Cost-effectiveness of a two-gene urine biomarker assay in MRI strategies for the initial detection of prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 91-91 ◽  
Author(s):  
Tim Govers ◽  
Matthew J. Resnick ◽  
Geert Trooskens ◽  
Wim Van Criekinge ◽  
Jack A. Schalken

91 Background: MRI is increasingly used in men with a suspicion for prostate cancer (PCa) to target abnormal areas next to systematic biopsy. Although, MRI increases the detection of clinically significant PCa compared to systematic biopsy alone, overdiagnosis and overtreatment of insignificant disease still exists. The 2-gene mRNA PCR urine test combined with traditional risk factors SelectMDx (MDxhealth Irvine Ca) predicts clinically significant PCa, and can be used to reduce overdiagnosis and overtreatment. We assessed the cost-effectiveness of SelectMDx in a population of U.S. men who in the current situation undergo initial MRI and biopsies. Methods: We developed a decision-analytic model to simulate the downstream outcomes in the current MRI strategy, i.e. systematic biopsy plus targeted biopsy in case of a positive MRI. SelectMDx was assessed in two different diagnostic pathways: 1) before MRI to select patients for MRI and biopsy, 2) after a negative MRI to select patients for systematic biopsy. Outcomes were quality-adjusted life years (QALYs) and costs. Model parameters were informed by literature. Two scenarios regarding the mortality of missed PCa were used, using SPCG trial data and using data from the PIVOT trial. Results: Using SelectMDx before MRI (1) resulted in a health gain of 0.003 and 0.030 QALY per patient compared to the current MRI strategy, using the SPCG and PIVOT data, respectively. Cost savings were $1590 per patient and about $496 million for the yearly population of men at risk in the U.S. (n = 311,879). SelectMDx after negative MRI (2) resulted in a health gain of 0.008 and 0,011 QALY per patient using the SPCG and PIVOT data.. Cost savings were $436 per patient and about $136 million for the yearly population. Conclusions: The use of SelectMDx to guide prostate biopsy decision-making can improve health outcomes and lower costs. Cost savings were highest when SelectMDx was used before MRI to select patients for MRI and biopsy. With respect to health gain, the use of SelectMDx after negative MRI was most beneficial when assuming higher mortality for missed PCa (SPCG). When the mortality was assumed to be lower (PIVOT) SelectMDx should be used before MRI to result in the highest health gain.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 340-340
Author(s):  
Jordan Hill ◽  
Mike Paulden ◽  
Christopher McCabe ◽  
Peter Venner ◽  
Brita Lavender Danielson ◽  
...  

340 Background: Several new therapies have changed the landscape of prostate cancer (PCa) treatment, primarily due to their effectiveness in treating patients with mCRPC. Enza has garnered much attention, but is relatively expensive (~$3175/month). Met is less expensive (~$8.00/month) and has been used for decades to treat patients with non-insulin dependent diabetes. Two recent large population-based studies of PCa have demonstrated that diabetics taking Met had improved PCa specific and overall survival compared to those not taking Met. As a result, we hypothesized that Met has the potential to be a cost-effective adjunct therapy to Enza, although it is not currently used as such. Methods: We constructed a Markov-based decision analytic model to compare the cost-effectiveness of Enza alone versus Enza combined with Met. Through expert elicitation, we assumed that adding Met to Enza increases its efficacy by 15%. All other costs, utilities, and transition probabilities were derived from existing literature or expert elicitation. Effectiveness was measured using quality-adjusted life years (QALYs). Costs and QALYs were considered over a lifetime horizon and discounted at 5% per annum. Cost-effectiveness was considered using a willingness to pay threshold of $50 000/QALY. Results: Adding Met to Enza increases expected lifetime costs per patient by $83 651, and improves the expected effectiveness of treatment by 3.74 QALYs, compared to Enza alone. The incremental cost-effectiveness ratio is $22 374/QALY. Accounting for parameter uncertainty, adding Met to Enza has a 72% probability of being cost-effective. Conclusions: Although Met is not currently used as an adjunct therapy to Enza, doing so would likely be cost-effective provided it is as effective as we have assumed in our model. Additionally, our results indicate that the combination of Enza and Met could be among the most cost effective interventions in oncology. However, given the uncertainty around the effectiveness of such an adjunct therapy, our results support the need for further clinical trials to provide more robust evidence of the effectiveness of such a combination therapy in clinical practice.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14660-14660 ◽  
Author(s):  
M. Botteman ◽  
V. Barghout ◽  
K. El Ouagari

14660 Background: Canadian guidelines recommend zoledronic acid (ZA) (4 mg every 3 weeks) in patients with hormone HRPC and asymptomatic or minimally symptomatic bone metastases to reduce skeletal-related events (SRE). However, IV pamidronate (90 mg every 3 weeks) (PA) is also routinely used in this setting in spite of no significant improvement in occurrence of SRE or pain compared to NT. Objectives: To assess the cost effectiveness of ZA, PA, or no bisphosphonate therapy (NT) in the management of prostate cancer patients with bone metastases in Canada. Methods: A literature-based decision analytic model was developed to estimate the incremental cost and quality-adjusted life years (QALY) associated with the 3 treatment options. The model included assumptions about SREs, mortality, drug and administration costs, cost of SREs, reduced quality of life due to SRE and bone pain, and therapy duration. Sensitivity analyses considered several scenarios in which various assumptions were used regarding treatment efficacy and QALY gains due to pain relief and SRE prevention. All costs were expressed in Canadian dollars (2004). Results: The cumulative number of SREs over a patient’s remaining lifetime (1.9 years) was estimated at 2.69 for PA and NT patients and 1.76 for ZA. Total discounted costs were $11,918 for NT, $17,593 for PA, and $19,312 for ZA. Compared with patients receiving NT or PA, quality-adjusted survival increased by 0.094 (range depending on scenario considered: 0.072 to 0.106) QALY per patient for those on ZA compared to PA or NT. Compared to NT, ZA resulted in a cost per QALY gained of $78,366 (range: $50,717 to $101,831). Compared to PA, ZA resulted in a cost per QALY gained of $18,343 (range: $2917 to $23,835) per QALY gained. PA was more expensive than NT but did not improve patient-related outcomes. Conclusions: For HRPC patients with bone metastasis, zoledronic acid appears to be the only clinically valuable and economically acceptable option in Canada with a cost effectiveness likely better than previously reported. No significant financial relationships to disclose.


2013 ◽  
Vol 44 (7) ◽  
pp. 1451-1460 ◽  
Author(s):  
S. Walker ◽  
J. Walker ◽  
G. Richardson ◽  
S. Palmer ◽  
Q. Wu ◽  
...  

BackgroundCo-morbid major depression occurs in approximately 10% of people suffering from a chronic medical condition such as cancer. Systematic integrated management that includes both identification and treatment has been advocated. However, we lack information on the cost-effectiveness of this combined approach, as published evaluations have focused solely on the systematic (collaborative care) treatment stage. We therefore aimed to use the best available evidence to estimate the cost-effectiveness of systematic integrated management (both identification and treatment) compared with usual practice, for patients attending specialist cancer clinics.MethodWe conducted a cost-effectiveness analysis using a decision analytic model structured to reflect both the identification and treatment processes. Evidence was taken from reviews of relevant clinical trials and from observational studies, together with data from a large depression screening service. Sensitivity and scenario analyses were undertaken to determine the effects of variations in depression incidence rates, time horizons and patient characteristics.ResultsSystematic integrated depression management generated more costs than usual practice, but also more quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) was £11 765 per QALY. This finding was robust to tests of uncertainty and variation in key model parameters.ConclusionsSystematic integrated management of co-morbid major depression in cancer patients is likely to be cost-effective at widely accepted threshold values and may be a better way of generating QALYs for cancer patients than some existing medical and surgical treatments. It could usefully be applied to other chronic medical conditions.


Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2502
Author(s):  
August Sigle ◽  
Cordula A. Jilg ◽  
Timur H. Kuru ◽  
Nadine Binder ◽  
Jakob Michaelis ◽  
...  

Background: Systematic biopsy (SB) according to the Ginsburg scheme (GBS) is widely used to complement MRI-targeted biopsy (MR-TB) for optimizing the diagnosis of clinically significant prostate cancer (sPCa). Knowledge of the GBS’s blind sectors where sPCa is missed is crucial to improve biopsy strategies. Methods: We analyzed cancer detection rates in 1084 patients that underwent MR-TB and SB. Cancerous lesions that were missed or underestimated by GBS were re-localized onto a prostate map encompassing Ginsburg sectors and blind-sectors (anterior, central, basodorsal and basoventral). Logistic regression analysis (LRA) and prostatic configuration analysis were applied to identify predictors for missing sPCa with the GBS. Results: GBS missed sPCa in 39 patients (39/1084, 3.6%). In 27 cases (27/39, 69.2%), sPCa was missed within a blind sector, with 17/39 lesions localized in the anterior region (43.6%). Neither LRA nor prostatic configuration analysis identified predictors for missing sPCa with the GBS. Conclusions: This is the first study to analyze the distribution of sPCa missed by the GBS. GBS misses sPCa in few men only, with the majority localized in the anterior region. Adding blind sectors to GBS defined a new sector map of the prostate suited for reporting histopathological biopsy results.


Author(s):  
Matthew D. Jones ◽  
Bryony Dean Franklin ◽  
D. K. Raynor ◽  
Howard Thom ◽  
Margaret C. Watson ◽  
...  

Abstract Aim In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing. Methods The costs and cost-effectiveness of user-testing were explored by modifying an existing probabilistic decision-analytic model. The adapted model considered administration of intravenous voriconazole to hospital inpatients by nurses. It included 11 error types, their probability of detection and level of harm. Model inputs (including costs) were derived from our previous study and other published data. Monte Carlo simulation using 20,000 samples (sufficient for convergence) was performed with a 5-year time horizon from the perspective of the 121 NHS trusts and health boards that use the IMG. Sensitivity analyses were undertaken for the risk of a medication error and other sources of uncertainty. Results The net monetary benefit at £20,000/quality-adjusted life year was £3,190,064 (95% credible interval (CrI): −346,709 to 8,480,665), favouring user-testing with a 96% chance of cost-effectiveness. Incremental cost-savings were £240,943 (95% CrI 43,527–491,576), also favouring user-tested guidelines with a 99% chance of cost-saving. The total user testing cost was £6317 (95% CrI 6012–6627). These findings were robust to assumptions about a range of input parameters, but greater uncertainty was seen with a lower medication error risk. Conclusions User-testing of injectable medicines guidelines is a low-cost intervention that is highly likely to be cost-effective, especially for high-risk medicines.


Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 931
Author(s):  
Chi-Leung Chiang ◽  
Sik-Kwan Chan ◽  
Shing-Fung Lee ◽  
Horace Cheuk-Wai Choi

Background: The IMbrave 150 trial revealed that atezolizumab plus bevacizumab (atezo–bev) improves survival in patients with unresectable hepatocellular carcinoma (HCC) (1 year survival rate: 67.2% vs. 54.6%). We assessed the cost-effectiveness of atezo–bev vs. sorafenib as first-line therapy in patients with unresectable HCC from the US payer perspective. Methods: Using data from the IMbrave 150, we developed a Markov model to compare the lifetime cost and efficacy of atezo–bev as first-line systemic therapy in HCC with those of sorafenib. The main outcomes were life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER). Results: Atezo–bev demonstrated a gain of 0.44 QALYs, with an additional cost of USD 79,074. The ICER of atezo–bev was USD 179,729 per QALY when compared with sorafenib. The model was most sensitive to the overall survival hazard ratio and body weight. If we assumed that all patients at the end of the IMbrave 150 trial were cured of HCC, atezo–bev was cost-effective (ICER USD 53,854 per QALY). However, if all patients followed the Surveillance, Epidemiology, and End Results data, the ICER of atezo–bev was USD 385,857 per QALY. Reducing the price of atezo–bev by 20% and 29% would satisfy the USD 150,000/QALY and 100,000/QALY willingness-to-pay threshold. Moreover, capping the duration of therapy to ≤12 months or reducing the dosage of bev to ≤10 mg/kg would render atezo–bev cost-effective. Conclusions: The long-term effectiveness of atezo–bev is a critical but uncertain determinant of its cost-effectiveness. Price reduction would favorably influence cost-effectiveness, even if long-term clinical outcomes were modest. Further studies to optimize the duration and dosage of therapy are warranted.


2021 ◽  
Author(s):  
Leonardo Rojas ◽  
María Rojas-Reyes ◽  
Diego Rosselli ◽  
Andres F. Cardona

Abstract BackgroundThe best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) in Colombia is unknown. This study aimed to identify the cost-effectiveness of various strategies to establish the necessity of adjuvant chemotherapy.MethodsThis study used an adapted decision-analytic model to compare cost and outcomes of care that includes Oncotype DX™ (ODX) or Mammaprint™ (MMP) test with routine care without ODX or MMP tests (application of adjuvant chemotherapy for all patients) over a 5-year time horizon, and the from the perspective of the Colombian National Health System (NHS) perspective (payer). Data were obtained from published literature and clinical trial database. The study population was composed of women with EBC, hormone-receptor positive (HR+), Her2-negative, lymph-node negative (LN0), with high-risk clinical criteria for recurrence. The outcome measures were incremental cost-effectiveness ratio (ICER; 2019 United States Dollar [USD] per quality-adjusted life years [QALY] gained) and net monetary benefit (NMB).ResultsODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2,445 and $570 compared with the standard strategy, respectively. The ICER for ODX was −$41,857 and that for MMP was −$18,253 per QALY; NMB was $2,821 and $771, respectively. Both tests were cost effective under defined threshold. When the two tests were compared, ODX was more cost effective than MMP. Sensitivity analysis revealed that, with a threshold of 1 GDP per capita, ODX will be cost effective in 95.5% of the cases compared with 70.2% of MMP. Probabilistic sensitivity analysis revealed that ODX was a consistently superior strategy.ConclusionsGenomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and Her2 − EBC is a cost-effective strategy that allows Colombian NHS saving money.


2021 ◽  
Author(s):  
Shuang Hao ◽  
Emelie Heintz ◽  
Ellinor Östensson ◽  
Andrea Discacciati ◽  
Fredrik Jäderling ◽  
...  

AbstractObjectiveAssess the cost-effectiveness of no screening and quadrennial magnetic resonance imaging (MRI)-based screening for prostate cancer using either Stockholm3 or prostate-specific antigen (PSA) test as a reflex test.MethodsTest characteristics were estimated from the STHLM3-MR study (NCT03377881). A cost-utility analysis was conducted from a lifetime societal perspective using a microsimulation model for men aged 55-69 in Sweden for no screening and three quadrennial screening strategies, including: PSA≥3ng/mL; and Stockholm3 with reflex test thresholds of PSA≥1.5 and 2ng/mL. Men with a positive test had an MRI, and those MRI positive had combined targeted and systematic biopsies. Predictions included the number of tests, cancer incidence and mortality, costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Uncertainties in key parameters were assessed using sensitivity analyses.ResultsCompared with no screening, the screening strategies were predicted to reduce prostate cancer deaths by 7-9% across a lifetime and were considered to be moderate costs per QALY gained in Sweden. Using Stockholm3 with a reflex threshold of PSA≥2ng/mL resulted in a 60% reduction in MRI compared with screening using PSA. This Stockholm3 strategy was cost-effective with a probability of 70% at a cost-effectiveness threshold of €47,218 (500,000 SEK).ConclusionsAll screening strategies were considered to be moderate costs per QALY gained compared with no screening. Screening with Stockholm3 test at a reflex threshold of PSA≥2ng/mL and MRI was predicted to be cost-effective in Sweden. Use of the Stockholm3 test may reduce screening-related harms and costs while maintaining the health benefits from early detection.


2020 ◽  
Vol 21 (3) ◽  
pp. 437-449 ◽  
Author(s):  
Alexander Kuhlmann ◽  
Henning Krüger ◽  
Susanne Seidinger ◽  
Andreas Hahn

Abstract Background The safe use of a prosthesis in activities of daily living is key for transfemoral amputees. However, the number of falls varies significantly between different prosthetic device types. This study aims to compare medical and economic consequences of falls in transfemoral amputees who use the microprocessor-controlled knee joint C-Leg with patients who use non-microprocessor-controlled (mechanical) knee joints (NMPK). The main objectives of the analysis are to investigate the cost-effectiveness and budget impact of C-Legs in transfemoral amputees with diabetes mellitus (DM) and without DM in Germany. Methods A decision-analytic model was developed that took into account the effects of prosthesis type on the risk of falling and fall-related medical events. Cost-effectiveness and budget impact analyses were performed separately for transfemoral amputees with and without DM. The study took the perspective of the statutory health insurance (SHI). Input parameters were derived from the published literature. Univariate and probabilistic sensitivity analyses (PSA) were performed to investigate the impact of changes in individual input parameter values on model outcomes and to explore parameter uncertainty. Results C-Legs reduced the rate of fall-related hospitalizations from 134 to 20 per 1000 person years (PY) in amputees without DM and from 146 to 23 per 1000 PY in amputees with DM. In addition, the C-Leg prevented 15 or 14 fall-related death per 1000 PY. Over a time horizon of 25 years, the incremental cost-effectiveness ratio (ICER) was 16,123 Euro per quality-adjusted life years gained (QALY) for amputees without DM and 20,332 Euro per QALY gained for amputees with DM. For the period of 2020–2024, the model predicted an increase in SHI expenditures of 98 Mio Euro (53 Mio Euro in prosthesis users without DM and 45 Mio Euro in prosthesis users with DM) when all new prosthesis users received C-Legs instead of NMPKs and 50% of NMPK user whose prosthesis wore out switched to C-Legs. Results of the PSA showed moderate uncertainty and a probability of 97–99% that C-Legs are cost-effective at an ICER threshold of 40,000 Euro (≈ German GDP per capita in 2018) per QALY gained. Conclusion Results of the study suggest that the C-Leg provides substantial additional health benefits compared with NMPKs and is likely to be cost-effective in transfemoral amputees with DM as well as in amputees without DM at an ICER threshold of 40,000 Euro per QALY gained.


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