk-benefit analysis of CS in this population is warranted.
Objective:COVID-19, coinciding with the opioid epidemic in the United States, has had significant impacts on health-care utilization. While mixed, early analyses signaled a potential resurgence in opioid use following the pandemic. The primary study objective was to assess the association of the COVID-19 pandemic with opioid utilization among Health First Colorado (Colorado's Medicaid Program) members and a non-Medicaid managed care cohort who did not have a diagnosis of cancer or sickle cell disease.Patients and Methods:Using an interrupted time series and segmented regression analysis, this population-level study assessed the association of the COVID-19 pandemic on prescribed utilization of long- and short-acting opioid analgesics among Health First Colorado members and a random sample of non-Medicaid managed care members. Pharmacy claims data for both cohorts were assessed between October 1, 2018, and September 30, 2021, with April 2020 identified as the interruption of interest. We evaluated the following monthly opioid use measures separately for short-acting and long-acting opioids: number of members filling an opioid, total fills, and total days supplied.Results:Short- and long-acting opioid utilization was significantly decreasing among Health First Colorado members in the 18 months prior to the start of COVID-19. After the onset of the pandemic, utilization stabilized and slopes were not significantly different from zero. Among the non-Medicaid managed care cohort, short- and long-acting opioid utilization significantly decreased in the 18 months leading up to the onset of the pandemic. After the onset of the pandemic, utilization of long-acting opioids stabilized, while utilization of short-acting opioids significantly increased.Conclusion:While we observed an increase in opioid utilization measures post-pandemic in the non-Medicaid managed care cohort, a similar increase was not observed in Health First Colorado members suggesting that thoughtful opioid policies put in place pre-pandemic may have been effective at controlling potential inappropriate opioid utilization.
Objectives In a randomized controlled trial, we found that applying implementation science (IS) methods and best practices in clinical decision support (CDS) design to create a locally customized, "enhanced" CDS significantly improved evidence-based prescribing of beta blockers (BB) for heart failure compared with an unmodified commercially available CDS. At trial conclusion, the enhanced CDS was expanded to all sites. The purpose of this study was to evaluate the real-world sustained effect of the enhanced CDS compared with the commercial CDS.Methods In this natural experiment of 28 primary care clinics, we compared clinics exposed to the commercial CDS (preperiod) to clinics exposed to the enhanced CDS (both periods). The primary effectiveness outcome was the proportion of alerts resulting in a BB prescription. Secondary outcomes included patient reach and clinician adoption (dismissals).Results There were 367 alerts for 183 unique patients and 171 unique clinicians (pre: March 2019-August 2019; post: October 2019-March 2020). The enhanced CDS increased prescribing by 26.1% compared with the commercial (95% confidence interval [CI]: 17.0-35.1%), which is consistent with the 24% increase in the previous study. The odds of adopting the enhanced CDS was 81% compared with 29% with the commercial (odds ratio: 4.17, 95% CI: 1.96-8.85). The enhanced CDS adoption and effectiveness rates were 62 and 14% in the preperiod and 92 and 10% in the postperiod.Conclusion Applying IS methods with CDS best practices was associated with improved and sustained clinician adoption and effectiveness compared with a commercially available CDS tool.
Background: Alabama's Human Life Protection Act (the Act) signed in 2019 became law in 2022, making provision of abortion a felony offense. Objective: In 2020, we assessed the accessibility of emergency contraception (EC) pills in Birmingham, Alabama prior to the Act's enactment given the probable increased need for EC access due to abortion criminalization. Study design: Pharmacy staff were asked about availability, price, location, and identification requirements to obtain EC. Results: Of 69 pharmacies, 59% had levonorgestrel EC and none had ulipristal acetate EC available. Conclusion: There are persistent barriers to EC accessibility that should be addressed as abortion is increasingly restricted. Published by Elsevier Inc.
High upfront costs and long-term benefit uncertainties of gene therapies challenge Medicaid budgets, making value-based contracts a potential solution. However, value-based contract design is hindered by cost-offset uncertainty. The aim of this study is to determine actual cost-offsets for valoctocogene roxaparvovec (hemophilia A) and etranacogene dezaparvovec (hemophilia B) from Colorado Medicaid’s perspective, defining payback periods and its uncertainty from the perspective of Colorado Medicaid. This cost analysis used 2018–2022 data from the Colorado Department of Health Care Policy Financing to determine standard-of-care costs and employed cost simulation models to estimate the cost of Medicaid if patients switched to gene therapy versus if they did not. Data encompassed medical and pharmacy expenses of Colorado Medicaid enrollees. Identified cohorts were patients aged 18+ with ICD-10-CM codes D66 (hemophilia A) and D67 (hemophilia B). Severe hemophilia A required ≥ 6 claims per year for factor therapies or emicizumab, while moderate/severe hemophilia B necessitated ≥ 4 claims per year for factor therapies. Patients were included in the cohort in the year they first met the criteria and were subsequently retained in the cohort for the duration of the observation period. Standard-of-care included factor VIII replacement therapy/emicizumab for hemophilia A and factor IX replacement therapies for hemophilia B. Simulated patients received valoctocogene roxaparvovec or etranacogene dezaparvovec. Main measures were annual standard-of-care costs, cost offset, and breakeven time when using gene therapies. Colorado Medicaid’s standard-of-care costs for hemophilia A and B were 426,000 [standard deviation (SD)353,000] and 546,000 (SD542,000) annually, respectively. Substituting standard-of-care with gene therapy for eligible patients yielded 8-year and 6-year average breakeven times, using real-world costs, compared with 5 years with published economic evaluation costs. Substantial variability in real-world standard-of-care costs resulted in a 48
OBJECTIVE:To compare the effectiveness of 2 clinical decision support (CDS) tools to avoid prescription of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with heart failure (HF): a "commercial" and a locally "customized" alert. METHODS:We conducted a retrospective cohort study of 2 CDS tools implemented within a large integrated health system. The commercial CDS tool was designed according to third-party drug content and EHR vendor specifications. The customized CDS tool underwent a user-centered design process informed by implementation science principles, with input from a cross disciplinary team. The customized CDS tool replaced the commercial CDS tool. Data were collected from the electronic health record via analytic reports and manual chart review. The primary outcome was effectiveness, defined as whether the clinician changed their behavior and did not prescribe an NSAID. RESULTS:A random sample of 366 alerts (183 per CDS tool) was evaluated that represented 355 unique patients. The commercial CDS tool was effective for 7 of 172 (4%) patients, while the customized CDS tool was effective for 81 of 183 (44%) patients. After adjusting for age, chronic kidney disease, ejection fraction, NYHA class, concurrent prescription of an opioid or acetaminophen, visit type (inpatient or outpatient), and clinician specialty, the customized alerts were at 24.3 times greater odds of effectiveness compared to the commercial alerts (OR: 24.3 CI: 10.20-58.06). CONCLUSION:Investing additional resources to customize a CDS tool resulted in a CDS tool that was more effective at reducing the total number of NSAID orders placed for patients with HF compared to a commercially available CDS tool.
The high-dose (HD) influenza vaccine is approved for use in adults ages ≥65 with evidence for reducing influenza infections and hospitalizations. The objective of this study was to determine the impact of the HD vs standard-dose (SD) influenza vaccine on hospitalizations among adults ages 50-80. A fuzzy regression discontinuity design was used to estimate the causal effect of the HD vaccine on respiratory hospitalizations. This design takes advantage of the discontinuity in likelihood of receiving the HD vaccine at age 65 to compare the outcomes of adults immediately above and below age 65. Data was extracted from IQVIA claims database for adults with an insurance claim for a HD or SD vaccine during the 2012-2018 influenza seasons (September-April). Outcomes and covariates were identified using International Classification of Diseases codes. The primary outcome was respiratory-related hospitalization. Covariates included demographics, comorbidities, and history of receiving the HD vaccine. The study included 384,180 individuals. The HD vaccine was used in 0.3% of adults 50-64 and 52% of adults 65 and older. Receipt of the HD vaccine decreased the probability of respiratory-related hospitalization by 0.5% points (95% CI -0.8%, -0.2%) compared to the SD vaccine (p=0.002) for adults who received HD because it was approved for their age group. Results were robust to various model specifications and sensitivity tests. The HD vaccine reduced the rate of respiratory-related hospitalization compared to the SD vaccine among adults who received HD vaccine because of their age. The results suggest that extending approval to adults ages 50-64 would reduce respiratory-related hospitalizations among those who become newly eligible.
Background: Data are limited regarding the incidence of thromboembolism post-hospital discharge among COVID-19 patients. Guidelines addressing the role of extended thromboprophylaxis for COVID-19 patients are limited and conflicting. Objective: The purpose of this study was to evaluate the incidence of post-discharge thromboembolic and bleeding events and the role of thromboprophylaxis among COVID-19 patients. Methods: A retrospective analysis was conducted of hospitalized patients with symptomatic COVID-19 infection who were discharged from a University of Colorado Health (UCHealth) hospital between March 1, 2020, and October 31, 2020. The primary outcome was objectively confirmed thromboembolism within 35 days post-discharge. The main secondary outcome was the incidence of bleeding events within 35 days post-discharge. Outcomes were compared between those who received extended prophylaxis and those who did not. Results: A total of 1171 patients met the study criteria. A total of 13 (1.1%) of patients had a documented thromboembolic event and 10 (0.9%) patients had a documented bleeding event within 35 days post-discharge. None of the 132 patients who received extended prophylaxis had a thromboembolic event compared to 13 of 1039 who did not receive extended prophylaxis (0 and 1.3%, respectively; P = .383). The incidence of bleeding was higher among patients who received extended prophylaxis compared to those who did not (3.0% vs 0.6%, P = .019). Conclusions and Relevance: These results suggest that post-discharge extended prophylaxis may be beneficial for select COVID-19 patients, while carefully weighing the risk of bleeding. Application of our findings may assist institutions in development of thromboprophylaxis protocols for discharged COVID-19 patients.