Optimizing diagnostic algorithms to advance Hepatitis C elimination in Italy: A cost effectiveness evaluation.
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ABSTRACT: Objectives
Optimized diagnostic algorithms to detect active infections are crucial to achieving HCV elimination. We evaluated the cost effectiveness and sustainability of different algorithms for HCV active infection diagnosis, in a context of a high endemic country for HCV infection.Methods
A Markov disease progression model, simulating six diagnostic algorithms in the birth cohort 1969-1989 over a 10-year horizon from a healthcare perspective was used. Conventionally diagnosis of active HCV infection is through detection of antibodies (HCV-Ab) detection followed by HCV-RNA or HCV core antigen (HCV-Ag) confirmatory testing either on a second sample or by same sample reflex testing. The undiagnosed and unconfirmed rates were evaluated by assays false negative estimates and each algorithm patients' drop-off. Age, liver disease stages distribution, liver disease stage costs, treatment effectiveness and costs were used to evaluate the quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratios (ICER).Results
The reference option was Rapid HCV-Ab followed by second sample HCV-Ag testing which produced the lowest QALYs (866,835 QALYs). The highest gains in health (QALYs=974,458) was obtained by HCV-RNA reflex testing which produced a high cost-effective ICER (€891/QALY). Reflex testing (same sample-single visit) vs two patients' visits algorithms, yielded the highest QALYs and high cost-effective ICERs (€566 and €635/QALY for HCV-Ag and HCV-RNA, respectively), confirmed in 99.9% of the 5,000 probabilistic simulations.Conclusions
Our data confirm, by a cost effectiveness point of view, the EASL and WHO clinical practice guidelines recommending HCV reflex testing as most cost effective diagnostic option vs other diagnostic pathways.
SUBMITTER: Marcellusi A
PROVIDER: S-EPMC9292516 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundMyanmar has set national hepatitis C (HCV) targets to achieve 50% of people diagnosed and 50% treated by 2030. The WHO has additional targets of reducing incidence by 80% and mortality by 65% by 2030. We aimed to estimate the impact, cost, cost-effectiveness and net economic benefit of achieving these targets.MethodsMathematical models of HCV transmission, disease progression and the care cascade were calibrated to 15 administrative regions of Myanmar. Cost data were collected from a community testing and treatment program in Yangon. Three scenarios were projected for 2020-2030: (1) baseline (current levels of testing/treatment); and testing/treatment scaled up sufficiently to reach (2) the national strategy targets; and (3) the WHO targets.FindingsWithout treatment scale-up, 333,000 new HCV infections and 97,000 HCV-related deaths were estimated to occur in Myanmar 2020-2030, with HCV costing a total $100 million in direct costs (testing, treatment, disease management) and $10.4 billion in lost productivity. In the model, treating 55,000 people each year was sufficient to reach the national strategy targets and prevented a cumulative 40,000 new infections (12%) and 25,000 HCV-related deaths (25%) 2020-2030. This was estimated to cost a total $189 million in direct costs ($243 per DALY averted compared to no treatment scale-up), but only $9.8 billion in lost productivity, making it cost-saving from a societal perspective by 2024 with an estimated net economic benefit of $553 million by 2030. Reaching the WHO targets required further treatment scale-up and additional direct costs but resulted in greater longer-term benefits.InterpretationCurrent levels of HCV testing and treatment in Myanmar are insufficient to reach the national strategy targets. Scaling up HCV testing and treatment in Myanmar to reach the national strategy targets is estimated to generate significant health and economic benefits.FundingGilead Sciences.
| S-EPMC8315611 | biostudies-literature
Project description:Lynch syndrome (LS) is an autosomal dominant condition caused by pathogenic variants in mismatch repair (MMR) genes that predispose individuals to different malignancies, such as colorectal cancer (CRC) and endometrial cancer. Current guidelines recommended testing for LS in individuals with newly diagnosed CRC to reduce cancer morbidity and mortality in relatives. Economic evaluations in support of such approach, however, are not available in Italy. We developed a decision-analytic model to analyze the cost-effectiveness of LS screening from the perspective of the Italian National Health System. Three testing strategies: the sequencing of all MMR genes without prior tumor analysis (Strategy 1), a sequential IHC and MS-MLPA analysis (Strategy 2), and an age-targeted strategy with a revised Bethesda criteria assessment before IHC and methylation-specific MLPA for patients ? than 70 years old (Strategy 3) were analyzed and compared to the "no testing" strategy. Quality Adjusted Life Years (QALYs) in relatives after colonoscopy, aspirin prophylaxis and an intensive gynecological surveillance were estimated through a Markov model. Assuming a CRC incidence rate of 0.09% and a share of patients affected by LS equal to 2.81%, the number of detected pathogenic variants among CRC cases ranges, in a given year, between 910 and 1167 depending on the testing strategy employed. The testing strategies investigated, provided one-time to the entire eligible population (CRC patients), were associated with an overall cost ranging between €1,753,059.93-€10,388,000.00. The incremental cost-effectiveness ratios of the Markov model ranged from €941.24 /QALY to €1,681.93 /QALY, thus supporting that "universal testing" versus "no testing" is cost-effective, but not necessarily in comparison with age-targeted strategies. This is the first economic evaluation on different testing strategies for LS in Italy. The results might support the introduction of cost-effective recommendations for LS screening in Italy.
| S-EPMC7329085 | biostudies-literature
Project description:BackgroundChronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany.MethodsWe used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates.ResultsTotal number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening).ConclusionsScreening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.
| S-EPMC6889318 | biostudies-literature
Project description:ImportanceAsymptomatic microscopic hematuria (AMH) is highly prevalent and may signal occult genitourinary (GU) malignant abnormality. Common diagnostic approaches differ in their costs and effectiveness in detecting cancer. Given the low prevalence of GU malignant abnormality among patients with AMH, it is important to quantify the cost implications of detecting cancer for each approach.ObjectiveTo estimate the effectiveness, costs, and incremental cost per cancer detected (ICCD) for 4 common diagnostic approaches evaluating AMH.Design, setting, and participantsA decision-analytic model-based cost-effectiveness analysis using inputs from the medical literature. PubMed searches were performed to identify relevant literature for all key model inputs, each of which was derived from the clinical study with the most robust data and greatest applicability. Analysis included adult patients with AMH on routine urinalysis with subgroups of high-risk patients (males, smokers, age ≥50 years) seen in the primary care or urologic referral setting.InterventionsFour diagnostic approaches were evaluated relative to the reference case of no evaluation: (1) computed tomography (CT) alone; (2) cystoscopy alone; (3) CT and cystoscopy combined; and (4) renal ultrasound and cystoscopy combined.Main outcomes and measuresAt termination of the diagnostic period, cancers detected, costs (payer perspective), and ICCD per 10 000 patients evaluated for AMH.ResultsOf the 4 diagnostic approaches analyzed, CT alone was dominated by all other strategies, detecting 221 cancers at a cost of $9 300 000. Ultrasound and cystoscopy detected 245 cancers and was most cost-effective with an ICCD of $53 810. Replacing ultrasound with CT detected just 1 additional cancer at an ICCD of $6 480 484. Ultrasound and cystoscopy remained the most cost-effective approach in subgroup analysis. The model was not sensitive to any inputs within the proposed ranges. Using probabilistic sensitivity analysis, ultrasound and cystoscopy was the dominant strategy in 100% of simulations.Conclusions and relevanceThe combination of renal ultrasound and cystoscopy is the most cost-effective among 4 diagnostic approaches for the initial evaluation of AMH. The use of ultrasound in lieu of CT as the first-line diagnostic strategy will optimize cancer detection and reduce costs associated with evaluation of AMH. Given our findings, we need to critically evaluate the appropriateness of our current clinical practices, and potentially alter our guidelines to reflect the most effective screening strategies for patients with AMH.
| S-EPMC5818826 | biostudies-literature
Project description:BACKGROUND:Tuberculosis (TB) is the leading cause of death among HIV-positive patients. We assessed the cost-effectiveness of including lateral-flow urine lipoarabinomannan (LF-LAM) in TB diagnostic algorithms for severely ill or immunosuppressed HIV-positive patients with symptoms of TB in Kenya. METHODS:From a decision-analysis tree, ten diagnostic algorithms were elaborated and compared. All algorithms included clinical exam. The costs of each algorithm were calculated using a 'micro-costing' method. The efficacy was estimated through a prospective study that included severely ill or immunosuppressed (CD4<200cells/μL) HIV-positive adults with symptoms of TB. The cost-effectiveness analysis was performed using the disability-adjusted life year (DALY) averted as effectiveness outcome. A 4% discount rate was applied. RESULTS:The algorithm that added LF-LAM alone to the clinical exam lead to the least average cost per TB case detected (€47) and was the most cost-effective with a cost/DALY averted of €4.6. The algorithms including LF-LAM, microscopy and X-ray, and LF-LAM and Xpert in sputum, detected a high number of TB cases with a cost/DALY averted of €6.1 for each of them. In the comparisons of the algorithms two by two, using LF-LAM instead of microscopy (clinic&LAM vs clinicµscopy) and using LF-LAM along with GeneXpert in sputum instead of GeneXpert in urine along with GeneXpert in sputum, (clinic&LAM&Xpert_sputum vs clinic&Xpert_sputum&Xpert_urine) led to the highest increase in the cost-effectiveness ratios (ICERs): €-7.2 and €-12.6 respectively. In these two comparisons, using LF-LAM increased the number of TB patients detected while reducing costs. Adding LF-LAM to smear microscopy alone or to smear microscopy and Xray led to the highest increase in the additional number of TB cases detected (31 and 25 respectively) with an incremental efficiency estimated at 134 and 344 DALYs respectively. The ICERs were €22.0 and €8.6 respectively. CONCLUSION:Including LF-LAM in TB diagnostic algorithms is cost-effective for severely ill or immunosuppressed HIV-positive patients.
| S-EPMC6992347 | biostudies-literature
Project description:Background and aimsIn Latin America, Mexico was first to launch a hepatitis C virus (HCV) elimination strategy, where people who inject drugs (PWID) are a main risk group for transmission. In Tijuana, HCV seroprevalence among PWID is > 90%, with minimal harm reduction (HR). We evaluated cost-effectiveness of strategies to achieve the incidence elimination target among PWID in Tijuana.MethodsModeling study using a dynamic, cost-effectiveness model of HCV transmission and progression among active and former PWID in Tijuana, to assess the cost-effectiveness of incidence elimination strategies from a health-care provider perspective. The model incorporated PWID transitions between HR stages (no HR, only opioid agonist therapy, only high coverage needle-syringe programs, both). Four strategies that could achieve the incidence target (80% reduction by 2030) were compared with the status quo (no intervention). The strategies incorporated the number of direct-acting anti-viral (DAA) treatments required with: (1) no HR scale-up, (2) HR scale-up from 2019 to 20% coverage among PWID, (3) HR to 40% coverage and (4) HR to 50% coverage. Costs (2019 US$) and health outcomes [disability-adjusted life years (DALYs)] were discounted 3% per year. Mean incremental cost-effectiveness ratios (ICER, $/DALY averted) were compared with one-time per capita gross domestic product (GDP) ($9698 in 2019) and purchasing power parity-adjusted per capita GDP ($4842-13 557) willingness-to-pay (WTP) thresholds.ResultsDAAs alone were the least costly elimination strategy [$173 million, 95% confidence interval (CI) = 126-238 million], but accrued fewer health benefits compared with strategies with HR. DAAs + 50% HR coverage among PWID averted the most DALYs but cost $265 million, 95% CI = 210-335 million). The optimal strategy was DAAs + 50% HR (ICER $6743/DALY averted compared to DAAs only) under the one-time per-capita GDP WTP ($9698).ConclusionsA combination of high-coverage harm reduction and hepatitis C virus treatment is the optimal cost-effective strategy to achieve the HCV incidence elimination goal in Mexico.
| S-EPMC8380744 | biostudies-literature
Project description:PurposeTo evaluate nodule management guidelines in a simulated cohort of Lung Reporting and Data System (Lung-RADS) 4 nodules based on real-world data.Materials and methodsIn this retrospective study, 100 000 patients were simulated from 151 patients with Lung-RADS 4 nodules (from January 2010 to August 2018). Each patient in the simulation was managed with each algorithm, and health outcomes were accumulated based on interventions and delays to cancer diagnosis. If the algorithm missed a cancer, it was diagnosed at the next annual screening round, although it would grow in the interim. Patient age-specific or cancer-specific mortality was assigned depending on whether the nodule was malignant, and quality-adjusted life years (QALYs) were calculated. Costs of interventions and cancer treatment were accumulated. One-way sensitivity analyses were performed.ResultsThe most effective algorithm was the British Thoracic Society (BTS; 10.041 QALYs), followed by the American College of Chest Physicians (10.035 QALYs) and Lung-RADS (10.021 QALYs). Only the BTS and Lung-RADS were on the efficient frontier, with an incremental cost-effectiveness ratio (ICER) of $52 634 (95% CI: $45 122, $60 619). Under nearly all sensitivity analyses, the only algorithms on the efficient frontier were BTS and Lung-RADS. The ICERs for BTS versus Lung-RADS were under $100 000 for all scenarios except an increased life expectancy in patients without cancer, in which case the ICER was $109 273.ConclusionThe BTS algorithm and Lung-RADS were cost-effective for managing category 4 nodules, with BTS yielding greater QALYs.Supplemental material is available for this article.© RSNA, 2021See also the commentary by Elicker in this issue.
| S-EPMC8098088 | biostudies-literature
Project description:BackgroundGiven that measles is eliminated in Canada and measles immunisation coverage in Ontario is high, it has been questioned whether Ontario's measles outbreak response is worthwhile.AimOur objective was to determine cost-effectiveness of measles containment protocols in Ontario from the healthcare payer perspective.MethodsWe developed a decision-analysis model comparing Ontario's measles containment strategy (based on actual 2015 outbreak data) with a hypothetical 'modified response'. The modified scenario assumed 10% response costs with reduced case and contact tracing and no outbreak-associated vaccinations; it was based on local and provincial administrative and laboratory data and parameters from peer-reviewed literature. Short- and long-term health outcomes, quality-adjusted life years (QALYs) and costs discounted at 1.5%, were estimated. We conducted one- and two-way sensitivity analyses.ResultsThe 2015 outbreak in Ontario comprised 16 measles cases and an estimated 3,369 contacts. Predictive modelling suggested that the outbreak response prevented 16 outbreak-associated cases at a cost of CAD 1,213,491 (EUR 861,579). The incremental cost-effectiveness ratio was CAD 739,063 (EUR 524,735) per QALY gained for the outbreak response vs modified response. To meet the commonly accepted cost-effectiveness threshold of CAD 50,000 (EUR 35,500) per QALY gained, the outbreak response would have to prevent 94 measles cases. In sensitivity analyses, the findings were robust.ConclusionsOntario's measles outbreak response exceeds generally accepted cost-effectiveness thresholds and may not be the most efficient use of public health resources from a healthcare payer perspective. These findings should be balanced against benefits of increased vaccine coverage and maintaining elimination status.
| S-EPMC6425553 | biostudies-literature
Project description:BackgroundDecisions about which subgroup of chronic hepatitis C (CHC) patients should be treated with direct acting anti-viral agents (DAAs) have economic importance due to high drug prices. Treat-all DAA strategies for CHC have gained acceptance despite high drug acquisition costs. However, there are also costs associated with the surveillance of CHC to determine a subgroup of patients with significant impairment. The aim of this systematic review was to describe the modelling methods used and summarise results in cost-effectiveness analyses (CEAs) of both CHC treatment with DAAs and surveillance of liver disease.MethodsElectronic databases including Embase and Medline were searched from inception to May 2015. Eligible studies included models predicting costs and/or outcomes for interventions, surveillance, or management of people with CHC. Narrative and quantitative synthesis were conducted. Quality appraisal was conducted using validated checklists. The review was conducted following principles published by NHS Centre for Research and Dissemination.ResultsForty-one CEAs met the eligibility criteria for the review; 37 evaluated an intervention and four evaluated surveillance strategies for targeting DAA treatment to those likely to gain most benefit. Included studies were of variable quality mostly due to reporting omissions. Of the 37 CEAs, eight models that enabled comparative analysis were fully appraised and synthesized. These models provided non-unique cost-effectiveness estimates in a specific DAA comparison in a specific population defined in terms of genotype, prior treatment status, and presence or absence of cirrhosis. Marked heterogeneity in cost-effectiveness estimates was observed despite this stratification. Approximately half of the estimates suggested that DAAs were cost-effective considering a threshold of US$30,000 and 73% with threshold of US$50,000. Two models evaluating surveillance strategies suggested that treating all CHC patients regardless of the staging of liver disease could be cost-effective.ConclusionsCEAs of CHC treatments need to better account for variability in their estimates. This analysis suggested that there are still circumstances where DAAs are not cost-effective. Surveillance in place of a treat-all strategy may still need to be considered as an option for deploying DAAs, particularly where acquisition cost is at the limit of affordability for a given health system.
| S-EPMC5998601 | biostudies-literature
Project description:BackgroundChina has the highest prevalence of hepatitis B virus (HBV) infection worldwide. Universal HBV screening might enable China to reach the WHO 2030 target of 90% diagnostics, 80% treatment, and 65% HBV-related death reduction, and eventually elimination of viral hepatitis. We evaluated the cost-effectiveness of implementing universal HBV screening in China and identified optimal screening strategies.MethodsWe used a Markov cohort model, inputting parameters based on data from previous studies and public databases, to assess the cost-effectiveness of four HBV serological screening strategies in China in different screening scenarios. We simulated universal screening scenarios in 15 adult age groups between 18 and 70 years, with different years of screening implementation (2021, 2026, and 2031) and compared to the status quo (ie, no universal screening); in total, we investigated 180 different screening scenarios. We calculated the incremental cost-effectiveness ratio (ICER) between the different screening strategies and the status quo (current screening strategy). We performed probabilistic and one-way deterministic sensitivity analyses to assess the robustness of our findings.FindingsWith a willingness-to-pay level of three times the Chinese gross domestic product (GDP) per capita (US$30 828), all universal screening scenarios in 2021 were cost-effective compared with the status quo. The serum HBsAg/HBsAb/HBeAg/HBeAb/HBcAb (five-test) screening strategy in people aged 18-70 years was the most cost-effective strategy in 2021 (ICER $18 295/quality-adjusted life-years [QALY] gained). This strategy remained the most cost-effective, when the willingness-to-pay threshold was reduced to 2 times GDP per capita. The two-test strategy for people aged 18-70 years became more cost-effective at lower willingness-to-pay levels. The five-test strategy could prevent 3·46 million liver-related deaths in China over the lifetime of the cohort. It remained the most cost-effective strategy when implementation was delayed until 2026 (ICER $20 183/QALY) and 2031 (ICER $23 123/QALY). Screening young people (18-30 years) will no longer be cost-effective in delayed scenarios.InterpretationThe five-test universal screening strategy in people aged 18-70 years, implemented within the next 10 years, is the optimal HBV screening strategy for China. Other screening strategies could be cost-effective alternatives, if budget is limited in rural areas. Delaying strategy implementation reduces overall cost-effectiveness. Early screening initiation will aid global efforts in achieving viral hepatitis elimination.FundingNational Natural Science Foundation of China.
| S-EPMC8789560 | biostudies-literature