Health Equity in Patients Receiving Durvalumab for Unresectable Stage III Non-Small Cell Lung Cancer in the US Veterans Health Administration.

BACKGROUND: Real-world evidence is limited regarding the relationship between race and use of durvalumab, an immunotherapy approved for use in adults with unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy (CRT). This study aimed to evaluate if durvalumab treatment patterns differed by race in patients with unresectable stage III NSCLC in a Veterans Health Administration (VHA) population. MATERIALS AND METHODS: This was a retrospective analysis of White and Black adults with unresectable stage III NSCLC treated with durvalumab presenting to any VHA facility in the US from January 1, 2017, to June 30, 2020. Data captured included baseline characteristics and durvalumab treatment patterns, including treatment initiation delay (TID), interruption (TI), and discontinuation (TD); defined as CRT completion to durvalumab initiation greater than 42 days, greater than 28 days between durvalumab infusions, and more than 28 days from the last durvalumab dose with no new durvalumab restarts, respectively. The number of doses, duration of therapy, and adverse events were also collected. RESULTS: A total of 924 patients were included in this study (White = 726; Black = 198). Race was not a significant factor in a multivariate logistic regression model for TID (OR, 1.39; 95% CI, 0.81-2.37), TI (OR, 1.58; 95% CI, 0.90-2.76), or TD (OR, 0.84; 95% CI, 0.50-1.38). There were also no significant differences in median (interquartile range [IQR]) number of doses (White: 15 [7-24], Black: 18 [7-25]; P = .25) or median (IQR) duration of therapy (White: 8.7 months [2.9-11.8], Black: 9.8 months [3.6-12.0]; P = .08), although Black patients were less likely to experience an immune-related adverse event (28% vs. 36%, P = .03) and less likely to experience pneumonitis (7% vs. 14%, P < .01). CONCLUSION: Race was not found to be linked with TID, TI, or TD in this real-world study of patients with unresectable stage III NSCLC treated with durvalumab at the VHA.

Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective.

BACKGROUND: The combinations of BRAF + MEK inhibitors-encorafenib (ENC) + binimetinib (BIN), cobimetinib (COB) + vemurafenib (VEM), and dabrafenib (DAB) + trametinib (TRA)-are recommended for the treatment of BRAF-mutated advanced melanoma. OBJECTIVE: To assess the cost-effectiveness and cost-utility of ENC + BIN versus COB + VEM versus DAB + TRA from a US payer perspective. METHODS: A Markov model was constructed to simulate a hypothetical cohort over a time horizon of 10 years. The overall survival (OS) and progression-free survival (PFS) curves were independently digitized from a randomized controlled trial for ENC + BIN and fitted using R software. Published and indirectly estimated hazard ratios were used to fit OS and PFS curves for COB + VEM and DAB + TRA. Costs, life-year gains, and quality-adjusted life years (QALYs) associated with the 3 treatment combinations were estimated. A base case analysis and probabilistic sensitivity analysis (PSA) were conducted to estimate the incremental cost-utility ratio (ICUR). A discount rate of 3.5% was applied on cost and outcomes. RESULTS: The ENC + BIN versus COB + VEM comparison was associated with an ICUR of $656 233 per QALY gained. The ENC + BIN versus DAB + TRA comparison was associated with an ICUR of $3 135 269 per QALY gained. The DAB + TRA combination dominated COB + VEM. The base case analysis estimates were confirmed by the PSA estimates. ENC + BIN was the most cost-effective combination at a high willingness-to-pay (WTP) threshold of $573 000 per QALY and $1.5 million/QALY when compared to COB + VEM and DAB + TRA, respectively. CONCLUSION AND RELEVANCE: Given current prices and acceptable WTP thresholds, our study suggests that DAB + TRA is the optimum treatment. In this study, ENC + BIN was cost-effective only at a very high WTP per QALY threshold.

Clostridioides difficile Infection Treatment and Outcome Disparities in a National Sample of United States Hospitals.

Clostridioides difficile infection (CDI) disproportionately affects certain populations, but few studies have investigated health outcome disparities among patients with CDI. This study aimed to characterize CDI treatment and health outcomes among patients by age group, sex, race, and ethnicity. This was a nationally representative, retrospective cohort study of patients with laboratory-confirmed CDI within the Premier Healthcare Database from January 2018 to March 2021. CDI therapies received and health outcomes were compared between patients by age group, sex, race, and Hispanic ethnicity using bivariable and multivariable statistical analyses. A total of 45,331 CDI encounters were included for analysis: 38,764 index encounters and 6567 recurrent encounters. CDI treatment patterns, especially oral vancomycin use, varied predominantly by age group. Older adult (65+ years), male, Black, and Hispanic patients incurred the highest treatment-related costs and were at greatest risk for severe CDI. Male sex was an independent predictor of in-hospital mortality (aOR 1.17, 95% CI 1.05−1.31). Male sex (aOR 1.25, 95% CI 1.18−1.32) and Black race (aOR 1.29, 95% CI 1.19−1.41) were independent predictors of hospital length of stay >7 days in index encounters. In this nationally representative study, CDI treatment and outcome disparities were noted by age group, sex, and race.

Cost-effectiveness of palonosetron and dexamethasone-based triple and quadruple regimens in preventing highly emetogenic chemotherapy-induced nausea and vomiting.

OBJECTIVE: Cost-effectiveness analyses that consider all currently used antiemetics in the case of emetogenic chemotherapy-induced nausea and vomiting (CINV) have not been performed yet. We aim to compare the cost-effectiveness of olanzapine (OLA), or/and neurokinin-1 receptor antagonists (NK-1-RAs), in combination with palonosetron (PAL) and dexamethasone (DEX) in preventing highly emetogenic CINV. METHODS: Two decision analytic models were constructed. The first model was based on overall complete response (CR); the second model was based on rate of absence of nausea. Four antiemetic regimens PAL + DEX, NK-1-RAs + PAL + DEX, OLA + PAL + DEX, and PAL + NK-1-RA + DEX + OLA were compared in terms of cost, overall CR and rate of absence of nausea. Base case incremental cost-effectiveness ratio (ICER) estimates were calculated. The study was from the US payer perspective. RESULTS: In terms of CR, the PAL + NK-1-RA + DEX + OLA was associated with the highest gains in the percentage of CR among all treatment regimens at base case ICERs of $4220 versus PAL + DEX, $4656 versus NK-1-RA + PAL + DEX, $16,471 versus OLA + PAL + DEX. In term of rate of absence of nausea, the PAL + NK-1-RA + DEX + OLA was associated with the highest rate of absence of nausea among all the treatment regimens at base case ICERs of $2291 versus PAL + DEX, $1304 versus NK-1-RA + PAL + DEX, $2657 versus OLA + PAL + DEX. CONCLUSION: from an economic perspective, our study revealed that whether to use overall CR or/and rate of absence of nausea as determinants in the antiemetic decision for the CINV patients, the CR-based-, and rate of absence of nausea-based cost-effectiveness analyses, showed negotiable ICER estimates for the treatment PAL + NK-1-RA + DEX + OLA over the combinations PAL + DEX, NK-1-RA + PAL + DEX, and OLA + PAL + DEX regimens.

National Disparities in Antibiotic Prescribing by Race, Ethnicity, Age Group, and Sex in United States Ambulatory Care Visits, 2009 to 2016.

While efforts have been made in the United States (US) to optimize antimicrobial use, few studies have explored antibiotic prescribing disparities that may drive future interventions. The objective of this study was to evaluate disparities in antibiotic prescribing among US ambulatory care visits by patient subgroups. This was a retrospective, cross-sectional study utilizing the National Ambulatory Medical Care Survey from 2009 to 2016. Antibiotic use was described as antibiotic visits per 1000 total patient visits. The appropriateness of antibiotic prescribing was determined by ICD-9 or ICD-10 codes assigned during the visit. Subgroup analyses were conducted by patient race, ethnicity, age group, and sex. Over 7.0 billion patient visits were included; 11.3% included an antibiotic prescription. Overall and inappropriate antibiotic prescription rates were highest in Black (122.2 and 78.0 per 1000) and Hispanic patients (138.6 and 79.8 per 1000). Additionally, overall antibiotic prescription rates were highest in patients less than 18 years (169.6 per 1000) and female patients (114.1 per 1000), while inappropriate antibiotic prescription rates were highest in patients 18 to 64 years (66.0 per 1000) and in males (64.8 per 1000). In this nationally representative study, antibiotic prescribing disparities were found by patient race, ethnicity, age group, and sex.

Comparative value of four measures of retention in expert care in predicting clinical outcomes and health care utilization in HIV patients.

This study compared the ability of four measures of patient retention in HIV expert care to predict clinical outcomes. This retrospective study examined Veterans Health Administration (VHA) beneficiaries with HIV (ICD-9-CM codes 042 or V08) receiving expert care (defined as HIV-1 RNA viral load and CD4 cell count tests occurring within one week of each other) at VHA facilities from October 1, 2006, to September 30, 2008. Patients were ≥18 years old and continuous VHA users for at least 24 months after entry into expert care. Retention measures included: Annual Appointments (≥2 appointments annually at least 60 days apart), Missed Appointments (missed ≥25% of appointments), Infrequent Appointments (>6 months without an appointment), and Missed or Infrequent Appointments (missed ≥25% of appointments or >6 months without an appointment). Multivariable nominal logistic regression models were used to determine associations between retention measures and outcomes. Overall, 8,845 patients met study criteria. At baseline, 64% of patients were virologically suppressed and 37% had a CD4 cell count >500 cells/mm3. At 24 months, 82% were virologically suppressed and 46% had a CD4 cell count >500 cells/mm3. During follow-up, 13% progressed to AIDS, 48% visited the emergency department (ED), 28% were hospitalized, and 0.3% died. All four retention measures were associated with virologic suppression and antiretroviral therapy initiation at 24 months follow-up. Annual Appointments correlated positively with CD4 cell count >500 cells/mm3. Missed Appointments was predictive of all primary and secondary outcomes, including CD4 cell count ≤500 cells/mm3, progression to AIDS, ED visit, and hospitalization. Missed Appointments was the only measure to predict all primary and secondary outcomes. This finding could be useful to health care providers and public health organizations as they seek ways to optimize the health of HIV patients.

Impact of cancer supportive care pathways compliance on emergency department visits and hospitalizations.

PURPOSE: To evaluate the effects of compliance to cancer supportive care pathways on emergency department (ED) visits and hospitalizations as a result of neutropenia, anemia, and chemotherapy-induced nausea and vomiting (CINV). METHODS: CareFirst claims database was used to evaluate data spanning 2 years of the clinical pathways program. Frequency of ED visits/hospitalizations for neutropenia, anemia, and CINV were compared between compliant and noncompliant pathway utilization of granulocyte colony-stimulating factors (G-CSFs), erythropoiesis-stimulating agents (ESAs), and antiemetics, respectively. Logistic regression analysis was used to control for drug expenditures and cancer types. RESULTS: A total of 4,144 lines of therapy were received by 3,191 patients from 46 practices across three states. Overall, there were 472 ED visits/hospitalizations for neutropenia, 34 visits for anemia, and 799 visits for CINV. G-CSF pathway-compliant treatment was associated with a significant reduction in neutropenia ED visits/hospitalizations compared with noncompliant treatment (odds ratio [OR] = 0.34; 95% CI, 0.25 to 0.45; P < .001). Adjusting for cancer type and G-CSF drug expenditures, a similar reduction in neutropenia ED visits/hospitalizations was observed (OR = 0.42; 95% CI 0.30 to 0.58; P < .001). Analogous analyses did not demonstrate a significant association between ESA and antiemetic pathway compliance and ED visits/hospitalizations for anemia (P = .069) and CINV (P = .106), respectively. G-CSF therapy pathway compliance was also associated with an average decrease of $1,085 in ED visit/hospitalization costs per line of therapy (P < .001). CONCLUSION: G-CSF pathway compliance was associated with a significant decrease in the rate of neutropenia ED visits/hospitalizations and resulting costs.

Treatment failure and costs in patients with methicillin-resistant Staphylococcus aureus (MRSA) skin and soft tissue infections: a South Texas Ambulatory Research Network (STARNet) study.

OBJECTIVE: To measure the incidence of treatment failure and associated costs in patients with methicillin-resistant Staphylococcus aureus skin and soft tissue infections (SSTIs). METHODS: This was a prospective, observational study in 13 primary care clinics. Primary care providers collected clinical data, wound swabs, and 90-day follow-up information. Patients were considered to have "moderate or complicated" SSTIs if they had a lesion ≥5 cm in diameter or diabetes mellitus. Treatment failure was evaluated within 90 days of the initial visit. Cost estimates were obtained from federal sources. RESULTS: Overall, treatment failure occurred in 21% of patients (21 of 98) at a mean additional cost of $1,933.71 per patient. In a subgroup analysis of patients who received incision and drainage, those with moderate or complicated SSTIs had higher rates of treatment failure than those with mild or uncomplicated SSTIs (36% vs. 10%; P=.04). CONCLUSIONS: One in 5 patients presenting to a primary care clinic for a methicillin-resistant S. aureus SSTI will likely require additional interventions at an associated cost of almost $2,000 per patient. Baseline risk stratification and new treatment approaches are needed to reduce treatment failures and costs in the primary care setting.

Documenting the benefits and cost savings of a large multistate cancer pathway program from a payer's perspective.

PURPOSE: Clinical pathways are viewed as valuable practice tools leading to presumed cost savings. CareFirst BlueCross BlueShield partnering with P4 Pathways implemented a multistate oncology clinical pathways program in 2008. This is the first comprehensive evaluation to our knowledge of a pathways program implemented on a broad scale. METHODS: This study used a retrospective single-group, pretest-post-test design. Data representing preclinical pathways (year -1) and 2 years after program initiation (years +1 and +2) were obtained from claims data. Participating sites with ≥one claim for breast, lung, or colorectal cancer treatment from each year were included in the evaluation. Compliance was defined as site attainment of prespecified annual thresholds for the use of chemotherapy and supportive care. Savings were determined by comparing per-patient changes in drug and hospital costs through year +2 with the projected annual expenditure increases of 12% and 7%, respectively. RESULTS: Forty-six sites representing 4,713 patients met inclusion criteria. The unadjusted site compliance rate for chemotherapy was 83% and 54% for years +1 and +2, respectively; supportive care site compliance was 74% for both years. Per-patient drug costs increased from $16,494 in year -1 to $16,906 in year +2 (P=.587), whereas hospitalization costs decreased from $2,502 to $1,064 (P=.004). Compared with projected cost increases, pathways resulted in $10.3 million in savings by participant sites ($7.0 million from drugs and $3.3 million from hospitalizations) or $30.9 million when extrapolated to the entire health plan. CONCLUSION: Broadly implemented clinical pathways can achieve reasonable physician compliance, resulting in substantial cost savings.