10-year Time Horizon Research Articles

Does an expanded allied health student training programme in regional New South Wales (Australia) result in a positive social return on investment? A protocol for a single-university education-based economic evaluation

Introduction20 years ago, health professional student placements in rural areas of Australia were identified as an important rural recruitment strategy and funding priority. Since then, there has been a growing...

37 Cost-effectiveness of treatment sequences with front-line nivolumab+ipilimumab therapy vs immuno-oncology+tyrosine kinase inhibitor therapies in intermediate/poor-risk metastatic renal cell carcinoma

Abstract Background Immuno-oncology (IO) and vascular endothelial growth factor (VEGF) targeted tyrosine kinase inhibitor (TKI) combinations have transformed the treatment of metastatic renal cell carcinoma (mRCC). However, there is a lack of evidence regarding the most cost-effective sequencing of these systemic therapies. This study aimed to assess the expected health and economic outcomes of various treatment sequences for newly diagnosed patients with intermediate/poor-risk RCC from a US payer perspective. Methods We developed a model using a continuous time micro-simulation framework. First-line treatment options included: nivolumab+ipilimumab, nivolumab+cabozantinib, pembrolizumab+lenvatinib, and pembrolizumab+axitinib. Second-line treatment options included: cabozantinib and everolimus+lenvatinib. In both lines, the source data for the overall survival (OS) and progression-free survival (PFS) distributions were obtained from the registrational randomized controlled trials (RCTs) of each therapy. The analysis included costs associated with drug acquisition in the US wholesale setting, drug administration and monitoring, management of treatment-related adverse events, disease management, and terminal care. Treatment duration for all first-line IO and TKI therapies was capped at 2 years. Quality-adjusted life-years (QALYs) were estimated by multiplying time in each phase of the disease by phase-specific utility values estimated from the CheckMate 214 trial data using US tariffs. The analysis was run 1000 times for cohorts of 100 patients over a 20-year time horizon. All costs and health outcomes were discounted annually at a 3% rate. Results Average per-patient QALYs were estimated for each sequence of interest: nivolumab+ipilimumab followed by cabozantinib (3.59), nivolumab+ipilimumab followed by lenvatinib+everolimus (3.26), pembrolizumab+axitinib followed by cabozantinib (3.14), pembrolizumab+axitinib followed by lenvatinib+everolimus (2.97), pembrolizumab+lenvatinib followed by cabozantinib (3.51), and nivolumab+cabozantinib followed by lenvatinib+everolimus (2.99). Average per-patient costs were estimated for each sequence of interest: nivolumab+ipilimumab followed by cabozantinib ($468,856), nivolumab+ipilimumab followed by lenvatinib+everolimus ($491,259), pembrolizumab+axitinib followed by cabozantinib ($675,714), pembrolizumab+axitinib followed by lenvatinib+everolimus ($700,411), pembrolizumab+lenvatinib followed by cabozantinib ($837,888), nivolumab+cabozantinib followed by lenvatinib+everolimus ($873,377). First-line drug acquisition costs accounted for the majority of costs for all sequences. Conclusions Based upon our model using data from registrational RCTs, first-line nivolumab+ipilimumab followed by cabozantinib represents the dominant treatment strategy for intermediate/poor-risk mRCC patients in the US, offering estimated cost savings of up to 45% when compared to IO+TKI options. Additional studies are needed to elucidate whether these cost savings translate to the real-world setting.

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Aims Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare). Materials and methods A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM). Results The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population. Conclusions Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

Cost-effectiveness analysis of osimertinib plus chemotherapy for patients with EGFR-mutated advanced non-small cell lung cancer.

First-line osimertinib plus chemotherapy significantly prolonged progression-free survival of patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) compared to osimertinib, according to the FLAURA2 trial. We established a Markov model to compare the cost-effectiveness of osimertinib plus chemotherapy with that of osimertinib alone. Clinical data were obtained from the FLAURA and FLAURA2 trials, and additional data were extracted from online resources and publications. Sensitivity analyses were conducted to evaluate the robustness of the findings. We used A willingness-to-pay threshold of $150,000 per quality-adjusted life-years (QALYs) gained. The main outcomes were QALYs, overall costs, incremental cost-effectiveness ratio (ICER), incremental net monetary benefit, and incremental net health benefit. Subgroup analyses were conducted according to patients' mutation type and central nervous system (CNS) metastatic status. In a 20-year time horizon, the ICER of osimertinib plus chemotherapy versus osimertinib alone was $223,727.1 per QALY gained. The sensitivity analyses identified the cost of osimertinib and the hazard ratio for overall survival as the top 2 influential factors and a 1.9% probability of osimertinib plus chemotherapy to be cost-effective. The subgroup analyses revealed ICERs of $132,614.1, $224,449.8, $201,464.1, and $130,159.7 per QALY gained for L858R mutations, exon 19 deletions, CNS metastases, and no CNS metastases subgroups, respectively. From the perspective of the United States health care system, osimertinib plus chemotherapy is not cost-effective compared to osimertinib alone for treatment-naïve patients with EGFR-mutated advanced NSCLC, but more favorable cost-effectiveness occurs in patients with L858R mutations and patients without baseline CNS metastases.

Cost-Utility of Real-Time Potassium Monitoring in United States Patients Receiving Hemodialysis

IntroductionPatients with kidney failure requiring hemodialysis are at high risk for hyperkalemia between treatments which is associated with increased cardiovascular morbidity and mortality. Early detection of hyperkalemic events may be useful to prevent adverse outcomes and their associated costs. We performed a cost-utility analysis comparing an intervention where a real-time potassium monitoring device is administered in hemodialysis patients in comparison to usual care. MethodsWe developed a cost-utility model with microsimulation from the perspective of the United States health care payer. Primary outcomes included the monthly cost-effectiveness threshold cost and break-even cost per patient attributable to the intervention and the incremental cost-effectiveness ratio comparing the intervention to usual care. A 25% reduction in hyperkalemic events was applied as a baseline device effectiveness estimate. Concurrent first and second order microsimulations were performed using 10%, 25%, and 50% effectiveness estimates as sensitivity analyses. Results are presented over a 10-year time horizon in 2022 United States Dollars (USD) and a willingness-to-pay threshold of $100,000 USD per quality-adjusted-life year (QALY) was considered. ResultsOver ten-years, threshold and break-even analysis yielded maximum monthly costs of $201.10 USD and $144.15 USD per patient respectively. The intervention was associated with reduced mean costs ($6,381.21 USD) and increased mean QALYs (0.03) per patient, therefore was considered dominant. In sensitivity analysis, the intervention was dominant in 99% of simulations performed at all effectiveness rates. ConclusionsImplementing a real-time potassium monitoring device in hemodialysis patients has the potential for cost savings and improved outcomes from the perspective of the Unites States health care payer.

The Cost-Effectiveness of Seizure Dogs for Persons Living With Severe Refractory Epilepsy: Results From the EPISODE Study

ObjectivesThe Epilepsy Support Dog Evaluation study was commissioned by the Dutch Ministry of Health, Welfare and Sports to inform a reimbursement decision on seizure dogs. The randomized trial found that seizure dogs reduce seizure frequency and improve health-related quality of life of persons with severe refractory epilepsy (PSREs). This article examined the cost-effectiveness (CE) of adding seizure dogs to usual care for PSREs in The Netherlands. MethodsA microsimulation model was developed, informed by generalized linear mixed models using patient-level trial data from the Epilepsy Support Dog Evaluation study. The model adopted a 10-year time horizon and took a societal perspective. Seizure frequency was predicted as a function of time with the seizure dog. Patient utilities, caregiver utilities, and costs were predicted as a function of seizure frequency and time with the seizure dog. ResultsQuality-adjusted life-years (QALYs) of PSREs with a seizure dog and usual care alone were estimated at 6.28 and 5.65, respectively (Δ 0.63). For caregivers, estimated QALYs were 6.94 and 6.52, respectively (Δ 0.42). Total costs were respectively €228 691 and €226 261 (Δ €2430). Intervention costs were largely offset by savings in informal care and healthcare. The incremental CE ratio was €2314/QALY. Probabilistic sensitivity analysis indicated a 91% probability of seizure dogs being cost-effective at the €50 000/QALY threshold. The incremental CE ratio fell well below this threshold in scenario analyses. ConclusionsSeizure dogs are likely to be a cost-effective addition to usual care for PSREs in The Netherlands.

Cost-Effectiveness Analysis of Rehabilitation Methods for Stroke Survivors

Background: One of the challenges in stroke management is how to provide rehabilitation services to stroke patients in Iran. Objectives: This study aimed to evaluate and compare the cost-effectiveness of rehabilitation interventions for stroke patients in three settings: Hospitals, stroke units, and homes. Methods: This cross-sectional study was conducted from the perspective of the health system. A Markov model with a 20-year time horizon and 3-month cycles was used to analyze costs and outcomes. Cost data were collected from 210 patients undergoing rehabilitation in hospitals, homes, or stroke units. The cost-effectiveness analysis (CEA) was conducted by calculating the incremental cost-effectiveness ratio (ICER) using Tree Age software. Results: The average rehabilitation cost for the home strategy ($2306 ± 35.018) was less than that for the hospital ($2955 ± 48.18) and stroke unit ($3485 ± 51.63) strategies. Furthermore, the QALY of the home strategy (26.03) was 8 times higher than that of the hospital (17.99) and 19 times higher than that of the stroke unit (7.03). The average cost-effectiveness ratios for the hospital, stroke unit, and home groups were $11424, $33159, and $7233 per QALY, respectively. The ICERs for stroke unit and home rehabilitation relative to hospital rehabilitation were $2517 and $2145 per QALY, respectively. Conclusions: According to the results, the home-based rehabilitation strategy is more cost-effective than hospital and stroke unit rehabilitation strategies. Given the high rates of stroke and its associated costs in Iran, it is suggested that policymakers lay the groundwork for providing these services at home.

Cost-Minimization Analysis for Subcutaneous Daratumumab in the Treatment of Newly Diagnosed Multiple Myeloma in Three Gulf Countries

Background: The second most common hematologic cancer worldwide is multiple myeloma (MM), with incidence and mortality rates that have more than doubled over the past 30 years. The safety and efficacy of daratumumab regimens in the treatment of newly diagnosed MM (NDMM) is demonstrated in clinical trials. Objective: To assess the financial effects of the adoption of subcutaneous daratumumab (dara-SC) rather than intravenous daratumumab (dara-IV) for the treatment of NDMM in three Gulf countries (Qatar, Oman and the United Arab Emirates; UAE), a cost-minimization model was constructed. Methods: We performed static cost minimization analyses from a societal perspective to evaluate the costs and possible reductions in resource utilization associated with a shift from dara-IV infusion to dara-SC injection for NDMM patients over a 5-year time horizon. The model included 2 scenarios: the current scenario in which 100% of patients with NDMM are treated with dara-IV infusion and a future scenario in which dara-SC injection is gradually adopted over the modeled time horizon. The model differentiated precisely between autologous stem cell transplantation (ASCT)–eligible and ASCT-ineligible NDMM patients in terms of their number in each group and the associated therapeutic regimens. One-way sensitivity analyses were also conducted. Results: The model showed that the use of dara-SC in NDMM patients who were eligible or ineligible for ASCT resulted in lower non-drug costs, including premedication drug costs, adverse-effect costs, administration costs, medical staff costs, and indirect costs. The resulting total savings over the 5-year time horizon of the model for Hamad Medical Corporation, Sultan Qaboos University Hospital/Royal Hospital, Sheikh Shakhbout Medical City (SSMC), and Tawam Hospital were QAR −2 522 686, OMR −143 214, AED −30 010 627, and AED −5 003 471, respectively. Conclusion: The introduction of dara-SC as a front-line treatment for NDMM patients in Qatar (Hamad Medical Corporation), Oman (Sultan Qaboos University Hospital, Royal Hospital-MOH), and the UAE (SSMC and Tawam Hospital) can help save resources and minimize constraints on the healthcare system.

Cost-effectiveness analysis of a ‘Termination of Resuscitation’ protocol for the management of out-of-hospital cardiac arrest

BackgroundHistorically in Singapore, all out-of-hospital cardiac arrests (OHCA) were transported to hospital for pronouncement of death. A ‘Termination of Resuscitation’ (TOR) protocol, implemented from 2019 onwards, enables emergency responders to pronounce death at-scene in Singapore. This study aims to evaluate the cost-effectiveness of the TOR protocol for OHCA management. MethodsAdopting a healthcare provider’s perspective, a Markov model was developed to evaluate three competing options: No TOR, Observed TOR reflecting existing practice, and Full TOR if TOR is exercised fully. The model had a cycle duration of 30 days after the initial state of having a cardiac arrest, and was evaluated over a 10-year time horizon. Probabilistic sensitivity analysis was performed to account for uncertainties. The costs per quality adjusted life years (QALY) was calculated. ResultsA total of 3,695 OHCA cases eligible for the TOR protocol were analysed; mean age of 73.0 ± 15.5 years. For every 10,000 hypothetical patients, Observed TOR and Full TOR had more deaths by approximately 19 and 31 patients, respectively, compared to No TOR. Full TOR had the least costs and QALYs at $19,633,369 (95% Uncertainty Interval (UI) 19,469,973 to 19,796,764) and 0 QALYs. If TOR is exercised for every eligible case, it could expect to save approximately $400,440 per QALY loss compared to No TOR, and $821,151 per QALY loss compared to Observed TOR. ConclusionThe application of the TOR protocol for the management of OHCA was found to be cost-effective within acceptable willingness-to-pay thresholds, providing some justification for sustainable adoption.

A danish healthcare-focused economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation

IntroductionThree randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective.MethodsIndividual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis.ResultsFirst-line cryoablation is dominant, meaning it results in lower costs (-€2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of €23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive ∼ 1.2 ablation procedures over a lifetime horizon.ConclusionFirst-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.

Cost-Effectiveness of Dupilumab and Oral Janus Kinase Inhibitors for the Treatment of Moderate-to-Severe Atopic Dermatitis in Singapore.

Atopic dermatitis (AD) affects both adults and children, impacting their quality of life and productivity; however, traditional systemic treatments such as cyclosporine have limitations. Emerging novel systemic interventions, including monoclonal antibodies and Janus kinase (JAK) inhibitors, have been shown to improve patient outcomes. This study evaluates the cost-effectiveness of novel systemic interventions for moderate-to-severe AD in adults compared with the best supportive care (BSC) in Singapore. The economic evaluation used a hybrid model consisting of a decision tree and Markov model. Treatment responses at 16 weeks were based on a network meta-analysis that was developed specifically for this study. Long-term response, discontinuation rates, episodes of flares and treatment-emergent adverse events were obtained from key dupilumab, abrocitinib, baricitinib and upadacitinib trials. The study had a 5-year time horizon and considered the healthcare payer's perspective. Sensitivity and scenario analyses were performed as well. Baricitinib 4mg and 2mg have the lowest incremental cost-effectiveness ratios, at Singapore dollars (S$)60,730/quality-adjusted life-year (QALY) and S$66,842/QALY, respectively. Upadacitinib 30mg offers the highest incremental QALY gain, while baricitinib 2mg offers the least. The cost of the intervention drugs accounted for the highest proportion of the overall expenses (68-93%) for those in the maintenance state. Other influential factors within the model included (1) the incremental utility derived from intervention response; (2) the probability of achieving Eczema Area and Severity Index 75 (EASI-75) with BSC; and (3) the relative risk of achieving EASI-75 with the interventions. In a scenario where the cost of all drugs is matched to the lowest-priced drug, the top three cost-effectiveness interventions are dupilumab, upadacitinib 30mg and abrocitinib 200mg, respectively. The interventions are not found to be cost-effective at their existing prices when compared with BSC. Ideally, a composite score of treatment success and quality-of-life scores ought to be included, but such data were unavailable. Future research should consider conditional discontinuation data and long-term outcomes when such data become accessible.

Cost-effectiveness analysis of amivantamab plus chemotherapy for non-small cell lung cancer patients with epidermal growth factor receptor exon 20 insertions in the UnitedStates.

Although amivantamab has shown clinical benefits for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertions, its cost-effectiveness requires further investigation. To evaluate the cost-effectiveness of amivantamab plus chemotherapy for the treatment of NSCLC patients with EGFR exon 20 insertions from the UnitedStates payer perspective. A partitioned survival model was developed based on the data from the PAPILLON trial. Costs were derived from the pricing files of Medicare and Medicaid Services and published literature, and utility values were derived from previous studies. A 3% annual discount rate was applied to both costs and outcomes. The primary outcome was the incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis, were conducted to test the model stability. Amivantamab plus chemotherapy yielded an additional 1.12 quality-adjusted life years (QALYs) while increasing costs by $483,769.50 relative to the chemotherapy regimen, leading to an ICER of $432,401.16/QALY. The combination of amivantamab with chemotherapy was not cost effective at a threshold of $150,000/QALY. In the scenario analysis, the results showed that the ICERs were $263,680.69/QALY and $418,416.35/QALY when different utility values and 10-year time horizons were adopted, respectively. For PSA, the probability that amivantamab plus chemotherapy would be cost-effective was 0% if the willingness-to-pay (WTP) threshold was $150,000/QALY. Amivantamab plus chemotherapy is unlikely to be a cost-effective option for NSCLC patients with EGFR exon 20 insertions. Reducing the cost of amivantamab may produce favorable economic outcomes.

A Cost-Effectiveness Analysis of Adjuvant Nivolumab for Patients with Resected Esophageal Cancer or Gastroesophageal Junction Cancer in France.

Esophageal and gastroesophageal junction cancer (EC/GEJC) is a poor prognosis disease with a high risk of recurrence even in patients curatively resected. Adjuvant nivolumab is currently used for patients with completely resected (R0) EC/GEJC who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. This study aimed to determine the cost effectiveness of nivolumab in this indication in France according to the collective perspective excluding indirect costs. A simplified four-health-state semi-Markov model was developed to model EC/GEJC patients who have residual disease after neoadjuvant chemoradiotherapy followed by R0 over a 15-year time horizon, comparing adjuvant nivolumab versus surveillance, which was the recommended French clinical practice before immunotherapy arrival. Time-to-recurrence (TTR) from CheckMate 577 was used to inform transition from disease-free to post-recurrence health state; patients who recurred were split according to the distribution of type of recurrence observed during the trial. Post-recurrence survival (PRS) according to the type of recurrence was derived from a real-world registry. Adjuvant treatment with nivolumab led to an incremental survival gain of 1.19 years (+34%), mostly in the disease-free state, an incremental cost of €48,634 and QALY of 0.98 resulting in an incremental cost-utility ratio (ICUR) of €49,572/QALY with limited uncertainty. 'Cure assumption' at 5years had an important impact on the results (€41,115/QALY; -17%), as that tends to increase life-years and QALYs while costs remain the same. Probabilistic sensitivity analyses confirmed reference ICUR (€52,542/QALY) with 80% probability of nivolumab being cost effective at a willingness-to-pay threshold of €75,000/QALY. Our analysis suggests that adjuvant nivolumab is cost effective in the treatment of EC/GEJC patients who have residual disease after neoadjuvant CRT followed by R0 resection. Compared with previously evaluated cost-effectiveness analyses for other immune-checkpoint inhibitors indicated in metastatic settings, ICUR appears particularly low in this early setting thanks to the important impact on health outcomes and capped treatment duration.

P-725 Automated follicular tracking with three-dimensional ultrasound and SonoAVC saves costs: debunking myths

Abstract Study question What is the incremental cost per patient and the budgetary impact of the SonoAVCTMfollicle technique compared to two-dimensional ultrasound in a private assisted reproduction center? Summary answer Our results support the implementation of follicular tracking with 3D ultrasound and SonoAVCTM from an economic point of view. What is known already Advantages of follicular tracking with 3D US and SonoAVC include increased precision and reproducibility, increased patient comfort, decreased ultrasonographer’s time and improved workflow. The main benefit of SonoAVC is that it allows quick measurements of follicular volume, which has been shown to be more precise than 2D diameters for estimation of follicular size. Until now, it has been assumed that 3D ultrasound represents an increase in costs, this being the main justification of professionals who refuse to implement it. Study design, size, duration Cost study and economic analysis. The costs associated with the adoption of the SonoAVC™follicle software and the 2D ultrasound were estimated as well as the cost of medical dedication time. Since the cost of the equipment represents an initial investment, we proceeded to annualize it. For the economic analysis we calculated a) cost for each patient included in the study and b) total annual cost for a private center to incorporate the SonoAVC™follicle program. Participants/materials, setting, methods Population: patients treated in our center in 2019 (N = 295). Budget impact analysis was performed from the perspective of a private assisted reproduction center with a 5-year time horizon. The analysis was adapted to three scenarios according to the size of the center: a private center with: a) 600 cycles/year including IVF/ICSI and oocyte donation b) 300 cycles/year and c) 100 cycles/year. Main results and the role of chance Equivalent annual cost of the ultrasound device and transvaginal probe after annualization was 3985.93 € for 2D and 4572.10 € for 3D. The corresponding cost per patient/cycle was 13,51€ for 2D and 15,50 € 3D. Medical dedication time cost was 5,6 € for 2D follicular monitoring and 3,3 € for 3D follicular monitoring. Total cost per patient/cycle for follicular monitoring, including hardware and medical dedication was 69,5€ for 2D and 48,5€ for 3D ultrasound. For the budget impact analysis, three different sizes of centers were considered: 600, 300 and 100 cycles/year. In all of them there was a saving with 3D ultrasound of 2101 €, 6303 € and 12606 € respectively. The net budgetary impact over 5 years, i.e., the difference between the current scenario (2D ultrasound) and the new scenario (3D ultrasound with SonoAVC™follicle) for a center with approximately 300 cycles/year, would be 31.515€. Therefore, the implementation of the new technique with SonoAVC™follicle would save costs. Limitations, reasons for caution In centers 600 cycles/year an extra ultrasound device may be included in the analysis. Wider implications of the findings Follicular monitoring with 3D ultrasound is cheaper than 2D ultrasound even in small centers and this saving is greater the larger the center is. Therefore, our results demonstrate that cost savings are another added advantage of follicular monitoring with 3D ultrasound and sonoAVC. Trial registration number not applicable

Unit costs and cost-effectiveness of a device to improve TB treatment adherence in China.

Adherence to TB drugs is crucial for improving treatment outcomes. Digital adherence technologies can improve adherence; however, there is a lack of evidence on cost-effectiveness. This study aimed to explore the cost-effectiveness of medication event reminder monitors (MERM) in China compared with the standard of care, using results from a pragmatic, cluster-randomised superiority trial of an electronic MERM in China. We collected primary unit cost data from the societal perspective, both at and above the health facility level. We estimated the incremental cost-effectiveness of MERM using a Markov model with a 20-year time horizon; a 3% discount rate was applied to costs and outcomes. We explored uncertainty through a series of sensitivity and scenario analyses. The incremental cost of MERM was $27.22 per patient. Probabilistic sensitivity analysis showed significant uncertainty about the intervention's cost-effectiveness. Changing assumptions around key parameters substantially affected our estimated incremental cost-effectiveness ratio. Although the incremental cost of the MERM box was low, current evidence does not indicate that the intervention would be cost-effective. However, the intervention's cost-effectiveness could improve if implemented as part of a broader strategy, including enhanced patient management.

Estimating the potential value of MSM-focused evidence-based implementation interventions in three Ending the HIV Epidemic jurisdictions in the United States: a model-based analysis.

Improving the delivery of existing evidence-based interventions to prevent and diagnose HIV is key to Ending the HIV Epidemic in the United States. Structural barriers in the access and delivery of related health services require municipal or state-level policy changes; however, suboptimal implementation can be addressed directly through interventions designed to improve the reach, effectiveness, adoption or maintenance of available interventions. Our objective was to estimate the cost-effectiveness and potential epidemiological impact of six real-world implementation interventions designed to address these barriers and increase the scale of delivery of interventions for HIV testing and pre-exposure prophylaxis (PrEP) in three US metropolitan areas. We used a dynamic HIV transmission model calibrated to replicate HIV microepidemics in Atlanta, Los Angeles (LA) and Miami. We identified six implementation interventions designed to improve HIV testing uptake ("Academic detailing for HIV testing," "CyBER/testing," "All About Me") and PrEP uptake/persistence ("Project SLIP," "PrEPmate," "PrEP patient navigation"). Our comparator scenario reflected a scale-up of interventions with no additional efforts to mitigate implementation and structural barriers. We accounted for potential heterogeneity in population-level effectiveness across jurisdictions. We sustained implementation interventions over a 10-year period and evaluated HIV acquisitions averted, costs, quality-adjusted life years and incremental cost-effectiveness ratios over a 20-year time horizon (2023-2042). Across jurisdictions, implementation interventions to improve the scale of HIV testing were most cost-effective in Atlanta and LA (CyBER/testing cost-saving and All About Me cost-effective), while interventions for PrEP were most cost-effective in Miami (two of three were cost-saving). We estimated that the most impactful HIV testing intervention, CyBER/testing, was projected to avert 111 (95% credible interval: 110-111), 230 (228-233) and 101 (101-103) acquisitions over 20 years in Atlanta, LA and Miami, respectively. The most impactful implementation intervention to improve PrEP engagement, PrEPmate, averted an estimated 936 (929-943), 860 (853-867) and 2152 (2127-2178) acquisitions over 20 years, in Atlanta, LA and Miami, respectively. Our results highlight the potential impact of interventions to enhance the implementation of existing evidence-based interventions for the prevention and diagnosis of HIV.

Devices for remote continuous monitoring of people with Parkinson's disease: a systematic review and cost-effectiveness analysis.

Parkinson's disease is a brain condition causing a progressive loss of co ordination and movement problems. Around 145,500 people have Parkinson's disease in the United Kingdom. Levodopa is the most prescribed treatment for managing motor symptoms in the early stages. Patients should be monitored by a specialist every 6-12 months for disease progression and treatment of adverse effects. Wearable devices may provide a novel approach to management by directly monitoring patients for bradykinesia, dyskinesia, tremor and other symptoms. They are intended to be used alongside clinical judgement. To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson's disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON. We performed systematic reviews of all evidence on the five devices, outcomes included: diagnostic accuracy, impact on decision-making, clinical outcomes, patient and clinician opinions and economic outcomes. We searched MEDLINE and 12 other databases/trial registries to February 2022. Risk of bias was assessed. Narrative synthesis was used to summarise all identified evidence, as the evidence was insufficient for meta-analysis. One included trial provided individual-level data, which was re-analysed. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time use and routine use of the device. Fifty-seven studies of Personal KinetiGraph, 15 of STAT-ON, 3 of Kinesia 360, 1 of KinesiaU and 1 of PDMonitor were included. There was some evidence to suggest that Personal KinetiGraph can accurately measure bradykinesia and dyskinesia, leading to treatment modification in some patients, and a possible improvement in clinical outcomes when measured using the Unified Parkinson's Disease Rating Scale. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical impact. The evidence for Kinesia 360, KinesiaU and PDMonitor is insufficient to draw any conclusions on their value in clinical practice. The base-case results for Personal KinetiGraph compared to standard of care for one-time and routine use resulted in incremental cost-effectiveness ratios of £67,856 and £57,877 per quality-adjusted life-year gained, respectively, with a beneficial impact of the Personal KinetiGraph on Unified Parkinson's Disease Rating Scale domains III and IV. The incremental cost-effectiveness ratio results for Kinesia 360 compared to standard of care for one-time and routine use were £38,828 and £67,203 per quality-adjusted life-year gained, respectively. The evidence was limited in extent and often low quality. For all devices, except Personal KinetiGraph, there was little to no evidence on the clinical impact of the technology. Personal KinetiGraph could reasonably be used in practice to monitor patient symptoms and modify treatment where required. There is too little evidence on STAT-ON, Kinesia 360, KinesiaU or PDMonitor to be confident that they are clinically useful. The cost-effectiveness of remote monitoring appears to be largely unfavourable with incremental cost-effectiveness ratios in excess of £30,000 per quality-adjusted life-year across a range of alternative assumptions. The main driver of cost-effectiveness was the durability of improvements in patient symptoms. This study is registered as PROSPERO CRD42022308597. This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135437) and is published in full in Health Technology Assessment; Vol. 28, No. 30. See the NIHR Funding and Awards website for further award information.

Budget impact analysis of biosimilar natalizumab in the US.

Biosimilars provide an opportunity for a more sustainable and cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential financial impact of implementing a formulary change from reference to biosimilar natalizumab (NTZ) from the US commercial payer perspective. The budget impact of transitioning to biosimilar NTZ for the treatment of relapsing-remitting MS (RRMS) was estimated over a 3-year time horizon based on real-world dosing. Additional scenario analyses were conducted by varying the price differential of biosimilar NTZ. The target population was estimated from a 1-million-member hypothetical commercial health plan. Model inputs were drug acquisition costs and treatment-related and patient coinsurance costs. Budget impact and cost savings per member per year were calculated by assuming a biosimilar uptake of 10% in year 1 to 20% in year 3. Over 3 years, 255 patients were estimated to be treated with high-efficacy disease-modifying therapies for RRMS. The inclusion of biosimilar NTZ onto a formulary would result in cumulative cost savings to payers of $452,611 over 3 years, with mean savings per treated member per year of $1179, $1769, and $2359 in years 1, 2, and 3, respectively. One-way sensitivity analyses indicated that budget impact results were most sensitive to drug acquisition costs of both reference and biosimilar NTZ. Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS.

Long-term outcomes in virtual surgical planning for mandibular reconstruction: A cost-effectiveness analysis.

This study is an economic evaluation comparing virtual surgical planning (VSP) utilization to free hand mandibular reconstruction (FHR) for advanced oral cavity cancer, for which the cost effectiveness remains poorly understood. The proposed clinical benefits of VSP must be weighed against the additional upfront costs. A Markov decision analysis model was created for VSP and FHR based on literature review and institutional data over a 35-year time horizon. Model parameters were derived and averaged from systematic review and institutional experience. VSP cost and surgical time saving was incorporated. We accounted for long-term risks including cancer recurrence and hardware failure/exposure. We calculated cost in US dollars and effectiveness in quality-adjusted-life-years (QALYs). A health care perspective was adopted, discounting costs and effectiveness at 3%/year. Deterministic and probabilistic sensitivity analyses tested model robustness. In the base case scenario, total VSP strategy cost was $49,498 with 8.37 QALYs gained while FHR cost was $42,478 with 8.27 QALY gained. An incremental cost-effectiveness ratio (ICER), or the difference in cost/difference in effectiveness, for VSP was calculated at $68,382/QALY gained. VSP strategy favorability was sensitive to variations of patient age at diagnosis and institutional VSP cost with one-way sensitivity analysis. VSP was less economically favorable for patients >75.5 years of age or for institutional VSP costs >$10,745. In a probabilistic sensitivity analysis, 55% of iterations demonstrated an ICER value below a $100,000/QALY threshold. VSP is economically favorable compared to FHR in patients requiring mandibular reconstruction for advanced oral cancer, but these results are sensitive to the patient's age at diagnosis and the institutional VSP cost. Our results do not suggest if one "should or should not" use VSP, rather, emphasizes the need for patient selection regarding which patients would most benefit from VSP when evaluating quality of life and long-term complications. Further studies are necessary to demonstrate improved long-term risk for hardware failure/exposure in VSP compared to FHR.

Economic evaluation of the effect of needle and syringe programs on skin, soft tissue, and vascular infections in people who inject drugs: a microsimulation modelling approach

BackgroundNeedle and syringe programs (NSP) are effective harm-reduction strategies against HIV and hepatitis C. Although skin, soft tissue, and vascular infections (SSTVI) are the most common morbidities in people who inject drugs (PWID), the extent to which NSP are clinically and cost-effective in relation to SSTVI in PWID remains unclear. The objective of this study was to model the clinical- and cost-effectiveness of NSP with respect to treatment of SSTVI in PWID.MethodsWe performed a model-based, economic evaluation comparing a scenario with NSP to a scenario without NSP. We developed a microsimulation model to generate two cohorts of 100,000 individuals corresponding to each NSP scenario and estimated quality-adjusted life-years (QALY) and cost (in 2022 Canadian dollars) over a 5-year time horizon (1.5% per annum for costs and outcomes). To assess the clinical effectiveness of NSP, we conducted survival analysis that accounted for the recurrent use of health care services for treating SSTVI and SSTVI mortality in the presence of competing risks.ResultsThe incremental cost-effectiveness ratio associated with NSP was $70,278 per QALY, with incremental cost and QALY gains corresponding to $1207 and 0.017 QALY, respectively. Under the scenario with NSP, there were 788 fewer SSTVI deaths per 100,000 PWID, corresponding to 24% lower relative hazard of mortality from SSTVI (hazard ratio [HR] = 0.76; 95% confidence interval [CI] = 0.72–0.80). Health service utilization over the 5-year period remained lower under the scenario with NSP (outpatient: 66,511 vs. 86,879; emergency department: 9920 vs. 12,922; inpatient: 4282 vs. 5596). Relatedly, having NSP was associated with a modest reduction in the relative hazard of recurrent outpatient visits (HR = 0.96; 95% CI = 0.95–0.97) for purulent SSTVI as well as outpatient (HR = 0.88; 95% CI = 0.87–0.88) and emergency department visits (HR = 0.98; 95% CI = 0.97–0.99) for non-purulent SSTVI.ConclusionsBoth the individuals and the healthcare system benefit from NSP through lower risk of SSTVI mortality and prevention of recurrent outpatient and emergency department visits to treat SSTVI. The microsimulation framework provides insights into clinical and economic implications of NSP, which can serve as valuable evidence that can aid decision-making in expansion of NSP services.