Aim: To compare the hospital-based costs among patients with femoropopliteal artery (FPA) disease treated with Eluvia™ versus Zilver ® PTX ® drug-eluting stents using a large real-world USA hospital database. Materials & methods: This retrospective study included adults in the Premier Healthcare Database who underwent lower extremity FPA endovascular revascularization with Eluvia or Zilver PTX between 1 April 2019 and 31 March 2022. Total hospital-based costs during the index procedure and cumulative 1- and 2-year post-discharge follow-up were compared using multivariable generalized linear models adjusted for age, sex, race and baseline chronic limb-threatening ischemia (CLTI) status. Prespecified subgroup analyses were conducted by care setting (hospital inpatient and hospital outpatient) and among patients with chronic kidney disease (CKD) and CLTI. Results: A total of 7208 patients were included, comprising 4218 treated with Eluvia and 2990 treated with Zilver PTX. Patients treated with Eluvia had a higher prevalence of several comorbidities, including congestive heart failure and CKD. Unadjusted mean hospital-based index procedure costs were similar between groups (Eluvia, $28,631 vs Zilver PTX, $28,359; difference, -$272; p = 0.7233). After adjustment, mean index procedure hospital-based costs did not differ significantly between treatment groups ($30,031, p = 0.8491). However, Eluvia was associated with lower adjusted cumulative hospital-based costs at the 1-year (difference, $4,017; p = 0.0066) and 2-year (difference, $6250; p = 0.0021) follow-up. Similar associations were observed in the hospital inpatient and CKD subgroups, whereas no statistically significant differences were observed in the CLTI subgroup. Conclusion: Across patients undergoing femoropopliteal endovascular revascularization, Eluvia was associated with significantly lower post-discharge cumulative hospital-based follow-up costs than Zilver PTX while index procedure costs were comparable. These findings reflect hospital-based costs captured within participating hospitals and do not include medication costs or costs of care received outside the Premier Healthcare Database; therefore, they should not be interpreted as total healthcare costs.
Aim: Pembrolizumab's six-week extended dosing (ED), approved as an alternative to the standard three-week schedule (SD), offers flexibility in treatment plans. Materials & methods: In this retrospective study across four Belgian hospitals, we described real-world pembrolizumab utilization using a pipeline that processed unstructured data with natural language processing (NLP) and mapped both structured and unstructured data to an OMOP-CDM database. Physicians and data analysts collaboratively developed the project-specific data dictionary and performed validation. Results: A total of 303 patients were included, 56% with non-small cell lung cancer (NSCLC). Most patients (72%) received monotherapy, with 89% starting on SD. For NSCLC first-line monotherapy, the median time on treatment (rwTOT) was 106 days in the ‘SD only’ cohort and 666 days in the ‘SD to ED’ cohort, while the median time to next treatment (rwTTNT) was 280 days for ‘SD only’ (median rwTTNT not reached for ‘SD to ED’). Dosing cohort distributions showed that 74% of patients in the ‘SD to ED’ group had NSCLC, compared with 77% with urothelial cancer in the ‘ED only’ group. The mean (StdDev) gap between administrations was 23 (7) days for SD and 43 (5) days for ED. Most patients receiving ED did so after starting on SD, and all ED initiators stayed on ED. Dosing patterns remained stable pre- and during COVID-19. Conclusion: This study describes real-world pembrolizumab dosing patterns across four Belgian hospitals and illustrates how integrating NLP and structured data within an OMOP-CDM framework can support such analyses. Patients switching from SD to ED showed longer rwTOT and rwTTNT than those on SD alone, though potential immortal time bias requires caution in interpretation.
Background: Given the effectiveness of pre-exposure prophylaxis (PrEP), the HIV prevention landscape is expanding rapidly – including recently approved injectable options which have shown high efficacy in clinical trials. As head-to-head trials of injectable PrEPs are not feasible, indirect treatment comparisons (ITCs) are of value to generate comparative estimates of efficacy and safety. However, several methodological challenges must be carefully considered when conducting these ITCs. This review outlines these complexities to support informed decision-making. Main text: We identified methodological considerations through a narrative review of available literature (including leveraging published systematic reviews), evidence from PrEP trials and, where applicable, reference to methodological guidelines. Our review suggests treatment effect modifiers (TEMs) for PrEP are poorly defined in the HIV PrEP literature and, due to the high efficacy of injectable compared with oral PrEP, encompass potential prognostic factors (such as background HIV incidence). Challenges in comparing potential TEMs across trials were also noted due to, for example, differences in measurement methodology and reporting timepoint for adherence. Accounting for variation in follow-up across studies within potential ITCs is critical as HIV acquisition is a rare, time-dependent event. Additionally, zero or few events occur within injectable PrEP trials in HIV, challenging variance estimation and necessitating alternative statistical approaches. Population-adjustment methods are similarly complicated. Conclusions: This review outlines key considerations and offers practical recommendations to inform robust conduct of ITCs of PrEP, and support the interpretation of results. Areas of further research to strengthen future comparative evidence are also highlighted.
