Cost-effectiveness of switching from tenofovir disoproxil fumarate to tenofovir alafenamide versus entecavir for chronic hepatitis B patients in Greece.

Aim: This study assessed the clinical impact and cost-effectiveness of switching from tenofovir disoproxil fumarate (TDF) to either tenofovir alafenamide (TAF) or entecavir (ETV) in a Greek chronic hepatitis B (CHB) population. Patients & methods: A Markov model from the perspective of a third-party payer in Greece quantified the health and economic benefits of switching from TDF to either TAF or ETV over a lifetime horizon. Results: Over a lifetime, patients who switch from TDF to TAF versus patients who switch from TDF to ETV had an overall lower incidence of compensated cirrhosis (0.4% lower), decompensated cirrhosis (0.04% lower) and hepatocellular carcinoma (0.25% lower). Chronic kidney disease and end-stage renal disease were also lower in patients who switch to TAF; major osteoporotic fractures were similar for both groups. While total costs were higher for switching from TDF to TAF versus TDF to ETV due to the higher cost of TAF, switching from TDF to TAF versus ETV was cost effective with an incremental cost-effectiveness ratio of €17,113 per quality-adjusted life year. Conclusion: Switching from TDF to TAF in patients living with CHB is a cost effective strategy to reduce adverse liver disease outcomes, while improving bone- and renal-related safety outcomes.

Long-term health and economic benefits of switching to tenofovir alafenamide versus continuing on entecavir in chronic hepatitis B patients with low-level viremia in Saudi Arabia.

BACKGROUND: Despite the success of current treatments, many chronic hepatitis B (CHB) patients still live with low-level viremia [LLV] resulting in liver disease progression. This study evaluated the long-term health and economic impact of switching to tenofovir alafenamide (TAF) from entecavir (ETV) in Saudi Arabia (SA) in chronic hepatitis B (CHB) LLV patients. METHODS: A hybrid decision tree Markov state-transition model was developed to simulate a cohort of patients with CHB LLV treated with ETV and switched to TAF over a lifetime horizon in SA. While on treatment, patients either achieved complete virologic response (CVR) or maintained LLV. CVR patients experienced slower progression to advanced liver disease stages as compared to LLV patients. Demographic data, transition probabilities, treatment efficacy, health state costs, and utilities were sourced from published literature. Treatment costs were sourced from publicly available databases. RESULTS: Base case analysis found that over a lifetime horizon, switching to TAF versus remaining on ETV increased the proportion of patients achieving CVR (76% versus 14%, respectively). Switching to TAF versus remaining on ETV resulted in a reduction in cases of compensated cirrhosis (-52%), decompensated cirrhosis (-5%), hepatocellular carcinoma (-22%), liver transplants (-12%), and a 37% reduction in liver-related deaths. Switching to TAF was cost-effective with an incremental cost-effectiveness ratio of $57,222, assuming a willingness-to-pay threshold of three times gross national income per capita [$65,790/QALY]. CONCLUSIONS: This model found that switching to TAF versus remaining on ETV in SA CHB LLV patients substantially reduced long-term CHB-related morbidity and mortality and was a cost-effective treatment strategy.

Remdesivir for Hospitalized COVID-19 Patients in the United States: Optimization of Health Care Resources.

INTRODUCTION: In addition to significant morbidity and mortality, the coronavirus disease (COVID-19) has strained health care systems globally. This study investigated the cost-effectiveness of remdesivir + standard of care (SOC) for hospitalized COVID-19 patients in the USA. METHODS: This cost-effectiveness analysis considered direct and indirect costs of remdesivir + SOC versus SOC alone among hospitalized COVID-19 patients in the US. Patients entered the model stratified according to their baseline ordinal score. At day 15, patients could transition to another health state, and on day 29, they were assumed to have either died or been discharged. Patients were then followed over a 1-year time horizon, where they could transition to death or be rehospitalized. RESULTS: Treatment with remdesivir + SOC avoided, per patient, a total of 4 hospitalization days: two general ward days and a day for both the intensive care unit and the intensive care unit plus invasive mechanical ventilation compared to SOC alone. Treatment with remdesivir + SOC presented net cost savings due to lower hospitalization and lost productivity costs compared to SOC alone. In increased and decreased hospital capacity scenarios, remdesivir + SOC resulted in more beds and ventilators being available versus SOC alone. CONCLUSIONS: Remdesivir + SOC alone represents a cost-effective treatment for hospitalized patients with COVID-19. This analysis can aid in future decisions on the allocation of healthcare resources.

Remdesivir for the treatment of patients hospitalized with COVID-19 receiving supplemental oxygen: a targeted literature review and meta-analysis.

This network meta-analysis (NMA) assessed the efficacy of remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen. Randomized controlled trials of hospitalized patients with COVID-19, where patients were receiving supplemental oxygen at baseline and at least one arm received treatment with remdesivir, were identified. Outcomes included mortality, recovery, and no longer requiring supplemental oxygen. NMAs were performed for low-flow oxygen (LFO2); high-flow oxygen (HFO2), including NIV (non-invasive ventilation); or oxygen at any flow (AnyO2) at early (day 14/15) and late (day 28/29) time points. Six studies were included (N = 5245 patients) in the NMA. Remdesivir lowered early and late mortality among AnyO2 patients (risk ratio (RR) 0.52, 95% credible interval (CrI) 0.34-0.79; RR 0.81, 95%CrI 0.69-0.95) and LFO2 patients (RR 0.21, 95%CrI 0.09-0.46; RR 0.24, 95%CrI 0.11-0.48); no improvement was observed among HFO2 patients. Improved early and late recovery was observed among LFO2 patients (RR 1.22, 95%CrI 1.09-1.38; RR 1.17, 95%CrI 1.09-1.28). Remdesivir also lowered the requirement for oxygen support among all patient subgroups. Among hospitalized patients with COVID-19 requiring supplemental oxygen at baseline, use of remdesivir compared to best supportive care is likely to improve the risk of mortality, recovery and need for oxygen support in AnyO2 and LFO2 patients.

Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States.

INTRODUCTION: Despite currently available treatments for adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL), survival outcomes remain poor, highlighting the need for new therapeutic strategies. This study estimates the cost-effectiveness of KTE-X19 to treat adults with R/R ALL from a US payer perspective. METHODS: The model had two components: a decision-tree, where pre-infusion costs for patients who ultimately did not receive KTE-X19 are accounted for, followed by a partitioned survival analysis, where all KTE-X19 infused patients would enter the three-state (pre-progression, progressed disease, death) model. Comparators included current standard of care treatments, i.e., blinatumomab (BLIN), inotuzumab ozogamicin (INO), and salvage chemotherapy (CHEMO). Both standard parametric and mixture cure models were used to model survival. Efficacy, safety, healthcare resource utilization, and health state utility inputs were derived from the ZUMA-3 trial (NCT02614066) and literature. Cost inputs were derived from literature or publicly available sources. Outcomes and costs were discounted 3% annually. Results of KTE-X19 versus comparators are reported as total and incremental life-years (LYs), quality-adjusted life-years (QALYs), costs, and resulting incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses (PSA) and key scenario analyses were also performed. RESULTS: In the base case, incremental QALYs for KTE-X19 were 2.44, 3.26, and 4.61 versus BLIN, INO, and CHEMO, respectively. Incremental costs were $50,913, $251,532, and $432,027, respectively, resulting in ICERs of $20,843/QALY (versus BLIN), $77,271/QALY (versus INO), and $93,768/QALY (versus CHEMO). Deterministic sensitivity analysis results were most sensitive to subsequent allogeneic stem cell transplant rates and post-progression utilities. PSA found that KTE-X19 is 78.4%, 74.0%, and 75.4% likely to be cost-effective versus BLIN, INO, and CHEMO, respectively. Across most scenarios, at a willingness-to-pay (WTP) threshold of $150,000/QALY, KTE-X19 was cost-effective versus all treatments. CONCLUSIONS: Compared to current options for adults with R/R ALL, KTE-X19 is cost-effective, driven primarily by improved survival.

Several treatments for adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) have been approved in the past decade in the US, including blinatumomab (BLIN) and inotuzumab ozogamicin (INO). However, despite the high costs associated with these treatments, survival for patients remains poor. KTE-X19, an autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, approved by the Food and Drug Administration in October 2021, has potential to improve survival, but its economic value has not yet been determined. This model comprehensively evaluated the long-term clinical and economic value of KTE-X19 versus current treatments, including BLIN, INO, and salvage chemotherapy (CHEMO). Inputs were derived from key clinical trials, the literature, and other publicly available sources. The model used the perspective of a US third party payer over a patient lifetime. Compared to BLIN, INO and CHEMO, KTE-X19 resulted in improved quality of life as measured with incremental quality-adjusted life years (QALYs) of 2.44 (vs BLIN), 3.26 (vs INO), and 4.61 (vs CHEMO). Treatment with KTE-X19 had incremental costs of $50,913 (vs BLIN), $251,532 (vs INO), and $432,027 (vs CHEMO). KTE-X19 was found to provide good value for money based on incremental cost-effectiveness ratios of $20,843/QALY (vs BLIN), $77,271/QALY (vs INO), and $93,768/QALY (vs CHEMO). These values are well below the commonly accepted thresholds to determine economic value. Results were also found to be robust across sensitivity and scenario analyses.

Cost-Effectiveness of Outreach Strategies for Stool-Based Colorectal Cancer Screening in a Medicaid Population.

Outreach, including patient navigation, has been shown to increase the uptake of colorectal cancer (CRC) screening in underserved populations. This analysis evaluates the cost-effectiveness of triennial multi-target stool DNA (mt-sDNA) versus outreach, with or without a mailed annual fecal immunochemical test (FIT), in a Medicaid population. A microsimulation model estimated the incremental cost-effectiveness ratio using quality-adjusted life years (QALY), direct costs, and clinical outcomes in a cohort of Medicaid beneficiaries aged 50-64 years, over a lifetime time horizon. The base case model explored scenarios of either 100% adherence or real-world reported adherence (51.3% for mt-sDNA, 21.1% for outreach with FIT and 12.3% for outreach without FIT) with or without real-world adherence for follow-up colonoscopy (66.7% for all). Costs and outcomes were discounted at 3.0%. At 100% adherence to both screening tests and follow-up colonoscopy, mt-sDNA costed more and was less effective compared with outreach with or without FIT. When real-world adherence rates were considered for screening strategies (with 100% adherence for follow-up colonoscopy), mt-sDNA resulted in the greatest reduction in incidence and mortality from CRC (41.5% and 45.8%, respectively) compared with outreach with or without FIT; mt-sDNA also was cost-effective versus outreach with and without FIT ($32,150/QALY and $22,707/QALY, respectively). mt-sDNA remained cost-effective versus FIT, with or without outreach, under real-world adherence rates for follow-up colonoscopy. Outreach or navigation interventions, with associated real-world adherence rates to screening tests, should be considered when evaluating the cost-effectiveness of CRC screening strategies in underserved populations.

Real-world cost-effectiveness of stool-based colorectal cancer screening in a Medicare population.

AIM: Multiple screening strategies are guideline-endorsed for average-risk colorectal cancer (CRC). The impact of real-world adherence rates on the cost-effectiveness of non-invasive stool-based CRC screening strategies remains undefined. METHODS: This cost-effectiveness analysis from the perspective of Medicare as a primary payer used the Colorectal Cancer and Adenoma Incidence and Mortality Microsimulation Model (CRC-AIM) to estimate cost and clinical outcomes for triennial multi-target stool DNA (mt-sDNA), annual fecal immunochemical test (FIT) and annual fecal occult blood test (FOBT) screening strategies in a simulated cohort of US adults aged 65 years, who were assumed to either be previously unscreened or initiating screening upon entry to Medicare. Reported real-world adherence rates for initial stool-based screening and colonoscopy follow up (after a positive stool test result) were defined as 71.1% and 73.0% for mt-sDNA, 42.6% and 47.0% for FIT, and 33.4% and 47.0% for FOBT, respectively. The incremental cost-effectiveness ratio using quality-adjusted life years (QALY) was defined as the primary outcome of interest; other cost and clinical outcomes were also reported in secondary analyses. Multiple sensitivity and scenario analyses were conducted. RESULTS: When reported real-world adherence rates were included only for initial stool-based screening, mt-sDNA was cost-effective versus FIT ($62,814/QALY) and FOBT ($39,171/QALY); mt-sDNA also yielded improved clinical outcomes. When reported real-world adherence rates were included for both initial stool-based screening and follow-up colonoscopy (when indicated), mt-sDNA was increasingly cost-effective compared to FIT and FOBT ($31,725/QALY and $28,465/QALY, respectively), with further improved clinical outcomes. LIMITATIONS: Results are based on real-world cross-sectional adherence rates and may vary in the context of other types of settings. Only guideline-recommended stool-based strategies were considered in this analysis. CONCLUSION: Comparisons of the effectiveness and benefits of specific CRC screening strategies should include both test-specific performance characteristics and real-world adherence to screening tests and, when indicated, follow-up colonoscopy.