ClinicoEconomics and Outcomes Research最新文献

Introduction: Time-driven activity-based costing (TDABC) is a highly accurate method for determining the true cost of delivering a healthcare service. However, TDABC is most often applied to a singular phase of care such as an outpatient visit or a surgical event. Here we broaden the scope by using TDABC to estimate the costs of surgically treating cervical myelopathy - from the moment of surgical scheduling until post-operative hospital discharge.

Methods: In a single-center retrospective study at a large tertiary academic institution, TDABC was employed to measure pre-operative, intra-operative, and post-operative (inpatient) costs for 63 patients undergoing elective surgery for cervical myelopathy. Cost patterns among different surgical approaches (anterior, posterior, anterior/posterior) were analyzed using generalized linear models and the Kruskal-Wallis test.

Results: 63 consecutive patients who underwent elective surgery for cervical myelopathy were examined (anterior approach: 36.5%, n=23; posterior approach: 54.0%, n=34; anterior/posterior approach: 9.5%, n=6). The average pre-operative, intraoperative, and postoperative costs were $352.83 ± $205, $10,809.09 ± $6052.69, and $5327.07 ± $5114.78, respectively. The average total episode cost for all cases was $16,488.99 ± $8,181,777. Kruskal-Wallis analysis revealed that total episode cost for the anterior-posterior approach was significantly higher than for both the anterior (p<0.001) and posterior approaches (p<0.05), while the total episode cost for the anterior approach was significantly less than that of the posterior (p<0.001).

Conclusion: We have demonstrated the feasibility of TDABC for estimating a large fraction of total episode costs for the surgical treatment of cervical myelopathy. This may also be the first attempt at understanding episode costs across multiple surgical options for a given spinal diagnosis, which will be relevant as condition-based bundled payments emerge. As expected, anterior cervical surgeries incurred lower costs than posterior surgeries, which incurred lower costs than anterior-posterior surgeries.

Purpose: Investments in antiretroviral therapy (ART) have shown to improve outcomes for those living with human immunodeficiency virus (HIV) and reduce exposure to and transmission of the virus. In the current work, we assess the impact of ART on government public accounts since its introduction in 1987.

Methods: National HIV epidemiological data from 1987 to 2023 were compared to a hypothetical no ART treatment scenario. This scenario was based on time series analysis, and on a transmission equation based on the effectiveness of ART. In the absence of historical epidemiological data, trend extrapolations were considered. The model assumes that individuals on ART are virally suppressed and, conservatively, excludes the impact of pre-exposure prophylaxis. The resulting differences in the number of HIV infections, acquired immunodeficiency syndrome (AIDS) cases and HIV-related deaths per year, were then considered to evaluate the impact on the labor market and on healthcare costs, based on the literature. The impact on employment was then used to estimate tax revenue and social benefits transfers. Results are presented separately with and without longevity effects.

Results: The investment in ART from 1987 to 2023 was estimated to prevent millions of new infections and AIDS cases and to avoid HIV-related deaths. This investment was estimated to provide a return of US$2.11 trillion from 1987 to 2023; each US$1 spent on ART was estimated to create a revenue of US$4.3 to the public sector in the USA. Results remained positive when longevity effects were included. One-way sensitivity analysis showed results were robust.

Conclusion: The analysis illustrates the broader economic benefits to the government attributed to public and private investments to develop and make ART available. The fiscal analysis of investing in ART shows a fourfold gain for the US government. This broader analysis is crucial to help shape health policy and funding decisions.

Purpose: This study aims to evaluate the economic value of Bictegravir/emtricitabine/tenofovir (B/F/TAF) as a first-line treatment for HIV-1 infection in China, where such evaluations are currently lacking.

Patients and methods: We developed a monthly-cycle Markov model to evaluate the economics of B/F/TAF versus dolutegravir/lamivudine (DTG/3TC) as a first-line ART for adult HIV-1 patients over a lifelong time. The social costs, quality-adjusted life years (QALYs), incremental net monetary benefit (INMB), and incremental cost-effectiveness ratio (ICER) have been analyzed using health economic methods. Sensitivity analyses were conducted for the result validation. Taking into account the transmissibility of HIV, we have developed a scenario within a dynamic model across the entire population in China, to conduct a health economic evaluation of the two drugs over 30 years. Model precision was tested using relative standard deviation (RSD).

Results: In the Markov model, B/F/TAF had higher per-person costs compared to DTG/3TC ($44,381.33 vs $42,160.13), but also resulted in greater QALYs (11.6771 vs 11.5389), leading to a per-person INMB of $3072.26 (WTP = 3GDP) and an ICER of $16,052.42 per QALY. Uncertainty analyses confirmed the robustness of these results. The dynamic model further indicated that B/F/TAF was both cost-benefit and cost-effective, with a per-person INMB of $7.33 (WTP = 3GDP) and an ICER of $7,953.72 per QALY, although it exhibited a higher RSD.

Conclusion: After adopting the B/F/TAF regimen in China, the cost-benefit and cost-effectiveness of HIV prevention and treatment have significantly improved. We should advocate for B/F/TAF as the first-line treatment to enhance HIV management.

Purpose: In the wake of ever-increasing health care costs, solutions are sought to make health care more affordable, such as moving hospital outpatient procedures to office-based laboratory (OBL) settings. A budget impact model was constructed to estimate the health plan cost benefit of moving 50% of yttrium-90 resin microspheres (Y-90) selective internal radiation therapy (SIRT) procedures for unresectable liver metastases associated with primary colorectal cancer (CRC) from a traditional hospital outpatient setting (HOPPS) to an OBL setting.

Methods: The eligible population was estimated using an incidence-based approach for a hypothetical health plan with 1 million covered lives. Modeled costs were based on 2024 Medicare reimbursement rates. Three treatment scenarios were considered: 1) base case HOPPS, 2) hybrid (HOPPS/OBL), and 3) OBL settings. Budget impacts were estimated as the differences in annual total cost of treatment after switching 50% of Y-90 SIRTs from HOPPS to the hybrid (HOPPS/OBL) or OBL setting. Per-member-per-month (PMPM) budget impacts were also calculated. Sensitivity analyses were conducted by varying the proportions of patients shifting settings and the treatment setting they were shifting into.

Results: Annually, 28 patients were estimated to have metastatic CRC and unresectable liver metastases in a health plan of 1 million members. Average estimated per-patient cost savings would be $8,791 by switching one patient to a hybrid setting and $17,697 for a patient switched to the OBL. Switching 50% of eligible procedures resulted in PMPM cost benefits to the plan of $0.0102 for hybrid setting and $0.0206 for OBL. In sensitivity analyses, annual cost savings for the health plan were affected by both the proportion of patients shifted and the setting they were shifted into.

Conclusion: Shifting a percentage of the treatment of unresectable liver metastases with Y-90 SIRT to the OBL setting results in modest cost benefits for US health plans.

Objective: Out-of-Hospital Cardiac Arrest (OHCA) is a significant public health issue in Poland, with only an 8.4% survival rate to hospital discharge. Early initiation of Basic Life Support and defibrillation through a Community First Responder (CFR) system can markedly improve survival rates and neurological outcomes.

Methods: A decision tree and Markov model compared the cost-effectiveness of three scenarios against standard care by estimating costs and quality-adjusted life years (QALYs). Scenario 1 involved raising public awareness and educating on the 30:2 CPR protocol. Scenario 2 added equipping blue-light service vehicles with Automated External Defibrillators (AEDs) and training personnel. Scenario 3 implemented a full CFR system with integrated AEDs, dispatch centers, and trained citizen responders. The analysis included survival to hospital discharge, with sensitivity analyses assessing robustness.

Results: The incremental cost-effectiveness ratios (ICERs) were €15,221 for Scenario 1, €30,659 for Scenario 2, and €16,205 for Scenario 3 per QALY gained-all below the threshold of €50,197. Improvements were observed in all stages, including survival to hospital discharge and neurologically intact survival. Probabilistic sensitivity analyses confirmed the robustness of the results.

Conclusion: Implementing a CFR system in Poland is a cost-effective strategy that enhances survival rates after OHCA at an acceptable cost per QALY. The study emphasizes the importance of AED accessibility, trained CFRs, and streamlined emergency responses to improve survival and quality of life for OHCA patients. These findings support policy development and resource allocation to strengthen Poland's emergency medical response to OHCA.

Purpose: Rheumatoid arthritis (RA) affects approximately 0.3 to 1.2% of the world's population. The objective of this study was to identify the existing literature on economic evaluations of RA in Latin America.

Patients and methods: Studies of economic evaluations of patients with RA from 2000 to 2023 were analyzed using the databases PubMed, Scopus, Web of Science, Embase, Cochrane, and the Virtual Health Library following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Study quality was assessed using the Joanna Briggs Institute (JBI) tool, and qualitative analysis was done (following SwiM guidelines).

Results: A total of 851 articles were identified. Following the application of inclusion criteria to titles and abstracts, 117 articles were initially considered eligible. Of these, 42 were excluded due to population or outcome-based errors, leaving 27 articles and 48 abstracts for analysis. Duplicates were removed prior to this process. The included studies involved various designs: cross-sectional, longitudinal, prospective, and retrospective. Brazil accounted for the highest proportion of publications (33.3%), followed by Colombia and Mexico, each contributing 26%. Most economic studies focused on cost analysis (86%), while cost-effectiveness studies and cost-utility studies represented 7.4% and 3.3%, respectively. Predominant perspectives included third-party payer 26%, insurers 14.8%, social providers 7.4%, and mixed providers 3.7%. In terms of publications of abstracts, Colombia leaded at 35.4%. The predominant perspective was that of the provider 66.6%, including the general perspective (37.5%), private (34.3%), public (22%), and mixed (6.2%) and the perspective of third-party payers (33.3%).

Conclusion: Economic evaluations of rheumatoid arthritis in Latin America remain limited, with most studies focusing on cost analysis. Brazil, Colombia, and Mexico lead in publications, primarily from a provider perspective. Greater emphasis on cost-effectiveness and broader economic evaluations is needed to guide health policy in the region.

Purpose: To compare the cost-effectiveness of mosunetuzumab with tisagenlecleucel for treating patients with relapsed or refractory follicular lymphoma (R/R FL 3L+) from the perspective of the Italian National Health Service (NHS).

Patients and methods: The analysis employs a weekly cycle partitioned survival model (PSM) with a lifetime horizon. The PSM model tracks patient outcomes based on time-to-event data, including progression-free survival (PFS) and post-progression survival (PPS). A matching-adjusted indirect treatment comparison (MAIC) approach was used to account for differences in trial population characteristics on the relative efficacy of mosunetuzumab to tisagenlecleucel. PFS and overall survival (OS) were extrapolated beyond the trial period by applying the hazard ratios from the MAIC to mosunetuzumab's parametric survival curves. Utility values and patient data are retrieved from the GO29781 trial. Economic inputs, from the perspective of the Italian NHS, include direct medical costs such as drugs, administration, monitoring, adverse event (AE) management, therapy following FL progression. Discontinuation and terminal care costs were also considered. Probabilistic sensitivity (PSA) and scenario analyses were conducted.

Results: Mosunetuzumab was found to be dominant compared to tisagenlecleucel, resulting in an increase of 0.98 life years (LYs) and 0.70 quality-adjusted life years (QALYs), while also being associated with lower overall costs. The sensitivity analysis consistently favored mosunetuzumab, with 94% of simulations demonstrating its cost-effectiveness based on the Italian WTP threshold of €40,000/QALY. Even in a scenario where tisagenlecleucel maintained a PFS advantage with assumed equivalence in OS, mosunetuzumab still showed a favorable cost-saving profile due to its lower incremental costs.

Conclusion: In the Italian setting, mosunetuzumab is a cost-effective treatment option compared to tisagenlecleucel for adult patients with R/R 3L+ FL, presenting favourable outcomes from the perspective of the NHS. Future research and data collection efforts are crucial to validate these findings and reduce uncertainties regarding long-term clinical and economic implications.

Purpose: Two analyses, a cost-minimization and a budget impact, were conducted to estimate the economic and financial impact of subcutaneous (SC) vs intravenous (IV) natalizumab in terms of administration times and costs in the Italian setting from the perspective of multiple sclerosis (MS) center, patient, and society.

Patients and methods: Cost minimization analysis (CMA) adopted a Markov model with three different states, and it is based on the results of REFINE study and its post-hoc analysis, which evaluated and demonstrated the non-inferiority of natalizumab SC vs IV formulation. The economic inputs came mainly from EASIER study, that estimated the administration time, resource consumption, and costs of natalizumab SC vs IV. A lifetime horizon was considered. Budget impact analysis (BIA) was conducted with a cost calculator approach and compared a base scenario (without SC natalizumab) with an alternative scenario (with SC natalizumab). The inputs were shared with the CMA and a 3-year time horizon was considered. A progressive increase in the number of patients treated with natalizumab SC was estimated from the 1st to the 2nd to the 3rd year after reimbursement in Italy.

Results: CMA estimated that savings due to the use of SC instead of IV natalizumab would be €2,824, €1,137, and €9,170 per patient from the perspectives of MS center, patient, and society, respectively, thus depicting a weak dominance (lower costs and non-inferiority efficacy). BIA estimated that the savings were approximately 3.2 million euros from the perspective of MS centers and around 10.3 million euros from the perspective of society in the first 3 years following reimbursement.

Conclusion: Administering natalizumab subcutaneously rather than intravenously to treatment-eligible patients would result in administration time and cost savings thus determining a favorable impact for the MS center, the patient and the society.

Purpose: Standard of care for patients with sickle cell disease (SCD) includes red blood cell transfusions (RBCTs). Data on clinical and economic outcomes of patients with SCD receiving frequent RBCTs are limited.

Materials and methods: This longitudinal, retrospective, claims-based analysis used the Merative™ MarketScan^® Commercial, Medicare, and Multi-State Medicaid databases. Patients with SCD (identified using ICD-9/10 codes) receiving frequent RBCTs (≥6 RBCTs during any 12-month period) between January 1, 2015, and March 1, 2019, were included. The index date was the date of the sixth RBCT. Eligible patients were required to have ≥12 months of continuous enrollment pre- and post-index. Patients were followed from index to end of enrollment, death, or end of the study period (February 29, 2020), whichever came first. Clinical complications, all-cause healthcare resource utilization (HCRU), and healthcare costs were descriptively summarized during follow-up.

Results: A total of 919 patients with SCD receiving frequent RBCTs met the eligibility criteria for inclusion. Patients experienced a mean of 4.0 vaso-occlusive crises (VOCs) per patient per year (PPPY) and received a mean of 8.3 RBCTs PPPY during follow-up. The most common clinical complications were iron overload (77%), infections (66%), and cerebrovascular disease (48%). Patients had a mean of 2.3 inpatient admissions, 83.5 outpatient visits, and 37.4 outpatient prescriptions PPPY during follow-up. Mean total annual healthcare costs were $106,123 PPPY, including mean inpatient, outpatient medical, and outpatient pharmacy costs of $48,463, $28,307, and $29,353, respectively. Compared to those with <2 baseline VOCs, patients with ≥2 baseline VOCs had more HCRU and higher annual healthcare costs.

Conclusion: Despite utilizing available care with frequent RBCTs, patients with SCD experienced a variety of disease and transfusion-related complications, including frequent VOCs and iron overload, which led to substantial HCRU and costs. These findings highlight the need for novel therapies for this patient group.

Purpose: To estimate the budget impact of adding elranatamab to the US formulary to treat adults with RRMM who have received ≥4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, and to assess the total cost of care and cost per month of progression-free survival (PFS) between elranatamab and available treatments.

Methods: An economic model was developed to assess the budget impact of elranatamab in a one-million-member US commercial and Medicare health plan. Epidemiology data was obtained from the SEER database and a large US real-world study. Key clinical inputs included treatment duration, PFS, overall survival, and adverse events (AEs). Costs associated with drug acquisition monitoring, medical resource use (specifically hospitalization and physician visits), and AEs were incorporated. Model inputs were sourced from clinical trial data, US government databases, and published literature. Total budget impact and per member per month (PMPM) were assessed. One-way sensitivity analyses (OWSA) were conducted to assess model input uncertainty. Total cost of care and cost per month of PFS were also assessed.

Results: An estimated 14 (commercial) and 60 (Medicare) RRMM patients per year would be eligible for treatment. Adding elranatamab resulted in a total budget impact of $553,607 ($0.05 PMPM) in commercial and $2,351,515 ($0.20 PMPM) in Medicare over three years. OWSA indicated results were most sensitive for elranatamab drug costs and relative dose intensity. Total cost of care per month of median PFS over one year was $19,642 with elranatamab, talquetamab ($33,391), teclistamab ($37,791), selinexor plus dexamethasone ($48,784), physician's choice of treatment ($65,886), idecabtagene vicleucel ($78,361), and ciltacabtagene autoleucel ($17,640).

Conclusion: Elranatamab for RRMM is projected to result in a minimal to small budget impact over 3 years and good economic value with lower cost of care per month of PFS compared with other available RRMM treatments except for ciltacabtagene autoleucel.